Cipro street price

How to cite this article:Singh cipro street price OP. Mental health in diverse India. Need for cipro street price advocacy. Indian J Psychiatry 2021;63:315-6”Unity in diversity” - That is the theme of India which we are quite proud of.

We have diversity in terms of geography – From the Himalayas cipro street price to the deserts to the seas. Every region has its own distinct culture and food. There are so many varieties of dress and language. There is huge difference between the states in terms of development, attitude toward women, health infrastructure, cipro street price child mortality, and other sociodemographic development indexes.

There is now ample evidence that sociocultural factors influence mental health. Compton and Shim[1] have described in their model of gene environment interaction how public policies and social norms act on the distribution of opportunity leading to social inequality, cipro street price exclusion, poor environment, discrimination, and unemployment. This in turn leads to reduced options, poor choices, and high-risk behavior. Combining genetic vulnerability and early brain cipro street price insult with low access to health care leads to poor mental health, disease, and morbidity.When we come to the field of mental health, we find huge differences between different states of India.

The prevalence of psychiatric disorders was markedly different while it was 5.8 and 5.1 for Assam and Uttar Pradesh at the lower end of the spectrum, it was 13.9 and 14.1 for Madhya Pradesh and Maharashtra at the higher end of the spectrum. There was also a huge difference between the rural areas and metros, particularly in terms of psychosis and bipolar disorders.[2] The difference was distinct not only in the prevalence but also in the type of psychiatric disorders. While the more developed southern states had higher prevalence of adult-onset disorders such as depression and cipro street price anxiety, the less developed northern states had more of childhood onset disorders. This may be due to lead toxicity, nutritional status, and perinatal issues.

Higher rates of cipro street price depression and anxiety were found in females. Apart from the genetic and hormonal factors, increase was attributed to gender discrimination, violence, sexual abuse, and adverse sociocultural norms. Marriage was cipro street price found to be a negative prognostic indicator contrary to the western norms.[3]Cultural influences on the presentation of psychiatric disorders are apparent. Being in recessive position in the family is one of the strongest predictors of psychiatric illnesses and psychosomatic disorders.

The presentation of depressive and anxiety disorders with more somatic symptoms results from inability to express due to unequal power equation in the family rather than the lack of expressions. Apart from culture bound syndromes, the role of cultural idioms of distress in manifestations of psychiatric symptoms is well acknowledged.When we look into suicide data, suicide cipro street price in lower socioeconomic strata (annual income <1 lakh) was 92,083, in annual income group of 1–5 lakhs, it was 41,197, and in higher income group, it was 4726. Among those who committed suicide, 67% were young adults, 34% had family problems, 23.4% of suicides occurred in daily laborers, 10.1% in unemployed persons, and 7.4% in farmers.[4]While there are huge regional differences in mental health issues, the challenges in mental health in India remain stigma reduction, conducting research on efficacy of early intervention, reaching the unreached, gender sensitive services, making quality mental healthcare accessible and available, suicide prevention, reduction of substance abuse, implementing insurance for mental health and reducing out-of-pocket expense, and finally, improving care for homeless mentally ill. All these require sustained advocacy aimed at promoting rights cipro street price of mentally ill persons and reducing stigma and discriminations.

It consists of various actions aimed at changing the attitudinal barriers in achieving positive mental health outcomes in the general population. Psychiatrists as Mental Health Advocates There is a debate whether psychiatrists who are overburdened with clinical care could or should be involved in the advocacy activities which require skills in other areas, and sometimes, they find themselves at the receiving end of mental health advocates. We must be involved and pathways should be to build technical evidence for mapping cipro street price out the problem, cost-effective interventions, and their efficacy.Advocacy can be done at institutional level, organizational level, and individual level. There has been huge work done in this regard at institution level.

Important research work cipro street price done in this regard includes the National Mental Health Survey, National Survey on Extent and Pattern of Substance Use in India, Global Burden of Diseases in Indian States, and Trajectory of Brain Development. Other activities include improving the infrastructure of mental hospitals, telepsychiatry services, provision of free drugs, providing training to increase the number of service providers. Similarly, at organizational level, the Indian Psychiatric Society (IPS) has filed a case for lacunae in Mental cipro street price Health-care Act, 2017. Another case filed by the IPS lead to change of name of the film from “Mental Hai Kya” to “Judgemental Hai Kya.” In LGBT issue, the IPS statement was quoted in the final judgement on the decriminalization of homosexuality.

The IPS has also started helplines at different levels and media interactions. The Indian Journal of Psychiatry has also come out with editorials highlighting the need of care of marginalized population such as migrant laborers and persons with cipro street price dementia. At an individual level, we can be involved in ensuring quality treatment, respecting dignity and rights of the patient, sensitization of staff, working with patients and caregivers to plan services, and being involved locally in media and public awareness activities.The recent experience of Brazil is an eye opener where suicide reduction resulted from direct cash transfer pointing at the role of economic decision in suicide.[5] In India where economic inequality is increasing, male-to-female ratio is abysmal in some states (877 in Haryana to 1034 in Kerala), our actions should be sensitive to this regional variation. When the enemy is economic inequality, our weapon is research highlighting cipro street price the role of these factors on mental health.

References 1.Compton MT, Shim RS. The social determinants of cipro street price mental health. Focus 2015;13:419-25. 2.Gururaj G, Varghese M, Benegal V, Rao GN, Pathak K, Singh LK, et al.

National Mental Health cipro street price Survey of India, 2015-16. Prevalence, Patterns and Outcomes. Bengaluru. National Institute of Mental Health and Neuro Sciences, NIMHANS Publication No.

129. 2016. 3.Sagar R, Dandona R, Gururaj G, Dhaliwal RS, Singh A, Ferrari A, et al. The burden of mental disorders across the states of India.

The Global Burden of Disease Study 1990–2017. Lancet Psychiatry 2020;7:148-61. 4.National Crime Records Bureau, 2019. Accidental Deaths and Suicides in India.

2019. Available from. Https://ncrb.gov.in. [Last accessed on 2021 Jun 24].

5.Machado DB, Rasella D, dos Santos DN. Impact of income inequality and other social determinants on suicide rate in Brazil. PLoS One 2015;10:e0124934. Correspondence Address:Om Prakash SinghDepartment of Psychiatry, WBMES, Kolkata, West Bengal.

AMRI Hospitals, Kolkata, West Bengal IndiaSource of Support. None, Conflict of Interest. NoneDOI. 10.4103/indianjpsychiatry.indianjpsychiatry_635_21Abstract Sexual health, an essential component of individual's health, is influenced by many complex issues including sexual behavior, attitudes, societal, and cultural factors on the one hand and while on the other hand, biological aspects, genetic predisposition, and associated mental and physical illnesses.

Sexual health is a neglected area, even though it influences mortality, morbidity, and disability. Dhat syndrome (DS), the term coined by Dr. N. N.

Wig, has been at the forefront of advancements in understanding and misunderstanding. The concept of DS is still evolving being treated as a culture-bound syndrome in the past to a syndrome of depression and treated as “a culturally determined idiom of distress.” It is bound with myths, fallacies, prejudices, secrecy, exaggeration, and value-laden judgments. Although it has been reported from many countries, much of the literature has emanated from Asia, that too mainly from India. The research in India has ranged from the study of a few cases in the past to recent national multicentric studies concerning phenomenology and beliefs of patients.

The epidemiological studies have ranged from being hospital-based to population-based studies in rural and urban settings. There are studies on the management of individual cases by resolving sexual myths, relaxation exercises, supportive psychotherapy, anxiolytics, and antidepressants to broader and deeper research concerning cognitive behavior therapy. The presentation looks into DS as a model case highlighting the importance of exploring sexual health concerns in the Indian population in general and in particular need to reconsider DS in the light of the newly available literature. It makes a fervent appeal for the inclusion of DS in the mainstream diagnostic categories in the upcoming revisions of the diagnostic manuals which can pave the way for a better understanding and management of DS and sexual problems.Keywords.

Culture-bound syndrome, Dhat syndrome, Dhat syndrome management, Dhat syndrome prevalence, psychiatric comorbidity, sexual disordersHow to cite this article:Sathyanarayana Rao T S. History and mystery of Dhat syndrome. A critical look at the current understanding and future directions. Indian J Psychiatry 2021;63:317-25 Introduction Mr.

President, Chairpersons, my respected teachers and seniors, my professional colleagues and friends, ladies and gentlemen:I deem it a proud privilege and pleasure to receive and to deliver DLN Murti Rao Oration Award for 2020. I am humbled at this great honor and remain grateful to the Indian Psychiatric Society (IPS) in general and the awards committee in particular. I would like to begin my presentation with my homage to Professor DLN Murti Rao, who was a Doyen of Psychiatry.[1] I have a special connection to the name as Dr. Doddaballapura Laxmi Narasimha Murti Rao, apart from a family name, obtained his medical degree from Mysore Medical College, Mysuru, India, the same city where I have served last 33 years in JSS Medical College and JSS Academy of Higher Education and Research.

His name carries the reverence in the corridors of the current National Institute of Mental Health and Neuro Sciences (NIMHANS) at Bangalore which was All India Institute of Mental Health, when he served as Head and the Medical Superintendent. Another coincidence was his untimely demise in 1962, the same year another Doyen Dr. Wig[2],[3] published the article on a common but peculiar syndrome in the Indian context and gave the name Dhat syndrome (DS). Even though Dr.

Wig is no more, his legacy of profound contribution to psychiatry and psychiatric education in general and service to the society and Mental Health, in particular, is well documented. His keen observation and study culminated in synthesizing many aspects and developments in DS.I would also like to place on record my humble pranams to my teachers from Christian Medical College, Vellore – Dr. Abraham Varghese, the first Editor of the Indian Journal of Psychological Medicine and Dr. K.

Kuruvilla, Past Editor of Indian Journal of Psychiatry whose legacies I carried forward for both the journals. I must place on record that my journey in the field of Sexual Medicine was sown by Dr. K. Kuruvilla and subsequent influence of Dr.

Ajit Avasthi from Postgraduate Institute of Medical Education and Research from Chandigarh as my role model in the field. There are many more who have shaped and nurtured my interest in the field of sex and sexuality.The term “Dhat” was taken from the Sanskrit language, which is an important word “Dhatu” and has known several meanings such as “metal,” a “medicinal constituent,” which can be considered as most powerful material within the human body.[4] The Dhat disorder is mainly known for “loss of semen”, and the DS is a well-known “culture-bound syndrome (CBS).”[4] The DS leads to several psychosexual disorders such as physical weakness, tiredness, anxiety, appetite loss, and guilt related to the loss of semen through nocturnal emission, in urine and by masturbation as mentioned in many studies.[4],[5],[6] Conventionally, Charaka Samhita mentions “waste of bodily humors” being linked to the “loss of Dhatus.”[5] Semen has even been mentioned by Aristotle as a “soul substance” and weakness associated with its loss.[6] This has led to a plethora of beliefs about “food-blood-semen” relationship where the loss of semen is considered to reduce vitality, potency, and psychophysiological strength. People have variously attributed DS to excessive masturbation, premarital sex, promiscuity, and nocturnal emissions. Several past studies have emphasized that CBS leads to “anxiety for loss of semen” is not only prevalent in the Indian subcontinent but also a global phenomenon.[7],[8],[9],[10],[11],[12],[13],[14],[15],[16],[17],[18],[19],[20]It is important to note that DS manifestation and the psychosexual features are based on the impact of culture, demographic profiles, and the socioeconomic status of the patients.[7],[8],[9],[10],[11],[12],[13],[14],[15],[16],[17],[18],[19],[20] According to Leff,[21] culture depends upon norms, values, and myths, based on a specific area, and is also shared by the indigenous individuals of that area.

Tiwari et al.[22] mentioned in their study that “culture is closely associated with mental disorders through social and psychological activities.” With this background, the paper attempts to highlight the multidimensional construct of DS for a better clinical understanding in routine practice. Dhat Syndrome. A Separate Entity or a “Cultural Variant” of Depression Even though DS has been studied for years now, a consensus on the definition is yet to be achieved. It has mostly been conceptualized as a multidimensional psychosomatic entity consisting of anxiety, depressive, somatic, and sexual phenomenology.

Most importantly, abnormal and erroneous attributions are considered to be responsible for the genesis of DS. The most important debate is, however, related to the nosological status of DS. Although considered to a CBS unique to India, it has also been increasingly reported in China, Europe, Japan, Malaysia, Russia, and America.[11] The consistency and validity of its diagnosis have been consistently debated, and one of the most vital questions that emerged was. Can there be another way to conceptualize DS?.

There is no single answer to that question. Apart from an independent entity, the diagnostic validity of which has been limited in longitudinal studies,[23] it has also been a cultural variant of depressive and somatization disorders. Mumford[11] in his study of Asian patients with DS found a significant association with depressed mood, anxiety, and fatigue. Around the same time, another study by Chadha[24] reported comorbidities in DS at a rate of 50%, 32%, and 18% related to depression, somatoform disorders, and anxiety, respectively.

Depression continued to be reported as the most common association of DS in many studies.[25],[26] This “cause-effect” dilemma can never be fully resolved. Whether “loss of semen” and the cultural attributions to it leads to the affective symptoms or whether low mood and neuroticism can lead to DS in appropriate cultural context are two sides of the argument. However, the cognitive biases resulting in the attributional errors of DS and the subsequently maintained attitudes with relation to sexuality can be explained by the depressive cognitions and concepts of learned helplessness. Balhara[27] has argued that since DS is not really culture specific as thought of earlier, it should not be solely categorized as a functional somatic syndrome, as that can have detrimental effects on its understanding and management.

He also mentions that the underlying “emotional distress and cultural contexts” are not unique to DS but can be related to any psychiatric syndrome for that matter. On the contrary, other researchers have warned that subsuming DS and other CBS under the broader rubric of “mood disorders” can lead to neglect and reductionism in disorder like DS that can have unique cultural connotations.[28] Over the years, there have been multiple propositions to relook and relabel CBS like DS. Considering it as a variant of depression or somatization can make it a “cultural phenotype” of these disorders in certain regions, thus making it easier for the classificatory systems. This dichotomous debate seems never-ending, but clinically, it is always better to err on over-diagnosing and over-treating depression and anxiety in DS, which can improve the well-being of the distressed patients.

Why Discuss Dhat Syndrome. Implications in Clinical Practice DS might occur independently or associated with multiple comorbidities. It has been a widely recognized clinical condition in various parts of the world, though considered specific to the Indian subcontinent. The presentation can often be polymorphic with symptom clusters of affective, somatic, behavioral, and cognitive manifestations.[29] Being common in rural areas, the first contacts of the patients are frequently traditional faith healers and less often, the general practitioners.

A psychiatric referral occurs much later, if at all. This leads to underdetection and faulty treatments, which can strengthen the already existing misattributions and misinformation responsible for maintaining the disorder. Furthermore, depression and sexual dysfunction can be the important comorbidities that if untreated, lead to significant psychosocial dysfunction and impaired quality of life.[30] Besides many patients of DS believe that their symptoms are due to failure of interpersonal relationships, s, and heredity, which might cause early death and infertility. This contributes to the vicious cycle of fear and panic.[31] Doctor shopping is another challenge and failure to detect and address the concern of DS might lead to dropping out from the care.[15] Rao[17] in their epidemiological study reported 12.5% prevalence in the general population, with 20.5% and 50% suffering from comorbid depression and sexual disorders.

The authors stressed upon the importance of early detection of DS for the psychosexual and social well-being. Most importantly, the multidimensional presentation of DS can at certain times be a facade overshadowing underlying neurotic disorders (anxiety, depression, somatoform, hypochondriasis, and phobias), obsessive-compulsive spectrum disorders and body dysmorphic disorders, delusional disorders, sexual disorders (premature ejaculation and erectile dysfunction) and infectious disorders (urinary tract s, sexually transmitted diseases), and even stress-related manifestations in otherwise healthy individuals.[4],[14],[15] This significant overlap of symptomatology, increased prevalence, and marked comorbidity make it all the more important for physicians to make sense out of the construct of DS. That can facilitate prompt detection and management of DS in routine clinical practice.In an earlier review study, it was observed that few studies are undertaken to update the research works from published articles as an updated review, systemic review, world literature review, etc., on DS and its management approach.[29],[32],[33],[34],[35] The present paper attempts to compile the evidence till date on DS related to its nosology, critique, manifestations, and management plan. The various empirical studies on DS all over the world will be briefly discussed along with the implications and importance of the syndrome.

The Construct of Dhat Syndrome. Summary of Current Evidence DS is a well-known CBS, which is defined as undue concern about the weakening effects after the passage of semen in urine or through nocturnal emission that has been stated by the International Statistical Classification of Diseases and Related Health Problems (ICD-10).[36] It is also known as “semen loss syndrome” by Shakya,[20] which is prevalent mainly in the Indian subcontinent[37] and has also been reported in the South-Eastern and western population.[15],[16],[20],[32],[38],[39],[40],[41] Individuals with “semen loss anxiety” suffer from a myriad of psychosexual symptoms, which have been attributed to “loss of vital essence through semen” (common in South Asia).[7],[15],[16],[17],[32],[37],[41],[42],[43] The various studies related to attributes of DS and their findings are summarized further.Prakash et al.[5] studied 100 DS patients through 139 symptoms of the Associated Symptoms Scale. They studied sociodemographic profile, Hamilton Depression Rating Scale, Hamilton Anxiety Rating Scale, Mini-International Neuropsychiatric Interview, and Postgraduate Institute Neuroticism Scale. The study found a wide range of physical, anxiety, depression, sexual, and cognitive symptoms.

Most commonly associated symptoms were found as per score ≥1. This study reported several parameters such as the “sense of being unhealthy” (99%), worry (99%), feeling “no improvement despite treatment” (97%), tension (97%), tiredness (95%), fatigue (95%), weakness (95%), and anxiety (95%). The common sexual disorders were observed as loss of masculinity (83%), erectile dysfunction (54%), and premature ejaculation (53%). Majority of patients had faced mild or moderate level of symptoms in which 47% of the patients reported severe weakness.

Overall distress and dysfunction were observed as 64% and 81% in the studied subjects, respectively.A study in Taiwan involved 87 participants from a Urology clinic. Most of them have sexual neurosis (Shen-K'uei syndrome).[7] More than one-third of the patients belonged to lower social class and symptoms of depression, somatization, anxiety, masturbation, and nocturnal emissions. Other bodily complaints as reported were sleep disturbances, fatigue, dizziness, backache, and weakness. Nearly 80% of them considered that all of their problems were due to masturbatory practices.De Silva and Dissanayake[8] investigated several manifestations on semen loss syndrome in the psychiatric clinic of Colombo General Hospital, Sri Lanka.

Beliefs regarding effects of semen loss and help-seeking sought for DS were explored. 38 patients were studied after psychiatrically ill individuals and those with organic disorders were excluded. Duration of semen loss varied from 1 to 20 years. Every participant reported excessive loss of semen and was preoccupied with it.

The common forms of semen loss were through nocturnal emission, masturbation, urinary loss, and through sexual activities. Most of them reported multiple modes of semen loss. Masturbatory frequency and that of nocturnal emissions varied significantly. More than half of the patients reported all types of complaints (psychological, sexual, somatic, and genital).In the study by Chadda and Ahuja,[9] 52 psychiatric patients (mostly adolescents and young adults) complained of passing “Dhat” in urine.

They were assessed for a period of 6 months. More than 80% of them complained of body weakness, aches, and pains. More than 50% of the patients suffered from depression and anxiety. All the participants felt that their symptoms were due to loss of “dhat” in urine, attributed to excessive masturbation, extramarital and premarital sex.

Half of those who faced sexual dysfunctions attributed them to semen loss.Mumford[11] proposed a controversial explanation of DS arguing that it might be a part of other psychiatric disorders, like depression. A total of 1000 literate patients were recruited from a medical outdoor in a public sector hospital in Lahore, Pakistan. About 600 educated patients were included as per Bradford Somatic Inventory (BSI). Men with DS reported greater symptoms on BSI than those without DS.

60 psychiatric patients were also recruited from the same hospital and diagnosed using Diagnostic and Statistical Manual (DSM)-III-R. Among them, 33% of the patients qualified for “Dhat” items on BSI. The symptoms persisted for more than 15 days. It was observed that symptoms of DS highly correlated with BSI items, namely erectile dysfunction, burning sensation during urination, fatigue, energy loss, and weakness.

This comparative study indicated that patients with DS suffered more from depressive disorders than without DS and the age group affected by DS was mostly the young.Grover et al.[15] conducted a study on 780 male patients aged >16 years in five centers (Chandigarh, Jaipur, Faridkot, Mewat, and New Delhi) of Northern India, 4 centers (2 from Kolkata, 1 each in Kalyani and Bhubaneswar) of Eastern India, 2 centers (Agra and Lucknow) of Central India, 2 centers (Ahmedabad and Wardha) of Western India, and 2 centers of Southern India (both located at Mysore) spread across the country by using DS questionnaire. Nearly one-third of the patients were passing “Dhat” multiple times a week. Among them, nearly 60% passed almost a spoonful of “Dhat” each time during a loss. This work on sexual disorders reported that the passage of “Dhat” was mostly attributed to masturbation (55.1%), dreams on sex (47.3%), sexual desire (42.8%), and high energy foods consumption (36.7%).

Mostly, the participants experienced passage of Dhat as “night falls” (60.1%) and “while passing stools” (59.5%). About 75.6% showed weakness in sexual ability as a common consequence of the “loss of Dhat.” The associated symptoms were depression, hopelessness, feeling low, decreased energy levels, weakness, and lack of pleasure. Erectile problems and premature ejaculation were also present.Rao[17] in his first epidemiological study done in Karnataka, India, showed the prevalence rate of DS in general male population as 12.5%. It was found that 57.5% were suffering either from comorbid depression or anxiety disorders.

The prevalence of psychiatric and sexual disorders was about three times higher with DS compared to non-DS subjects. One-third of the cases (32.8%) had no comorbidity in hospital (urban). One-fifth (20.5%) and 50% subjects (51.3%) had comorbid depressive disorders and sexual dysfunction. The psychosexual symptoms were found among 113 patients who had DS.

The most common psychological symptoms reported by the subjects with DS were low self-esteem (100%), loss of interest in any activity (95.60%), feeling of guilt (92.00%), and decreased social interaction (90.30%). In case of sexual disorders, beliefs were held commonly about testes becoming smaller (92.00%), thinness of semen (86.70%), decreased sexual capabilities (83.20%), and tilting of penis (70.80%).Shakya[20] studied a clinicodemographic profile of DS patients in psychiatry outpatient clinic of B. P. Koirala Institute of Health Sciences, Dharan, Nepal.

A total of 50 subjects were included in this study, and the psychiatric diagnoses as well as comorbidities were investigated as per the ICD-10 criteria. Among the subjects, most of the cases had symptoms of depression and anxiety, and all the subjects were worried about semen loss. Somehow these subjects had heard or read that semen loss or masturbation is unhealthy practice. The view of participants was that semen is very “precious,” needs preservation, and masturbation is a malpractice.

Beside DS, two-thirds of the subjects had comorbid depression.In another Indian study, Chadda et al.[24] compared patients with DS with those affected with neurotic/depressive disorders. Among 100 patients, 50%, 32%, and 18% reported depression, somatic problems, and anxiety, respectively. The authors argued that cases of DS have similar symptom dimensions as mood and anxiety disorders.Dhikav et al.[31] examined prevalence and management depression comorbid with DS. DSM-IV and Hamilton Depression Rating Scale were used for assessments.

About 66% of the patients met the DSM-IV diagnostic criteria of depression. They concluded that depression was a frequent comorbidity in DS patients.In a study by Perme et al.[37] from South India that included 32 DS patients, the control group consisted of 33 people from the same clinic without DS, depression, and anxiety. The researchers followed the guidelines of Bhatia and Malik's for the assessment of primary complaints of semen loss through “nocturnal emissions, masturbation, sexual intercourse, and passing of semen before and after urine.” The assessment was done based on several indices, namely “Somatization Screening Index, Illness Behavior Questionnaire, Somatosensory Amplification Scale, Whitley Index, and Revised Chalder Fatigue Scale.” Several complaints such as somatic complaints, hypochondriacal beliefs, and fatigue were observed to be significantly higher among patients with DS compared to the control group.A study conducted in South Hall (an industrial area in the borough of Middlesex, London) included Indian and Pakistani immigrants. Young men living separately from their wives reported promiscuity, some being infected with gonorrhea and syphilis.

Like other studies, nocturnal emission, weakness, and impotency were the other reported complaints. Semen was considered to be responsible for strength and vigor by most patients. Compared to the sexual problems of Indians, the British residents complained of pelvic issues and backache.In another work, Bhatia et al.[42] undertook a study on culture-bound syndromes and reported that 76.7% of the sample had DS followed by possession syndrome and Koro (a genital-related anxiety among males in South-East Asia). Priyadarshi and Verma[43] performed a study in Urology Department of S M S Hospital, Jaipur, India.

They conducted the study among 110 male patients who complained of DS and majority of them were living alone (54.5%) or in nuclear family (30%) as compared to joint family. Furthermore, 60% of them reported of never having experienced sex.Nakra et al.[44] investigated incidence and clinical features of 150 consecutive patients who presented with potency complaints in their clinic. Clinical assessments were done apart from detailed sexual history. The patients were 15–50 years of age, educated up to mid-school and mostly from a rural background.

Most of them were married and reported premarital sexual practices, while nearly 67% of them practiced masturbation from early age. There was significant guilt associated with nocturnal emissions and masturbation. Nearly 27% of the cases reported DS-like symptoms attributing their health problems to semen loss.Behere and Nataraj[45] reported that majority of the patients with DS presented with comorbidities of physical weakness, anxiety, headache, sad mood, loss of appetite, impotence, and premature ejaculation. The authors stated that DS in India is a symptom complex commonly found in younger age groups (16–23 years).

The study subjects presented with complaints of whitish discharge in urine and believed that the loss of semen through masturbation was the reason for DS and weakness.Singh et al.[46] studied 50 cases with DS and sexual problems (premature ejaculation and impotence) from Punjab, India, after exclusion of those who were psychiatrically ill. It was assumed in the study that semen loss is considered synonymous to “loss of something precious”, hence its loss would be associated with low mood and grief. Impotency (24%), premature ejaculation (14%), and “Dhat” in urine (40%) were the common complaints observed. Patients reported variety of symptoms including anxiety, depression, appetite loss, sleep problems, bodily pains, and headache.

More than half of the patients were independently diagnosed with depression, and hence, the authors argued that DS may be a manifestation of depressive disorders.Bhatia and Malik[47] reported that the most common complaints associated with DS were physical weakness, fatigue and palpitation, insomnia, sad mood, headache, guilt feeling and suicidal ideation, impotence, and premature ejaculation. Psychiatric disorders were found in 69% of the patients, out of which the most common was depression followed by anxiety, psychosis, and phobia. About 15% of the patients were found to have premature ejaculation and 8% had impotence.Bhatia et al.[48] examined several biological variables of DS after enrolment of 40 patients in a psychosexual clinic in Delhi. Patients had a history of impotence, premature ejaculation, and loss of semen (after exclusion of substance abuse and other psychiatric disorders).

Twenty years was the mean age of onset and semen loss was mainly through masturbation and sexual intercourse. 67.5% and 75% of them reported sexual disorders and psychiatric comorbidity while 25%, 12.5%, and 37.5% were recorded to suffer from ejaculatory impotence, premature ejaculation, and depression (with anxiety), respectively.Bhatia[49] conducted a study on CBS among 60 patients attending psychiatric outdoor in a teaching hospital. The study revealed that among all patients with CBSs, DS was the most common (76.7%) followed by possession syndrome (13.3%) and Koro (5%). Hypochondriasis, sexually transmitted diseases, and depression were the associated comorbidities.

Morrone et al.[50] studied 18 male patients with DS in the Dermatology department who were from Bangladesh and India. The symptoms observed were mainly fatigue and nonspecific somatic symptoms. DS patients manifested several symptoms in psychosocial, religious, somatic, and other domains. The reasons provided by the patients for semen loss were urinary loss, nocturnal emission, and masturbation.

Dhat Syndrome. The Epidemiology The typical demographic profile of a DS patient has been reported to be a less educated, young male from lower socioeconomic status and usually from rural areas. In the earlier Indian studies by Carstairs,[51],[52],[53] it was observed that majority of the cases (52%–66.7%) were from rural areas, belonged to “conservative families and posed rigid views about sex” (69%-73%). De Silva and Dissanayake[8] in their study on semen loss syndrome reported the average age of onset of DS to be 25 years with most of them from lower-middle socioeconomic class.

Chadda and Ahuja[9] studied young psychiatric patients who complained of semen loss. They were mainly manual laborers, farmers, and clerks from low socioeconomic status. More than half were married and mostly uneducated. Khan[13] studied DS patients in Pakistan and reported that majority of the patients visited Hakims (50%) and Homeopaths (24%) for treatment.

The age range was wide between 12 and 65 years with an average age of 24 years. Among those studied, majority were unmarried (75%), literacy was up to matriculation and they belonged to lower socioeconomic class. Grover et al.[15] in their study of 780 male subjects showed the average age of onset to be 28.14 years and the age ranged between 21 and 30 years (55.3%). The subjects were single or unmarried (51.0%) and married (46.7%).

About 23.5% of the subjects had graduated and most were unemployed (73.5%). Majority of subjects were lower-middle class (34%) and had lower incomes. Rao[17] studied 907 subjects, in which majority were from 18 to 30 years (44.5%). About 45.80% of the study subjects were illiterates and very few had completed postgraduation.

The subjects were both married and single. Majority of the subjects were residing in nuclear family (61.30%) and only 0.30% subjects were residing alone. Most of the patients did not have comorbid addictive disorders. The subjects were mainly engaged in agriculture (43.40%).

Majority of the subjects were from lower middle and upper lower socioeconomic class.Shakya[20] had studied the sociodemographic profile of 50 patients with DS. The average age of the studied patients was 25.4 years. The age ranges in decreasing order of frequency were 16–20 years (34%) followed by 21–25 years (28%), greater than 30 years (26%), 26–30 years (10%), and 11–15 years (2%). Further, the subjects were mostly students (50%) and rest were in service (26%), farmers (14%), laborers (6%), and business (4%), respectively.

Dhikav et al.[31] conducted a study on 30 patients who had attended the Psychiatry Outpatient Clinic of a tertiary care hospital with complaints of frequently passing semen in urine. In the studied patients, the age ranged between 20 and 40 years with an average age of 29 years and average age of onset of 19 years. The average duration of illness was that of 11 months. Most of the studied patients were unmarried (64.2%) and educated till middle or high school (70%).

Priyadarshi and Verma[43] performed a study in 110 male patients with DS. The average age of the patients was 23.53 years and it ranged between 15 and 68 years. The most affected age group of patients was of 18–25 years, which comprised about 60% of patients. On the other hand, about 25% ranged between 25 and 35 years, 10% were lesser than 18 years of age, and 5.5% patients were aged >35 years.

Higher percentage of the patients were unmarried (70%). Interestingly, high prevalence of DS was found in educated patients and about 50% of patients were graduate or above but most of the patients were either unemployed or student (49.1%). About 55% and 24.5% patients showed monthly family income of <10,000 and 5000 Indian Rupees (INR), respectively. Two-third patients belonged to rural areas of residence.

Behere and Nataraj[45] found majority of the patients with DS (68%) to be between 16 and 25 years age. About 52% patients were married while 48% were unmarried and from lower socioeconomic strata. The duration of DS symptoms varied widely. Singh[46] studied patients those who reported with DS, impotence, and premature ejaculation and reported the average age of the affected to be 21.8 years with a younger age of onset.

Only a few patients received higher education. Bhatia and Malik[47] as mentioned earlier reported that age at the time of onset of DS ranged from 16 to 24 years. More than half of them were single. It was observed that most patients had some territorial education (91.67%) but few (8.33%) had postgraduate education or professional training.

Finally, Bhatia et al.[48] studied cases of sexual dysfunctions and reported an average age of 21.6 years among the affected, majority being unmarried (80%). Most of those who had comorbid DS symptoms received minimal formal education. Management. A Multimodal Approach As mentioned before, individuals affected with DS often seek initial treatment with traditional healers, practitioners of alternative medicine, and local quacks.

As a consequence, varied treatment strategies have been popularized. Dietary supplements, protein and iron-rich diet, Vitamin B and C-complexes, antibiotics, multivitamin injections, herbal “supplements,” etc., have all been used in the treatment though scientific evidence related to them is sparse.[33] Frequent change of doctors, irregular compliance to treatment, and high dropout from health care are the major challenges, as the attributional beliefs toward DS persist in the majority even after repeated reassurance.[54] A multidisciplinary approach (involving psychiatrists, clinical psychologists, psychiatric social workers) is recommended and close liaison with the general physicians, the Ayurveda, Yoga, Unani, Siddha, Homeopathy practitioners, dermatologists, venereologists, and neurologists often help. The role of faith healers and local counselors is vital, and it is important to integrate them into the care of DS patients, rather than side-tracking them from the system. Community awareness needs to be increased especially in primary health care for early detection and appropriate referrals.

Follow-up data show two-thirds of patients affected with DS recovering with psychoeducation and low-dose sedatives.[45] Bhatia[49] studied 60 cases of DS and reported better response to anti-anxiety and antidepressant medications compared to psychotherapy alone. Classically, the correction of attributional biases through empathy, reflective, and nonjudgmental approaches has been proposed.[38] Over the years, sex education, psychotherapy, psychoeducation, relaxation techniques, and medications have been advocated in the management of DS.[9],[55] In psychotherapy, cognitive behavioral and brief solution-focused approaches are useful to target the dysfunctional assumptions and beliefs in DS. The role of sex education is vital involving the basic understanding of sexual anatomy and physiology of sexuality. This needs to be tailored to the local terminology and beliefs.

Biofeedback has also been proposed as a treatment modality.[4] Individual stress factors that might have precipitated DS need to be addressed. A detailed outline of assessment, evaluation, and management of DS is beyond the scope of this article and has already been reported in the IPS Clinical Practice Guidelines.[56] The readers are referred to these important guidelines for a comprehensive read on management. Probably, the most important factor is to understand and resolve the sociocultural contexts in the genesis of DS in each individual. Adequate debunking of the myths related to sexuality and culturally appropriate sexual education is vital both for the prevention and treatment of DS.[56] Adequate treatment of comorbidities such as depression and anxiety often helps in reduction of symptoms, more so when the DS is considered to be a manifestation of the same.

Future of Dhat Syndrome. The Way Forward Classifications in psychiatry have always been fraught with debates and discussion such as categorical versus dimensional, biological versus evolutionary. CBS like DS forms a major area of this nosological controversy. Longitudinal stability of a diagnosis is considered to be an important part of its independent categorization.

Sameer et al.[23] followed up DS patients for 6.0 ± 3.5 years and concluded that the “pure” variety of DS is not a stable diagnostic entity. The authors rather proposed DS as a variant of somatoform disorder, with cultural explanations. The right “place” for DS in classification systems has mostly been debated and theoretically fluctuant.[14] Sridhar et al.[57] mentioned the importance of reclassifying DS from a clinically, phenomenologically, psycho-pathologically, and diagnostically valid standpoint. Although both ICD and DSM have been culturally sensitive to classification, their approach to DS has been different.

While ICD-10 considers DS under “other nonpsychotic mental disorders” (F48), DSM-V mentions it only in appendix section as “cultural concepts of distress” not assigning the condition any particular number.[12],[58] Fundamental questions have actually been raised about its separate existence altogether,[35] which further puts its diagnostic position in doubt. As discussed in the earlier sections, an alternate hypothesization of DS is a cultural variant of depression, rather than a “true syndrome.”[27] Over decades, various schools of thought have considered DS either to be a global phenomenon or a cultural “idiom” of distress in specific geographical regions or a manifestation of other primary psychiatric disorders.[59] Qualitative studies in doctors have led to marked discordance in their opinion about the validity and classificatory area of DS.[60] The upcoming ICD-11 targets to pay more importance to cultural contexts for a valid and reliable classification. However, separating the phenomenological boundaries of diseases might lead to subsetting the cultural and contextual variants in broader rubrics.[61],[62] In that way, ICD-11 might propose alternate models for distinction of CBS like DS at nosological levels.[62] It is evident that various factors include socioeconomics, acceptability, and sustainability influence global classificatory systems, and this might influence the “niche” of DS in the near future. It will be interesting to see whether it retains its diagnostic independence or gets subsumed under the broader “narrative” of depression.

In any case, uniformity of diagnosing this culturally relevant yet distressing and highly prevalent condition will remain a major area related to psychiatric research and treatment. Conclusion DS is a multidimensional psychiatric “construct” which is equally interesting and controversial. Historically relevant and symptomatically mysterious, this disorder provides unique insights into cultural contexts of human behavior and the role of misattributions, beliefs, and misinformation in sexuality. Beyond the traditional debate about its “separate” existence, the high prevalence of DS, associated comorbidities, and resultant dysfunction make it relevant for emotional and psychosexual health.

It is also treatable, and hence, the detection, understanding, and awareness become vital to its management. This oration attempts a “bird's eye” view of this CBS taking into account a holistic perspective of the available evidence so far. The clinical manifestations, diagnostic and epidemiological attributes, management, and nosological controversies are highlighted to provide a comprehensive account of DS and its relevance to mental health. More systematic and mixed methods research are warranted to unravel the enigma of this controversial yet distressing psychiatric disorder.AcknowledgmentI sincerely thank Dr.

Debanjan Banerjee (Senior Resident, Department of Psychiatry, NIMHANS, Bangalore) for his constant selfless support, rich academic discourse, and continued collaboration that helped me condense years of research and ideas into this paper.Financial support and sponsorshipNil.Conflicts of interestThere are no conflicts of interest. References 1.2.3.Srinivasa Murthy R, Wig NN. A man ahead of his time. In.

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29.Prakash O, Kar SK. Dhat syndrome. A review and update. J Psychosexual Health 2019;1:241-5.

30.Grover S, Avasthi A, Gupta S, Dan A, Neogi R, Behere PB, et al. Comorbidity in patients with Dhat syndrome. A nationwide multicentric study. J Sex Med 2015;12:1398-401.

31.Dhikav V, Aggarwal N, Gupta S, Jadhavi R, Singh K. Depression in Dhat syndrome. J Sex Med 2008;5:841-4. 32.Paris A.

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Dhat syndrome. A review of the world literature. Indian J Psychol Med 2013;35:326-31. [PUBMED] [Full text] 34.Udina M, Foulon H, Valdés M, Bhattacharyya S, Martín-Santos R.

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1992. 37.Perme B, Ranjith G, Mohan R, Chandrasekaran R. Dhat (semen loss) syndrome. A functional somatic syndrome of the Indian subcontinent?.

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39.Clyne MB. Indian patients. Practitioner 1964;193:195-9. 40.Yap PM.

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Problems in medical practice. A study on its prevalence in an outpatient setting. Indian J Psychiatry 1997:Suppl 39:53. 42.Bhatia MS, Thakkur KN, Chadda RK, Shome S.

Koro in Dhat syndrome. Indian J Soc Psychiatry 1992;8:74-5. 43.Priyadarshi S, Verma A. Dhat syndrome and its social impact.

Urol Androl Open J 2015;1:6-11. 44.Nakra BR, Wig NN, Verma VK. A study of male potency disorders. Indian J Psychiatry 1977;19:13-8.

[Full text] 45.Behere PB, Natraj GS. Dhat syndrome. The phenomenology of a culture bound sex neurosis of the orient. Indian J Psychiatry 1984;26:76-8.

[PUBMED] [Full text] 46.Singh G. Dhat syndrome revisited. Indian J Psychiatry 1985;27:119-22. [PUBMED] [Full text] 47.Bhatia MS, Malik SC.

Dhat syndrome – A useful diagnostic entity in Indian culture. Br J Psychiatry 1991;159:691-5. 48.Bhatia MS, Choudhry S, Shome S. Dhat syndrome - Is it a syndrome of Dhat only?.

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62.Sharan P, Keeley J. Cultural perspectives related to international classification of diseases-11. Indian J Soc Psychiatry 2018;34 Suppl S1:1-4. Correspondence Address:T S Sathyanarayana RaoDepartment of Psychiatry, JSS Medical College and Hospital, JSS Academy of Higher Education and Research, Mysore - 570 004, Karnataka IndiaSource of Support.

None, Conflict of Interest. NoneDOI. 10.4103/psychiatry.IndianJPsychiatry_791_20.

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OTTAWA, ONTARIO (October 16, 2020) – The Honourable Marc Miller, the Honourable Carolyn Bennett, cipro used to treat the Honourable Patty Hajdu and the Honourable Daniel Vandal, issued the following statement today regarding the virtual gathering with Indigenous Peoples and organizations, healthcare professionals, and provincial and territorial representatives published here to work toward eliminating systematic racism in the healthcare system. €œInstitutions across the country continue to fail Indigenous Peoples. The healthcare system failed Joyce cipro used to treat Echaquan and her family, and it has failed Indigenous Peoples. All orders of government are responsible for this ongoing failure.

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The federal government alone cannot implement all the changes needed. We must work together with Indigenous partners cipro used to treat and health professionals, governing bodies, and provinces and territories in order to end racism and systemic discrimination and ensure equal and compassionate care of Indigenous Peoples. We each have the moral obligation to call out racism in all its forms and to come together to continue the work to eliminate the systemic racism experienced by First Nations, Inuit and Métis in Canada’s healthcare systems. As such, the Government of Canada convened a virtual gathering today to listen to Indigenous Peoples and healthcare professionals share the lived experience of the systemic racism in federal, provincial and territorial healthcare systems.

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The Speech from the Throne reinforced the government’s commitment to co-develop distinctions-based Indigenous cipro used to treat health legislation. While new legislation itself is not a solution to all, it offers opportunities to advance our joint commitment with partners to bring about meaningful change. Each and every one of us needs to do our part to eliminate racism and discrimination against Indigenous Peoples. We all have a responsibility to gain greater cultural awareness and challenge racism where and cipro used to treat when we see it.”October 9, 2020Our file number.

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OTTAWA, ONTARIO (October 16, 2020) – The Honourable Marc Miller, the Honourable Carolyn Bennett, the cipro street price Honourable Patty Hajdu and the Honourable Daniel Vandal, issued the following statement today regarding the virtual gathering with Indigenous Peoples and organizations, healthcare professionals, and provincial and territorial representatives to work toward eliminating systematic racism in the http://seniorji-upokojenci.si/doxazosin-online-purchase/ healthcare system. €œInstitutions across the country continue to fail Indigenous Peoples. The healthcare system failed Joyce Echaquan and her family, and it has failed cipro street price Indigenous Peoples.

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The result is a fear and distrust in a system that can only succeed through trust. The avoidance of care and the denial of care contributes to and exacerbates significant inequities in health and social outcomes. All Indigenous Peoples must have fair and equal access cipro street price to quality and culturally safe healthcare services, from any medical professional, anywhere they are and any time they need it.

We must immediately act to address racism against Indigenous Peoples within Canada’s healthcare systems to ensure that everyone is treated with respect, dignity and care when seeking medical support. This is cipro street price not a new concern. But it is an urgent one.

The federal government alone cannot implement all the changes needed. We must work cipro street price together with Indigenous partners and health professionals, governing bodies, and provinces and territories in order to end racism and systemic discrimination and ensure equal and compassionate care of Indigenous Peoples. We each have the moral obligation to call out racism in all its forms and to come together to continue the work to eliminate the systemic racism experienced by First Nations, Inuit and Métis in Canada’s healthcare systems.

As such, the Government of Canada convened a virtual gathering today to listen to Indigenous Peoples and healthcare professionals share the lived experience of the systemic racism in federal, provincial and territorial healthcare systems. Today, all cipro street price present acknowledged the critical need to take real action to address the unacceptable racism and discrimination in all of our institutions. The experiences shared by the participants will inform urgent, concrete short-term measures that governments, health authorities, educational institutions, health professional associations, regulatory colleges and accreditation organizations can implement to prevent and document systemic and overt racism and ensure consequences and accountability.

Today’s dialogue also emphasized the actions we need to take to strengthen the representation of Indigenous Peoples in the delivery of health services, support improved safety of Indigenous Peoples in the healthcare system and improve culturally safe approaches to care and services. This work involves, but is not limited to, greater efforts for cipro street price improved post-secondary education support for Indigenous Peoples, introducing patient centered care and resources in Indigenous languages, and mandatory, ongoing anti-racism, cultural safety and humility training for all health practitioners. As we move forward, the Government of Canada is committed to convening another gathering in January 2021, where proposed and implemented measures will be presented by governments and healthcare organizations.

These will be used to develop concrete national plans that address cultural safety in all institutions and include accountability measures to eliminate racism in our healthcare cipro street price systems. In the meantime, we remain dedicated to supporting equitable and culturally safe, community-led, community-driven and distinctions-based approaches to healthcare. We will continue to work with all partners to increase cultural safety and respect for Indigenous Peoples in Canada’s healthcare systems.

The Speech from the Throne reinforced the government’s commitment to co-develop distinctions-based cipro street price Indigenous health legislation. While new legislation itself is not a solution to all, it offers opportunities to advance our joint commitment with partners to bring about meaningful change. Each and every one of us needs to do our part to eliminate racism and discrimination against Indigenous Peoples.

We all have a responsibility to gain greater cultural awareness and challenge racism where and when cipro street price we see it.”October 9, 2020Our file number. 20-113699-873 As a standing regulatory member of the International Council for Harmonisation (ICH), Health Canada is committed to the adoption and implementation of all ICH guidance. By way of this Notice, Health Canada is advising of its intent to implement ICH Q12.

Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management and the ICH Q12 cipro street price associated annexes. This guidance has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. The ICH Assembly has endorsed cipro street price the final draft and recommended its implementation by membership of ICH.

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It will allow regulators (assessors and inspectors) to better understand the firms' Pharmaceutical Quality Systems (PQSs) for management of post-approval CMC changes.ICH Q12 should be read in conjunction with this accompanying notice and with the relevant sections of other applicable Health Canada guidances. This and other ICH Guidance documents are available on the ICH Website. Please note that cipro street price the ICH website is only available in English.

If you would like to request a copy of the French version of the document, please contact the HPFB ICH inbox.Contact InformationFor any comments or inquiries related to this notice, please contact:Health Canada – ICH CoordinatorE-mail. Hc.ich.sc@canada.ca Please include "Implementation of ICH Q12" in the subject line..

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Pregnant women and new mothers experiencing mental illness will soon have access to specialist care alongside their babies at the state’s second Mother and Baby Unit (MBU) at Westmead Hospital.Minister for Mental Health Bronnie Taylor said the purpose-built 8-bed unit will be based at Redbank House within Westmead Hospital, increasing support for NSW mothers who require care in a hospital for perinatal mental illness.“This new mother and baby unit at Westmead Hospital will enable up to 120 women each year to receive specialist multi-disciplinary mental health care during the crucial early bonding period, without needing to be separated from their babies,” Mrs Taylor said.The new how much cipro cost unit offers integrated mental health care with access to maternity, obstetric, paediatric and other medical services. It has been co-designed with women with a lived experience of mental illness, their families and clinicians to ensure it meets the needs of women who will access the service, as well as create a family-friendly environment for partners and siblings.“Each bedroom how much cipro cost is large enough to accommodate a mother, their baby, partner and other children, and has been specially designed to meet different levels of care,” Mrs Taylor said.The unit will have a landscaped outdoor area for exercise, relaxation and family visits. It will also include space and equipment for antenatal care, a 24-hour respite nursery, a parent craft room, a retreat room, and consultation and group therapy rooms.Professor Bill Brakoulias, Mental Health Executive Director at Western Sydney Local Health how much cipro cost District, said the Westmead MBU is a welcome addition to the mental health services delivered in Western Sydney.“Greater Western Sydney is a rapidly growing region with the highest birth rate in NSW,” Prof. Brakoulias said.“We want to ensure all mothers have access to the specialist perinatal and infant mental health care they need, as well as the opportunity to form a bond with their babies in those all-important, formative months.“This state-wide service for mothers and babies will be available to local mums, as well as those from other metro, rural and regional areas in NSW.”Construction of the Westmead MBU is expected to commence in late 2021 and will be completed how much cipro cost in 2022. The Royal Prince Alfred Hospital MBU is currently under construction and is expected to be completed by early 2022.Both new how much cipro cost units are part of the NSW Government’s $700 million Statewide Mental Health Infrastructure Program – the single biggest investment in mental health infrastructure to date..

Pregnant women and new mothers experiencing mental illness will soon have access cipro street price to specialist care alongside their babies at the state’s second Mother and Baby Unit (MBU) at Westmead Hospital.Minister for Mental Health Bronnie Taylor said the purpose-built 8-bed unit will be based at Redbank House within Westmead Hospital, increasing support for NSW mothers who require care in a hospital for perinatal mental illness.“This new mother and baby unit at Westmead Hospital will enable up to 120 women each year to receive specialist multi-disciplinary mental health care during the crucial early bonding period, without needing to be separated from their babies,” Mrs Taylor said.The new unit offers integrated mental health care with access to maternity, obstetric, paediatric and other medical services. It has been co-designed with women with a lived experience of mental illness, their families and clinicians to ensure it meets the needs of women who will access the service, as well as create a family-friendly cipro street price environment for partners and siblings.“Each bedroom is large enough to accommodate a mother, their baby, partner and other children, and has been specially designed to meet different levels of care,” Mrs Taylor said.The unit will have a landscaped outdoor area for exercise, relaxation and family visits. It will also include space and equipment for antenatal care, a 24-hour respite nursery, a parent craft room, a retreat room, and cipro street price consultation and group therapy rooms.Professor Bill Brakoulias, Mental Health Executive Director at Western Sydney Local Health District, said the Westmead MBU is a welcome addition to the mental health services delivered in Western Sydney.“Greater Western Sydney is a rapidly growing region with the highest birth rate in NSW,” Prof. Brakoulias said.“We want to ensure all mothers have access to the specialist perinatal and infant mental health care they need, as well as the opportunity to form a bond with their babies in those all-important, formative months.“This state-wide service for mothers and babies will cipro street price be available to local mums, as well as those from other metro, rural and regional areas in NSW.”Construction of the Westmead MBU is expected to commence in late 2021 and will be completed in 2022. The Royal Prince Alfred Hospital MBU is currently under construction and cipro street price is expected to be completed by early 2022.Both new units are part of the NSW Government’s $700 million Statewide Mental Health Infrastructure Program – the single biggest investment in mental health infrastructure to date..

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Body+Soul’s new monthly columnist, Sophie Delezio talks life after the accidents and what’s buy cipro canada next for her.In 2003, a car crashed into Sophie Delezio’s daycare centre in Sydney, landing on a shelf which fell on top of the two-and-a-half-year-old and burst into flames.Just over two years later, as Delezio’s carer was pushing her across a pedestrian crossing in a wheelchair, a driver was blinded by the sun and hit her with his car.Now, at 20 years old, Delezio speaks to Body+Soul about the freak accidents that left her fighting for her arbol cipres significado life and everything she’s learnt about herself in the process.Like what you see?. Sign up to our bodyandsoul.com.au newsletter for more stories like this.The first accident caused arbol cipres significado severe damage, including third-degree burns to 85 per cent of your body, and the loss of both feet, some fingers and an ear. In the second, you flew 18 metres, and suffered brain damage and extensive internal injuries. Do you have any recollections arbol cipres significado of either?. I don’t know whether it’s my body’s defence mechanism to protect itself, or the brain damage or medication, but I don’t remember anything.

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I survived. The doctors helped arbol cipres significado me live.I was unlucky – in the wrong place at the wrong time. So I felt that I didn’t deserve that title. There are a lot of people who have suffered arbol cipres significado far greater who just haven’t had that coverage in the media.Is it hard not to ask “Why me?. € People ask “Do you wish it never happened?.

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I haven’t had the easiest life, but it’s a life I know, a life that I love.Starting next week, you will be joining Body+Soul as a guest contributor, and each month you’ll be speaking with fellow members of this unique “survivor’s club”. What does resilience mean arbol cipres significado to you?. Resilience is everything – it’s about not stopping because it’s too hard. Without it, arbol cipres significado it’s a scary world. There are always going to be challenges, and sometimes you’re not given a choice.I hope I’ve helped people understand that just because you have a disability – or whatever you have – it shouldn’t limit your experiences.

Don’t restrict your life because of it arbol cipres significado. You can’t stay inside and hide from the world.Delezio’s monthly interview series starts next week with Lauren Huxley, who in 2005 was brutally attacked at home by a stranger.When disaster strikesPsychologist Farnaz Ali’s five ways to ensure tragedy doesn’t define you.1. Don’t blame yourselfIt’s common to look arbol cipres significado for things we could have done differently to prevent a tragedy, but remember, most are unlikely to have been preventable.2. Find purpose and meaningIdentify your values, strengths and passion, and focus on things in your control. Set small arbol cipres significado goals.3.

Practise gratitudeGratitude has been shown to develop post-traumatic growth and wellbeing. Note what things you arbol cipres significado appreciate and can still do.4. Reach out for supportWe’re wired for connection and receiving support from trusted people (and/or a mental health professional) can help to restore our sense of safety..

Body+Soul’s new monthly columnist, go to this website Sophie Delezio talks life after the accidents and what’s next for her.In 2003, a car crashed into Sophie Delezio’s daycare centre in Sydney, landing on a shelf which fell on top of the two-and-a-half-year-old and burst into flames.Just over two years later, as Delezio’s carer was pushing her across a pedestrian crossing in a wheelchair, a driver was blinded by the sun and hit her with his car.Now, at 20 cipro street price years old, Delezio speaks to Body+Soul about the freak accidents that left her fighting for her life and everything she’s learnt about herself in the process.Like what you see?. Sign up to our bodyandsoul.com.au newsletter cipro street price for more stories like this.The first accident caused severe damage, including third-degree burns to 85 per cent of your body, and the loss of both feet, some fingers and an ear. In the second, you flew 18 metres, and suffered brain damage and extensive internal injuries.

Do you have cipro street price any recollections of either?. I don’t know whether it’s my body’s defence mechanism to protect itself, or the brain damage or medication, but I don’t remember anything. And when you have cipro street price no memory, [it’s] like it happened to someone else.

I’ve always been numb to the story.Everyone says, “It’s so tragic.” And don’t get me wrong, it is – if it happened to anyone else, I’d be like, “Oh my God.” But I don’t remember life before. I see old photos and I’m cipro street price just like, “There’s a photo of me with limbs.”You became a household name after your story made national headlines. And in the years following, the public’s appreciation of you only increased, with your beaming face becoming a symbol of strength.

I’ve struggled with being called an inspiration until quite recently because cipro street price I didn’t do anything. I survived. The doctors helped me live.I was unlucky – in the wrong place at the wrong cipro street price time.

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What are your hopes for this chapter?. This is the 18th year since my accident and I’ve never gone cipro street price a year without surgery, so my goal is no surgeries this year.I don’t know what my future holds, but I live in a wonderful location, I have wonderful people [around me], and I’m very happy. I haven’t had the easiest life, but it’s a life I know, a life that I love.Starting next week, you will be joining Body+Soul as a guest contributor, and each month you’ll be speaking with fellow members of this unique “survivor’s club”.

What does cipro street price resilience mean to you?. Resilience is everything – it’s about not stopping because it’s too hard. Without it, it’s cipro street price a scary world.

There are always going to be challenges, and sometimes you’re not given a choice.I hope I’ve helped people understand that just because you have a disability – or whatever you have – it shouldn’t limit your experiences. Don’t restrict your cipro street price life because of it. You can’t stay inside and hide from the world.Delezio’s monthly interview series starts next week with Lauren Huxley, who in 2005 was brutally attacked at home by a stranger.When disaster strikesPsychologist Farnaz Ali’s five ways to ensure tragedy doesn’t define you.1.

Don’t blame yourselfIt’s common to look for things we could have done differently to prevent a tragedy, but remember, most are unlikely to have been cipro street price preventable.2. Find purpose and meaningIdentify your values, strengths and passion, and focus on things in your control. Set small cipro street price goals.3.

Practise gratitudeGratitude has been shown to develop post-traumatic growth and wellbeing. Note what things cipro street price you appreciate and can still do.4. Reach out for supportWe’re wired for connection and receiving support from trusted people (and/or a mental health professional) can help to restore our sense of safety..

Cipro and irregular heartbeat

On this page Policy objectiveThis guidance is to provide Canadians with access to information How to get diflucan without prescription on the safety and efficacy/effectiveness of products being used for the buy antibiotics cipro and irregular heartbeat cipro. These products are being imported and sold in Canada under 2 interim orders. All personal and confidential business information (CBI) will be protected prior to release.

The disclosed information will be made publicly available for non-commercial purposes after Health Canada completes its regulatory review process, while adhering to Canada’s Privacy Act.Providing public access cipro and irregular heartbeat to this information supports Canada’s objective for transparent decision-making. Public access also provides valuable information that may help with the use or development of buy antibiotics19 drugs and medical devices.This guidance document outlines the process for publicly disclosing information in a market authorization application under the 2 interim orders. The process includes.

procedures when releasing information types of information that fall under the guidelines for CBI and that may be eligible for redaction protection cipro and irregular heartbeat of personal informationScope and application This document applies to information relied upon to issue a market authorization under the. Interim order respecting the importation, sale and advertising of drugs for use in relation to buy antibiotics (September 16, 2020) and interim order respecting the importation and sale of medical devices for use in relation to buy antibiotics(March 18, 2020)The public release of safety and efficacy/effectiveness information reviewed under the 2 interim orders is governed by common law. Information requested for release is assessed case by case to determine what is CBI.

Personal information is removed before the safety and efficacy/effectiveness information is released to the public.Following cipro and irregular heartbeat Health Canada’s review of an application, safety and efficacy information will be released as follows. Automatically disclosed in applications submitted under the interim order for importing, selling and advertising drugs (proactive release) disclosed on request in applications submitted under the interim order for importing and selling medical devices (released upon request)Information in applications that have been authorized, including those authorized and then revoked, is in scope for public release. This includes.

Original application documents documents filed after market authorization is issued (filed at Health Canada’s request or to meet a condition of approval)Information in applications that are cipro and irregular heartbeat refused and were never authorized is out of scope for public release. This document does not apply to clinical information submitted to support the market authorization of a medical device under the Medical Device Regulations or of a new drug submission under the Food and Drug Regulations (FDR). The exception are new drug submissions for buy antibiotics indications submitted under the FDR.

For more information on the public release of this cipro and irregular heartbeat information, see the Public Release of Clinical Information. Guidance document.Also not applicable under this document is the CBI disclosure authority under section 21.1(3)(c) of the Food and Drugs Act. This section permits the Minister of Health to disclose CBI to certain persons for the purpose of protection or promotion of human health or the safety of the public.

For information on this authority, see the guidance document Disclosure of Confidential Business Information under Paragraph 21.1(3)(c) of the Food and cipro and irregular heartbeat Drugs Act.Proactive release of drug application informationWe will proactively publish safety and efficacy information used to support interim order drug applications upon authorization. This includes clinical information in applications submitted under sections 3, 6 and 14 of the interim order.How to request clinical information in medical device applicationsWe will publish safety and effectiveness information used to support interim order medical device applications when we receive a request from the public and within the limits of our administrative capacity. Requests made for multiple applications will be processed in sequence and subject to prioritization.

Further prioritization may be given to products that have a greater impact on the health cipro and irregular heartbeat system, such as. Products that are used a lot products that have a higher public interestRequests received for information in applications under the interim order will be prioritized over requests for clinical information in non-buy antibiotics19-related drugs submissions and device applications.To request clinical information on medical device applications, use our special portal to submit an electronic request form. Be sure to identify the product name listed on the following sites.

Publication process Publication of safety and efficacy information used to support drug interim order applications The publication of information follows the process described in section 4 and cipro and irregular heartbeat Appendix C of the Public Release of Clinical Information guidance document.In accordance with PRCI timelines, we aim to publish a final redacted and anonymized package on our clinical information portal within 120 calendar days from starting the process. The process starts automatically on the day an authorization is issued.Step 1. Notice to the company and request for proposed CBI redactions and anonymizationFollowing the authorization of a drug under the interim order, Health Canada will give the manufacturer an opportunity to take part in a process initiation meeting.

The first 60 days of the 120-day publication process is allocated for the company to review cipro and irregular heartbeat the clinical information. The company uses the Proposed Redaction Control Sheet (Appendix E, Public Release of Clinical Information (PRCI) guidance document) to propose any redaction of CBI. Proposed CBI redactions should pertain to information that meets the definition of confidential business information.

This is defined in Section 2 of the Food and Drugs Act, which mirrors common law in the context of confidential business information that meets each cipro and irregular heartbeat of the following 3 elements of the definition. That is not publicly available in respect of which the person has taken measures that are reasonable in the circumstances to ensure that it remains not publicly available and that has actual or potential economic value to the person or their competitors because it is not publicly available and its disclosure would result in a material financial loss to the person or a material financial gain to their competitorsFollowing an assessment of the proposals, text within an in-scope document found to meet the above definition will be protected. Similar to Public Release of Clinical Information policies, any information that meets the definition of “clinical information” will not be considered confidential business information.

Exceptions to the PRCI regulations described in C.08.009.2(2)(a) and (b) of the Food and Drug Regulations or section 43.12(2)(a) and (b) of the Medical Device Regulations cipro and irregular heartbeat will be considered when applying redactions to confidential business information. Further information on the application of these exceptions can be found in the Health Canada PRCI guidance document.All personal information should be anonymized in accordance with section 6 of the Public Release of Clinical Information guidance document. The proposal package from the manufacturer should include.

The proposed redaction control sheet the draft anonymization report annotated documentsManufacturers submit for Health Canada assessment using either CanadaPost ePost Connect or a suitable cipro and irregular heartbeat secure file transfer site of the manufacturer’s choosing.Step 2. Health Canada assessment of company representationsWithin 30 days of receiving the proposal package, Health Canada will complete and return our assessment of the proposed CBI redactions and anonymization methodology. Proposed redactions that meet the definition of confidential business information will be protected.

We will review cipro and irregular heartbeat the anonymization methodology to ensure all personal information is protected while maximizing the disclosure of useful clinical information. Step 3. Revision of proposed CBI redactions and anonymizationIf proposed CBI redactions are rejected or revision is required to the anonymization methodology, in accordance with the Public Release of Clinical Information.

Guidance document, the manufacturer will be given 15 days to make the cipro and irregular heartbeat revisions and resubmit. We will send our final assessment to the manufacturer within 5 days of receiving the revised package. Step 4.

Finalization and publicationWithin 5 days cipro and irregular heartbeat of receiving our final assessment, the manufacturer must format and submit the final redacted and anonymization clinical documents within 5 days of receiving our final assessment. The final documents must comply with the Guidance Document. Preparation of Regulatory Activities using the Electronic Common Technical Document (eCTD) Format.

These documents are to be submitted using the cipro and irregular heartbeat Common Electronic Submission Gateway. We will publish the final redacted documents within 5 days of receiving the final sequence.Publication of safety and effectiveness information used to support medical device interim order applicationsThe publication of information within an interim order application will proceed through the abbreviated process described below. Our goal is to publish a final redacted and anonymized package on our clinical information portal within 120 calendar days from initiation of the process.Step 1.

Health Canada screening cipro and irregular heartbeat of requestsAfter we receive a request for information, we will retrieve the interim order application from docubridge (or other location). Information related to safety and effectiveness will be considered in-scope of publication. Other information will not be released publicly.

Only information available cipro and irregular heartbeat at the time the request is made will be considered for disclosure. Information submitted after the original request for disclosure will be considered for public release upon receipt of a subsequent request.Examples of in scope information include. Clinical testing information validation testing that supports the effectiveness of the product, including testing performed in vitro or in silico summaries or overviews on safety or efficacy pre- or post-market, including literature reviewsExamples of out of scope information include.

Manufacturing details not related to safety or efficacy engineering and design details general documents, such as user manuals, package inserts and instructions for use cipro and irregular heartbeat individual patient information, such as patient listings and case report forms, that require extensive anonymization interim clinical study data (see the PRCI guidance)Step 2a. Health Canada assessment of confidential business information To reduce administrative burden on the manufacturer, we will review in-scope records for confidential business information, as defined in Section 2 of the Food and Drugs Act, which mirrors common law in the context of confidential business information that meets each of the following 3 elements of the definition will be protected. That is not publicly available in respect of which the person has taken measures that are reasonable in the circumstances to ensure that it remains not publicly available and that has actual or potential economic value to the person or their competitors because it is not publicly available and its disclosure would result in a material financial loss to the person or a material financial gain to their competitorsText in an in-scope document found to meet this definition will be redacted using a PDF redaction tool.

Similar to Public Release of Clinical Information policies, any information that meets the definition of cipro and irregular heartbeat “clinical information” will not be considered confidential business information. Exceptions to the PRCI regulations are outlined section 43.12(2)(a) and (b) of the Medical Device Regulations. These exceptions will be considered when applying redactions to confidential business information.

Further information on the application of these exceptions cipro and irregular heartbeat can be found in the PRCI guidance document.Step 2b. Assessing personal informationIn general, in-scope records do not contain a large volume of personal identification information. Any personal information, as defined in the Privacy Act and in accordance with PRCI guidance, information that could help to identify an individual will be protected.

For example, this can include the names of authors and investigators as well as subject identification numbers.A large volume of indirectly identifying information is not expected in cipro and irregular heartbeat the medical device records that are in-scope of publication. Consequently, limited protection of personal information is anticipated.Personal information will be redacted using a PDF redaction tool. Step 3.

Notice to the cipro and irregular heartbeat company and request for redaction proposalFollowing the review and redaction of in scope documents, we will send the manufacturer a written notice indicating our intent to publish the identified documents. A copy of the release package will be sent for the manufacturer’s review. Any further proposed redactions by the manufacturer must be received within 14 calendar days.Manufacturer are asked to use the Proposed Redaction Control Sheet (see Appendix E of the PRCI guidance document) to suggest further redactions.Step 4.

Health Canada assessment of company representationsAny cipro and irregular heartbeat further redactions proposed by the manufacturer will be assessed in accordance with the process outlined in step 2, above. Those that meet the definition of personal or confidential business information will be accepted.Step 5. PublicationIn-scope documents will be published within 120 days following receipt of the request.

The redacted information will be cipro and irregular heartbeat uploaded to the Clinical Information Portal, indexed by application number. Published documents will carry a watermark and be subject to terms of use, as described in the PRCI guidance.Mailing addressInformation Science and Openness DivisionResource Management and Operations DirectorateHealth Products and Food BranchHealth Canada Graham Spry Building 250 Lanark Ave Ottawa ON K1A 0K9 Telephone. 613-960-4687Email.

Hc.clinicaldata-donneescliniques.sc@canada.ca Terminology and definitions cipro and irregular heartbeat Anonymization. Means the process through which personal information is modified by. removing direct identifiers and any related code that would enable linkage with identifying information and ensuring that the remaining indirect identifiers no longer present a serious possibility of re-identifying an individual CBI.

Confidential business information, as meant in common law and as defined in Section cipro and irregular heartbeat 2 of the Food and Drugs Act. in respect of a person to whose business or affairs the information relates, means (subject to the regulations) business information that. Is not publicly available in respect of which the person has taken measures that are reasonable in the circumstances to ensure that it remains not publicly available has actual or potential economic value to the person or their competitors because it is not publicly available and its disclosure would result in a material financial loss to the person or a material financial gain to their competitors Clinical information.

Means information in respect of a clinical trial, clinical cipro and irregular heartbeat studies or investigational testing, such as. clinical overviews, clinical summaries and clinical study reports for drugs summaries and detailed information of all clinical studies and investigational testing that provided evidence of safety and effectiveness for medical devices Clinical study report. Means an "integrated" full report of an individual study of any therapeutic, prophylactic or diagnostic agent (drug or treatment) conducted in patients, in which.

the clinical cipro and irregular heartbeat and statistical description, presentations and analyses are integrated into a single report incorporating tables and figures into the main text of the report or at the end of the text appendices contain the protocol, sample case report forms, investigator-related information, information related to the test drugs/investigational products, including active control/comparators, technical statistical documentation, related publications, patient data listings and technical statistical details such as derivations, computations, analyses and computer output FDA. Food and Drugs Act FDR. Food and Drug Regulations IMDRF ToC.

International Medical Device Regulators Forum cipro and irregular heartbeat Table of Contents Medical device. Has the same meaning as insee the Medical Devices Regulations. For information on the classification of medical devices, please see the guidance documents on the.

risk-based classification system for in vitro diagnostic cipro and irregular heartbeat devices (IVDDs) risk-based classification system for non-in vitro diagnostic devices (non-IVDDs) Non-commercial purpose. Means the information will not be used to support a marketing authorization application anywhere in the world or sold or traded to another person Personal information. Has the same meaning as in Section 3 of the Privacy Act Related linksOn this page About the guidance document This guidance document supports the Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to buy antibiotics.

The Minister of Health approved the Interim Order on March 30, 2020, to address the unprecedented demand and urgent need for medical devices to treat, diagnose and protect cipro and irregular heartbeat Canadians against buy antibiotics. The guidance covers sections 15 to 19 of the Interim Order. It remains in effect as long as the Interim Order is in effect.

Under the cipro and irregular heartbeat Interim Order, manufacturers and importers must report medical device shortages related to buy antibiotics to Health Canada. The devices to which the shortages apply are on the List of Medical Devices — Notification of Shortages (specified medical devices). A specified medical device is a device that is either.

set out in the list of medical devices cipro and irregular heartbeat or part of a category of medical devices that is set out in that list The guidance is intended to help manufacturers and importers meet their regulatory obligations. It outlines their responsibilities concerning the mandatory reporting of medical device shortages. About medical device shortages and reporting A medical device shortage occurs when a manufacturer is unable to meet Canadian market demand for the device or for its components, accessories, parts or consumable materials.

This does not apply when a substitute device, component, accessory, part or consumable material cipro and irregular heartbeat is available in Canada. There are 2 types of shortages. actual, when the current supply can’t meet current demand anticipated, when the future supply can’t meet projected demand Manufacturers and importers must.

report a medical device shortage provide a shortage status update if there is a change in the shortage information submitted provide additional information related to cipro and irregular heartbeat a shortage when requested by Health Canada report an end of a medical device shortage This guidance document also provides some guidance on how to voluntarily report a medical device shortage that does not fall under the Interim Order. Everyone has a role to play Manufacturers and importers Manufacturers and importers have a key role to play in preventing and reducing the impact of medical device shortages. They can control the volume of medical devices in the supply chain and can take steps to resolve a medical device shortage when one occurs.

They are also in the best position to communicate to customers cipro and irregular heartbeat about the availability of their devices. When a manufacturer experiences a shortage of a critical medical device it sells, we expect that the manufacturer will take all necessary measures to resolve the shortage as quickly as possible. Provincial/territorial governments and health care authorities Provincial and territorial governments and health care authorities also have an important role to play in preventing and mitigating critical medical device shortages.

They can cipro and irregular heartbeat. conserve and reallocate stock within regions or provinces to where it is most needed and collaborate to share supply identify and secure additional supplies of medical devices from other vendors or another provincial or territorial government identify and secure other compatible substitute medical devices Government of Canada The federal government administers the Food and Drugs Act, Radiation Emitting Devices Act and Medical Devices Regulations. We do not provide or control the supply of medical devices in Canada or have the authority to compel a manufacturer to supply a device.

We work with stakeholders across the medical device supply chain to help determine the details and status of cipro and irregular heartbeat a shortage. We also coordinate and facilitate information sharing. When it comes to medical device shortages, Health Canada depends on early reporting of anticipated or actual shortages to help us.

prevent or manage impacts related to medical device shortages work with industry to identify mitigation strategies inform the cipro and irregular heartbeat procurement of medical devices for Canada Depending on the situation, our options include. prioritizing the review and approval of regulatory applications received from manufacturers (for example, an application to authorize or import an acceptable compatible device) expediting the process for issuing Medical Device Establishment Licences (MDELs) permitting the importation and sale of medical devices that do not fully meet Canadian regulatory requirements, but are manufactured to comparable standards to help address product shortages due to the buy antibiotics cipro working with international regulators to identify other manufacturers and to share needed safety and manufacturing information helping health care professionals and institutions get access to compatible substitute medical devices on an emergency basis (for example, the Special Access Programme can be used to provide access to unlicensed alternative medical devices) As part of the Government of Canada’s response to buy antibiotics, the Public Health Agency of Canada is working with other government departments to procure bulk shipments to facilitate access to much-needed medical devices. These include ventilators, testing swabs, reagents and test kits as well as personal protective equipment.

Related linksOctober 9, 2020Our cipro and irregular heartbeat file number. 20-113699-873 As a standing regulatory member of the International Council for Harmonisation (ICH), Health Canada is committed to the adoption and implementation of all ICH guidance. By way of this Notice, Health Canada is advising of its intent to implement ICH Q12.

Technical and cipro and irregular heartbeat Regulatory Considerations for Pharmaceutical Product Lifecycle Management and the ICH Q12 associated annexes. This guidance has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. The ICH Assembly has endorsed the final draft and recommended its implementation by membership of ICH.

The target timeframe for Health Canada implementation of ICH Q12 has been set to the third quarter of 2021 in order to allow sufficient time for the preparation of regulators and stakeholders cipro and irregular heartbeat. Health Canada will be launching a stakeholder consultation in early 2021 to gather feedback on the final elements of the implementation of the Q12 guidance in Canada.This new Guideline is proposed to provide a framework to facilitate the management of post-approval Chemistry, Manufacturing and Controls (CMC) changes in a more predictable and efficient manner across the product lifecycle. Implementation of this new ICH Guideline will promote innovation and continual improvement in the biopharmaceutical sector and strengthen quality assurance and reliable supply of product, including proactive planning of supply chain adjustments.

It will allow regulators (assessors and inspectors) to better understand the firms' cipro and irregular heartbeat Pharmaceutical Quality Systems (PQSs) for management of post-approval CMC changes.ICH Q12 should be read in conjunction with this accompanying notice and with the relevant sections of other applicable Health Canada guidances. This and other ICH Guidance documents are available on the ICH Website. Please note that the ICH website is only available in English.

If you would like to request a copy of the French version of the document, please contact the HPFB ICH inbox.Contact InformationFor any comments cipro and irregular heartbeat or inquiries related to this notice, please contact:Health Canada – ICH CoordinatorE-mail. Hc.ich.sc@canada.ca Please include "Implementation of ICH Q12" in the subject line.The Register of Innovative Drugs is maintained pursuant to C.08.004.1 of the Food and Drug Regulations. The register indicates the drugs that are eligible for data protection.

Under C.08.004.1 (3) a subsequent manufacturer that seeks a notice of compliance on the basis of a direct or indirect comparison between the new drug and an innovative drug may not file a submission before the end of a period of six years after the day on which the first notice of compliance was issued for the innovative new drug. In addition, the notice of compliance cannot be issued before the end of a period of eight years after the day on which the first notice of compliance was issued to the innovator. The format of the Register of Innovative Drugs is an electronic table, which is updated weekly.

The register lists, in alphabetical order, the medicinal ingredients in the innovative drugs which were not previously approved in a drug by the Minister and that are not variations of a previously approved medicinal ingredient. Please note that there may be other medicinal ingredients included in the drugs. The register was re-formatted in summer 2016 to increase the clarity of the information provided regarding the medicinal ingredient, brand name and manufacturer of each innovative drug.

On this page Policy objectiveThis guidance is to sites provide Canadians with access to information on the safety and efficacy/effectiveness of products being cipro street price used for the buy antibiotics cipro. These products are being imported and sold in Canada under 2 interim orders. All personal and confidential business information (CBI) will be protected prior to release. The disclosed information will be made publicly available for non-commercial purposes after Health Canada completes its regulatory review process, while adhering to Canada’s Privacy Act.Providing public access to this information supports Canada’s objective cipro street price for transparent decision-making.

Public access also provides valuable information that may help with the use or development of buy antibiotics19 drugs and medical devices.This guidance document outlines the process for publicly disclosing information in a market authorization application under the 2 interim orders. The process includes. procedures when releasing information types of information that fall under the guidelines for CBI and that cipro street price may be eligible for redaction protection of personal informationScope and application This document applies to information relied upon to issue a market authorization under the. Interim order respecting the importation, sale and advertising of drugs for use in relation to buy antibiotics (September 16, 2020) and interim order respecting the importation and sale of medical devices for use in relation to buy antibiotics(March 18, 2020)The public release of safety and efficacy/effectiveness information reviewed under the 2 interim orders is governed by common law.

Information requested for release is assessed case by case to determine what is CBI. Personal information is removed before the safety and efficacy/effectiveness information is released to the cipro street price public.Following Health Canada’s review of an application, safety and efficacy information will be released as follows. Automatically disclosed in applications submitted under the interim order for importing, selling and advertising drugs (proactive release) disclosed on request in applications submitted under the interim order for importing and selling medical devices (released upon request)Information in applications that have been authorized, including those authorized and then revoked, is in scope for public release. This includes.

Original application documents documents filed after market authorization is issued (filed at cipro street price Health Canada’s request or to meet a condition of approval)Information in applications that are refused and were never authorized is out of scope for public release. This document does not apply to clinical information submitted to support the market authorization of a medical device under the Medical Device Regulations or of a new drug submission under the Food and Drug Regulations (FDR). The exception are new drug submissions for buy antibiotics indications submitted under the FDR. For more cipro street price information on the public release of this information, see the Public Release of Clinical Information.

Guidance document.Also not applicable under this document is the CBI disclosure authority under section 21.1(3)(c) of the Food and Drugs Act. This section permits the Minister of Health to disclose CBI to certain persons for the purpose of protection or promotion of human health or the safety of the public. For information on this authority, see the guidance document Disclosure of Confidential Business Information under Paragraph 21.1(3)(c) of the Food and Drugs Act.Proactive release of drug application informationWe will proactively publish safety and efficacy information used to support interim cipro street price order drug applications upon authorization. This includes clinical information in applications submitted under sections 3, 6 and 14 of the interim order.How to request clinical information in medical device applicationsWe will publish safety and effectiveness information used to support interim order medical device applications when we receive a request from the public and within the limits of our administrative capacity.

Requests made for multiple applications will be processed in sequence and subject to prioritization. Further prioritization may be given to products that have a greater impact cipro street price on the health system, such as. Products that are used a lot products that have a higher public interestRequests received for information in applications under the interim order will be prioritized over requests for clinical information in non-buy antibiotics19-related drugs submissions and device applications.To request clinical information on medical device applications, use our special portal to submit an electronic request form. Be sure to identify the product name listed on the following sites.

Publication process Publication of safety and efficacy information used to support drug interim order applications The publication of information follows the process described in section 4 and Appendix C cipro street price of the Public Release of Clinical Information guidance document.In accordance with PRCI timelines, we aim to publish a final redacted and anonymized package on our clinical information portal within 120 calendar days from starting the process. The process starts automatically on the day an authorization is issued.Step 1. Notice to the company and request for proposed CBI redactions and anonymizationFollowing the authorization of a drug under the interim order, Health Canada will give the manufacturer an opportunity to take part in a process initiation meeting. The first 60 days of the cipro street price 120-day publication process is allocated for the company to review the clinical information.

The company uses the Proposed Redaction Control Sheet (Appendix E, Public Release of Clinical Information (PRCI) guidance document) to propose any redaction of CBI. Proposed CBI redactions should pertain to information that meets the definition of confidential business information. This is defined in Section 2 of the Food and Drugs Act, which mirrors common law in cipro street price the context of confidential business information that meets each of the following 3 elements of the definition. That is not publicly available in respect of which the person has taken measures that are reasonable in the circumstances to ensure that it remains not publicly available and that has actual or potential economic value to the person or their competitors because it is not publicly available and its disclosure would result in a material financial loss to the person or a material financial gain to their competitorsFollowing an assessment of the proposals, text within an in-scope document found to meet the above definition will be protected.

Similar to Public Release of Clinical Information policies, any information that meets the definition of “clinical information” will not be considered confidential business information. Exceptions to the PRCI regulations described in C.08.009.2(2)(a) and (b) of the Food and Drug Regulations or section 43.12(2)(a) and (b) of the Medical Device Regulations will be considered when applying cipro street price redactions to confidential business information. Further information on the application of these exceptions can be found in the Health Canada PRCI guidance document.All personal information should be anonymized in accordance with section 6 of the Public Release of Clinical Information guidance document. The proposal package from the manufacturer should include.

The proposed redaction control sheet the draft anonymization report annotated documentsManufacturers submit for Health Canada assessment using either CanadaPost ePost Connect or a cipro street price suitable secure file transfer site of the manufacturer’s choosing.Step 2. Health Canada assessment of company representationsWithin 30 days of receiving the proposal package, Health Canada will complete and return our assessment of the proposed CBI redactions and anonymization methodology. Proposed redactions that meet the definition of confidential business information will be protected. We will review the anonymization methodology to ensure all personal information is protected while maximizing the disclosure of useful clinical information cipro street price.

Step 3. Revision of proposed CBI redactions and anonymizationIf proposed CBI redactions are rejected or revision is required to the anonymization methodology, in accordance with the Public Release of Clinical Information. Guidance document, the cipro street price manufacturer will be given 15 days to make the revisions and resubmit. We will send our final assessment to the manufacturer within 5 days of receiving the revised package.

Step 4. Finalization and publicationWithin 5 days of receiving our final assessment, the manufacturer must format and submit the final cipro street price redacted and anonymization clinical documents within 5 days of receiving our final assessment. The final documents must comply with the Guidance Document. Preparation of Regulatory Activities using the Electronic Common Technical Document (eCTD) Format.

These documents cipro street price are to be submitted using the Common Electronic Submission Gateway. We will publish the final redacted documents within 5 days of receiving the final sequence.Publication of safety and effectiveness information used to support medical device interim order applicationsThe publication of information within an interim order application will proceed through the abbreviated process described below. Our goal is to publish a final redacted and anonymized package on our clinical information portal within 120 calendar days from initiation of the process.Step 1. Health Canada screening of requestsAfter we receive a request for information, we cipro street price will retrieve the interim order application from docubridge (or other location).

Information related to safety and effectiveness will be considered in-scope of publication. Other information will not be released publicly. Only information available at the time the request is made will be considered cipro street price for disclosure. Information submitted after the original request for disclosure will be considered for public release upon receipt of a subsequent request.Examples of in scope information include.

Clinical testing information validation testing that supports the effectiveness of the product, including testing performed in vitro or in silico summaries or overviews on safety or efficacy pre- or post-market, including literature reviewsExamples of out of scope information include. Manufacturing details not related to safety or efficacy engineering and design details general documents, such as user manuals, package cipro street price inserts and instructions for use individual patient information, such as patient listings and case report forms, that require extensive anonymization interim clinical study data (see the PRCI guidance)Step 2a. Health Canada assessment of confidential business information To reduce administrative burden on the manufacturer, we will review in-scope records for confidential business information, as defined in Section 2 of the Food and Drugs Act, which mirrors common law in the context of confidential business information that meets each of the following 3 elements of the definition will be protected. That is not publicly available in respect of which the person has taken measures that are reasonable in the circumstances to ensure that it remains not publicly available and that has actual or potential economic value to the person or their competitors because it is not publicly available and its disclosure would result in a material financial loss to the person or a material financial gain to their competitorsText in an in-scope document found to meet this definition will be redacted using a PDF redaction tool.

Similar to Public Release of Clinical Information policies, any information that meets the cipro street price definition of “clinical information” will not be considered confidential business information. Exceptions to the PRCI regulations are outlined section 43.12(2)(a) and (b) of the Medical Device Regulations. These exceptions will be considered when applying redactions to confidential business information. Further information cipro street price on the application of these exceptions can be found in the PRCI guidance document.Step 2b.

Assessing personal informationIn general, in-scope records do not contain a large volume of personal identification information. Any personal information, as defined in the Privacy Act and in accordance with PRCI guidance, information that could help to identify an individual will be protected. For example, this can include the names of authors and investigators as well as subject identification numbers.A large volume cipro street price of indirectly identifying information is not expected in the medical device records that are in-scope of publication. Consequently, limited protection of personal information is anticipated.Personal information will be redacted using a PDF redaction tool.

Step 3. Notice to the company and request for redaction proposalFollowing the review and redaction cipro street price of in scope documents, we will send the manufacturer a written notice indicating our intent to publish the identified documents. A copy of the release package will be sent for the manufacturer’s review. Any further proposed redactions by the manufacturer must be received within 14 calendar days.Manufacturer are asked to use the Proposed Redaction Control Sheet (see Appendix E of the PRCI guidance document) to suggest further redactions.Step 4.

Health Canada assessment of company representationsAny further redactions proposed by the manufacturer will be assessed in accordance with the cipro street price process outlined in step 2, above. Those that meet the definition of personal or confidential business information will be accepted.Step 5. PublicationIn-scope documents will be published within 120 days following receipt of the request. The redacted cipro street price information will be uploaded to the Clinical Information Portal, indexed by application number.

Published documents will carry a watermark and be subject to terms of use, as described in the PRCI guidance.Mailing addressInformation Science and Openness DivisionResource Management and Operations DirectorateHealth Products and Food BranchHealth Canada Graham Spry Building 250 Lanark Ave Ottawa ON K1A 0K9 Telephone. 613-960-4687Email. Hc.clinicaldata-donneescliniques.sc@canada.ca Terminology cipro street price and definitions Anonymization. Means the process through which personal information is modified by.

removing direct identifiers and any related code that would enable linkage with identifying information and ensuring that the remaining indirect identifiers no longer present a serious possibility of re-identifying an individual CBI. Confidential business information, as cipro street price meant in common law and as defined in Section 2 of the Food and Drugs Act. in respect of a person to whose business or affairs the information relates, means (subject to the regulations) business information that. Is not publicly available in respect of which the person has taken measures that are reasonable in the circumstances to ensure that it remains not publicly available has actual or potential economic value to the person or their competitors because it is not publicly available and its disclosure would result in a material financial loss to the person or a material financial gain to their competitors Clinical information.

Means information in respect of cipro street price a clinical trial, clinical studies or investigational testing, such as. clinical overviews, clinical summaries and clinical study reports for drugs summaries and detailed information of all clinical studies and investigational testing that provided evidence of safety and effectiveness for medical devices Clinical study report. Means an "integrated" full report of an individual study of any therapeutic, prophylactic or diagnostic agent (drug or treatment) conducted in patients, in which. the clinical and statistical description, presentations and analyses are integrated into a single report incorporating tables and cipro street price figures into the main text of the report or at the end of the text appendices contain the protocol, sample case report forms, investigator-related information, information related to the test drugs/investigational products, including active control/comparators, technical statistical documentation, related publications, patient data listings and technical statistical details such as derivations, computations, analyses and computer output FDA.

Food and Drugs Act FDR. Food and Drug Regulations IMDRF ToC. International Medical Device Regulators Forum cipro street price Table of Contents Medical device. Has the same meaning as insee the Medical Devices Regulations.

For information on the classification of medical devices, please see the guidance documents on the. risk-based classification system for in vitro diagnostic devices (IVDDs) risk-based classification system for non-in vitro diagnostic devices (non-IVDDs) cipro street price Non-commercial purpose. Means the information will not be used to support a marketing authorization application anywhere in the world or sold or traded to another person Personal information. Has the same meaning as in Section 3 of the Privacy Act Related linksOn this page About the guidance document This guidance document supports the Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to buy antibiotics.

The Minister of cipro street price Health approved the Interim Order on March 30, 2020, to address the unprecedented demand and urgent need for medical devices to treat, diagnose and protect Canadians against buy antibiotics. The guidance covers sections 15 to 19 of the Interim Order. It remains in effect as long as the Interim Order is in effect. Under the cipro street price Interim Order, manufacturers and importers must report medical device shortages related to buy antibiotics to Health Canada.

The devices to which the shortages apply are on the List of Medical Devices — Notification of Shortages (specified medical devices). A specified medical device is a device that is either. set out in the list of medical devices or part of a category of medical devices that is set out in that list cipro street price The guidance is intended to help manufacturers and importers meet their regulatory obligations. It outlines their responsibilities concerning the mandatory reporting of medical device shortages.

About medical device shortages and reporting A medical device shortage occurs when a manufacturer is unable to meet Canadian market demand for the device or for its components, accessories, parts or consumable materials. This does not apply when a substitute device, component, accessory, cipro street price part or consumable material is available in Canada. There are 2 types of shortages. actual, when the current supply can’t meet current demand anticipated, when the future supply can’t meet projected demand Manufacturers and importers must.

report a medical device shortage provide a shortage status update if there is a change in the shortage information submitted provide additional information related cipro street price to a shortage when requested by Health Canada report an end of a medical device shortage This guidance document also provides some guidance on how to voluntarily report a medical device shortage that does not fall under the Interim Order. Everyone has a role to play Manufacturers and importers Manufacturers and importers have a key role to play in preventing and reducing the impact of medical device shortages. They can control the volume of medical devices in the supply chain and can take steps to resolve a medical device shortage when one occurs. They are also in the best cipro street price position to communicate to customers about the availability of their devices.

When a manufacturer experiences a shortage of a critical medical device it sells, we expect that the manufacturer will take all necessary measures to resolve the shortage as quickly as possible. Provincial/territorial governments and health care authorities Provincial and territorial governments and health care authorities also have an important role to play in preventing and mitigating critical medical device shortages. They can cipro street price. conserve and reallocate stock within regions or provinces to where it is most needed and collaborate to share supply identify and secure additional supplies of medical devices from other vendors or another provincial or territorial government identify and secure other compatible substitute medical devices Government of Canada The federal government administers the Food and Drugs Act, Radiation Emitting Devices Act and Medical Devices Regulations.

We do not provide or control the supply of medical devices in Canada or have the authority to compel a manufacturer to supply a device. We work with cipro street price stakeholders across the medical device supply chain to help determine the details and status of a shortage. We also coordinate and facilitate information sharing. When it comes to medical device shortages, Health Canada depends on early reporting of anticipated or actual shortages to help us.

prevent or manage impacts related to medical device shortages work with industry to identify mitigation strategies inform the procurement of medical devices cipro street price for Canada Depending on the situation, our options include. prioritizing the review and approval of regulatory applications received from manufacturers (for example, an application to authorize or import an acceptable compatible device) expediting the process for issuing Medical Device Establishment Licences (MDELs) permitting the importation and sale of medical devices that do not fully meet Canadian regulatory requirements, but are manufactured to comparable standards to help address product shortages due to the buy antibiotics cipro working with international regulators to identify other manufacturers and to share needed safety and manufacturing information helping health care professionals and institutions get access to compatible substitute medical devices on an emergency basis (for example, the Special Access Programme can be used to provide access to unlicensed alternative medical devices) As part of the Government of Canada’s response to buy antibiotics, the Public Health Agency of Canada is working with other government departments to procure bulk shipments to facilitate access to much-needed medical devices. These include ventilators, testing swabs, reagents and test kits as well as personal protective equipment. Related linksOctober 9, 2020Our file number cipro street price.

20-113699-873 As a standing regulatory member of the International Council for Harmonisation (ICH), Health Canada is committed to the adoption and implementation of all ICH guidance. By way of this Notice, Health Canada is advising of its intent to implement ICH Q12. Technical and Regulatory cipro street price Considerations for Pharmaceutical Product Lifecycle Management and the ICH Q12 associated annexes. This guidance has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process.

The ICH Assembly has endorsed the final draft and recommended its implementation by membership of ICH. The target timeframe for Health Canada implementation of ICH cipro street price Q12 has been set to the third quarter of 2021 in order to allow sufficient time for the preparation of regulators and stakeholders. Health Canada will be launching a stakeholder consultation in early 2021 to gather feedback on the final elements of the implementation of the Q12 guidance in Canada.This new Guideline is proposed to provide a framework to facilitate the management of post-approval Chemistry, Manufacturing and Controls (CMC) changes in a more predictable and efficient manner across the product lifecycle. Implementation of this new ICH Guideline will promote innovation and continual improvement in the biopharmaceutical sector and strengthen quality assurance and reliable supply of product, including proactive planning of supply chain adjustments.

It will allow regulators cipro street price (assessors and inspectors) to better understand the firms' Pharmaceutical Quality Systems (PQSs) for management of post-approval CMC changes.ICH Q12 should be read in conjunction with this accompanying notice and with the relevant sections of other applicable Health Canada guidances. This and other ICH Guidance documents are available on the ICH Website. Please note that the ICH website is only available in English. If you would like to request a copy of the French version of the document, cipro street price please contact the HPFB ICH inbox.Contact InformationFor any comments or inquiries related to this notice, please contact:Health Canada – ICH CoordinatorE-mail.

Hc.ich.sc@canada.ca Please include "Implementation of ICH Q12" in the subject line.The Register of Innovative Drugs is maintained pursuant to C.08.004.1 of the Food and Drug Regulations. The register indicates the drugs that are eligible for data protection. Under C.08.004.1 (3) a subsequent manufacturer that seeks a notice of compliance on the basis of a direct cipro street price or indirect comparison between the new drug and an innovative drug may not file a submission before the end of a period of six years after the day on which the first notice of compliance was issued for the innovative new drug. In addition, the notice of compliance cannot be issued before the end of a period of eight years after the day on which the first notice of compliance was issued to the innovator.

The format of the Register of Innovative Drugs is an electronic table, which is updated weekly. The register lists, in alphabetical order, the medicinal ingredients in the innovative drugs which were not previously approved in a drug by the Minister and that are not variations of a previously approved medicinal ingredient. Please note that there may be other medicinal ingredients included in the drugs. The register was re-formatted in summer 2016 to increase the clarity of the information provided regarding the medicinal ingredient, brand name and manufacturer of each innovative drug.