Viagra Soft

Professor Djillali Annane

• General Intensive Care Unit,
• Department of Acute Medicine
• Raymond Poincar? hospital (AP-HP)
• University of Versailles SQY
• (UniverSud Paris)
• 104 boulevard Raymond Poincar?,
• 92380 Garches, France

In the placebo-controlled study impotence drugs for men generic viagra soft 100 mg with mastercard, there was no significant difference in the primary efficacy measure (time until development of any mood episode) among patients treated with divalproex causes of erectile dysfunction in 40s discount 100mg viagra soft with visa, lithium erectile dysfunction condom purchase viagra soft online from canada, and placebo impotence 25 years old viagra soft 100mg mastercard, although there was a nonsignificant difference favoring divalproex over lithium (p=0 erectile dysfunction treatment in qatar purchase 50 mg viagra soft with visa. Divalproex was superior to placebo on rate of early termination for any mood episode (24% versus 38% impotence vs erectile dysfunction order 50mg viagra soft fast delivery, respectively; p<0. Early termination for intolerance or noncompliance favored divalproex over lithium (22% versus 35%, respectively; p<0. The divalproex advantage over placebo was greater in the subset of 149 patients who had received divalproex treatment for their manic episode during the open period, with rates of early termination for any mood episode of 29% and 50%, respectively (p<0. One randomized, 18-month open study of valproate (formu lated as valpromide) versus lithium reported a 20% lower rate of new episodes among valpro mide-treated patients than among lithium-treated patients (388). Relative to patients given lithium, a lower proportion of patients given valpromide had their treatment discontinued be cause of intolerance or lack of efficacy. Divalproex and lithium were comparably effective in a 1-year, open, naturalistic, longitudinal study that allowed addition of any needed medication (254). Finally, divalproex was effective both as monotherapy and when added to lithium ther apy in a large, open maintenance trial of patients with rapid-cycling presentations (368). These findings indicate efficacy and generally good tolerability of divalproex in maintenance treat ment, with effectiveness at least comparable to lithium. Treatment of Patients With Bipolar Disorder 49 Copyright 2010, American Psychiatric Association. As with lithium, dosing guidelines for maintenance treatment are less evidence-based than for acute treatment of mania, and lower levels are sometimes used for maintenance treatment. Lamotrigine Lamotrigine has been studied in one large, 18-month, randomized, double-blind, placebo-con trolled study of patients who had experienced a manic or hypomanic episode within 60 days of entry into an open treatment phase (386). Patients who improved during the open treatment phase were randomly assigned to maintenance treatment with lamotrigine, lithium, or placebo. For the primary outcome measure (time until additional pharmacotherapy required for treat ment of a mood episode), both lamotrigine and lithium were superior to placebo (p<0. The median time until one-quarter of the patients in each treatment group developed a mood episode was 72 weeks for those given lamotrigine, 58 weeks for those receiving lithium, and 35 weeks for those given placebo. On a secondary outcome measure (time until discontinuation for any reason), lamotrigine was superior to placebo, but lithium was not (p=0. Lamotrigine did not significantly prolong the time until a manic episode but was superior to placebo in prolonging the time until a depressive ep isode (p<0. The prima ry efficacy measure, time until additional medication required for treatment of a mood episode, did not differ significantly (p=0. Time until additional pharmacotherapy was required did not differ significantly among patients with bipolar I disorder. Also, the proportion of patients who completed the study without requiring additional medication was greater among those treated with lamotrigine than for those given placebo (41% versus 26%, p=0. Among patients requiring additional pharmacotherapy, 80% required medication for depressive symptoms; 20% required medication for manic, hypo manic, or mixed symptoms (39). These results are consistent with those of an open study of patients with bipolar disorder treated with lamotrigine for up to 48 weeks either as monotherapy or as part of combination therapy (329). Carbamazepine the effectiveness of carbamazepine for maintenance treatment of bipolar disorder is unclear (362). Carbamazepine was inferior to lithium on most outcome measures in one randomized, open, 2. Crossover studies have reported carbamazepine somewhat less effective than lithium in maintenance treatment of bipolar disorder (362, 390). The proportion of time spent in a manic episode dropped from 25% before treatment to 19% in patients treated with carbamazepine and 9% in patients treated with lithium (p<0. The proportion of time spent in a depressive episode did not change after initiation of either drug (before treatment: 32%, in patients treat ed with carbamazepine: 26%, in patients treated with lithium: 31%) (362). Antipsychotic medications the one placebo-controlled study of prophylactic treatment with an antipsychotic drug did not show an advantage of flupentixol plus lithium compared with lithium alone (391). Open case reports and one randomized, open study of clozapine plus usual care compared with usual care alone have indicated benefits of maintenance clozapine treatment over 1 year (303). Of the patients with bipolar disorder, 78% showed at least some improvement, and 33% were much improved. Seven of these individuals were diagnosed with bipolar disorder, and four had shown a rapid-cycling course. Of the 58 depressed patients in the study, 12 had a diagnosis of bipolar disorder. At 5 years, the difference in survival between the two groups was even more striking (73% versus 18%, respec tively). Proportional hazards regression did not demonstrate statistically significant rate differ ences between patients with bipolar disorder and those with major depressive disorder. Patients with bipolar disorder suffer from the psychosocial consequences of past episodes, the ongoing vulnerability to future episodes, and the burdens of adhering to a long-term treatment plan that may involve unpleasant side effects. In addition, many patients have clinically significant residual symptoms or mood instability between major episodes. The primary goals of psychotherapeutic treatments are to reduce distress and improve the patient’s functioning between episodes as well as decrease the likelihood and severity of future episodes (408). Treatment of Patients With Bipolar Disorder 51 Copyright 2010, American Psychiatric Association. Most patients with bipolar disorder struggle with some of the following issues: 1) emotional consequences of episodes of mania and depression; 2) coming to terms with having a poten tially chronic mental illness; 3) problems associated with stigmatization; 4) delays or major deviations in development; 5) fears of recurrence and consequent inhibition of more autono mous functioning; 6) interpersonal difficulties, including issues pertaining to marriage, family, childbearing, and parenting; 7) academic and occupational problems; and 8) other legal, social, and emotional problems that arise from reckless, inappropriate, withdrawn, or violent behavior that may occur during episodes. Although a specific psychotherapeutic approach (in addition to psychiatric management) may be needed to address these issues, the form, intensity, and fo cus of psychotherapy will vary over time for each patient. There are now a range of specific psychotherapeutic interventions that have been shown to be helpful when used in combination with pharmacotherapy and psychiatric management for treatment of bipolar disorder. The best-studied treatment approaches have been developed around psychoeducational, interpersonal, family, and cognitive behavior therapies. Formal studies have been conducted for these treatments, and additional investigations are underway. Further, psychodynamic and other forms of therapy may be indicated for some patients. The available psychotherapeutic treatments are discussed as separate entities, even though psychia trists commonly use a combination or synthesis of different approaches depending on both training and the patient’s needs and preferences. Efficacy Evidence concerning the utility of specific psychosocial interventions for patients with bipolar disorder is slowly building. The research summarized here involves the specific forms of psy chotherapy that have been studied in randomized, controlled clinical trials. When compared with a group randomly assigned to a treatment-as-usual condition, pa tients receiving psychoeducation (in addition to pharmacotherapy) experienced a significant re duction in risk of manic relapses as well as improved social and vocational functioning. A brief (approximately six sessions) inpatient family intervention (409) has been developed for patients with schizophrenia or bipolar disorder. Goals include accepting the reality of the illness, identifying precipitating stressors and likely future stressors inside and outside the fam ily, elucidating family interactions that produce stress on the patient, planning strategies for managing or minimizing future stressors, and bringing about the patient’s family’s acceptance of the need for continued treatment after hospital discharge. In the initial study (410), the fam ily intervention resulted in improved outcomes for female patients with affective disorders but not for male patients. In a subsequent study by this group (410), ongoing couples therapy (ex tending for up to 11 months after hospitalization) was found to significantly enhance treat ment adherence and improve global functioning. Unfortunately, this study was too small (intent-to-treat N=42) to reliably detect more modest effects, such as a reduction of relapse risk. When the functional impairments of bipolar disorder are severe and persistent, other services may be necessary, such as case management, assertive community treatment, psychosocial rehabil itation, and supported employment. These approaches, which have traditionally been studied in patients with schizophrenia, also show effectiveness for certain individuals with bipolar disorder. Family-focused treatment was developed for patients who have recently had an episode of ma nia or depression (411). Family-focused therapy is behaviorally based and includes psychoeduca tion, communication skills training, and problem-solving skills training. One adequately sized trial of behavioral family treatment has been completed; the investigators found that behavioral family management (in concert with adequate pharmacotherapy) resulted in a substantial decrease in de pressive relapse rates when compared with a treatment-as-usual control condition (412). A cognitive behavior therapy program for patients with bipolar disorder has been developed by Basco and Rush (413). The goals of the program are to educate the patient regarding bipolar disorder and its treatment, teach cognitive behavior skills for coping with psychosocial stressors and attendant problems, facilitate compliance with treatment, and monitor the occurrence and severity of symptoms. A large study of the impact of cognitive behavior therapy for prophylaxis against bipolar recurrences is underway. Preliminary studies suggest that this approach may help reduce depressive symptoms (414), improve longer-term outcomes (415), and improve treatment adherence (416). The observation that many patients with bipolar disorder experience less mood lability when they maintain a regular pattern of daily activities (including sleeping, eating, physical ac tivity, and emotional stimulation) has led to the development of a formalized psychotherapy called interpersonal and social rhythm therapy (417). This form of psychotherapy builds upon the traditional focus of interpersonal psychotherapy by incorporating a behavioral self-moni toring program intended to help patients with bipolar disorder initiate and maintain a lifestyle characterized by more regular sleep-wake cycles, meal times, and other so-called social zeit gebers. The ultimate goal is to help regulate circadian disturbances that may provoke or exag gerate episodes of mood disorder. Frank and colleagues have reported several findings from their ongoing study of inter personal and social rhythm therapy. First, interpersonal and social rhythm therapy (in combi nation with pharmacotherapy) was associated with significant increases in targeted lifestyle regularities when compared with a clinical management plus pharmacotherapy control group (418). However, interpersonal and social rhythm therapy was not associated with a faster time to recovery from manic (419) or depressive (420) episodes. The withdrawal of interpersonal and social rhythm therapy after stabilization was associated with a significant increase in relapse rates (421). Across 2 years of maintenance treatment, interpersonal and social rhythm therapy led to a reduction of both depressive symptoms and manic/hypomanic symptoms and an in crease in days of euthymia when compared with treatment as usual (unpublished 2001 study by E. Finally, preliminary results of a trial comparing group psychoeducation to standard medical care alone among a group of patients with bipolar disorder suggest that patients receiving psychoedu cation had significantly fewer manic episodes, depressive episodes, and hospitalizations (422). Psychotherapeutic treatment of mania Psychosocial therapies alone are generally not useful treatments for acute mania. Perhaps the only indications for psychotherapy alone are when all established treatments have been refused, involuntary treatment is not appropriate, and the primary focus of therapy is focused and crisis oriented. In one study of bipolar I dis order patients with acute mania or hypomania, treatment with the combination of interper sonal and social rhythm therapy and pharmacotherapy did not produce an additive effect on manic symptoms or reduce time to remission when compared with an intensive clinical para digm plus medication (419). Moreover, patients withdrawn from this psychotherapy after completion of acute treatment had a poorer prognosis when compared with those who either received monthly maintenance psychotherapy sessions or recovered with intensive clinical management and pharmacotherapy (421). Psychotherapeutic treatment of depression Several psychotherapeutic approaches, including cognitive behavior therapy (423) and interper sonal therapy (424–426), have demonstrated efficacy in patients with unipolar depression, either in lieu of or in addition to pharmacotherapy. Treatment of Patients With Bipolar Disorder 53 Copyright 2010, American Psychiatric Association. For unipolar depression, the application of a specific, effective psychotherapy in lieu of phar macotherapy may be considered for patients with mild to moderate symptoms. For bipolar de pression, the use of focused psychotherapy instead of antidepressant pharmacotherapy has potential appeal, particularly with respect to avoiding antidepressant side effects and minimizing the risk of treatment-emergent mania or induction of rapid cycling. However, only a handful of reports have described such an approach, and there have been no definitive studies to date. Patients were randomly assigned to receive weekly interpersonal and social rhythm ther apy sessions or treatment as usual. All patients received pharmacotherapy (principally lithium salts); about two-thirds of the patients also received antidepressants. They com pared their patients’ outcomes to a contemporaneous group of age and sex-matched patients with unipolar depression. Further, no depressed patient receiving cognitive behavior therapy developed treatment-emergent mania or hypomania. All studies used “add-on” designs, with patients continuing pharmacotherapies such as lithium and divalproex. Many of these re ports described preliminary or pilot studies; nevertheless, results of three larger, more definitive studies have been published for psychoeducation (27), interpersonal and social rhythm therapy (427), and family-focused (412) interventions. Overall, these studies demonstrated that the addition of a time-limited individual psycho social intervention appropriately modified for bipolar disorder is likely to improve outcomes across 1–2 years of follow-up. When feasible, group psychoeducational interventions also ap pear useful (428), which may improve the cost efficiency of treatment. Despite these promising results, however, improvements have not been consistently documented across studies on the full range of syndromal, functional, adherence, and interpersonal domains. On the basis of a methodological review of the more numerous studies of unipolar depression (429), such incon sistencies in findings are more likely to be attributable to differences in patient populations and statistical power than true therapeutic specificity. Nevertheless, the weight of the evidence suggests that patients with bipolar disorder are likely to gain some additional benefit during the maintenance phase from a concomitant psychosocial intervention, including psychotherapy, that addresses illness management. The more commonly practiced supportive and dynamic-eclectic therapies have not been studied in randomized, controlled trials as maintenance treatments for patients with bipolar disorder. Addressing comorbid disorders and psychosocial consequences Patients in remission from bipolar disorder suffer from the psychosocial consequences of past episodes and ongoing vulnerability to future episodes. In addition, patients with this disorder remain vulnerable to other psychiatric disorders, including, most commonly, substance use dis orders (66) and personality disorders (430, 431). Psychosocial treatments, including psychotherapy, should address issues of comorbidity and complications that are present. The majority of in formation available about pharmacological treatments for bipolar disorder in youth relies upon open studies, case series, and case reports. Lithium There are more data available for lithium than for any other medication in the treatment of bipolar disorder in children and adolescents. There was significantly greater improvement in global functioning with lithium treatment than with placebo. Significantly more patients in the lithium-treatment group experienced thirst, polyuria, nausea, vomiting, and dizziness.

Consequently doctor for erectile dysfunction philippines 50 mg viagra soft for sale, the choice of treatment with a drug reference biological or with a biosimilar remains a clinical decision entrusted to the specialist physician prescriber erectile dysfunction drugs from india purchase generic viagra soft pills. In the context of all biological medicines erectile dysfunction treatment without medication discount viagra soft 50 mg fast delivery, it is important that careful consideration is given by healthcare professionals to decisions of this nature erectile dysfunction increases with age purchase viagra soft toronto. If it is planned to change the medicine a patient receives from a reference to a biosimilar medicine or vice versa what causes erectile dysfunction in 30s buy 50mg viagra soft amex, the treating physician should be involved; this should involve discussion between the prescriber/ patient impotence bicycle seat order cheap viagra soft, and prescriber /dispensing pharmacist. It is important to highlight that under this legislation biological medicines are specifically excluded from being added to interchangeable medicine lists. As such they cannot be subjected to pharmacy substitution as exists for small chemical molecules. New patients can be treated with a biosimilar right away; uncontrolled exchange between biological medicines (regardless of whether they are innovator products or biosimilar medicines) must be avoided. In other words, a patient must receive adequate clinical monitoring and clear instructions; and if a patient is treated with a biological medicine, detailed product and batch information must be recorded in the patient file to guarantee the traceability of the product in the event of problems. It can apply to the following situations: Switching from reference drug to biosimilar. Further clinical studies confirming safety of switching are considered unnecessary. The decision on switching products is made by the treating physician or hospital, who have to provide the necessary information to patients. To ensure traceability, adverse reactions with biological drugs should be reported with the drug name, active substance and batch number. Competition leads to price reductions that reduce the financial burden of expensive biological drugs in the healthcare system. In Norway, automatic substitution in pharmacies of biological or biosimilar products is not allowed. The Norwegian Medicines Agency has proposed that the Pharmacy Act § 6-6, which is the basis for generic (automatic) substitution in pharmacies, should be altered, eventually permitting automatic substitution of new classes of medicinal products. Poland – Minister of Health (2014) Minister of Health (MoH) – MoH position on biosimilar infliximab within the scope of the drug prescription programmes Not available Summary: the Minister of Health takes the view that any exchange within the scope of drugs containing infliximab at any level of therapy is permissible. There is sufficient evidence to consider that the switch from a reference biologic medicine of infliximab, etanercept and rituximab to the respective biosimilar medicine in patients under treatment will not cause loss of efficacy or increase of adverse effects. This evidence applies to all indications approved for the respective biosimilar medicine (the position on adalimumab will be reviewed after their availability in the Portuguese market). This ensures adequate control of the procedure, with permanent registration of medicinal products, brands, lots and the therapeutic schemes of each patient and pathology. The initiation of treatment should be carried out with the less costly biosimilar or reference biologic medicine (for the institution that makes these medicines available); a goal to be achieved in all naïve patients. When the assessment of alternative brands of the same biologic medicine translates in a significant reduction of costs (for the institution) in patients already under treatment with a biological medicinal product, a process of switch for the lowest cost medicine should be implemented. Each institution should have as objective the promotion of switch in all patients clinically stable. The process of switching from a reference biological medicinal product to a biosimilar medicine, or vice versa, musts take into consideration the following conditions: a. The switch of the medicine cannot occur in a period of treatment that is less than 6 months. All the prescribers and other technicians involved in the switching program (physicians, pharmacists and nurses) must be involved and informed about the process and their benefits. The decision to switch must be explained by the prescriber to the patient, clarifying the decision and providing all the necessary information. The process should safeguard the necessary time for the physician and patient to know the conditions of switching. Until the clarification of the reason for refusal, the medicine that the patient was already using should be available. The date of the switch, the brand and the batch of the new medicine available will then be registered. The monitoring and recording of adverse effects or other events related to the new medicine, such as the presence of signs of immunogenicity, should be maintained but do not require an additional monitoring compared with the reference biologic medicine. Therefore, the same trademark of the medicine should be maintained during the required time to its traceability. This period may be defined in the ‘Medicines National Formulary’ for different medicines, but when omitted, it should not be less than 6 months. It states that the originator biologic medicine and biosimilar are interchangeable for established patients, except if its non-interchangeability is scientifically proven. Individual patients may be switched to another biological medicine, including a biosimilar medicine, as part of a clinician led management programme which has appropriate monitoring in place. There are differing clinical characteristics within specialties which may be important to consider when using biosimilar medicines. While practice is evolving, some specialties may consider that it is most appropriate to use biosimilar medicines in new patients. Substitution should only be considered if the prescribing physician gives prior consent. The authorization of a biosimilar confirms that the differences between the biosimilar and its reference preparation do not affect safety or efficacy. However, the approval of the Institute does not state whether a biosimilar can be used interchangeably with the reference preparation. By authorising a biosimilar medicine, Swissmedic confirms that the differences between the biosimilar and its reference product do not affect its safety and efficacy. Swissmedic’s authorisation nevertheless contains no recommendation regarding whether a biosimilar can be substituted for the reference product. As a result, the prescriber can switch a patient from the reference biological medicine to its biosimilar. The decision to prescribe a biological medicine for an individual patient, whether a reference or biosimilar medicine (or to change between the two), rests with the responsible prescriber in consultation with the patient; in line with the principles of shared decision making. Evolving evidence and treatment guidance should be made available to patients and prescribers to support them in their decision-making. This should take into consideration therapeutic need and whether or not the patient is likely to adhere to treatment. If more than 1 treatment is suitable, the least expensive should be chosen (taking into account administration costs, dosage and price per dose). The Committee concluded that its recommendations for infliximab could apply both to the reference product and to its biosimilars. Start treatment with the least expensive drug (taking into account administration costs, dose needed and product price per dose). This may need to be varied for some people because of differences in the mode of administration and treatment schedules. Many regulatory authorities, healthcare providers and clinician associations accept that there are no clinically meaningful differences between biosimilars and originators and that biosimilars are safe and effective treatment options that can be equally prescribed to patients. Other government institutions Italy – Council of State on Tuscany (2015) Ruling by the Council of State on Tuscany region Not available Summary: the court confirms the quality, safety and efficacy of biosimilars not just for naïve patients but also as new opportunities in the continuity of care. Biosimilar medicines may be used for non-naïve patients “when previous exposure to the drug is sufficiently distant in time”, as well as when use of a particular version of the drug causes problems for a patient. Ireland – Irish Parliamentary Health Committee (2015) Irish Parliamentary Health Committee – Recommendation! Available here Summary: One option is for the State to enact legislation to facilitate the listing of bio-similar or High Tech molecule medicines as “interchangeable”, something which is currently prohibited. In Committee hearings, it was stated that this could reduce the State’s pharmaceutical bill, treat more patients within existing budgets, and allow improved access for patients to newer, innovative medicines. Such a measure would impact on prescriber behaviour / procurement processes in hospitals and facilitate switching to a bio-similar alternative. Available here Summary: the availability of biosimilars must significantly lower the cost of treating an individual patient and increase access to optimal therapy for all patients with rheumatic disease. Available here Summary: Many patients consider that leaving open the possibility of switching, interchangeability and substitution would introduce unacceptable uncertainties into that decision-making process. In September 2013, the first biosimilar of infliximab was introduced into the pharmaceutical market. Since then, more data have accumulated for both adults and children demonstrating biosimilars are an effective and safe alternative to the originator. Physicians/institutions should keep records of brands and batch numbers of all biological medicines (including biosimilars) administered. Healthcare professionals should ensure that people with diabetes well managed on an existing insulin are not changed to another insulin formulation, including biosimilars, without good clinical reason and evidence of interchangeability. Comprehensive data on interchangeability in practice, pharmacovigilance and post-marketing surveillance should be provided. Austria –Multiple relevant medical societies (2014) Medical dialogue consensus statement – Biosimilars: current status Available here (German only) Summary: No summary available. Meanwhile, we recommend to start with naïve patients but not to switch a patient who has a durable response on infliximab to the biosimilar-infliximab. Cyprus – Cyprus League Against Rheumatism (2014) the 10 commandments of access to biological treatments Available here (Greek only) Summary: No summary available patients. Last year they were very hesitant towards switch and did not understand decision that was taken to switch patients when a tender was won and a biosimilar infliximab was recommended. So today they are positive towards biosimilars and see the possibilities in a switch and the long-term positive outcome. At initiation, the choice is clear between the originator and biosimilar infliximab. In a patient during treatment, it is recommended to treat, to the extent possible, with the same specialty without making any changes within a biosimilar family, so not to switch between infliximab. The switch of infliximab to another is not recommended but is nevertheless possible. It is understood that this must remain at the initiative of the prescriber which would otherwise be liable if any. In addition, it is important to remember that we must not give another infliximab if a first infliximab was not tolerated and that kits of infliximab assays and antibodies to infliximab seem suitable for all infliximabs. If additional information on the safety of biosimilar infliximab was brought to our attention, these recommendations may be revised. AkdÄ recommends prescribing the more cost-effective biosimilars in treatment initiation and supports changes between biosimilars for subsequent prescriptions. The detailed information and advice provided by doctors to their patients is an essential prerequisite for the prescription and use of biosimilars. Without this, unfounded fears could lead to a reduction in adherence and compromise therapeutic success in patients. Automatic substitutions of biosimilars for reference medicinal products are therefore rejected. Germany – German Rheumatism League (2014) Deutsche Rheuma-Liga Positioning of the German Rheumatism League Bundesverband on introducing biosimilars in Germany Available here (German only) Summary: the Rheumatism League believes it is essential that patients with rheumatic diseases whose disease activity was brought under control with a biotechnologically manufactured drug will not be forced to change to another biotechnology drug due to cost-considerations. And if a change should take place per se, only on the basis of medical considerations and justified in terms of patient welfare. Because the practice shows that often neither the patient nor the clinicians are informed about this exchange. In patients who start with a therapy of a biotechnologically manufactured drug, the security must be at the forefront. There are concerns when the biosimilar was not tested for the specific indication but was admitted by extrapolation. In this case studies must have shown that the safety profile for this specific indication does not differ from the reference product and no undesirable side effects for the indication occur. Switches have to be the responsibility of the treating physician while a general substitution is rejected. This applies for example to the extent of use of biosimilars effective in the forms of inflammatory arthritis in patients with spondylo-arthritis and, especially, to those suffering from entero-artritis and paediatric patients. Validation should be conducted by comparing the results of the innovative product with those obtained with the original treatment. Although greater access to appropriate use of biological therapies for entero-artritis paediatric reumopatie is a potential, for significant savings in direct costs, the strict test of a controlled clinical trial is required to ensure that the effectiveness and safety standards are met. We believe that the assertion that biosimilar epoetin alpha should only be used to treat naive patients might be limiting. In addition, the change must be approved by the specialist prescribing the original biologic and be implemented after obtaining the patient’s written informed consent. The complexity of the molecule, dosing, and immunogenicity issues needs careful investigation on these aspects. Interchangeability cannot be automatic, unless its effectiveness and safety will be exhaustively demonstrated. Neither other paramedical characters nor Healthcare payers should be allowed to change the prescription or impose the use of biosimilars instead of their originator. The switch may be considered only in patient who respond to infliximab treatment; despite the encouraging results obtained to date, the possibility that neutralizing antibodies directed against the originator molecule would diminish the efficacy of cT-P13 cannot be ruled out and therefore switching may be considered with caution. Patients should be adequately informed about the advantages and the possible adverse effects of biotechnological therapy before starting treatment. Clinically well controlled patients should not be switched from an original drug to its biosimilar, or vice versa. Medical and immunological considerations, including high-quality evidence of bioequivalence, quality, efficacy and safety of each developed biosimilar should always take priority over any economic or financial benefit. However, since several biosimilars are being evaluated in psoriasis patients, these agents should be chosen to treat psoriasis patients instead of biosimilars studied in other conditions. Moreover, patients should be kept informed about their treatment agent, and should not be transitioned for other agent without their knowledge and informed consent. Post marketing surveillance, mainly through national registers, is crucial to permanently assess safety and increase confidence in the use of biosimilars. A biosimilar is a medicine that, using molecular biology techniques, is intended to provide an action equivalent to that of the product it attempts to copy and requires a complex process based on all the preclinical and clinical trials demanded by European Law. A licence obtained for the management of a certain disease allows an extrapolation of results to a different disorder, if the European Medicine Agency considers it based on the results of trials mentioned previously.

That is why the process of externalization erectile dysfunction 37 years old buy cheap viagra soft 50 mg line, of going out do erectile dysfunction pills work order discount viagra soft, should gain a special value on the list of performance practices and movement research tools and methods erectile dysfunction without pills purchase viagra soft with a visa. In the last in stance impotence genetic buy viagra soft 100mg without prescription, these publics seem to be the only environ-ment where new subjectivities could emerge erectile dysfunction caused by prostate removal purchase viagra soft 50 mg otc. This is so since alienation itself is not a personal and indi-vidual mat ter; “it is not a loss of what is most unique and personal but a loss of connection to what is most generic and shared impotence at 80 100mg viagra soft with visa. This is also a common way to use the term “process” in contemporary dance and perfor-mance parlance in Europe. In some cas es, the performance is still considered a side-efect of an ongoing practice, while in oth-ers constructing a performance practice to commodify it directly into a performance becomes an efcient tool to respond to the extremely accelerated speed with which many artists need to produce performances in order to stay inside the project economy of art. A similar ambivalence can be found in recent programs of “sharing practice” in the form of public programs of institutions, such as festivals of practice and practice symposia. We don’t has-ten to discard these cases as “commodifcation of practice” and will later go back to them, but we do want to draw the attention to their ambivalent status in the economy of 370 art-making and art-doing. The person is in vited to close her eyes and lie down on a mattress placed on the foor. Around the mattress, on the foor, one can see several blankets, pillows, and diferent kinds of cloth, stones, and other objects. During the thirty minutes that the experience lasts, the performer weaves a non verbal narrative of space, made of the activation of the present objects and materials which will come in contact through sound or touch with the lying body. The person will hardly notice the performer’s presence; nor will she fully recognize his or her gestures, his or her movements. A blurriness seeps into the mind around what one feels, imagine, recall, or think: a strange mixture of sleep and wakefulness where a diferent regime of images appears. It was frst put to work in the framework of La Piscine, an experience that took place at the end of Myriam Lefowitz’s residency at a public swimming pool. The experience is described as a place of crossing between a health treatment and an aesthetic encounter, and consists of “a singular itinerary proposed to each spectator through the following means: a silent, eyes closed walk in and out of the pool, an audio guide in and out of the water, political therapies which aim to link the mental and the corporal space”. Collective and heterogeneous assemblages of practice Myriam Lefowitz describes her practice of dance as one that has left the studio and the stage and that attempts to connect the skills and tools learnt in the context of dance training with other tools, other skills and other practices that can be described as therapeutic, somatic, or magic. Lefowitz’s practice has the ambition to give rise to a regime of sensations that is generally not available because of the strict separation between animate bodies and inanimate objects, and between public, private and intimate spaces. Valentina Desideri — long-time collaborator of Lefowitz in the framework of La Piscine — in her prac tice of reading, developed with theorist Denise Ferreira Da Silva, which summons tools as diferent as Tarot, poetry, Reiki, political therapy, or Astrology. Desideri and Ferreira Da Silva conceive an ethics “with/out the subject”2, bringing to light the necessity to reconnect the subject to its environment and to acknowledge the complex network of dependences that the subject is em bedded in. Along with choreographer Alice Chauchat, Lefowitz also places an emphasis on dance practice as a practice of attention, a space of speculation, of inven tion and practice of alternatives. In her work, Lefowitz tries to set up the conditions for the exploration of the body’s faculties, questioning what could be the capaci ties in regard to attention and perception that we may have not yet experienced. Contrary to the neoliberal ideology appropriating somatic practices to promote an idea of individual well-being in the service of performance and produc tive efciency, Lefowitz considers the individual body entangled in a network of relationships. She situates the possibility of emancipation within the production of a collective space of shared intimacy and expanded im agination, within which a (potentially infnite) variety of practices can be used as tools, including collective reading of theoretical texts by feminist authors, shiatsu or remote viewing. Reciprocity is central to this work: while the person who is lying down on the foor may ask herself: “What is touching me? In this work both persons engaged in the relation proposed by the work experience a diferent form of consciousness. The person lying down, eyes closed, in a state of near inertia, on the verge of sleep, comes into contact with objects, textures, weights, heat and sounds, through principles of scarcity, slowness and duration. The body becomes a sort of resounding box; one can gradually be more aware of the body as an assemblage of skin, bones, fesh or muscles. Deprived of sight, objects are envisioned through a whole new range of param eters. Specifc to the experience for the person on the foor is the blurriness in regards to what exactly touches the body: the object becomes the extension of the per former’s body. Feminist theorist Sara Ahmed writes: “we are afected by “what” we come in contact with. In other words, emotions are directed to what we come into contact with: they move us “toward” and “away” from such objects. The approach is not simply about the arrival of an object: it is also how we turn toward that object, while 379 it also apprehends the object in a certain way, as being fearsome. For an object to make this impression is dependent on past histories, which surface as impressions on the skin. Orientations shape not only how we inhabit space, but how we apprehend this world of shared inhabitance, as well as “who” or “what” we direct our energy and atten tion toward. A redistribution of roles and places In the context of the season of exhibitions and cultural programme titled “Your hands in my shoes” (September 2016 July 2017) at the art centre La Galerie, in Noisy le-Sec, Emilie Renard, others members of the team working at the art centre and I were trained by Myriam Lefowitz to perform this practice. Emilie Renard and 380 I, co-curators of the exhibition, approached Myriam Lefowitz with the desire to discuss with her specifc concerns with the bodies of the members of the gallery team as well as the bodies of the visitors. We were look ing for means to address the bodies of people inhabiting the institution everyday and the bodies of those more punctually walking through the art centre. We wanted to address these bodies specifcally and individually as bodies situated in relation to gender, race, social class, but also as a possible community to be invented. The sensorial practice conceived by Myriam Lefowitz proposed a unique dispositif, that is a distinct methodology, repeating itself session after session. Yet this approach is founded on a relationship that is en tirely redefned with every new encounter. Myriam Lefowitz transmitted her practice, gestures and tools to the members of the team of the art centre who wanted to learn and in turn practice this experi ence with visitors of the exhibition. The possibility of transmission of this practice, its sharing and handing in to practitioners other than the artist herself – par ticularly people who have not been trained as dancers – plays a central role in Myriam Lefowitz’s approach to her work in the feld of dance. Being trained in per forming this practice also meant for the members of the team — no matter their position — to acquire new skills and share a privileged relationship with the artist. In the context of this collective transmission, physical 381 contact was introduced in the relationships between colleagues who agreed in engaging in the project. Myriam Lefowitz taught the members of the team a series of exercises in order to warm their bodies up, implicating an exploration of diferent modes of con tact and touch, trying to demonstrate the possibility to move beyond the habitual limits set by the physical contours of our bodies. The collective engagement with Lefowitz’s practice, and the sharing of a similar place and role within the context of her work, meant that there was a crucial movement in regards to our diferent professional functions in the context of the art centre. We alternatively received and per formed the work within the framework of the group. It allowed a very diferent space to emerge, separate from the habitual professional space and set of relationships. It helped making visible individual desires and skills that could not habitually fnd ways to be articulated. Be my body for me the practice that Myriam Lefowitz names How can one know in such darkness? In that sense, and in my view, it falls under the fabulous realm of passivity, which can be defned as a mode of 382 being that does not let itself be appropriated by the in dividual subject and can only be conceived as a mode of relating: it characterizes a mode of being in the world, immersed in a complex set of relationships with bodies — subjects, objects, as well as other possible modes of existence — and exposes their diference. Passivity thus encourages us to take into consideration the gap and the movement that ceaselessly deviates us from individual entities in order to think of relations and of difer ence. Jean-Luc Nancy, Mikkel Borch-Jacobsen and Eric Michaud wrote in an introduction to the series of essays titled Hypnoses: “What is at stake, we will see, is passion, if not “the frst of all passions”, or passivity. It is not a property, passivity is improper and accidental — properly and by essence. Something crucial in Myriam Lefowitz’s approach of dance, and more broad ly of her practice as an artist borrowing from various disciplines, assembling diferent tools, is the refusal of claiming something as her own. On the contrary, cen tral to her approach are gestures of sharing, transmit ting, passing on, which converge towards a questioning of what might be common: neither public, nor private, but a resource that can be used, and cared for, in order to be prolonged in time and space. The signifcance granted by Lefowitz to this particular context of trans 383 mission recalls the centrality of the practice of teaching in the work of choreographers Jennifer Lacey and Alice Chauchat, whose mutual commitment to the creation of collaborative structures such as Nobod’s Business (initi ated together with Eleanor Bauer and Ellen Söderhult), Teachback next to open invitations to daily practices and creation processes such as Lacey’s “Les Assistantes” as contexts for sharing techniques and practices consti tute fundamental points of reference in Lefowitz’s own trajectory. Friendship and companionship are central modes of relating in the work of Jennifer Lacey, Alice Chauchat or Myriam Lefowitz. It seems fundamental to acknowledge that the mean ing of companionship goes beyond the idea of working together. In her writing, Chauchat brings forward the fgure of the lady’s companion, which “points to the dancer’s labour as one of attention, perception, entering a relational mode that hosts not-knowing and blind approximation as necessary eforts. Judith Butler, in a conversation with Athéna Athanasiou, writes : “In a world of diferentially shared sociality, if we are already ‘outside ourselves’, beyond ourselves, given over, bound to others, and bound by claims that emerge from outside or from deep inside ourselves; our very notion of responsibility requires this sense of 384 dispossession as disposition, exposure and self-other ing. In the context of my own curatorial practice, the ap proach put forward by Myriam Lefowitz stressed a convergence of concerns, more specifcally concerning issues of property and sovereignty that are central to the defnition of authorship in neo-liberal conditions, which forcefully apply in artistic contexts. Through the use of the term ‘passivity’ in the framework of curatorial practice, I attempt to name a regime of attention and of action that embraces the empathetic desire to engage with a specifc artistic practice and allow it to afect and alter the curator’s position. Curatorial passivity thus describes the disruption, displacement and disposses sion of disciplined professional expectations. Engaging with the work Myriam Lefowitz helped carrying out such displacement and disruption of curatorial practice. Instead, it is meant to indicate the generality of the terms in which we will discuss the prob lem. Dance is one art form among many others; thus, we need to locate it in a wider aesthetic discussion. A good place to start is with Immanuel Kant’s Critique of Judgment, which even at a distance of more than two centuries remains unsurpassed in its infuence on aesthetic theory. As far as I can recall, dance is only1 mentioned twice in this masterwork: once in con nection with the important topic of charm, and again when Kant discusses the hybrid fusion of genres found in certain types of art. Let’s begin by quoting both passag es, given in a somewhat lengthy form to make sure we are aware of the context of Kant’s references to dance. Any difculty the reader might experience in following them now will be remedied by our ensuing treatment of both; this article will not be a close reading of Kant’s mammoth text, but will simply use these two passages 388 as wood for the freplace. In any event, the frst passage runs as follows: All forms of objects of the senses (the outer senses or, indirectly, the inner sense as well) is either shape or play; if the latter, it is either play of shapes (in space, namely, mimetic art and dance), or mere play of sensations (in time). The charm of colors or of the agreeable tone of an instrument may be added, but it is the design in the frst case [i. For all they do is make the form intuitable more precisely, determinately, and completely, while they also enliven the presentation by means of their charm, by arousing and sustaining the attention we direct toward the object itself. Moreover, the exhibition of the sublime may, insofar as it belongs to fne art, be combined with beauty in a tragedy in verse, in a didactic poem, or in an orato rio; and in these combinations fne art is even more artistic. But whether it is also more beautiful (given how great a variety of diferent kinds of liking cross one another) may in some of these cases be doubted. But what is essential in all fne art is the form that is purposive for our observation and judging, rather than the matter of sensation. For the pleasure we take in purposive form is also culture, and it attunes the spirit to ideas, and so makes it receptive to more such pleasure and entertainment; in the case of the matter of sensation, however, the aim is merely enjoyment, which leaves nothing behind as an idea and makes the spirit dull, the object gradually disgusting, and the mind dissatisfed with itself and moody because it is conscious that in reason’s judgment its attunement is contrapurposive. By “object” I mean not just solid material entities, but anything that has a reality irreducible either downward to its pieces or upward to its appearances and efects. Consider the example of a table, which I once discussed at length in a catalog essay for the 2012 Documenta art festival. In one sense, the table needs to have parts,5 ranging in size from its legs and single top surface, on down to the granular patterns of its wood, and ultimate ly to the organic molecules of which it is composed, as well as the even smaller particles—known and still unknown—of which the wood of the table consists. All that exists are the ultimate particles or felds or other elements from which the table is made. None of these thinkers was satisfed with talking about mid-sized everyday objects. Instead, all tried to identify the ultimate physical roots of which everything is made: water, air, a combination of air-earth-fre-water, or indivisible atoms, depending 391 on which thinker we consider. The problem is that even if the table apparently needs some physical materials in order to exist, the table cannot be identifed with some micro-layer of ultimate elements. Because within certain vaguely defned limits, we can replace many of the table’s pieces without changing the table. It hardly matters if this piece of furniture loses a few thousand atoms here and there, or adds bits of mud and sand to its surface over the course of time. There are cases where undermining is very useful: throughout most of the sciences, for instance. Undermining is an essential type of human knowledge that helps us greatly, but the table is not the same thing as its underlying tiny elements. From this standpoint, the table is a table through its various uses, from its exact positioning by an interior decorator, or by the visual impression it leaves on us. This too is an important form of knowl edge about objects, one that the human race cannot do 392 without. If we claim that the table is nothing more than what it does, we are ignoring the fact that it might do other things at other times, including new things that it has never done be fore in human history, and might even do nothing at all for long stretches of history before eventually becoming an important item for someone once again. Overmining fails because the table is no more identical with its actions than with its tiny components. The table is a surplus lying beneath its various actions, since only this assumption makes sense of the indeterminate future history of every object. Except for certain philosophers who heavily stress ei ther the undermined or overmined versions of objects, most people are well aware that objects can be consid ered both in terms of their composition and in terms of their use and their efects more generally. For scientifc pur poses, we usually analyze the physical composition of things; for everyday needs we do the opposite, and treat the thing as a sum total of uses and efects. The problem with this assumption is that it merely compounds the errors found in undermining and over mining taken individually. The underminer missed the emergence of objects over and above their pieces, and 393 the overminer missed the submergence of objects under and beneath their current efects. The duominer com bines both of these defciencies simultaneously, merely distracting us from this difculty through its facility in swinging between one extreme and the other. This is no petty problem, and for a simple reason: every form of knowledge either undermines, overmines, or duomines.

Immunity to one serotype does not produce signifcant immunity to the other serotypes erectile dysfunction pump amazon cheap viagra soft online master card. Poliovirus infections among immunized laboratory workers are uncommon but remain undetermined in the absence of laboratory confrmation erectile dysfunction teenager purchase viagra soft 50mg online. An immunized laboratory worker may unknowingly be a source of poliovirus transmission to unvaccinated persons in the community erectile dysfunction scrotum pump buy viagra soft mastercard. Transmission of wild poliovirus ceased in the United States in 1979 erectile dysfunction natural remedies over the counter herbs purchase viagra soft 50 mg overnight delivery, or possibly earlier erectile dysfunction doctors in nj generic viagra soft 50mg on line. A polio eradication program conducted by the Pan American Health Organization led to elimination of polio from the Western Hemisphere in 1991 erectile dysfunction caused by fatigue cheap viagra soft 100mg on line. The Global Polio Eradication Program has dramatically reduced poliovirus transmission throughout the world. Humans are the only known reservoir of poliovirus, which is transmitted most frequently by persons with unapparent infections. Person-to-person spread of poliovirus via the fecal-oral route is the most important route of transmission, although the oral-oral route may account for some cases. Laboratory Safety and Containment Recommendations the agent is present in the feces and in throat secretions of infected persons and in lymph nodes, brain tissue, and spinal cord tissue in fatal cases. For non immunized persons in the laboratory, ingestion or parenteral inoculation are the primary routes of infection. For immunized persons, the primary risks are the same, except for parenteral inoculation, which likely presents a lower risk. Laboratory animal-associated infections have not been reported, but infected nonhuman primates should be considered to present a risk. Laboratory personnel working with such materials must have documented polio vaccination. Safety recommendations are subject to change based on international polio eradication activities. Poxviruses Four genera of the subfamily Chordopoxvirinae, family Poxviridae, (Orthopoxvirus, Parapoxvirus, Yatapoxvirus, and Molluscipoxvirus) contain species that can cause lesions on human skin or mucous membranes with mild to severe systemic rash illness in laboratorians. In addition, vaccination with live vaccinia virus sometimes has side effects, which range from mild events. Importation of African rodents into North America in 2003 resulted in an outbreak of monkeypox in humans. Sources of laboratory-acquired infection include exposure to aerosols, environmental samples, naturally or experimentally infected animals, infectious cultures, or clinical samples, including vesiculopustular rash lesion fuid or crusted scabs, various tissue specimens, excretions and respiratory secretions. Vaccination is advised every three years for work with monkeypox virus and every 10 years for cowpox and vaccinia viruses (neither vaccination nor vaccinia immunoglobulin protect against poxviruses of other genera). Vaccination is not required for individuals working only in laboratories where no other orthopoxviruses or recombinants are handled. Members of the group include Australian bat lyssavirus, Duvenhage virus, European bat lyssavirus1, European bat lyssavirus2, Lagos bat virus, and Mokola virus. Both resulted from presumed exposure to high concentrations of infectious aerosols, one generated in a vaccine production facility,78 and the other in a research facility. Natural Modes of Infection the natural hosts of rabies are many bat species and terrestrial carnivores, but most mammals can be infected. The saliva of infected animals is highly infectious, and bites are the usual means of transmission, although infection through superfcial skin lesions or mucosa is possible. The most likely sources for exposure of laboratory and animal care personnel are accidental parenteral inoculation, cuts, or needle sticks with contaminated laboratory equipment, bites by infected animals, and exposure of mucous membranes or broken skin to infectious tissue or fuids. Infectious aerosols have not been a demonstrated hazard to personnel working with routine clinical materials or conducting diagnostic examinations. Fixed and attenuated strains of virus are presumed to be less hazardous, but the two recorded cases of laboratory-associated rabies resulted from presumed exposure to the fxed Challenge Virus Standard and Street Alabama Dufferin strains, respectively. Pre-exposure rabies vaccination is recommended for all individuals prior to working with lyssaviruses or infected animals, or engaging in diagnostic, production, or research activities with these viruses. Prompt administration of postexposure booster vaccinations is recommended following recognized exposures in previously vaccinated individuals per current guidelines. If a Stryker saw is used to open the skull, avoid contacting brain tissue with the blade of the saw. Cases reported in these two systems are classifed as either documented or possible occupational transmission. Though no specifc incident was recalled, this worker had dermatitis on the forearms and hands while working with the infected blood specimens. To date there is no evidence of illness or immunological incompetence in any of these workers. Natural Modes of Infection Retroviruses are widely distributed as infectious agents of vertebrates. Within the human population, spread is by close sexual contact or parenteral exposure through blood or blood products. This also reduces the potential for exposure to other microorganisms that may cause other types of infections. Limited data exist on the concentration of virus in semen, saliva, cervical secretions, urine, breast milk, and amniotic fuid. Needles, sharp instruments, broken glass, and other sharp objects must be carefully handled and properly discarded. Care must be taken to avoid spilling and splashing infected cell-culture liquid and other potentially infected materials. Asian countries, North America, South America, and Europe following major airline routes. The majority of disease spread occurred in hospitals, among family members and contacts of hospital workers. Review of probable cases indicates that the shortness of breath sometimes rapidly progresses to respiratory failure requiring ventilation. Laboratory-acquired infections in China during 2004 demonstrated secondary and tertiary spread of the disease to close contacts and healthcare providers of one of the employees involved. All personnel who use respiratory protective devices should be enrolled in an appropriately constituted respiratory protection program. Work surfaces should be decontaminated upon completion of work with appropriate disinfectants. The worker and the supervisor, in consultation with occupational health or infection control personnel, should evaluate the break in procedure to determine if an exposure occurred (see Special Issues, below). They should be evaluated for possible exposure and the clinical features and course of their illness should be closely monitored. The plan, at a minimum, should contain procedures for managing: identifable breaks in laboratory procedures; exposed workers without symptoms; exposed workers who develop symptoms within ten days of an exposure; and symptomatic laboratory workers with no recognized exposure. Laboratory rat associated outbreak of haemorrhagic fever with renal syndrome due to Hantaan-like virus in Belgium. Laboratory management of agents associated with hantavirus pulmonary syndrome: interim biosafety guidelines. Genetic identifcation of a new hantavirus causing severe pulmonary syndrome in Argentina. Hantavirus pulmonary syndrome outbreak in Argentina: molecular evidence for person-to-person transmission of Andes virus. Genetic identifcation of a hantavirus associated with an outbreak of acute respiratory illness. The retrospective diagnosis of a second outbreak of equine morbillivirus infection. Investigation of a second focus of equine morbillivirus infection in coastal Queensland. Transmission studies of Hendra virus (equine morbillivirus) in fruit bats, horses and cats. Sequence analysis of the Hendra virus nucleoprotein gene comparison with other members of the subfamily paramyxovirinae. Serologic evidence for the presence in Pteropus bats of a paramyxovirus related to equine morbillivirus. Nipah virus infection: pathology and pathogenesis of an emerging paramyxoviral zoonosis. The presence of Nipah virus in respiratory secretions and urine of patients during an outbreak of Nipah virus encephalitis in Malaysia. A cohort study of health care workers to assess nosocomial transmissibility of Nipah virus, Malaysia, 1999. Recommendations for follow-up of healthcare workers after occupational exposure to hepatitis C virus. Recommendations for prevention of and therapy for exposure to B virus (Cercopithecine herpesvirus 1). Fatal cercopithecine herpesvirus 1 (B virus) infection following a muccutaneous exposure and Interim Recommendations for worker protection. Committee on Occupational Health and Safety in the Care and Use of Non Human Primates. Guidelines for prevention of Herpesvirus simiae (B virus) infection in monkey handlers. Transmission of human herpesvirus 8 infection from renal transplant donors to recipients. Human herpesvirus 8-associated diseases in solid-organ transplantation: importance of viral transmission from the donor. Human herpes 8 infection and transfusion history in children with sickle-cell disease in Uganda. Detection of antibodies to human herpesvirus 8 in Italian children: evidence for horizontal transmission. A nosocomial outbreak of infuenza during a period without infuenza epidemic activity. Laboratory studies of a lymphocytic choriomeningitis virus outbreak in man and laboratory animals. Lymphocytic choriomeningitis virus infection in organ transplant recipients: Massachusetts, Rhode Island, 2005. Congenital lymphocytic choriomeningitis virus syndrome: a disease that mimics congenital toxoplasmosis or Cytomegalovirus infection. Genetic analysis of wild type poliovirus importation into the Netherlands (1979-1995). Risk of occupational exposure to potentially infectious nonhuman primate materials and to simian immunodefciency virus. Update: universal precautions for prevention of transmission of human immunodefciency virus, hepatitis B virus and other bloodborne pathogens in healthcare settings. These recommendations are based, in part, on risk assessments derived from information provided by a worldwide survey of laboratories working with arboviruses, new published reports on the viruses, as well as discussions with scientists working with each virus. In addition, many of the organisms are classifed as select agents and require special security measures to possess, use, or transport. They were submitted by a panel of experts for more detailed consideration due to one or more of the following factors: at the time of writing this edition, the organism represented an emerging public health threat in the United States; the organism presented unique biocontainment challenge(s) that required further detail; and the organism presented a signifcant risk of laboratory-acquired infection. These recommendations were made in August 2005; requirements for biosafety, shipping, and select agent registration can change. A lower level may be recommended for variants with well-defned reduced virulence characteristics. A7 Placed at this biosafety level based on close antigenic or genetic relationship to other viruses in a group of 3 or more viruses, all of which are classifed at this level. This indicates a) no overt laboratory-associated infections are reported, b) infections resulted from exposures other than by infectious aerosols, or c) if disease from aerosol exposure is documented, it is uncommon. The primary laboratory hazards comprise accidental parenteral inoculation, contact of the virus with broken skin or mucous membranes, and bites of infected laboratory rodents or arthropods. Large quantities and/or high concentrations of any virus have the potential to overwhelm both innate immune mechanisms and vaccine-induced immunity. The primary laboratory hazards are exposure to aerosols of infectious solutions and animal bedding, accidental parenteral inoculation, and contact with broken skin. A licensed attenuated live virus is available for immunization against yellow fever. It is recommended for all personnel who work with this agent or with infected animals, and those entering rooms where the agents or infected animals are present. The use of investigational vaccines for laboratory personnel should be considered if the vaccine is available. Initial studies have shown the vaccine to be effective in producing an appropriate immunologic response, and the adverse effects of vaccination are within acceptable parameters. The decision to recommend vaccines for laboratory personnel must be carefully considered and based on an risk assessment which includes a review of the characteristics of the agent and the disease, benefts versus the risk of vaccination, the experience of the laboratory personnel, laboratory procedures to be used with the agent, and the contraindications for vaccination including the health status of the employee. If the investigational vaccine is contraindicated, does not provide acceptable reliability for producing an immune response, or laboratory personnel refuse vaccination, the use of appropriate personal protective equipment may provide an alternative. Any respiratory protection equipment must be provided in accordance with the institution’s respiratory protection program. Other degrees of respiratory protection may be warranted based on an assessment of risk as defned in Chapter 2 of this manual. All personnel in a laboratory with the infectious agent must use comparable personal protective equipment that meets or exceeds the requirements, even if they are not working with the organism. Additional appropriate training for all animal care personnel should be considered. Respiratory exposure to infectious aerosols, mucous membrane exposure to infectious droplets, and accidental parenteral inoculation are the primary hazards to laboratory or animal care personnel.

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