![Report on the Deliberation Results April 27, 2012 Evaluation and](http://s1.studyres.com/store/data/017624133_1-51336c17188e4bead5b208b8c3483340-300x300.png)
Report on the Deliberation Results April 27, 2012 Evaluation and
... 2 diabetes mellitus has been demonstrated and its safety is acceptable in view of its observed benefits. Safety information on hypoglycemia, gastrointestinal disorder, pancreatitis, hepatic impairment, etc., as well as the safety and efficacy in patients with renal impairment, patients with hepatic ...
... 2 diabetes mellitus has been demonstrated and its safety is acceptable in view of its observed benefits. Safety information on hypoglycemia, gastrointestinal disorder, pancreatitis, hepatic impairment, etc., as well as the safety and efficacy in patients with renal impairment, patients with hepatic ...
November 2015 – Positive Recommendations (Word 80KB)
... (Minor Submission) AFLIBERCEPT 40 mg/mL solution for intravitreal injection. The injection volume is 50µL (equivalent to 2mg aflibercept) / Single-use vial or prefilled syringe / 1 single-use vial in a carton or pre-filled syringe in a blister pack. Eylea® ...
... (Minor Submission) AFLIBERCEPT 40 mg/mL solution for intravitreal injection. The injection volume is 50µL (equivalent to 2mg aflibercept) / Single-use vial or prefilled syringe / 1 single-use vial in a carton or pre-filled syringe in a blister pack. Eylea® ...
data sheet
... Use in Children: Pallidone is not recommended for use in children less than 18 years of age since documented clinical experience has been insufficient to establish a suitable dosage regimen. Furthermore, children are particularly sensitive to the respiratory and central nervous system effects of met ...
... Use in Children: Pallidone is not recommended for use in children less than 18 years of age since documented clinical experience has been insufficient to establish a suitable dosage regimen. Furthermore, children are particularly sensitive to the respiratory and central nervous system effects of met ...
Aricept
... Most Common Adverse Reactions The most common adverse reactions, defined as those occurring at a frequency of at least 5% in patients receiving 10 mg/day and twice the placebo rate, are largely predicted by ARICEPT’s cholinomimetic effects. These include nausea, diarrhea, insomnia, vomiting, muscle ...
... Most Common Adverse Reactions The most common adverse reactions, defined as those occurring at a frequency of at least 5% in patients receiving 10 mg/day and twice the placebo rate, are largely predicted by ARICEPT’s cholinomimetic effects. These include nausea, diarrhea, insomnia, vomiting, muscle ...
Aricept
... Most Common Adverse Reactions The most common adverse reactions, defined as those occurring at a frequency of at least 5% in patients receiving 10 mg/day and twice the placebo rate, are largely predicted by ARICEPT’s cholinomimetic effects. These include nausea, diarrhea, insomnia, vomiting, muscle ...
... Most Common Adverse Reactions The most common adverse reactions, defined as those occurring at a frequency of at least 5% in patients receiving 10 mg/day and twice the placebo rate, are largely predicted by ARICEPT’s cholinomimetic effects. These include nausea, diarrhea, insomnia, vomiting, muscle ...
[FDA Approved Labeling for Zoloft® for the Treatment of Social... Attachment to FDA Approval Letter for NDA 19-839/S-045]
... multicenter, placebo-controlled, parallel group study in a pediatric outpatient population (children and adolescents, ages 6-17). Patients receiving ZOLOFT in this study were initiated at doses of either 25 mg/day (children, ages 6-12) or 50 mg/day (adolescents, ages 13-17), and then titrated over t ...
... multicenter, placebo-controlled, parallel group study in a pediatric outpatient population (children and adolescents, ages 6-17). Patients receiving ZOLOFT in this study were initiated at doses of either 25 mg/day (children, ages 6-12) or 50 mg/day (adolescents, ages 13-17), and then titrated over t ...
Inhaled synthetic surfactant abolishes the early allergen-induced response in asthma K.S. Babu
... clinical trial was restarted. Consequently, the data presented in this paper are of the seven subjects subsequently treated postmechanical failure, all of whom are reported in this study, and who had complete and evaluable data, and had received full doses of the study medication. The study was appr ...
... clinical trial was restarted. Consequently, the data presented in this paper are of the seven subjects subsequently treated postmechanical failure, all of whom are reported in this study, and who had complete and evaluable data, and had received full doses of the study medication. The study was appr ...
NEW ZEALAND DATA SHEET TOPIRAMATE ACTAVIS 15, 25, 50
... Use in patients undergoing haemodialysis Topiramate is cleared by haemodialysis. To avoid rapid reduction in topiramate plasma concentration during haemodialysis, a supplemental dose of topiramate equal to approximately one-half the daily dose should be administered on hemodialysis days. The supple ...
... Use in patients undergoing haemodialysis Topiramate is cleared by haemodialysis. To avoid rapid reduction in topiramate plasma concentration during haemodialysis, a supplemental dose of topiramate equal to approximately one-half the daily dose should be administered on hemodialysis days. The supple ...
London 2012 Paralympic Games Pharmacy Guide
... clinical use of medicines in a clear, concise and accessible manner. The BNF is designed for prescribers, pharmacists and other healthcare professionals, situated within the United Kingdom. The Publisher works to ensure that the information provided in the BNF is accurate and up-to-date as at the da ...
... clinical use of medicines in a clear, concise and accessible manner. The BNF is designed for prescribers, pharmacists and other healthcare professionals, situated within the United Kingdom. The Publisher works to ensure that the information provided in the BNF is accurate and up-to-date as at the da ...
Adenosine Injection, USP
... Clinical studies of injected adenosine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, ...
... Clinical studies of injected adenosine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, ...
VetyFormula2009
... Parts per million (ppm): This is the way of expressing strength particularly concentrations of very dilute preparations. A 1 ppm solution contains one part of the solute in one million parts of solution. It is important that two parts must have same units except in metric system where 1gm = 1ml. Int ...
... Parts per million (ppm): This is the way of expressing strength particularly concentrations of very dilute preparations. A 1 ppm solution contains one part of the solute in one million parts of solution. It is important that two parts must have same units except in metric system where 1gm = 1ml. Int ...
HIGHLIGHTS OF PRESCRIBING INFORMATION
... Pseudomembranous colitis has been reported with nearly all antibacterial agents, including clarithromycin and amoxicillin, and may range in severity from mild to life threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administra ...
... Pseudomembranous colitis has been reported with nearly all antibacterial agents, including clarithromycin and amoxicillin, and may range in severity from mild to life threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administra ...
RISPERDAL
... 3 mg per day. Although efficacy has been demonstrated in studies of adolescent patients with schizophrenia at doses between 1 mg to 6 mg per day, no additional benefit was observed above 3 mg per day, and higher doses were associated with more adverse events. Doses higher than 6 mg per day have no ...
... 3 mg per day. Although efficacy has been demonstrated in studies of adolescent patients with schizophrenia at doses between 1 mg to 6 mg per day, no additional benefit was observed above 3 mg per day, and higher doses were associated with more adverse events. Doses higher than 6 mg per day have no ...
MORPHINE Juno
... tissue such as the kidneys, lungs, liver and spleen. Lower concentrations are found in skeletal muscle and brain tissue. Morphine diffuses across the placenta and trace amounts are found in sweat and breast milk. Only small quantities of morphine cross the blood brain barrier. About 35% is protein b ...
... tissue such as the kidneys, lungs, liver and spleen. Lower concentrations are found in skeletal muscle and brain tissue. Morphine diffuses across the placenta and trace amounts are found in sweat and breast milk. Only small quantities of morphine cross the blood brain barrier. About 35% is protein b ...
BREVIBLOC [Injection esmolol hydrochloride]
... If treatment is considered, the uteroplacental blood flow should be monitored because beta blockers may reduce placental perfusion. Use of BREVIBLOC products in the second or third trimester of pregnancy or during labor or delivery has been reported to cause fetal bradycardia, which continued after ...
... If treatment is considered, the uteroplacental blood flow should be monitored because beta blockers may reduce placental perfusion. Use of BREVIBLOC products in the second or third trimester of pregnancy or during labor or delivery has been reported to cause fetal bradycardia, which continued after ...
Commentary: Reproductive Risks of Leflunomide (ArravaR
... After single doses of leflunomide to healthy subjects, peak plasma concentrations of the active metabolite were approached between 6 and 12 hours. Plasma concentrations then declined monoexponentially, with a half-life of approximately 8 days. Based on determination of the active metabolite, the bio ...
... After single doses of leflunomide to healthy subjects, peak plasma concentrations of the active metabolite were approached between 6 and 12 hours. Plasma concentrations then declined monoexponentially, with a half-life of approximately 8 days. Based on determination of the active metabolite, the bio ...
AusPAR: Vernakalant - Therapeutic Goods Administration
... Brinavess should be administered in a monitored clinical setting appropriate for cardioversion. Brinavess is administered based on patient body weight. The standard recommended dose is 3 mg/kg to be infused over a 10 minute period. If conversion to sinus rhythm does not occur within 15 minutes after ...
... Brinavess should be administered in a monitored clinical setting appropriate for cardioversion. Brinavess is administered based on patient body weight. The standard recommended dose is 3 mg/kg to be infused over a 10 minute period. If conversion to sinus rhythm does not occur within 15 minutes after ...
Buprenorphine dosing every 1, 2, or 3 days in opioid
... Calif., USA). Samples also were analyzed for the presence of barbiturates, benzodiazepines, cannabinoids, and cocaine on one randomly selected scheduled urinalysis day each week. If a subject submitted an opioid-positive urine sample, no medication was provided for that day, and data collected since ...
... Calif., USA). Samples also were analyzed for the presence of barbiturates, benzodiazepines, cannabinoids, and cocaine on one randomly selected scheduled urinalysis day each week. If a subject submitted an opioid-positive urine sample, no medication was provided for that day, and data collected since ...
Studies on PJP prophylaxis efficacy
... either the background risk of PJP or the efficacy of prophylaxis. Unknown number of cases within the NHL group with PCP diagnosed by throat swab only, and no clinical symptoms. This implies carriage and not disease therefore the study is unreliable and cannot be used to determine a PCP rate for NHL ...
... either the background risk of PJP or the efficacy of prophylaxis. Unknown number of cases within the NHL group with PCP diagnosed by throat swab only, and no clinical symptoms. This implies carriage and not disease therefore the study is unreliable and cannot be used to determine a PCP rate for NHL ...
19529550 Albuterol PI
... maintaining FEV1 values 15% or more above baseline) which was still apparent at 6 hours. Continued effectiveness of albuterol was demonstrated over a 13-week period in these same trials. In clinical studies, 2 inhalations of albuterol taken approximately 15 minutes prior to exercise prevented exerci ...
... maintaining FEV1 values 15% or more above baseline) which was still apparent at 6 hours. Continued effectiveness of albuterol was demonstrated over a 13-week period in these same trials. In clinical studies, 2 inhalations of albuterol taken approximately 15 minutes prior to exercise prevented exerci ...
Pediatric allergic rhinitis: Factors affecting treatment
... can be taken to reduce the allergen load. Aggressive cleaning––particularly of carpets, curtains, and bedding––can be effective. However, the efficacy of nonallergenic bedcovering products is still questionable; whereas some studies have shown that they are associated with a reduction in allergic rhi ...
... can be taken to reduce the allergen load. Aggressive cleaning––particularly of carpets, curtains, and bedding––can be effective. However, the efficacy of nonallergenic bedcovering products is still questionable; whereas some studies have shown that they are associated with a reduction in allergic rhi ...
Acne management Acne Acne severity Treatment of Acne
... 2. depresses sebum excretion by 70%, 3. anti-inflammatory, 4. reduces P acnes. ...
... 2. depresses sebum excretion by 70%, 3. anti-inflammatory, 4. reduces P acnes. ...
Ofloxacin
Ofloxacin is a synthetic antibiotic of the fluoroquinolone drug class considered to be a second-generation fluoroquinolone.Ofloxacin was first patented in 1982 (European Patent Daiichi) and received approval from the U.S. Food and Drug Administration (FDA) on December 28, 1990. Ofloxacin is sold under a wide variety of brand names as well as generic drug equivalents, for oral and intravenous administration. Ofloxacin is also available for topical use, as eye drops and ear drops (marketed as Ocuflox and Floxin Otic respectively in the United States and marketed as Optiflox, eylox respectively in Jordan and Saudi Arabia).Ofloxacin is a racemic mixture, which consists of 50% levofloxacin (the biologically active component) and 50% of its “mirror image” or enantiomer dextrofloxacin.Ofloxacin has been associated with adverse drug reactions, such as tendon damage (including spontaneous tendon ruptures) and peripheral neuropathy (which may be irreversible); tendon damage may manifest long after therapy had been completed, and, in severe cases, may result in lifelong disabilities.