Israel - English - Ministry of Health

rafa laboratories ltd - brotizolam - tablets - brotizolam 0.25 mg - brotizolam - brotizolam - treatment of insomnia.

United States - English - NLM (National Library of Medicine)

pfizer laboratories div pfizer inc - varenicline tartrate (unii: 82269asb48) (varenicline - unii:w6hs99o8zo) - varenicline 0.5 mg - chantix is indicated for use as an aid to smoking cessation treatment. chantix is contraindicated in patients with a known history of serious hypersensitivity reactions or skin reactions to chantix. risk summary available data have not suggested an increased risk for major birth defects following exposure to varenicline in pregnancy, compared with women who smoke [see data]. smoking during pregnancy is associated with maternal, fetal, and neonatal risks (see clinical considerations) . in animal studies, varenicline did not result in major malformations but caused decreased fetal weights in rabbits when dosed during organogenesis at exposures equivalent to 50 times the exposure at the maximum recommended human dose (mrhd). additionally, administration of varenicline to pregnant rats during organogenesis through lactation produced developmental toxicity in offspring at maternal exposures equivalent to 36 times human exposure at the mrhd [see data] . the estimated background risk of oral clefts is increased by

United States - English - NLM (National Library of Medicine)

dr.reddy's laboratories limited - montelukast sodium (unii: u1o3j18sfl) (montelukast - unii:mhm278sd3e) - montelukast 10 mg - montelukast sodium is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 2 years of age and older. montelukast sodium is indicated for prevention of exercise-induced bronchoconstriction (eib) in patients 6 years of age and older. montelukast sodium is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 2 years of age and older. because the benefits of montelukast sodium may not outweigh the risk of neuropsychiatric symptoms in patients with allergic rhinitis [see warnings and precautions ( 5.1)], reserve use for patients who have an inadequate response or intolerance to alternative therapies. montelukast sodium is not indicated for the treatment of an acute asthma attack. montelukast sodium is contraindicated in patients with hypersensitivity to any of its components. risk summary available data from published prospective and retrospective cohort studies over decades with

United States - English - NLM (National Library of Medicine)

prasco laboratories - montelukast sodium (unii: u1o3j18sfl) (montelukast - unii:mhm278sd3e) - montelukast 4 mg - montelukast sodium oral granules are indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older. montelukast sodium oral granules are indicated for prevention of exercise-induced bronchoconstriction (eib) in patients 6 years of age and older. montelukast sodium oral granules are indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 6 months of age and older. because the benefits of montelukast sodium may not outweigh the risk of neuropsychiatric symptoms in patients with allergic rhinitis [see warnings and precautions (5.1)] , reserve use for patients who have an inadequate response or intolerance to alternative therapies. - hypersensitivity to any component of this product. risk summary available data from published prospective and retrospective cohort studies over decades with montelukast use in pregnant women have not established a drug-associated risk

United States - English - NLM (National Library of Medicine)

novel laboratories, inc. - phenelzine sulfate (unii: 2681d7p965) (phenelzine - unii:o408n561gf) - phenelzine 15 mg - phenelzine sulfate tablets, usp has been found to be effective in depressed patients clinically characterized as “atypical,” “nonendogenous,” or “neurotic.” these patients often have mixed anxiety and depression and phobic or hypochondriacal features. there is less conclusive evidence of its usefulness with severely depressed patients with endogenous features. phenelzine sulfate tablets should rarely be the first antidepressant drug used. rather, it is more suitable for use with patients who have failed to respond to the drugs more commonly used for these conditions. phenelzine sulfate tablets should not be used in patients who are hypersensitive to the drug or its ingredients, with pheochromocytoma, congestive heart failure, severe renal impairment or renal disease, a history of liver disease, or abnormal liver function tests. the potentiation of sympathomimetic substances and related compounds by mao inhibitors may result in hypertensive crises (see warnings). therefore, patients being treated with phenelzi

United States - English - NLM (National Library of Medicine)

caraco pharmaceutical laboratories, ltd. - clonazepam (unii: 5pe9fde8gb) (clonazepam - unii:5pe9fde8gb) - clonazepam 0.5 mg - seizure disorders: clonazepam tablets usp are useful alone or as an adjunct in the treatment of the lennox-gastaut syndrome (petit mal variant), akinetic and myoclonic seizures. in patients with absence seizures (petit mal) who have failed to respond to succinimides, clonazepam tablets may be useful. in some studies, up to 30% of patients have shown a loss of anticonvulsant activity, often within 3 months of administration. in some cases, dosage adjustment may reestablish efficacy. panic disorder: clonazepam tablets usp are indicated for the treatment of panic disorder, with or without agoraphobia, as defined in dsm-iv. panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. the efficacy of clonazepam tablets usp were established in two 6- to 9-week trials in panic disorder patients whose diagnoses correspon

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

tillomed laboratories ltd - citalopram hydrobromide - oral tablet - 20mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

bristol laboratories ltd - citalopram hydrobromide - oral tablet - 10mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

bristol laboratories ltd - citalopram hydrobromide - oral tablet - 20mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

bristol laboratories ltd - fluoxetine hydrochloride - oral capsule - 20mg