مالطا - الإنجليزية - Medicines Authority

abbvie limited citywest business campus, dublin 24, ireland - powder for solution for injection - botulinum toxin type a 100 allergan units/0.1 millilitre - muscle relaxants

مالطا - الإنجليزية - Medicines Authority

abbvie limited citywest business campus, dublin 24, ireland - powder for solution for injection - botulinum toxin type a 50 allergan units/0.1 millilitre - muscle relaxants

مالطا - الإنجليزية - Medicines Authority

abbvie limited citywest business campus, dublin 24, ireland - powder for solution for injection - botulinum toxin type a 200 allergan units/0.1 millilitre - muscle relaxants

أستراليا - الإنجليزية - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - trimeprazine tartrate -

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

allergan, inc. - estradiol acetate (unii: 5r97f5h93p) (estradiol - unii:4ti98z838e) - estradiol 0.05 mg in 1 d - femring is contraindicated in women with any of the following conditions: - undiagnosed abnormal genital bleeding - known, suspected, or history of breast cancer - known or suspected estrogen-dependent neoplasia - active dvt, pe, or history of these conditions - active arterial thromboembolic disease (for example, stroke and mi), or a history of these conditions - known anaphylactic reaction or angioedema to femring - known liver impairment or disease  - known protein c, protein s, or antithrombin deficiency, or other known thrombophilic disorders - known or suspected pregnancy  femring should not be used during pregnancy [ see   contraindications (4) ] . there appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins as an oral contraceptive inadvertently during early pregnancy. femring should not be used during lactation. estrogen administration to nursing women has been shown to decrease the quantity and quality of the breast milk. detectabl

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

allergan, inc. - norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norethindrone acetate 1 mg - lo minastrin fe is indicated for use by females of reproductive age to prevent pregnancy [ see clinical studies (14) ] .  the efficacy of lo minastrin fe in women with a body mass index (bmi) of more than 35 kg/m2 has not been evaluated. do not prescribe lo minastrin fe to women who are known to have the following conditions: - a high risk of arterial or venous thrombotic diseases. examples include women who are known to: • smoke, if over age 35 [see boxed warning and  warnings and precautions (5.1) ] • have deep vein thrombosis or pulmonary embolism, now or in the past [see warnings and precautions (5.1) ] • have cerebrovascular disease [see warnings and precautions (5.1) ] • have coronary artery disease [see warnings and precautions (5.1) ] • have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see warnings and precautions (5.1) ] • have inherited or acquired hypercoagulop

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

allergan, inc. - nebivolol hydrochloride (unii: jgs34j7l9i) (nebivolol - unii:030y90569u) - nebivolol 5 mg - byvalson is indicated for the treatment of hypertension, to lower blood pressure. lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including the β-blocker class to which nebivolol principally belongs and the arb class to which valsartan principally belongs. there are no controlled trials demonstrating risk reduction with byvalson. control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. many patients will require more than one drug to achieve blood pressure goals. for specific advice on goals and management, see published guidelines, such as those of the national high blood pressure education program's joint national committee on

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

allergan, inc. - norethindrone (unii: t18f433x4s) (norethindrone - unii:t18f433x4s), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norethindrone 0.4 mg - femcon fe is indicated for use by females of reproductive potential to prevent pregnancy. do not prescribe femcon fe to women who are known to have the following conditions: - a high risk of arterial or venous thrombotic diseases. examples include women who are known to: ▪ smoke, if over age 35 [see boxed warning and warnings and precautions (5.1) ] ▪ have deep vein thrombosis or pulmonary embolism, now or in the past [see warnings and precautions (5.1) ] ▪ have inherited or acquired hypercoagulopathies [see warnings and precautions (5.1)] ▪ have cerebrovascular disease [see warnings and precautions (5.1) ] ▪ have coronary artery disease [see warnings and precautions (5.1) ] ▪ have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see warnings and precautions (5.1) ] ▪ have uncontrolled hypertension [see warnings and precautions (5.4) ] ▪ have diabetes mellitus with vascul

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

allergan, inc. - ketorolac tromethamine (unii: 4eve5946bq) (ketorolac - unii:yzi5105v0l) - acuvail ® ophthalmic solution is indicated for the treatment of pain and inflammation following cataract surgery. acuvail solution is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formulation. teratogenic effects. pregnancy category c :  ketorolac tromethamine, administered during organogenesis, was not teratogenic in rabbits and rats at oral doses of 3.6 mg/kg/day and 10 mg/kg/day, respectively. these doses are approximately 600 times and 1700 times higher respectively than the typical human topical ophthalmic daily dose of 0.35 mg (4.5 mg/ml x 0.04 ml/drop, twice daily) to an affected eye on a mg/kg basis. additionally, when administered to rats after day 17 of gestation at oral doses up to 1.5 mg/kg/day (approximately 300 times the typical human topical ophthalmic daily dose), ketorolac tromethamine resulted in dystocia and increased pup mortality. there are no adequate and well-controlled studies in pregnant women. acuvail solution should be us

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

allergan, inc. - dapsone (unii: 8w5c518302) (dapsone - unii:8w5c518302) - dapsone 75 mg in 1 g - aczone ® (dapsone)  gel, 7.5%, is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. none. risk summary there are no available data on aczone gel, 7.5%, use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. in animal reproduction studies, oral doses of dapsone administered to pregnant rats and rabbits during organogenesis that resulted in systemic exposures more than 400 times the systemic exposure at the maximum recommended human dose (mrhd) of aczone gel, 7.5%, resulted in embryocidal effects. when orally administered to rats from the onset of organogenesis through the end of lactation at systemic exposures approximately 500 times the exposure at the mrhd, dapsone resulted in increased stillbirths and decreased pup weight [see data] .   the estimated background risks of major birth defects and miscarriage for the indicated population are unknown. in the u.s. general population, the estimated background risk of major birth defe