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

alexion pharmaceuticals, inc. - asfotase alfa (unii: z633861eim) (asfotase alfa - unii:z633861eim) - asfotase alfa 18 mg in 0.45 ml - strensiq® is indicated for the treatment of patients with perinatal/infantile- and juvenile-onset hypophosphatasia (hpp). none. risk summary there are no available data on strensiq use in pregnant women to inform a drug associated risk. in animal reproduction studies, asfotase alfa administered intravenously to pregnant rats and rabbits during the period of organogenesis showed no evidence of fetotoxicity, embryolethality or teratogenicity at doses causing plasma exposures up to 21 and 24 times, respectively, the exposure at the recommended human dose (see data) . in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data asfotase alfa administered during the period of organogenesis to rats (from gestation day 6 to day 19 post-partum) and rabbits (on gestation days 7 to 19) at intravenous doses up to 50 mg/kg/day, approximately 21 and 24 times the human auc of 65486 ng.h/ml

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

lantheus medical imaging, inc. - perflutren (unii: ck0n3wh0sr) (perflutren - unii:ck0n3wh0sr) - definity rt is indicated, after activation, for use in adult and pediatric patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border. definty rt is contraindicated in patients with known or suspected hypersensitivity to perflutren lipid microsphere or its components, such as polyethylene glycol (peg) [see warnings and precautions (5.2) and description (11)]. risk summary available data from case reports with definity rt use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. definity rt has a very short half-life; therefore, administration of definity rt to a pregnant woman is not expected to result in clinically relevant fetal exposure. no adverse developmental outcomes were observed in animal reproduction studies with administration of activated definity, another formulation of perflutren lipid microspheres, in pregnant rats and rabbits during organogenesis at doses up to 8 and 16 times, respectively, the maximum human dose based on body surface area (see data) . all pregnancies have a background risk of birth defects, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data animal data definity was administered intravenously to rats at doses of 0.1ml/kg, 0.3 ml/kg, and 1 ml/kg (approximately 0.8, 2.4, and 8 times the recommended maximum human dose based on body surface area); definity doses were administered daily from day 6 to day 17 of gestation. definity was administered intravenously to rabbits at doses of 0.1ml/kg, 0.3 ml/kg, and 1 ml/kg (approximately, 1.6, 4.8, and 16 times the recommended maximum human dose based on body surface area); definity doses were administered daily from day 7 to day 19 of gestation. no significant findings on the fetus were observed. risk summary there are no data on the presence of perflutren lipid microspheres in human milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for definity rt and any potential adverse effects on the breastfed infant from definity rt or from the underlying maternal condition. the safety and effectiveness of definity rt have been established for use in pediatric patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve delineation of the left endocardial border. use of definity rt for this indication is supported by evidence from adequate and well-controlled studies in adults [see clinical studies (14)] , a pharmacodynamic and safety study in 40 pediatric patients 1 month of age and older [see adverse reactions (6.1) and clinical pharmacology (12.2)] , and published studies in 149 patients 5 years to 24 years of age [see adverse reactions (6.1)] . of the total number of subjects in clinical trials of definity, 144 (33%) were 65 and over. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences between the elderly and younger patients.

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

bausch health us, llc - tretinoin (unii: 5688utc01r) (tretinoin - unii:5688utc01r) - altreno® (tretinoin) lotion, 0.05% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. none. risk summary available data from published observational studies of topical tretinoin in pregnant women have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. there are no data on altreno use in pregnant women. the systemic levels following topical administration are lower than with administration of oral tretinoin; however, absorption of this product may result in fetal exposure. there are reports of major birth defects similar to those seen in infants exposed to oral retinoids, but these case reports do not establish a pattern or association with tretinoin-related embryopathy (see data). animal reproduction studies have not been conducted with altreno. topical administration of tretinoin in a different formulation to pregnant rats during organogenesis was associated with malformations (craniofacial abnorma

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

ge healthcare inc. - human albumin microspheres (unii: t8c6w1n6nw) (human albumin microspheres - unii:t8c6w1n6nw), perflutren (unii: ck0n3wh0sr) (perflutren - unii:ck0n3wh0sr) - human albumin microspheres 10 mg in 1 ml - optison is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricle and to improve the delineation of the left ventricular endocardial borders. do not administer optison to patients with known or suspected hypersensitivity to perflutren or albumin [see warnings and precautions (5.5)] . risk summary there are no data with optison use in pregnant women to inform any drug-associated risks. no adverse developmental outcomes were observed in animal reproduction studies with intravenous administration of optison to pregnant rats and rabbits during organogenesis at doses up to at least 5 and 10 times the recommended human dose based on body surface area (see data ). in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data animal data optison was administered intravenously to rats at doses of 0.25, 5 and 10 ml/kg/day (approximately 0.2, 5 and 10 times the recommended maximum human dose of 8.7 ml, respectively, based on body surface area) and to rabbits at 0.25, 2.5 and 5 ml/kg/day (approximately 0.5, 5 and 10 times the recommended maximum human dose, respectively, based on body surface area) during organogenesis. no significant findings attributable solely to a direct effect on the fetus were detected in the studies. there are no data on the presence of perflutren protein-type a microspheres in human milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for optison and any potential adverse effects on the breastfed infant from optison or from the underlying maternal condition. safety and effectiveness in pediatric patients have not been established. of the total number of subjects in a clinical study of optison, 35% were 65 and over, while 14% were 75 and over. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Malta - English - Medicines Authority

colep laupheim gmbh & co.kg fockestrasse 12, 88471 laupheim, germany - methyl salicylate, menthol - cream - methyl salicylate 30 % (w/w) menthol 8 % (w/w) - topical products for joint and muscular pain

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

pharmathen international s.a. - isotretinoin - capsules soft - 10mg

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

pharmathen international s.a. - isotretinoin - capsules soft - 20mg

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

pharmathen international s.a. - isotretinoin - capsules soft - 20mg

Australia - English - Department of Health (Therapeutic Goods Administration)

pharmacare laboratories pty ltd - ascorbic acid, quantity: 6 mg; hydrolysed collagen, quantity: 1.25 g; zinc oxide, quantity: 809 microgram (equivalent: zinc, qty 650 microgram); dl-alpha-tocopheryl acetate, quantity: 2.5 mg - pastille - excipient ingredients: gelatin; vegetable oil; purified water; malic acid; sucralose; maltitol solution; carnauba wax; starch sodium octenyl succinate; potable water; silicon dioxide; colour; flavour - antioxidant/reduce free radicals formed in the body ; helps reduce/decrease free radical damage to body cells ; helps enhance/promote collagen formation ; maintain/support collagen formation ; maintain/support collagen health ; maintain/support general health and wellbeing ; maintain/support hair health ; maintain/support hair strength/thickness ; maintain/support nail health/strength/thickness ; helps enhance/improve/promote/increase skin firmness ; maintain/support skin firmness ; helps enhance/promote skin health ; maintain/support skin health ; helps enhance/improve skin internal structure ; maintain/support skin elasticity ; helps enhance/improve skin elasticity ; maintain/support skin integrity/structure ; helps enhance/improve skin strength

Australia - English - Department of Health (Therapeutic Goods Administration)

pharmacare laboratories pty ltd - hydrolysed collagen, quantity: 1.25 g; ascorbic acid, quantity: 6 mg; zinc oxide, quantity: 1.245 mg (equivalent: zinc, qty 1 mg); dl-alpha-tocopheryl acetate, quantity: 2.5 mg - pastille - excipient ingredients: maltitol solution; sucralose; gelatin; vegetable oil; glycerol; purified water; carnauba wax; malic acid; colour; starch sodium octenyl succinate; potable water; silicon dioxide; flavour - antioxidant/reduce free radicals formed in the body ; helps reduce/decrease free radical damage to body cells ; helps enhance/promote collagen formation ; maintain/support collagen formation ; maintain/support collagen health ; maintain/support general health and wellbeing ; maintain/support hair health ; maintain/support hair strength/thickness ; maintain/support nail health/strength/thickness ; maintain/support connective tissue health ; maintain/support immune system health ; maintain/support healthy immune system function ; helps enhance/improve/promote/increase skin firmness ; maintain/support skin firmness ; helps enhance/promote skin health ; maintain/support skin health ; helps enhance/improve skin internal structure ; maintain/support skin elasticity ; helps enhance/improve skin elasticity ; maintain/support skin integrity/structure ; helps enhance/improve skin strength