Israel - English - Ministry of Health

cts chemical industries ltd, israel - carbocisteine - drops - carbocisteine 75 mg/ml - carbocisteine - carbocisteine - treatment of disorders of the respiratory tract characterized by excessive or viscous mucus.

Israel - English - Ministry of Health

cts chemical industries ltd, israel - carbocisteine - lozenges - carbocisteine 375 mg - carbocisteine - carbocisteine - treatment of disorders of the respiratory tract characterised by excessive or viscous mucus.

Malta - English - Medicines Authority

jed pharma limited questum business park, south ballingarrane clonmel, co tipperary, e91 v329 , ireland - oral solution - carbocisteine 750 mg - cough and cold preparations

New Zealand - English - Medsafe (Medicines Safety Authority)

abbvie limited - bimatoprost 0.3 mg/ml;   - topical solution - 0.3 mg/ml - active: bimatoprost 0.3 mg/ml   excipient: benzalkonium chloride citric acid monohydrate dibasic sodium phosphate heptahydrate hydrochloric acid purified water sodium chloride sodium hydroxide - latisse® is indicated to treat hypotrichosis of the eyelashes by increasing their growth including length, thickness, and darkness.

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

allergan, inc. - bimatoprost (unii: qxs94885mz) (bimatoprost - unii:qxs94885mz) - latisse ® (bimatoprost ophthalmic solution) 0.03% is indicated to treat hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness. latisse ® is contraindicated in patients with hypersensitivity to bimatoprost or to any of the ingredients [see adverse reactions (6.2) ]. risk summary there are no adequate and well-controlled studies of latisse ® (bimatoprost ophthalmic solution) 0.03% administration in pregnant women. there is no increase in the risk of major birth defects or miscarriages based on bimatoprost postmarketing experience. in embryofetal development studies, administration of bimatoprost to pregnant mice and rats during organogenesis resulted in abortion and early delivery at oral doses at least 33 times (mice) or 94 times (rats) the human exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on the area under the curve (auc). these adverse effects were not observed at 2.6 times (mice) and 47 times (rats) the human exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on auc. in pre/postnatal development studies, administration of bimatoprost to pregnant rats from organogenesis to the end of lactation resulted in reduced gestation length and fetal body weight, and increased fetal and pup mortality at oral doses at least 41 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on auc. no adverse effects were observed in rat offspring at exposures estimated at 14 times the human exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on auc. because animal reproductive studies are not always predictive of human response latisse ®   0.03% should be administered during pregnancy only if the potential benefit justifies the potential risk to the fetus. data animal data in an embryofetal development rat study, abortion was observed in pregnant rats administered bimatoprost orally during organogenesis at 0.6 mg/kg/day (94 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on auc). the no observed adverse effect level (noael) for abortion was 0.3 mg/kg/day (estimated at 47 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily based on auc). no abnormalities were observed in rat fetuses at doses up to 0.6 mg/kg/day. in an embryofetal development mouse study, abortion and early delivery were observed in pregnant mice administered bimatoprost orally during organogenesis at doses greater than or equal to 0.3 mg/kg/day (33 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on auc). the noael for abortion and early delivery was 0.1 mg/kg/day (2.6 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on auc). no abnormalities were observed in mouse fetuses at doses up to 0.6 mg/kg/day (72 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on auc). in a pre/postnatal development study, treatment of pregnant rats with bimatoprost orally from gestation day 7 to lactation day 20 resulted in reduced gestation length, increased late resorptions, fetal deaths, and postnatal pup mortality, and reduced pup body weight at doses greater than or equal to 0.3 mg/kg/day. these effects were observed at exposures at least 41 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on auc. the noael for postnatal development and mating performance of the offspring was 0.1 mg/kg/day (estimated at 14 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on auc). risk summary it is not known whether topical ocular treatment with latisse ®   0.03% could result in sufficient systemic absorption to produce detectable quantities in human milk. in animal studies, bimatoprost has been shown to be present in breast milk of lactating rats at an intravenous dose (i.e., 1 mg/kg) 324 times the recommended human ophthalmic dose (on a mg/m2 basis), however no animal data is available at clinically relevant doses.   the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for latisse ®   0.03% and any potential adverse effects on the breastfed child from latisse ®  0.03%. use of latisse ®  was evaluated in a sixteen-week double-masked, randomized, vehicle-controlled study conducted in pediatric patients who were post-chemotherapy or had alopecia areata, and adolescents who had hypotrichosis with no associated medical condition. no new safety issues were observed. the results of the global eyelash assessment (gea) are provided in table 1. no overall clinical differences in safety or effectiveness have been observed between elderly and other adult patients.

Malta - English - Medicines Authority

dompe farmaceutici spa via san martino 12, 20122, milan, italy - carbocisteine - powder for oral solution - carbocisteine 1.35 g - cough and cold preparations

Philippines - English - FDA (Food And Drug Administration)

boie inc - carbocisteine - suspension - 250mg/5ml

Philippines - English - FDA (Food And Drug Administration)

888 pharma distributor - carbocisteine - syrup

Philippines - English - FDA (Food And Drug Administration)

j.b. orchid pharma'l inc - carbocisteine - syrup - 100mg/5ml

Philippines - English - FDA (Food And Drug Administration)

scheele labs phils. inc. - carbocisteine - syrup (oral drops) - 50mg/ml