Malta - English - Medicines Authority

accord healthcare ireland ltd euro house, euro business park, little island cork, t45 k857, ireland - bimatoprost - eye drops, solution - bimatoprost 0.3 mg/ml - ophthalmologicals

Israel - English - Ministry of Health

k.s.kim international (sk- pharma) ltd., israel - bimatoprost - ophthalmic solution - bimatoprost 0.3 mg / 1 ml - bimatoprost - reduction of elevated intraocular pressure in chronic open angle glaucoma and ocular hypertension (as monotherapy or as adjunctive therapy to beta-blockers).

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

micro labs limited - bimatoprost (unii: qxs94885mz) (bimatoprost - unii:qxs94885mz) - bimatoprost ophthalmic solution 0.03% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. bimatoprost ophthalmic solution 0.03% 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 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 developmental studies, administration of bimatoprost in 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 at the recommended clinical dose (based on blood area under the curve [auc] levels). these adverse effects were not observed at 2.6 times (mice) and 47 times (rats) the human exposure at the recommended clinical dose. 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 at the recommended clinical dose (based on blood auc levels).  no adverse effects were observed in rat offspring at exposures estimated at 14 times the human exposure at the recommended clinical dose (based on blood auc levels). because animal reproductive studies are not always predictive of human response bimatoprost ophthalmic solution 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 at the recommended human ophthalmic dose [rhod], 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 at the rhod, 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 at the rhod, based on auc). the noael for abortion and early delivery was 0.1 mg/kg/day (2.6 times the human systemic exposure at the rhod, 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 at the rhod, 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 at the rhod, 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 at the rhod, based on auc). risk summary it is not known whether topical ocular treatment with bimatoprost ophthalmic solution 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 rhod (on a m 2 g/m 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 bimatoprost ophthalmic solution, 0.03% and any potential adverse effects on the breastfed child from bimatoprost ophthalmic solution, 0.03%. use in pediatric patients below the age of 16 years is not recommended because of potential safety concerns related to increased pigmentation following long-term chronic use. no overall clinical differences in safety or effectiveness have been observed between elderly and other adult patients. bimatoprost ophthalmic solution 0.03% before you use bimatoprost ophthalmic solution 0.03% for the first time: 1. check to make sure that the tamper evident ring between the bottle and the cap is not broken (see figure a). if the tamper evident ring is broken or missing, contact your pharmacist. 2. tear off the tamper evident ring (see figure b). 3. to open the bottle, remove the cap by turning it in the counterclockwise direction (see figure c). this instructions for use has been approved by the u.s. food and drug administration. manufactured by: micro labs limited bangalore-560099, india. manufactured for: micro labs usa, inc. somerset, nj 08873 rev.01/2024

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

arrotex pharmaceuticals pty ltd - bimatoprost, quantity: 0.3 mg/ml - eye drops, solution - excipient ingredients: water for injections; hydrochloric acid; sodium hydroxide; citric acid monohydrate; sodium chloride; dibasic sodium phosphate heptahydrate; benzalkonium chloride - bimatoprost is indicated for the reduction of elevated intraocular pressure, or open angle glaucoma, as first line therapy or monotherapy or as adjunctive therapy to topical beta-blockers.

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

arrotex pharmaceuticals pty ltd - bimatoprost, quantity: 0.3 mg/ml - eye drops, solution - excipient ingredients: dibasic sodium phosphate heptahydrate; sodium chloride; citric acid monohydrate; water for injections; sodium hydroxide; hydrochloric acid; benzalkonium chloride - bimatoprost is indicated for the reduction of elevated intraocular pressure, or open angle glaucoma, as first line therapy or monotherapy or as adjunctive therapy to topical beta-blockers.

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

arrotex pharmaceuticals pty ltd - bimatoprost, quantity: 0.3 mg/ml - eye drops, solution - excipient ingredients: hydrochloric acid; sodium hydroxide; dibasic sodium phosphate heptahydrate; citric acid monohydrate; water for injections; sodium chloride; benzalkonium chloride - bimatoprost is indicated for the reduction of elevated intraocular pressure, or open angle glaucoma, as first line therapy or monotherapy or as adjunctive therapy to topical beta-blockers.

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

arrotex pharmaceuticals pty ltd - bimatoprost, quantity: 0.3 mg/ml - eye drops, solution - excipient ingredients: citric acid; sodium hydroxide; dibasic sodium phosphate; benzalkonium chloride; sodium chloride; water for injections; hydrochloric acid - the reduction of elevated intraocular pressure, or open angle glaucoma, as first line therapy or monotherapy or as adjunctive therapy to topical beta-blockers.

Israel - English - Ministry of Health

teva israel ltd - bimatoprost - ophthalmic solution - bimatoprost 0.3 mg / 1 ml - bimatoprost - reduction of elevated intraocular pressure in chronic open angle glaucoma and ocular hypertension (as monotherapy or as adjunctive therapy to beta-blockers).

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

aspire pharma ltd - bimatoprost - eye drops - 300microgram/1ml

Malta - English - Medicines Authority

sandoz limited 200 frimley business park, frimley camberley, surrey gu16 7sr, united kingdom - bimatoprost - eye drops, solution - bimatoprost 0.3 mg/ml - ophthalmologicals