Сингапур - английский - HSA (Health Sciences Authority)

bausch & lomb (singapore) private limited - besifloxacin hcl 6.63mg/ml eqv besifloxacin base - suspension, sterile - 6 mg/ml - besifloxacin hcl 6.63mg/ml eqv besifloxacin base 6 mg/ml

Сингапур - английский - HSA (Health Sciences Authority)

allergan singapore pte. ltd. - epinastine hcl - solution, sterile - 0.05 % w/v - epinastine hcl 0.05 % w/v

Соединенные Штаты - английский - NLM (National Library of Medicine)

akorn - apraclonidine hydrochloride (unii: d2vw67n38h) (apraclonidine - unii:843cen85di) - apraclonidine 5 mg in 1 ml - apraclonidine ophthalmic solution, usp 0.5% as base is indicated for short-term adjunctive therapy in patients on maximally tolerated medical therapy who require additional iop reduction. patients on maximally tolerated medical therapy who are treated with apraclonidine ophthalmic solution, usp 0.5% as base to delay surgery should have frequent follow-up examinations and treatment should be discontinued if the intraocular pressure rises significantly. the addition of apraclonidine ophthalmic solution, usp 0.5% as base to patients already using two aqueous suppressing drugs (i.e., beta-blocker plus carbonic anhydrase inhibitor) as part of their maximally tolerated medical therapy may not provide additional benefit. this is because apraclonidine ophthalmic solution, usp 0.5% as base is an aqueous suppressing drug and the addition of a third aqueous suppressant may not significantly reduce iop. the iop lowering efficacy of apraclonidine ophthalmic solution, usp 0.5% as base diminishes over time in some patients.

Соединенные Штаты - английский - NLM (National Library of Medicine)

merck sharp & dohme corp. - cyclosporine (unii: 83hn0gtj6d) (cyclosporine - unii:83hn0gtj6d) - cyclosporine 2 mg in 1 g - optimmune® ophthalmic ointment is indicated for management of chronic keratoconjunctivitis sicca (kcs) and chronic superficial keratitis (csk) in dogs.

Соединенные Штаты - английский - NLM (National Library of Medicine)

par pharmaceutical, inc. - travoprost (unii: wj68r08kx9) (travoprost - unii:wj68r08kx9) - travoprost 0.04 mg in 1 ml - travoprost ophthalmic solution usp, 0.004% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. none pregnancy category c teratogenic effects: travoprost was teratogenic in rats, at an intravenous (iv) dose up to 10 mcg/kg/day (250 times the maximal recommended human ocular dose (mrhod), evidenced by an increase in the incidence of skeletal malformations as well as external and visceral malformations, such as fused sternebrae, domed head and hydrocephaly. travoprost was not teratogenic in rats at iv doses up to 3 mcg/kg/day (75 times the mrhod), or in mice at subcutaneous doses up to 1 mcg/kg/day (25 times the mrhod). travoprost produced an increase in post-implantation losses and a decrease in fetal viability in rats at iv doses >3 mcg/kg/day (75 times the mrhod) and in mice at subcutaneous doses >0.3 mcg/kg/day (7.5 times the mrhod). in the offspring of female rats that received travoprost subcutaneously from day 7 of pregnancy to lacta

Соединенные Штаты - английский - NLM (National Library of Medicine)

glaukos corporation - riboflavin 5'-phosphate sodium anhydrous (unii: 957e53wv42) (riboflavin 5'-phosphate - unii:7n464ure7e) - flavin mononucleotide 1.46 mg in 1 ml - photrexa® viscous and photrexa® are indicated for use in corneal collagen cross-linking in combination with the kxl™ system for the treatment of none. risk summary animal development and reproduction studies have not been conducted with the photrexa® viscous/photrexa® /kxl® system. since it is not known whether the corneal collagen cross-linking procedure can cause fetal harm or affect reproduction capacity, it should not be performed on pregnant women. risk summary there are no data on the presence of photrexa viscous or photrexa 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 the photrexa/kxl corneal collagen cross-linking procedure and any potential adverse effects on the breastfed child from the photrexa/kxl corneal collagen cross-linking procedure or from the underlying maternal condition. the safety and effectiveness of corneal collagen cross-linking has not been established in pediatric patients below the age of 14 years. no patients enrolled in the clinical studies were 65 years of age or older.

Соединенные Штаты - английский - NLM (National Library of Medicine)

alembic pharmaceuticals inc. - azelastine hydrochloride (unii: 0l591qr10i) (azelastine - unii:zqi909440x) - azelastine hydrochloride ophthalmic solution 0.05% is indicated for the treatment of itching of the eye associated with allergic conjunctivitis. azelastine hydrochloride ophthalmic solution 0.05% is contraindicated in persons with known or suspected hypersensitivity to any of its components.

Соединенные Штаты - английский - NLM (National Library of Medicine)

alembic pharmaceuticals inc. - tobramycin (unii: vz8rrz51vk) (tobramycin - unii:vz8rrz51vk) - tobramycin ophthalmic solution, 0.3 % is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of tobramycin ophthalmic solution. clinical studies have shown tobramycin to be safe and effective for use in children. tobramycin ophthalmic solution, 0.3 % is contraindicated in patients with known hypersensitivity to any of its components.

Соединенные Штаты - английский - NLM (National Library of Medicine)

alembic pharmaceuticals inc. - bromfenac sodium (unii: 8ecv571y37) (bromfenac - unii:864p0921dw) - bromfenac ophthalmic solution 0.09% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. none. teratogenic effects: pregnancy category c . reproduction studies performed in rats at oral doses up to 0.9 mg/kg/day (1300 times the recommended human ophthalmic dose [rhod]) and in rabbits at oral doses up to 7.5 mg/kg/day (11,000 times rhod) revealed no evidence of teratogenicity due to bromfenac. however, 0.9 mg/kg/day in rats caused embryo-fetal lethality, increased neonatal mortality, and reduced postnatal growth. pregnant rabbits treated with 7.5 mg/kg/day caused increased post implantation loss. there are no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. nonteratogenic effects: because of the known effects of p

Соединенные Штаты - английский - NLM (National Library of Medicine)

micro labs limited - dorzolamide hydrochloride (unii: qzo5366ew7) (dorzolamide - unii:9jdx055tw1) - dorzolamide hydrochloride ophthalmic solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. dorzolamide hydrochloride ophthalmic solution is contraindicated in patients who are hypersensitive to any component of this product [see warnings and precautions (5.1)]. risk summary   there are no adequate and well-controlled studies in pregnant women with dorzolamide hydrochloride ophthalmic solution. dorzolamide caused fetal vertebral malformations when administered orally to rabbits at 2.5 mg/kg/day (37 times the clinical exposure). dorzolamide administered during the period of organogenesis was not teratogenic in rabbits dosed up to 1 mg/kg/day (15 times the clinical exposure). dorzolamide hydrochloride administered orally to rats during late gestation and lactation caused growth delays in offspring at 7.5 mg/kg/day (52 times the clinical exposure). growth was not delayed at 1 mg/kg/day (8.0 times the clinic