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

dr. reddy's laboratories inc. - difluprednate (unii: s8a06qg2qe) (difluprednate - unii:s8a06qg2qe) - difluprednate ophthalmic emulsion (0.05%) is a topical corticosteroid, indicated for the treatment of inflammation and pain associated with ocular surgery. difluprednate ophthalmic emulsion (0.05%) is also indicated for the treatment of endogenous anterior uveitis. the use of difluprednate ophthalmic emulsion (0.05%), as with other ophthalmic corticosteroids, is contraindicated in most active viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal disease of ocular structures. pregnancy category c. difluprednate has been shown to be embryotoxic (decrease in embryonic body weight and a delay in embryonic ossification) and teratogenic (cleft palate and skeletal anomalies) when administered subcutaneously to rabbits during organogenesis at a dose of 1 to 10 mcg/kg/day. the no-observed-effect-level (noel) for these effects was 1 mcg/kg/day, and 10 mcg/kg/day was considered t

Israel - English - Ministry of Health

novartis israel ltd - dexamethasone; neomycin as sulfate; polymyxin b sulfate - ophthalmic suspension - dexamethasone 1.0 mg/ml; neomycin as sulfate 3,500 iu/ml; polymyxin b sulfate 6000 iu/ml - polymyxin b - polymyxin b - maxitrol is indicated in ocular inflammation when concurrent use of antimicrobial in judged necessary.

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

instrumed - 62674 - ophthalmic soft-tissue surgical forceps, tweezers-like, reusable - a hand-held manual surgical instrument designed to facilitate the grasping, manipulation, and/or disruption of ophthalmic soft-tissues. it has a tweezers-like design with two blades joined at the proximal (non-working) end, and variously designed tips at the working end; it is not probe-like in design (i.e., not cannulated) but may be pointed for capsulorhexis. it is made of high-grade stainless steel, available in various sizes, and may have carbide inserts at the working end. this is a reusable device.

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

instrumed - 13490 - ophthalmic tenotomy scissors - a hand-held ophthalmic instrument used to cut and/or divide tendon tissue in the eye during surgery, typically to correct a deformity. it comprises two pivoted blades that usually have finger and thumb ring-handles, and which cut with a shearing action (i.e., the fine blades cut when the sharpened edges pass one another as they are closed). it is typically made of high-grade stainless steel and is available in various designs and sizes. this is a reusable device.

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

sandoz inc - moxifloxacin hydrochloride (unii: c53598599t) (moxifloxacin - unii:u188xyd42p) - moxifloxacin 5 mg in 1 ml - moxifloxacin ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: corynebacterium species* micrococcus luteus* staphylococcus aureus staphylococcus epidermidis staphylococcus haemolyticus staphylococcus hominis staphylococcus warneri* streptococcus pneumoniae streptococcus viridans group acinetobacter lwoffii* haemophilus influenza haemophilus parainfluenzae* chlamydia trachomatis *efficacy for this organism was studied in fewer than 10 infections. moxifloxacin ophthalmic solution is contraindicated in patients with a history of hypersensitivity to moxifloxacin, to other quinolones, or to any of the components in this medication. risk summary there are no adequate and well-controlled studies with moxifloxacin ophthalmic solution in pregnant women to inform any drug-associated risks. oral administration of moxifloxacin to pregnant rats and monkeys and intravenously to pregnant rabbi

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

a-s medication solutions - moxifloxacin hydrochloride (unii: c53598599t) (moxifloxacin - unii:u188xyd42p) - moxifloxacin ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: corynebacterium species* micrococcus luteus* staphylococcus aureus staphylococcus epidermidis staphylococcus haemolyticus staphylococcus hominis staphylococcus warneri* streptococcus pneumoniae streptococcus viridans group acinetobacter lwoffii* haemophilus influenzae haemophilus parainfluenzae* chlamydia trachomatis *efficacy for this organism was studied in fewer than 10 infections. moxifloxacin ophthalmic solution is contraindicated in patients with a history of hypersensitivity to moxifloxacin, to other quinolones, or to any of the components in this medication. risk summary there are no adequate and well-controlled studies with moxifloxacin ophthalmic solution in pregnant women to inform any drug-associated risks. oral administration of moxifloxacin to pregnant rats and monkeys and intravenously to pregnant rabbits during the period of organogenesis did not produce adverse maternal or fetal effects at clinically relevant doses. oral administration of moxifloxacin to pregnant rats during late gestation through lactation did not produce adverse maternal, fetal or neonatal effects at clinically relevant doses [see data]. data animal data embryo-fetal studies were conducted in pregnant rats administered with 20, 100 or 500 mg/kg/day moxifloxacin by oral gavage on gestation days 6 to 17, to target the period of organogenesis. decreased fetal body weight and delayed skeletal development were observed at 500 mg/kg/day (277 times the human auc at the recommended human ophthalmic dose). the no-observed-adverse-effect-level (noael) for developmental toxicity was 100 mg/kg/day (30 times the human auc at the recommended human ophthalmic dose). embryo-fetal studies were conducted in pregnant rabbits administered with 2, 6.5 or 20 mg/kg/day moxifloxacin by intravenous administration on gestation days 6 to 20, to target the period of organogenesis. abortions, increased incidence of fetal malformations, delayed fetal skeletal ossification, and reduced placental and fetal body weights were observed at 20 mg/kg/day (1086 times the human auc at the recommended human ophthalmic dose), a dose that produced maternal body weight loss and death. the noael for developmental toxicity was 6.5 mg/kg/day (246 times the human auc at the recommended human ophthalmic dose). pregnant cynomolgus monkeys were administered moxifloxacin at doses of 10, 30 or 100 mg/kg/day by intragastric intubation between gestation days 20 and 50, targeting the period of organogenesis. at the maternal toxic doses of ≥ 30 mg/kg/day, increased abortion, vomiting and diarrhea were observed. smaller fetuses/reduced fetal body weights were observed at 100 mg/kg/day (2864 times the human auc at the recommended human ophthalmic dose). the noael for fetal toxicity was 10 mg/kg/day (174 times the human auc at the recommended human ophthalmic dose). in a pre and postnatal study, rats were administered moxifloxacin by oral gavage at doses of 20, 100 and 500 mg/kg/day from gestation day 6 until the end of lactation. maternal death occurred during gestation at 500 mg/kg/day. slight increases in the duration of pregnancy, reduced pup birth weight, and decreased prenatal and neonatal survival were observed at 500 mg/kg/day (estimated 277 times the human auc at the recommended human ophthalmic dose). the noael for pre- and postnatal development was 100 mg/kg/day (estimated 30 times the human auc at the recommended human ophthalmic dose). risk summary there is no data regarding the presence of moxifloxacin ophthalmic solution in human milk, the effects on the breastfed infants, or the effects on milk production/excretion to inform risk of moxifloxacin ophthalmic solution to an infant during lactation.   a study in lactating rats has shown transfer of moxifloxacin into milk following oral administration. systemic levels of moxifloxacin following topical ocular administration are low [see clinical pharmacology (12.3)], and it is not known whether measurable levels of moxifloxacin would be present in maternal milk following topical ocular administration. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for moxifloxacin ophthalmic solution and any potential adverse effects on the breastfed child from moxifloxacin ophthalmic solution. the safety and effectiveness of moxifloxacin ophthalmic solution 0.5% have been established in all ages. use of moxifloxacin ophthalmic solution is supported by evidence from adequate and well controlled studies of moxifloxacin ophthalmic solution in adults, children, and neonates [see clinical studies (14) ]. there is no evidence that the ophthalmic administration of moxifloxacin ophthalmic solution has any effect on weight bearing joints, even though oral administration of some quinolones has been shown to cause arthropathy in immature animals. no overall differences in safety and effectiveness have been observed between elderly and younger patients.

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

gland pharma limited - moxifloxacin hydrochloride (unii: c53598599t) (moxifloxacin - unii:u188xyd42p) - moxifloxacin ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: corynebacterium species* micrococcus luteus* staphylococcus aureus staphylococcus epidermidis staphylococcus haemolyticus staphylococcus hominis staphylococcus warneri* streptococcus pneumoniae streptococcus viridans group acinetobacter lwoffii* haemophilus influenzae haemophilus parainfluenzae* chlamydia trachomatis *efficacy for this organism was studied in fewer than 10 infections. moxifloxacin ophthalmic solution is contraindicated in patients with a history of hypersensitivity to moxifloxacin, to other quinolones, or to any of the components in this medication. risk summary there are no adequate and well-controlled studies with moxifloxacin ophthalmic solution in pregnant women to inform any drug-associated risks. oral administration of moxifloxacin to pregnant rats and monkeys and intravenously to pregnant rabb

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

fosun pharma usa inc. - moxifloxacin hydrochloride (unii: c53598599t) (moxifloxacin - unii:u188xyd42p) - moxifloxacin ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: corynebacterium species * micrococcus luteus* staphylococcus aureus staphylococcus epidermidis staphylococcus haemolyticus staphylococcus hominis staphylococcus warneri* streptococcus pneumoniae streptococcus viridans group acinetobacter lwoffii* haemophilus influenzae haemophilus parainfluenzae* chlamydia trachomatis *efficacy for this organism was studied in fewer than 10 infections. moxifloxacin ophthalmic solution is contraindicated in patients with a history of hypersensitivity to moxifloxacin, to other quinolones, or to any of the components in this medication. pregnancy c

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

alembic pharmaceuticals inc. - travoprost (unii: wj68r08kx9) (travoprost - unii:wj68r08kx9) - 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 pregnanc

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

micro labs limited - travoprost (unii: wj68r08kx9) (travoprost - unii:wj68r08kx9) - travoprost ophthalmic solution 0.004% (ionic buffered solution) is indicated for the reduction of elevated intraocular pressure (iop) in patients with open-angle glaucoma or ocular hypertension. none. risk summary there are no adequate and well-controlled studies in pregnant women to inform a drug-associated risk. in animal reproduction studies, subcutaneous (sc) administration of travoprost to pregnant mice and rats throughout the period of organogenesis produced embryo-fetal lethality, spontaneous abortion, and premature delivery at potentially clinically relevant doses. advise pregnant women of a potential risk to a fetus. because animal reproductive studies are not always predictive of human response, travoprost ophthalmic solution 0.004% (ionic buffered solution) should be administered during pregnancy only if the potential benefit justifies the potential risk to the fetus. the background risk of major birth defects and miscarriage for the indicated population is unknown; however, in the u.s. general pop