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

sandoz inc - difluprednate (unii: s8a06qg2qe) (difluprednate - unii:s8a06qg2qe) - difluprednate ophthalmic emulsion, 0.05%, a topical corticosteroid, is indicated for the treatment of inflammation and pain associated with ocular surgery. difluprednate ophthalmic emulsion is also indicated for the treatment of endogenous anterior uveitis. the use of difluprednate ophthalmic emulsion, 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 1-10 mcg/kg/day. the no-observed-effect-level (noel) for these effects was 1 mcg/kg/day, and 10 mcg/kg/day was considered to be a teratogenic

Австралия - английский - Department of Health (Therapeutic Goods Administration)

boc ophthalmic instruments pty ltd - 39659 - ophthalmic stand, electric - stand to hold ophthalmic testing instruments

Австралия - английский - Department of Health (Therapeutic Goods Administration)

designs for vision aust pty ltd - 46840 - ophthalmic cannulation set, single use - it provides an entry port in the eye of for ophthalmic instrument access through the sclera for posterior segment ophthalmic surgery.

Австралия - английский - Department of Health (Therapeutic Goods Administration)

instrumed - 32772 - curette, ophthalmic - a scraping ophthalmic surgical instrument with a fenestrated, spoon shaped or ring-like tip which can be either sharp or blunt. the instrument is used to obtain or remove eye tissue.

Австралия - английский - Department of Health (Therapeutic Goods Administration)

instrumed - 32764 - knife, ophthalmic - a cutting surgical instrument with a handle and a blade of various shapes and sizes used in ophthalmic surgery involving the eye and surrounding structures.

Австралия - английский - Department of Health (Therapeutic Goods Administration)

instrumed - 32772 - curette, ophthalmic - a scraping ophthalmic surgical instrument with a fenestrated, spoon shaped or ring-like tip which can be either sharp or blunt. the instrument is used to obtain or remove eye tissue.

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

alembic pharmaceuticals 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. 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.

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

rpk pharmaceuticals, 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. 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 r

Танзания - английский - Tanzania Medicinces & Medical Devices Authority

ajanta pharma limited, india - levofloxacin ophthalmic solution 1.5% w/v - ophthalmic solution - 1.5

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

sandoz inc - travoprost (unii: wj68r08kx9) (travoprost - unii:wj68r08kx9) - travoprost ophthalmic solution 0.004% 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 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 population, the estimated background risk of major birth defec