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

bryant ranch prepack - 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 defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. data animal data an embryo-fetal study was conducted in pregnant rats administered travoprost once daily by sc injection from gestation day (gd) 6 to 18, to target the period of organogenesis. at 10 mcg/kg (60 times the maximum recommended human ocular dose [mrhod], based on estimated plasma cmax ), travoprost was teratogenic in rats, evidenced by an increase in the incidence of skeletal malformations as well as external and visceral malformations, including fused sternebrae, domed head and hydrocephaly. travoprost caused post-implantation loss at 10 mcg/kg. the no observed adverse effect level (noael) for post-implantation loss was 3 mcg/kg (18 times the mrhod, based on estimated plasma cmax ). the maternal noael was 10 mcg/kg. an embryo-fetal study was conducted in pregnant mice administered travoprost once daily by sc injection from gd 6 to 11, to target the period of organogenesis. at 1 mcg/kg (6 times the mrhod, based on estimated plasma cmax ), travoprost caused postimplantation loss and decreased fetal weight. the no observed adverse effect level (noael) for malformations was 0.3 mcg/kg (2 times the mrhod, based on estimated plasma cmax ). the maternal noael was 1 mcg/kg. pre/postnatal studies were conducted in rats administered travoprost once daily by subcutaneous injection from gd 7 (early embryonic period) to postnatal day 21 (end of lactation period). at doses of greater than or equal to 0.12 mcg/kg/day (0.7 times the mrhod, based on estimated plasma cmax ), adverse pregnancy outcomes (embryo-fetal lethality, abortion, and early delivery), low-birth weight and developmental delays were observed. the noael for adverse pregnancy outcomes, low-birth weight and developmental delay was 0.1 mcg/kg (0.6 times the mhrod, based on estimated plasma cmax ). the noael for maternal toxicity was 0.72 mcg/kg (4 times the mhrod, based on estimated plasma cmax ). risk summary there are no data on the effects of travoprost on the breastfed child or milk production. it is not known if travoprost is present in human milk following ophthalmic administration. a study in lactating rats demonstrated that radio-labeled travoprost and/or its metabolites were excreted in milk following subcutaneous administration. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for travoprost ophthalmic solution and any potential adverse effects on the breastfed child from travoprost ophthalmic solution. 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. travoprost ophthalmic solution 0.004% has been studied in patients with hepatic impairment and also in patients with renal impairment. no clinically relevant changes in hematology, blood chemistry, or urinalysis laboratory data were observed in these patients.

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

apotex corp. - brimonidine tartrate (unii: 4s9cl2dy2h) (brimonidine - unii:e6gnx3hhte), timolol maleate (unii: p8y54f701r) (timolol anhydrous - unii:5jky92s7br) - brimonidine tartrate/timolol maleate ophthalmic solution 0.2%/0.5% is an alpha-adrenergic receptor agonist with a beta-adrenergic receptor inhibitor indicated for the reduction of elevated intraocular pressure (iop) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled iop; the iop-lowering of brimonidine tartrate/timolol maleate ophthalmic solution dosed twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol maleate ophthalmic solution dosed twice a day and 0.2% brimonidine tartrate ophthalmic solution dosed three times per day. brimonidine tartrate/timolol maleate ophthalmic solution is contraindicated in patients with reactive airway disease including bronchial asthma; a history of bronchial asthma; severe chronic obstructive pulmonary disease [see warnings and precautions (5.1, 5.3)] . brimonidine tartrate/timolol maleate ophthalmic solution is contraindicated in patients with sinus bradycardia; second or third degree atrioventricular block; overt cardiac failure [see warnings and precautions (5.2)] ; cardiogenic shock. brimonidine tartrate/timolol maleate ophthalmic solution is contraindicated in neonates and infants (under the age of 2 years). local hypersensitivity reactions have occurred following the use of different components of brimonidine tartrate/timolol maleate ophthalmic solution. brimonidine tartrate/timolol maleate ophthalmic solution is contraindicated in patients who have exhibited a hypersensitivity reaction to any component of this medication in the past. teratogenicity studies have been performed in animals. brimonidine tartrate was not teratogenic when given orally during gestation days 6 through 15 in rats and days 6 through 18 in rabbits. the highest doses of brimonidine tartrate in rats (2.5 mg/kg/day) and rabbits (5 mg/kg/day) achieved auc exposure values 580 and 37-fold higher, respectively, than similar values estimated in humans treated with brimonidine tartrate/timolol maleate ophthalmic solution, 1 drop in both eyes twice daily. teratogenicity studies with timolol in mice, rats, and rabbits at oral doses up to 50 mg/kg/day [4,200 times the maximum recommended human ocular dose of 0.012 mg/kg/day on a mg/kg basis (mrhod)] demonstrated no evidence of fetal malformations. although delayed fetal ossification was observed at this dose in rats, there were no adverse effects on postnatal development of offspring. doses of 1,000 mg/kg/day (83,000 times the mrhod) were maternotoxic in mice and resulted in an increased number of fetal resorptions. increased fetal resorptions were also seen in rabbits at doses 8,300 times the mrhod without apparent maternotoxicity. there are no adequate and well-controlled studies in pregnant women; however, in animal studies, brimonidine crossed the placenta and entered into the fetal circulation to a limited extent. because animal reproduction studies are not always predictive of human response, brimonidine tartrate/timolol maleate ophthalmic solution should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. timolol has been detected in human milk following oral and ophthalmic drug administration. it is not known whether brimonidine tartrate is excreted in human milk, although in animal studies, brimonidine tartrate has been shown to be excreted in breast milk. because of the potential for serious adverse reactions from brimonidine tartrate/timolol maleate ophthalmic solution in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. brimonidine tartrate/timolol maleate ophthalmic solution is contraindicated in children under the age of 2 years [see contraindications (4.3)] . during post-marketing surveillance, apnea, bradycardia, coma, hypotension, hypothermia, hypotonia, lethargy, pallor, respiratory depression, and somnolence have been reported in infants receiving brimonidine. the safety and effectiveness of brimonidine tartrate and timolol maleate have not been studied in children below the age of 2 years. the safety and effectiveness of brimonidine tartrate/timolol maleate ophthalmic solution have been established in the age groups 2 – 16 years of age. use of brimonidine tartrate/timolol maleate ophthalmic solution in these age groups is supported by evidence from adequate and well-controlled studies of brimonidine tartrate/timolol maleate ophthalmic solution in adults with additional data from a study of the concomitant use of brimonidine tartrate ophthalmic solution 0.2% and timolol maleate ophthalmic solution in pediatric glaucoma patients (ages 2 to 7 years). in this study, brimonidine tartrate ophthalmic solution 0.2% was dosed three times a day as adjunctive therapy to beta-blockers. the most commonly observed adverse reactions were somnolence (50%-83% in patients 2 to 6 years) and decreased alertness. in pediatric patients 7 years of age or older (>20 kg), somnolence appears to occur less frequently (25%). approximately 16% of patients on brimonidine tartrate ophthalmic solution discontinued from the study due to somnolence. no overall differences in safety or effectiveness have been observed between elderly and other adult patients.

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

beaver-visitec international australia pty ltd - 46705 - ophthalmic cannula, irrigation/aspiration, non-illumiating, single-use - used in various ophthalmic procedures and surgeries to irrigate and/or aspirate ophthalmic solutions and liquids in or out of the eye, and remove materials where appropriate.

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

alcon laboratories australia pty ltd - 46840 - ophthalmic cannulation set, single use - it provides an entry port in the eye for ophthalmic instrument access through the sclera for posterior segment ophthalmic surgery.

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

bausch & lomb australia pty ltd - 46840 - ophthalmic cannulation set, single use - to provide an ocular working channel (i.e. an entry port in the eye for ophthalmic instrument access) through the sclera for posterior segment ophthalmic surgery.

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

beaver-visitec international australia pty ltd - 46741 - ophthalmic knife, single-use - used to create an incision to allow insertion of further ophthalmic instruments in various ophthalmic surgical procedures.

Австралия - английский - APVMA (Australian Pesticides and Veterinary Medicines Authority)

jurox pty limited - gentamicin sulfate - misc. aural, ophthalmic, oro/naso pharyngeal - gentamicin sulfate antibiotic active 5.0 mg/ml - ophthalmic preparations - cat | dog | horse | bitch | castrate | cat - queen | cat - tom | colt | donkey | endurance horse | filly | foal | gelding | high - infection - ocular | eye infections | ocular infections

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

bausch & lomb australia pty ltd - 47124 - ophthalmic trocar - this device is a hand-held surgical instrument intended for use as a trocar/cannula for establishing an entry site conduit for passing ophthalmic instruments/accessories used to perform posterior ophthalmic surgical procedures.

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

bausch & lomb australia pty ltd - 46705 - ophthalmic cannula, irrigation/aspiration, non-illumiating, single-use - the ophthalmic cannula is a manual ophthalmic surgical instrument. it is intended to aid or perform ophthalmic surgical procedures. ophthalmic cannulas are used for tissue manipulation and the injection of fluid during an ophthalmic surgical procedure. for injection, the cannula is attached to a syringe filled with fluid or attached to a handpiece for surgical manoeuvre not involving injection.

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

boc ophthalmic instruments pty ltd - 16809 - ophthalmic tonometer, battery-operated - the instruments purposes is to measure the intraocular pressure of the eye, using a contact method to detect the possibility of glaucoma