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

santen incorporated - cyclosporine (unii: 83hn0gtj6d) (cyclosporine - unii:83hn0gtj6d) - verkazia ophthalmic emulsion is indicated for the treatment of vernal keratoconjunctivitis (vkc) in children and adults. none risk summary there are no adequate and well-controlled studies of verkazia administration in pregnant women to inform a drug-associated risk. oral administration of cyclosporine to pregnant rats or rabbits did not produce teratogenicity at clinically relevant doses [see data ] . data animal data oral administration of cyclosporine oral solution (usp) to pregnant rats or rabbits was teratogenic at maternally toxic doses of 30 mg/kg/day in rats and 100 mg/kg/day in rabbits, as indicated by increased pre- and postnatal mortality, reduced fetal weight and skeletal retardations. these doses (normalized to body weight) were approximately 320 and 2150 times higher than the daily maximum recommended human ophthalmic dose (mrhod) of 0.015 mg/kg/day, respectively. no adverse embryofetal effects were observed in rats or rabbits receiving cyclosporine during organogenesis at oral doses up to

Kenya - English - Pharmacy and Poisons Board

macleods pharmaceuticals limited atlanta arcade church road near leela hotel - cycloserine capsules usp 250 mg - capsule, hard - cycloserine usp 250 mg - antimycobacterials: antibiotics

Malta - English - Medicines Authority

central procurement & supplies unit ub002 industrial estate, san gwann sgn 3000, malta - capsule - cycloserine 250 mg - antimycobacterials

Malta - English - Medicines Authority

central procurement & supplies unit ub002 industrial estate, san gwann sgn 3000, malta - capsule - cycloserine 250 mg - antimycobacterials

New Zealand - English - Ministry for Primary Industries

elanco australasia pty ltd - cyclosporin a. - cyclosporin a. 95.24 g/litre - anti-inflammatory

New Zealand - English - Ministry for Primary Industries

elanco australasia pty ltd - cyclosporin a. - cyclosporin a. 100 g/litre - immunomodulator

New Zealand - English - Ministry for Primary Industries

schering-plough animal health limited - cyclosporin a. - cyclosporin a. 2 g/kg - immunomodulator

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

allergan, inc. - cyclosporine (unii: 83hn0gtj6d) (cyclosporine - unii:83hn0gtj6d) - restasis  multidose tm   ophthalmic emulsion is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs. restasis  multidose tm is contraindicated in patients with known or suspected hypersensitivity to any of the ingredients in the formulation [see adverse reactions (6.2) ]. risk summary clinical administration of cyclosporine ophthalmic emulsion 0.05% is not detected systemically following topical ocular administration [see clinical pharmacology (12.3) ] , and maternal use is not expected to result in fetal exposure to the drug. oral administration of cyclosporine to pregnant rats or rabbits did not produce teratogenicity at clinically relevant doses [see data] . data animal data at maternally toxic doses (30 mg/kg/day in rats and 100 mg/kg/day in rabbits),

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

sun pharmaceutical industries, inc. - cyclosporine (unii: 83hn0gtj6d) (cyclosporine - unii:83hn0gtj6d) - cequa ophthalmic solution is a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye). (1) none. (4) risk summary there are no adequate and well-controlled studies of cequa administration in pregnant women to inform a drug-associated risk. oral administration of cyclosporine to pregnant rats or rabbits did not produce teratogenicity at clinically relevant doses [see data]. data animal data oral administration of cyclosporine oral solution (usp) to pregnant rats or rabbits was teratogenic at maternally toxic doses of 30 mg/kg/day in rats and 100 mg/kg/day in rabbits, as indicated by increased pre- and postnatal mortality, reduced fetal weight and skeletal retardations. these doses (normalized to body weight) were approximately 3200 and 21000 times higher than the maximum recommended human ophthalmic dose (mrhod) of 1.5 mcg/kg/day, respectively. no adverse embryofetal effects were observed in rats or rabbits receiving cyclosporine duri

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

ax pharmaceutical corp - cyclosporine (unii: 83hn0gtj6d) (cyclosporine - unii:83hn0gtj6d) -