Sjedinjene Američke Države - engleski - 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

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

novaliq gmbh - cyclosporine (unii: 83hn0gtj6d) (cyclosporine - unii:83hn0gtj6d) - vevye is indicated for the treatment of the signs and symptoms of dry eye disease. none. risk summary there are no adequate and well-controlled studies of vevye 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. vevye doses are approximately 4,700 times lower than recommended oral doses, with blood concentrations being undetectable after topical administration. data animal data oral administration of cyclosporine oral solution 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 7,250 and 48,000 times higher than the daily maximum recommended human ophthalmic dose (mrhod) of 0.67 mcg/kg/day, respectively. no adverse embryofetal eff

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

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

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

american pharmaceutical ingredients llc - cyclosporine (unii: 83hn0gtj6d) (cyclosporine - unii:83hn0gtj6d) - cyclosporine 1 g in 1 g

Kanada - engleski - Health Canada

teva canada limited - cyclosporine - emulsion - 0.05% - cyclosporine 0.05% - anti-inflammatory agents, miscellaneous

Kanada - engleski - Health Canada

apotex inc - cyclosporine - solution - 100mg - cyclosporine 100mg - immunosuppressive agents

Kanada - engleski - Health Canada

sandoz canada incorporated - cyclosporine - capsule - 100mg - cyclosporine 100mg - immunosuppressive agents

Kanada - engleski - Health Canada

sandoz canada incorporated - cyclosporine - capsule - 25mg - cyclosporine 25mg - immunosuppressive agents

Kanada - engleski - Health Canada

sandoz canada incorporated - cyclosporine - capsule - 50mg - cyclosporine 50mg - immunosuppressive agents

Sjedinjene Američke Države - engleski - 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),