Australien - Englisch - Department of Health (Therapeutic Goods Administration)

apotex pty ltd - donepezil hydrochloride -

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

nucare pharmaceuticals,inc. - donepezil hydrochloride (unii: 3o2t2pj89d) (donepezil - unii:8ssc91326p) - donepezil hydrochloride tablets, usp are indicated for the treatment of dementia of the alzheimer's type. efficacy has been demonstrated in patients with mild, moderate, and severe alzheimer's disease. donepezil hydrochloride tablets are contraindicated in patients with known hypersensitivity to donepezil hydrochloride or to piperidine derivatives. pregnancy category c there are no adequate or well-controlled studies in pregnant women. donepezil hydrochloride tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. oral administration of donepezil to pregnant rats and rabbits during the period of organogenesis did not produce any teratogenic effects at doses up to 16 mg/kg/day (approximately 16 times the maximum recommended human dose [mrhd] of 10 mg/day on a mg/m 2 basis) and 10 mg/kg/day (approximately 20 times the mrhd on a mg/m 2 basis), respectively. oral administration of donepezil (1, 3, 10 mg/kg/day) to rats during late gestation and throughout

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

remedyrepack inc. - donepezil hydrochloride (unii: 3o2t2pj89d) (donepezil - unii:8ssc91326p) - donepezil hydrochloride tablets, usp are indicated for the treatment of dementia of the alzheimer's type. efficacy has been demonstrated in patients with mild, moderate, and severe alzheimer's disease. donepezil hydrochloride tablets are contraindicated in patients with known hypersensitivity to donepezil hydrochloride or to piperidine derivatives. risk summary there are no adequate data on the developmental risks associated with the use of donepezil in pregnant women. in animal studies, developmental toxicity was not observed when donepezil was administered to pregnant rats and rabbits during organogenesis, but administration to rats during the latter part of pregnancy and throughout lactation resulted in increased stillbirths and decreased offspring survival at clinically relevant doses [ see data ]. in the u.s. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively. the background risks of majo

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

preferred pharmaceuticals inc. - donepezil hydrochloride (unii: 3o2t2pj89d) (donepezil - unii:8ssc91326p) - donepezil hydrochloride tablet, usp is indicated for the treatment of dementia of the alzheimer's type. efficacy has been demonstrated in patients with mild, moderate, and severe alzheimer's disease. donepezil hydrochloride tablet is contraindicated in patients with known hypersensitivity to donepezil hydrochloride or to piperidine derivatives. pregnancy category c there are no adequate or well-controlled studies in pregnant women. donepezil hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. oral administration of donepezil to pregnant rats and rabbits during the period of organogenesis did not produce any teratogenic effects at doses up to 10 mg/kg/day (approximately 7 times the mrhd on a mg/m2 basis). oral administration of donepezil (1, 3, 10 mg/kg/day) to rats during late gestation and throughout lactation to weaning produced an increase in stillbirths and reduced offspring survival through postpartum day 4 at the highest dose. the

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

nucare pharmaceuticals,inc. - donepezil hydrochloride (unii: 3o2t2pj89d) (donepezil - unii:8ssc91326p) - donepezil hydrochloride tablet, usp is indicated for the treatment of dementia of the alzheimer's type. efficacy has been demonstrated in patients with mild, moderate, and severe alzheimer's disease. donepezil hydrochloride tablet is contraindicated in patients with known hypersensitivity to donepezil hydrochloride or to piperidine derivatives. pregnancy category c there are no adequate or well-controlled studies in pregnant women. donepezil hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. oral administration of donepezil to pregnant rats and rabbits during the period of organogenesis did not produce any teratogenic effects at doses up to 10 mg/kg/day (approximately 7 times the mrhd on a mg/m 2 basis). oral administration of donepezil (1, 3, 10 mg/kg/day) to rats during late gestation and throughout lactation to weaning produced an increase in stillbirths and reduced offspring survival through

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

nucare pharmaceuticals,inc. - donepezil hydrochloride (unii: 3o2t2pj89d) (donepezil - unii:8ssc91326p) - donepezil hydrochloride tablet, usp is indicated for the treatment of dementia of the alzheimer's type. efficacy has been demonstrated in patients with mild, moderate, and severe alzheimer's disease. donepezil hydrochloride tablet is contraindicated in patients with known hypersensitivity to donepezil hydrochloride or to piperidine derivatives. pregnancy category c there are no adequate or well-controlled studies in pregnant women. donepezil hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. oral administration of donepezil to pregnant rats and rabbits during the period of organogenesis did not produce any teratogenic effects at doses up to 10 mg/kg/day (approximately 7 times the mrhd on a mg/m 2 basis). oral administration of donepezil (1, 3, 10 mg/kg/day) to rats during late gestation and throughout lactation to weaning produced an increase in stillbirths and reduced offspring survival through

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

quallent pharmaceuticals health llc - donepezil hydrochloride (unii: 3o2t2pj89d) (donepezil - unii:8ssc91326p) - donepezil hydrochloride tablets are indicated for the treatment of dementia of the alzheimer’s type. efficacy has been demonstrated in patients with mild, moderate, and severe alzheimer’s disease. donepezil hydrochloride tablets are contraindicated in patients with known hypersensitivity to donepezil hydrochloride or to piperidine derivatives.  risk summary there are no adequate data on the developmental risks associated with the use of donepezil hydrochloride in pregnant women. in animal studies, developmental toxicity was not observed when donepezil was administered to pregnant rats and rabbits during organogenesis, but administration to rats during the latter part of pregnancy and throughout lactation resulted in increased stillbirths and decreased offspring survival at clinically relevant doses [see data] . in the u.s. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively. the backgr

Australien - Englisch - Department of Health (Therapeutic Goods Administration)

pharmacor pty ltd - donepezil hydrochloride -

Australien - Englisch - Department of Health (Therapeutic Goods Administration)

apotex pty ltd - donepezil hydrochloride -

Australien - Englisch - Department of Health (Therapeutic Goods Administration)

apotex pty ltd - donepezil hydrochloride -