আয়ার্লণ্ড - ইংরেজি - HPRA (Health Products Regulatory Authority)

wockhardt uk limited - donepezil hydrochloride - film-coated tablet - 5 milligram(s) - anticholinesterases; donepezil

আয়ার্লণ্ড - ইংরেজি - HPRA (Health Products Regulatory Authority)

wockhardt uk limited - donepezil hydrochloride - film-coated tablet - 10 milligram(s) - anticholinesterases; donepezil

অস্ট্রেলিয়া - ইংরেজি - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - donepezil hydrochloride, quantity: 10 mg (equivalent: donepezil, qty 9.12 mg) - tablet, film coated - excipient ingredients: magnesium stearate; microcrystalline cellulose; maize starch; lactose monohydrate; hyprolose; titanium dioxide; macrogol 8000; hypromellose; purified talc; iron oxide yellow - aricept (donepezil hydrochloride) is indicated for the treatment of mild, moderate and severe alzheimer's disease.

অস্ট্রেলিয়া - ইংরেজি - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - donepezil hydrochloride, quantity: 5 mg (equivalent: donepezil, qty 4.56 mg) - tablet, film coated - excipient ingredients: maize starch; lactose monohydrate; hyprolose; magnesium stearate; microcrystalline cellulose; titanium dioxide; hypromellose; macrogol 8000; purified talc - aricept (donepezil hydrochloride) is indicated for the treatment of mild, moderate and severe alzheimer's disease.

মার্কিন যুক্তরাষ্ট্র - ইংরেজি - NLM (National Library of Medicine)

dr. reddys laboratories limited - 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. 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), respectively. 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 d

মার্কিন যুক্তরাষ্ট্র - ইংরেজি - 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

মার্কিন যুক্তরাষ্ট্র - ইংরেজি - 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

মার্কিন যুক্তরাষ্ট্র - ইংরেজি - NLM (National Library of Medicine)

major pharmaceuticals - 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 major

মার্কিন যুক্তরাষ্ট্র - ইংরেজি - NLM (National Library of Medicine)

biomes pharmaceuticals llc - donepezil hydrochloride (unii: 3o2t2pj89d) (donepezil - unii:8ssc91326p) - donepezil hydrochloride 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 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 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 6 times the maximum recommended human dose [mrhd] of 23 mg/day on a mg/m2 basis) and 10 mg/kg/day (approximately 7 times the mrhd on a mg/m2 basis), respectively. oral administration of donepezil (1, 3, 10 mg/kg/day) to rats during late gestation and throughout lactation to weaning prod

মার্কিন যুক্তরাষ্ট্র - ইংরেজি - NLM (National Library of Medicine)

cardinal health 107, llc - 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 major birth defects and miscarriage for the indicated population are unknown. data animal data 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/m2 basis) and 10 mg/kg/day (approximately 20 times the mrhd on a mg/m2 basis), respectively. 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 no-effect dose of 3 mg/kg/day is approximately 3 times the mrhd on a mg/m2 basis. risk summary there are no data on the presence of donepezil or its metabolites in human milk, the effects on the breastfed infant, or on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for donepezil and any potential adverse effects on the breastfed infant from donepezil or from the underlying maternal condition. the safety and effectiveness in pediatric patients have not been established. alzheimer’s disease is a disorder occurring primarily in individuals over 55 years of age. the mean age of patients enrolled in the clinical studies with donepezil hydrochloride tablets was 73 years; 80% of these patients were between 65 and 84 years old, and 49% of patients were at or above the age of 75. the efficacy and safety data presented in the clinical trials section were obtained from these patients. there were no clinically significant differences in most adverse events reported by patient groups ≥ 65 years old and < 65 years old.