Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

southern cross pharma pty ltd - galantamine hydrobromide, quantity: 20.504 mg (equivalent: galantamine, qty 16 mg) - capsule, modified release - excipient ingredients: iron oxide red; ethylcellulose; titanium dioxide; hypromellose; gelatin; magnesium stearate; microcrystalline cellulose - galantamine is indicated for the treatment of mild to moderately severe dementia of the alzheimer type

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

southern cross pharma pty ltd - galantamine hydrobromide, quantity: 10.252 mg (equivalent: galantamine, qty 8 mg) - capsule, modified release - excipient ingredients: magnesium stearate; gelatin; ethylcellulose; microcrystalline cellulose; titanium dioxide; hypromellose - galantamine is indicated for the treatment of mild to moderately severe dementia of the alzheimer type

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

southern cross pharma pty ltd - galantamine hydrobromide, quantity: 30.756 mg (equivalent: galantamine, qty 24 mg) - capsule, modified release - excipient ingredients: iron oxide yellow; hypromellose; magnesium stearate; titanium dioxide; microcrystalline cellulose; iron oxide red; gelatin; ethylcellulose; erythrosine; indigo carmine - galantamine is indicated for the treatment of mild to moderately severe dementia of the alzheimer type

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

southern cross pharma pty ltd - galantamine hydrobromide, quantity: 10.252 mg (equivalent: galantamine, qty 8 mg) - capsule, modified release - excipient ingredients: magnesium stearate; ethylcellulose; titanium dioxide; hypromellose; gelatin; microcrystalline cellulose - galantamine is indicated for the treatment of mild to moderately severe dementia of the alzheimer type

Málta - angol - Medicines Authority

syri limited - galantamine - oral solution - galantamine 4 mg/ml - psychoanaleptics

Egyesült Államok - angol - NLM (National Library of Medicine)

bryant ranch prepack - galantamine hydrobromide (unii: mj4ptd2vvw) (galantamine - unii:0d3q044kca) - galantamine hydrobromide extended-release capsules are indicated for the treatment of mild to moderate dementia of the alzheimer's type. galantamine hydrobromide extended-release capsules are contraindicated in patients with known hypersensitivity to galantamine hydrobromide or to any excipients used in the formulation. risk summary there are no adequate data on the developmental risk associated with the use of galantamine hydrobromide extended-release capsules in pregnant women. in studies conducted in animals, administration of galantamine during pregnancy resulted in developmental toxicity (increased incidence of morphological abnormalities and decreased growth in offspring) at doses similar to or greater than those used clinically (see data). in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. data animal data in rats, administration of galantamine (oral doses of 2, 8, or 16 mg/kg/day), from day 14 (females) or day 60 (males) prior to mating and continuing in females through the period of organogenesis, resulted in an increased incidence of fetal skeletal variations at the two highest doses, which were associated with maternal toxicity. the no-effect dose for embryo-fetal developmental toxicity in rats (2 mg/kg/day) is approximately equal to the maximum recommended human dose (mrhd) of 24 mg/day on a body surface area (mg/m2 ) basis. when galantamine (oral doses of 4, 12, 28, or 40 mg/kg/day) was administered to pregnant rabbits throughout the period of organogenesis, small increases in fetal visceral malformations and skeletal variations were observed at the highest dose which was associated with maternal toxicity. the no-effect dose for embryo-fetal developmental toxicity in rabbits (28 mg/kg/day) is approximately 20 times the mrhd on a mg/m2 basis. in a study in which pregnant rats were orally dosed with galantamine (2, 8, or 16 mg/kg/day) from the beginning of organogenesis through day 21 post-partum, pup weights were decreased at birth and during the lactation period at the two highest doses. the no-effect dose for pre- and postnatal developmental toxicity in rats (2 mg/kg/day) is approximately equal to the mrhd on a mg/m2 basis. risk summary there are no data on the presence of galantamine in human milk, the effects on the breastfed infant, or the effects of galantamine hydrobromide extended-release capsules on milk production.   the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for galantamine hydrobromide extended-release capsules and any potential adverse effects on the breastfed infant from galantamine hydrobromide extended-release capsules or from the underlying maternal condition. the safety and effectiveness in pediatric patients have not been established. eight double-blind, placebo-controlled clinical trials and 5 open-label trials in a total of 6,519 patients have investigated galantamine hydrobromide extended-release capsules in the treatment of mild to moderate dementia of the alzheimer’s type [see adverse reactions (6.1) and clinical studies (14)] . the mean age of patients enrolled in these clinical studies was 75 years; 78% of these patients were between 65 and 84 years of age, and 10% of patients were 85 years of age or older. in patients with moderate hepatic impairment, a dosage adjustment is recommended. the use of galantamine hydrobromide extended-release capsules in patients with severe hepatic impairment is not recommended [see dosage and administration (2.3) and clinical pharmacology (12.3)] . in patients with a creatinine clearance of 9 to 59 ml/min, a dosage adjustment is recommended. the use of galantamine hydrobromide extended-release capsules in patients with creatinine clearance less than 9 ml/min is not recommended [see dosage and administration (2.4) and clinical pharmacology (12.3)] .

Egyesült Államok - angol - NLM (National Library of Medicine)

bryant ranch prepack - galantamine hydrobromide (unii: mj4ptd2vvw) (galantamine - unii:0d3q044kca) - galantamine hydrobromide extended-release capsules are indicated for the treatment of mild to moderate dementia of the alzheimer's type. galantamine hydrobromide extended-release capsules are contraindicated in patients with known hypersensitivity to galantamine hydrobromide or to any excipients used in the formulation. risk summary there are no adequate data on the developmental risk associated with the use of galantamine hydrobromide extended-release capsules in pregnant women. in studies conducted in animals, administration of galantamine during pregnancy resulted in developmental toxicity (increased incidence of morphological abnormalities and decreased growth in offspring) at doses similar to or greater than those used clinically (see data). in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. data animal data in rats, administration of galantamine (oral doses of 2, 8, or 16 mg/kg/day), from day 14 (females) or day 60 (males) prior to mating and continuing in females through the period of organogenesis, resulted in an increased incidence of fetal skeletal variations at the two highest doses, which were associated with maternal toxicity. the no-effect dose for embryo-fetal developmental toxicity in rats (2 mg/kg/day) is approximately equal to the maximum recommended human dose (mrhd) of 24 mg/day on a body surface area (mg/m2 ) basis. when galantamine (oral doses of 4, 12, 28, or 40 mg/kg/day) was administered to pregnant rabbits throughout the period of organogenesis, small increases in fetal visceral malformations and skeletal variations were observed at the highest dose which was associated with maternal toxicity. the no-effect dose for embryo-fetal developmental toxicity in rabbits (28 mg/kg/day) is approximately 20 times the mrhd on a mg/m2 basis. in a study in which pregnant rats were orally dosed with galantamine (2, 8, or 16 mg/kg/day) from the beginning of organogenesis through day 21 post-partum, pup weights were decreased at birth and during the lactation period at the two highest doses. the no-effect dose for pre- and postnatal developmental toxicity in rats (2 mg/kg/day) is approximately equal to the mrhd on a mg/m2 basis. risk summary there are no data on the presence of galantamine in human milk, the effects on the breastfed infant, or the effects of galantamine hydrobromide extended-release capsules on milk production.   the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for galantamine hydrobromide extended-release capsules and any potential adverse effects on the breastfed infant from galantamine hydrobromide extended-release capsules or from the underlying maternal condition. the safety and effectiveness in pediatric patients have not been established. eight double-blind, placebo-controlled clinical trials and 5 open-label trials in a total of 6,519 patients have investigated galantamine hydrobromide extended-release capsules in the treatment of mild to moderate dementia of the alzheimer’s type [see adverse reactions (6.1) and clinical studies (14)] . the mean age of patients enrolled in these clinical studies was 75 years; 78% of these patients were between 65 and 84 years of age, and 10% of patients were 85 years of age or older. in patients with moderate hepatic impairment, a dosage adjustment is recommended. the use of galantamine hydrobromide extended-release capsules in patients with severe hepatic impairment is not recommended [see dosage and administration (2.3) and clinical pharmacology (12.3)] . in patients with a creatinine clearance of 9 to 59 ml/min, a dosage adjustment is recommended. the use of galantamine hydrobromide extended-release capsules in patients with creatinine clearance less than 9 ml/min is not recommended [see dosage and administration (2.4) and clinical pharmacology (12.3)] .

Egyesült Államok - angol - NLM (National Library of Medicine)

major pharmaceuticals - galantamine hydrobromide (unii: mj4ptd2vvw) (galantamine - unii:0d3q044kca) - galantamine tablets are indicated for the treatment of mild to moderate dementia of the alzheimer’s type. galantamine tablets are contraindicated in patients with known hypersensitivity to galantamine hydrobromide or to any excipients used in the formulation. risk summary there are no adequate data on the developmental risk associated with the use of galantamine tablets in pregnant women. in studies conducted in animals, administration of galantamine during pregnancy resulted in developmental toxicity (increased incidence of morphological abnormalities and decreased growth in offspring) at doses similar to or greater than those used clinically (see data). in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. data animal data in rats, administration of galantamine (oral d

Egyesült Államok - angol - NLM (National Library of Medicine)

bryant ranch prepack - galantamine hydrobromide (unii: mj4ptd2vvw) (galantamine - unii:0d3q044kca) - galantamine hydrobromide extended-release capsules are indicated for the treatment of mild to moderate dementia of the alzheimer's type. galantamine hydrobromide extended-release capsules are contraindicated in patients with known hypersensitivity to galantamine hydrobromide or to any excipients used in the formulation. risk summary there are no adequate data on the developmental risk associated with the use of galantamine hydrobromide extended-release capsules in pregnant women. in studies conducted in animals, administration of galantamine during pregnancy resulted in developmental toxicity (increased incidence of morphological abnormalities and decreased growth in offspring) at doses similar to or greater than those used clinically (see data). in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. data animal data in rats, administration of galantamine (oral doses of 2, 8, or 16 mg/kg/day), from day 14 (females) or day 60 (males) prior to mating and continuing in females through the period of organogenesis, resulted in an increased incidence of fetal skeletal variations at the two highest doses, which were associated with maternal toxicity. the no-effect dose for embryo-fetal developmental toxicity in rats (2 mg/kg/day) is approximately equal to the maximum recommended human dose (mrhd) of 24 mg/day on a body surface area (mg/m2 ) basis. when galantamine (oral doses of 4, 12, 28, or 40 mg/kg/day) was administered to pregnant rabbits throughout the period of organogenesis, small increases in fetal visceral malformations and skeletal variations were observed at the highest dose which was associated with maternal toxicity. the no-effect dose for embryo-fetal developmental toxicity in rabbits (28 mg/kg/day) is approximately 20 times the mrhd on a mg/m2 basis. in a study in which pregnant rats were orally dosed with galantamine (2, 8, or 16 mg/kg/day) from the beginning of organogenesis through day 21 post-partum, pup weights were decreased at birth and during the lactation period at the two highest doses. the no-effect dose for pre- and postnatal developmental toxicity in rats (2 mg/kg/day) is approximately equal to the mrhd on a mg/m2 basis. risk summary there are no data on the presence of galantamine in human milk, the effects on the breastfed infant, or the effects of galantamine hydrobromide extended-release capsules on milk production.   the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for galantamine hydrobromide extended-release capsules and any potential adverse effects on the breastfed infant from galantamine hydrobromide extended-release capsules or from the underlying maternal condition. the safety and effectiveness in pediatric patients have not been established. eight double-blind, placebo-controlled clinical trials and 5 open-label trials in a total of 6,519 patients have investigated galantamine hydrobromide extended-release capsules in the treatment of mild to moderate dementia of the alzheimer’s type [see adverse reactions (6.1) and clinical studies (14)] . the mean age of patients enrolled in these clinical studies was 75 years; 78% of these patients were between 65 and 84 years of age, and 10% of patients were 85 years of age or older. in patients with moderate hepatic impairment, a dosage adjustment is recommended. the use of galantamine hydrobromide extended-release capsules in patients with severe hepatic impairment is not recommended [see dosage and administration (2.2) and clinical pharmacology (12.3)] . in patients with a creatinine clearance of 9 to 59 ml/min, a dosage adjustment is recommended. the use of galantamine hydrobromide extended-release capsules in patients with creatinine clearance less than 9 ml/min is not recommended [see dosage and administration (2.3) and clinical pharmacology (12.3)] .

Egyesült Államok - angol - NLM (National Library of Medicine)

bryant ranch prepack - galantamine hydrobromide (unii: mj4ptd2vvw) (galantamine - unii:0d3q044kca) - galantamine hydrobromide extended-release capsules are indicated for the treatment of mild to moderate dementia of the alzheimer's type. galantamine hydrobromide extended-release capsules are contraindicated in patients with known hypersensitivity to galantamine hydrobromide or to any excipients used in the formulation. risk summary there are no adequate data on the developmental risk associated with the use of galantamine hydrobromide extended-release capsules in pregnant women. in studies conducted in animals, administration of galantamine during pregnancy resulted in developmental toxicity (increased incidence of morphological abnormalities and decreased growth in offspring) at doses similar to or greater than those used clinically (see data). in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. data animal data in rats, administration of galantamine (oral doses of 2, 8, or 16 mg/kg/day), from day 14 (females) or day 60 (males) prior to mating and continuing in females through the period of organogenesis, resulted in an increased incidence of fetal skeletal variations at the two highest doses, which were associated with maternal toxicity. the no-effect dose for embryo-fetal developmental toxicity in rats (2 mg/kg/day) is approximately equal to the maximum recommended human dose (mrhd) of 24 mg/day on a body surface area (mg/m2 ) basis. when galantamine (oral doses of 4, 12, 28, or 40 mg/kg/day) was administered to pregnant rabbits throughout the period of organogenesis, small increases in fetal visceral malformations and skeletal variations were observed at the highest dose which was associated with maternal toxicity. the no-effect dose for embryo-fetal developmental toxicity in rabbits (28 mg/kg/day) is approximately 20 times the mrhd on a mg/m2 basis. in a study in which pregnant rats were orally dosed with galantamine (2, 8, or 16 mg/kg/day) from the beginning of organogenesis through day 21 post-partum, pup weights were decreased at birth and during the lactation period at the two highest doses. the no-effect dose for pre- and postnatal developmental toxicity in rats (2 mg/kg/day) is approximately equal to the mrhd on a mg/m2 basis. risk summary there are no data on the presence of galantamine in human milk, the effects on the breastfed infant, or the effects of galantamine hydrobromide extended-release capsules on milk production.   the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for galantamine hydrobromide extended-release capsules and any potential adverse effects on the breastfed infant from galantamine hydrobromide extended-release capsules or from the underlying maternal condition. the safety and effectiveness in pediatric patients have not been established. eight double-blind, placebo-controlled clinical trials and 5 open-label trials in a total of 6,519 patients have investigated galantamine hydrobromide extended-release capsules in the treatment of mild to moderate dementia of the alzheimer’s type [see adverse reactions (6.1) and clinical studies (14)] . the mean age of patients enrolled in these clinical studies was 75 years; 78% of these patients were between 65 and 84 years of age, and 10% of patients were 85 years of age or older. in patients with moderate hepatic impairment, a dosage adjustment is recommended. the use of galantamine hydrobromide extended-release capsules in patients with severe hepatic impairment is not recommended [see dosage and administration (2.2) and clinical pharmacology (12.3)] . in patients with a creatinine clearance of 9 to 59 ml/min, a dosage adjustment is recommended. the use of galantamine hydrobromide extended-release capsules in patients with creatinine clearance less than 9 ml/min is not recommended [see dosage and administration (2.3) and clinical pharmacology (12.3)] .