Australia - English - Department of Health (Therapeutic Goods Administration)

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

Australia - English - Department of Health (Therapeutic Goods Administration)

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

Australia - English - Department of Health (Therapeutic Goods Administration)

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

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

mylan pharmaceuticals inc. - galantamine hydrobromide (unii: mj4ptd2vvw) (galantamine - unii:0d3q044kca) - galantamine 4 mg - 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. there are no adequate and well-controlled studies 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. galantamine tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. in rats, administration of galantamine (oral doses of 2 mg/kg/day, 8 mg/kg/day, 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. th

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

mylan institutional inc. - galantamine hydrobromide (unii: mj4ptd2vvw) (galantamine - unii:0d3q044kca) - galantamine 4 mg - 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. there are no adequate and well-controlled studies 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. galantamine tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. in rats, administration of galantamine (oral doses of 2 mg/kg/day, 8 mg/kg/day, 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. th

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

ncs healthcare of ky, inc dba vangard labs - galantamine hydrobromide (unii: mj4ptd2vvw) (galantamine - unii:0d3q044kca) - galantamine 4 mg - 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.

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

west-ward pharmaceuticals corp. - galantamine hydrobromide (unii: mj4ptd2vvw) (galantamine - unii:0d3q044kca) - galantamine 4 mg - galantamine is indicated for the treatment of mild to moderate dementia of the alzheimer’s type. galantamine is contraindicated in patients with known hypersensitivity to galantamine hydrobromide or to any excipients used in the formulation. pregnancy category c there are no adequate and well-controlled studies 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. galantamine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. in rats, administration of galantamine (oral doses of 2 mg, 8 mg, 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. the no-effect dose fo

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

apotex corp. - galantamine hydrobromide (unii: mj4ptd2vvw) (galantamine - unii:0d3q044kca) - galantamine 4 mg - 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 hydrobromide 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 to 4% and 15 to 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

Canada - English - Health Canada

marcan pharmaceuticals inc - galantamine (galantamine hydrobromide) - capsule (extended release) - 8mg - galantamine (galantamine hydrobromide) 8mg - parasympathomemetic (cholinergic) agents

Canada - English - Health Canada

marcan pharmaceuticals inc - galantamine (galantamine hydrobromide) - capsule (extended release) - 16mg - galantamine (galantamine hydrobromide) 16mg - parasympathomemetic (cholinergic) agents