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

amneal pharmaceuticals of new york llc - memantine hydrochloride (unii: jy0wd0ua60) (memantine - unii:w8o17sjf3t) - memantine hydrochloride 5 mg - memantine hydrochloride tablets are indicated for the treatment of moderate to severe dementia of the alzheimer’s type. memantine hydrochloride tablets are contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation. risk summary there are no adequate data on the developmental risk associated with the use of memantine hydrochloride in pregnant women. adverse developmental effects (decreased body weight, and skeletal ossification) were observed in the offspring of rats administered memantine during pregnancy at doses associated with minimal maternal toxicity. these doses are higher than those used in humans at the maximum recommended daily dose of memantine hydrochloride [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 populat

Kanada - engleski - Health Canada

apotex inc - memantine hydrochloride - tablet - 10mg - memantine hydrochloride 10mg - miscellaneous central nervous system agents

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

avkare, inc. - memantine hydrochloride (unii: jy0wd0ua60) (memantine - unii:w8o17sjf3t) - memantine hydrochloride 5 mg - memantine hydrochloride (hcl) tablets, usp are indicated for the treatment of moderate to severe dementia of the alzheimer’s type. memantine hcl tablets, usp are contraindicated in patients with known hypersensitivity to memantine hydrochloride, usp or to any excipients used in the formulation. pregnancy category b there are no adequate and well-controlled studies of memantine in pregnant women. memantine hcl should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. memantine given orally to pregnant rats and pregnant rabbits during the period of organogenesis was not teratogenic up to the highest doses tested (18 mg/kg/day in rats and 30 mg/kg/day in rabbits, which are 9 and 30 times, respectively, the maximum recommended human dose [mrhd] on a mg/m 2 basis). slight maternal toxicity, decreased pup weights and an increased incidence of non-ossified cervical vertebrae were seen at an oral dose of 18 mg/kg/day in a study in which rats were given oral memantine be

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

bryant ranch prepack - memantine hydrochloride (unii: jy0wd0ua60) (memantine - unii:w8o17sjf3t) - memantine hydrochloride 10 mg - memantine hydrochloride tablets are indicated for the treatment of moderate to severe dementia of the alzheimer’s type. memantine hydrochloride tablets are contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation. risk summary there are no adequate data on the developmental risk associated with the use of memantine hydrochloride in pregnant women. adverse developmental effects (decreased body weight, and skeletal ossification) were observed in the offspring of rats administered memantine during pregnancy at doses associated with minimal maternal toxicity. these doses are higher than those used in humans at the maximum recommended daily dose of memantine hydrochloride [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

Novi Zeland - engleski - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - memantine hydrochloride 10mg; memantine hydrochloride 10mg - film coated tablet - 10 mg - active: memantine hydrochloride 10mg excipient: colloidal silicon dioxide lactose monohydrate magnesium stearate methacrylic acid - ethyl acrylate copolymer microcrystalline cellulose polysorbate 80 purified talc   purified water simeticone sodium laurilsulfate triacetin active: memantine hydrochloride 10mg excipient: colloidal silicon dioxide croscarmellose sodium hypromellose iron oxide yellow macrogol 400 magnesium stearate microcrystalline cellulose titanium dioxide - treatment of patients with moderate to severe alzheimer's disease

Tanzanija - engleski - Tanzania Medicinces & Medical Devices Authority

unichem laboratories limited, india - memantine - film coated tablet - 10

Tanzanija - engleski - Tanzania Medicinces & Medical Devices Authority

unichem laboratories limited, india - memantine - film coated tablet - 10

Australija - engleski - Department of Health (Therapeutic Goods Administration)

sun pharma anz pty ltd - memantine hydrochloride, quantity: 10 mg - tablet, film coated - excipient ingredients: croscarmellose sodium; colloidal anhydrous silica; magnesium stearate; microcrystalline cellulose; purified talc; titanium dioxide; hypromellose; macrogol 400 - treatment of the symptoms of moderately severe to severe alzheimer's disease

Australija - engleski - Department of Health (Therapeutic Goods Administration)

sun pharma anz pty ltd - memantine hydrochloride, quantity: 20 mg - tablet, film coated - excipient ingredients: magnesium stearate; purified talc; microcrystalline cellulose; colloidal anhydrous silica; croscarmellose sodium; titanium dioxide; hypromellose; iron oxide yellow; iron oxide red; macrogol 400 - treatment of the symptoms of moderately severe to severe alzheimer's disease

Australija - engleski - Department of Health (Therapeutic Goods Administration)

sun pharma anz pty ltd - memantine hydrochloride, quantity: 20 mg - tablet, film coated - excipient ingredients: purified talc; microcrystalline cellulose; croscarmellose sodium; magnesium stearate; colloidal anhydrous silica; titanium dioxide; hypromellose; iron oxide yellow; iron oxide red; macrogol 400 - treatment of the symptoms of moderately severe to severe alzheimer's disease