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

alphapharm pty ltd - glatiramer acetate, quantity: 40 mg - injection, solution - excipient ingredients: mannitol; water for injections - reduction of the frequency of relapses in patients with relapsing remitting multiple sclerosis.,treatment of patients with a single clinical event suggestive of multiple sclerosis and at least two clinically silent mri lesions characteristic of multiple sclerosis, if alternative diagnoses have been excluded.

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

juno pharmaceuticals pty ltd - glatiramer acetate, quantity: 20 mg/ml - injection, solution - excipient ingredients: mannitol; water for injections - reduction of the frequency of relapses in patients with relapsing remitting multiple sclerosis.,treatment of patients with a single clinical event suggestive of multiple sclerosis and at least two clinically silent mri lesions characteristic of multiple sclerosis, if alternative diagnoses have been excluded.

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

juno pharmaceuticals pty ltd - glatiramer acetate, quantity: 40 mg/ml - injection, solution - excipient ingredients: mannitol; water for injections - reduction of the frequency of relapses in patients with relapsing remitting multiple sclerosis.,treatment of patients with a single clinical event suggestive of multiple sclerosis and at least two clinically silent mri lesions characteristic of multiple sclerosis, if alternative diagnoses have been excluded.

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

bryant ranch prepack - glatiramer acetate (unii: 5m691hl4bo) (glatiramer - unii:u782c039qp) - glatopa is indicated for the treatment of relapsing forms of multiple sclerosis (ms), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. glatopa is contraindicated in patients with known hypersensitivity to glatiramer acetate or mannitol. available human data on the use of glatopa in pregnant women are not sufficient to support conclusions about drug-associated risk for major birth defects and miscarriage. administration of glatiramer acetate by subcutaneous injection to pregnant rats and rabbits resulted in no adverse effects on embryo-fetal or offspring development (see data ). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the us 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. data human data there are no adequate and well-controlled studies of glatopa in pregnant women. the available postmarketing reports, case series, and small cohort studies do not provide sufficient information to support conclusions about drug-associated risk for major birth defects and miscarriage. animal data in rats or rabbits receiving glatiramer acetate by subcutaneous injection during the period of organogenesis, no adverse effects on embryo-fetal development were observed at doses up to 37.5 mg/kg/day (18 and 36 times, respectively, the therapeutic human dose of 20 mg/day on a mg/m2 basis). in rats receiving subcutaneous glatiramer acetate at doses of up to 36 mg/kg from day 15 of pregnancy throughout lactation, no significant effects on delivery or on offspring growth and development were observed. risk summary there are no data on the presence of glatiramer acetate in human milk, the effects on breastfed infants, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for glatopa and any potential adverse effects on the breastfed infant from glatopa or from the underlying maternal condition. the safety and effectiveness of glatopa have not been established in patients under 18 years of age. glatopa has not been studied in elderly patients. the pharmacokinetics of glatiramer acetate in patients with impaired renal function have not been determined.

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

bryant ranch prepack - glatiramer acetate (unii: 5m691hl4bo) (glatiramer - unii:u782c039qp) - glatopa is indicated for the treatment of relapsing forms of multiple sclerosis (ms), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. glatopa is contraindicated in patients with known hypersensitivity to glatiramer acetate or mannitol. available human data on the use of glatopa in pregnant women are not sufficient to support conclusions about drug-associated risk for major birth defects and miscarriage. administration of glatiramer acetate by subcutaneous injection to pregnant rats and rabbits resulted in no adverse effects on embryo-fetal or offspring development (see data ). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the us 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. data human data there are no adequate and well-controlled studies of glatopa in pregnant women. the available postmarketing reports, case series, and small cohort studies do not provide sufficient information to support conclusions about drug-associated risk for major birth defects and miscarriage. animal data in rats or rabbits receiving glatiramer acetate by subcutaneous injection during the period of organogenesis, no adverse effects on embryo-fetal development were observed at doses up to 37.5 mg/kg/day (18 and 36 times, respectively, the therapeutic human dose of 20 mg/day on a mg/m2 basis). in rats receiving subcutaneous glatiramer acetate at doses of up to 36 mg/kg from day 15 of pregnancy throughout lactation, no significant effects on delivery or on offspring growth and development were observed. risk summary there are no data on the presence of glatiramer acetate in human milk, the effects on breastfed infants, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for glatopa and any potential adverse effects on the breastfed infant from glatopa or from the underlying maternal condition. the safety and effectiveness of glatopa have not been established in patients under 18 years of age. glatopa has not been studied in elderly patients. the pharmacokinetics of glatiramer acetate in patients with impaired renal function have not been determined.

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

teva pharma australia pty ltd - glatiramer acetate, quantity: 20 mg - injection, solution - excipient ingredients: mannitol; water for injections - copaxone is indicated for the reduction of the frequency of relapses in patients with relapsing remitting multiple sclerosis. treatment of patients with a single clinical event suggestive of multiple sclerosis and at least two clinically silent mri lesions characteristic of multiple sclerosis, if alternative diagnoses have been excluded.

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

teva pharma australia pty ltd - glatiramer acetate, quantity: 40 mg - injection, solution - excipient ingredients: mannitol; water for injections - copaxone is indicated for the: 1- reduction of the frequency of relapses in patients with relapsing remitting multiple sclerosis. 2-treatment of patients with a single clinical event suggestive of multiple sclerosis and at least two clinically silent mri lesions characteristic of multiple sclerosis, if alternative diagnoses have been excluded.

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

teva pharma australia pty ltd - glatiramer acetate, quantity: 20 mg - injection, solution - excipient ingredients: mannitol; water for injections - glatiramer acetate-teva is indicated for the reduction of the frequency of relapses in patients with relapsing remitting multiple sclerosis. treatment of patients with a single clinical event suggestive of multiple sclerosis and at least two clinically silent mri lesions characteristic of multiple sclerosis, if alternative diagnoses have been excluded.

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

teva pharma australia pty ltd - glatiramer acetate, quantity: 40 mg - injection, solution - excipient ingredients: mannitol; water for injections - glatiramer acetate is indicated for the: 1- reduction of the frequency of relapses in patients with relapsing remitting multiple sclerosis. 2-treatment of patients with a single clinical event suggestive of multiple sclerosis and at least two clinically silent mri lesions characteristic of multiple sclerosis, if alternative diagnoses have been excluded.

Israel - English - Ministry of Health

teva israel ltd - glatiramer acetate - solution for injection - glatiramer acetate 40 mg - glatiramer acetate - copaxone 40 mg/ml is indicated for reducing the frequency of relapses in patients with relapsing-remitting multiple sclerosis.