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

bayer healthcare pharmaceuticals inc. - interferon beta-1b (unii: ttd90r31wz) (interferon beta-1b - unii:ttd90r31wz) - interferon beta-1b 0.25 mg in 1 ml - betaseron 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. betaseron is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta, albumin (human), or any other component of the formulation. although there have been no well-controlled studies in pregnant women, available data, which includes prospective observational studies, have not generally indicated a drug-associated risk of major birth defects with interferon beta-1b during pregnancy. administration of betaseron to monkeys during gestation resulted in increased embryo-fetal death at or above exposures greater than 3 times the human therapeutic dose (see animal 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 o

Israel - English - Ministry of Health

bayer israel ltd - interferon beta 1b - powder and solvent for solution for injection - interferon beta 1b 0.3 mg/vial - interferon beta-1b - interferon beta-1b - use in ambulatory patients with relapsing-remitting multiple sclerosis (rrms) and relapsing progressive m.s. to reduce the frequency of clinical exacerbations. treatment of secondary progressive (sp) form of multiple sclerosis. treatment of patients who have experienced a single demyelinating event with an active inflammatory process, if it is severe enough to warrant treatment with intravenous corticosteroids, if alternative diagnoses have been excluded, including the prescence of mri abnormalities characteristic of m.s. and if they are determined to be at high risk of developing clinically definite multiple sclerosis.

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

biogen inc. - peginterferon beta-1a (unii: i8309403r0) (peginterferon beta-1a - unii:i8309403r0) - peginterferon beta-1a 94 ug in 0.5 ml - plegridy 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. plegridy is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta or peginterferon, or any other component of plegridy [see warnings and precautions ( 5.3)] . risk summary data from a large population-based cohort study, as well as other published studies over several decades, have not identified a drug-associated risk of major birth defects with the use of interferon beta products during early pregnancy. findings regarding a potential risk for low birth weight or miscarriage with the use of interferon beta products in pregnancy have been inconsistent (see data). in a study in pregnant monkeys, administration of interferon beta during pregnancy resulted in an increased rate of abortion (see data ). in the u.s. general population, the estimated backgro

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

novartis pharmaceuticals corporation - interferon beta-1b (unii: ttd90r31wz) (interferon beta-1b - unii:ttd90r31wz) - interferon beta-1b 0.25 mg in 1.0 ml - extavia 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. extavia is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta, albumin (human), or any other component of the formulation. risk summary although there have been no well-controlled studies in pregnant women, available data, which include prospective observational studies, have not generally indicated a drug-associated risk of major birth defects with interferon beta-1b during pregnancy. administration of interferon beta-1b to monkeys during gestation resulted in increased embryo-fetal death at or above exposures greater than 3 times the human therapeutic dose (see animal 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%, respective

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

biogen inc. - interferon beta-1a (unii: xro4566q4r) (interferon beta-1a - unii:xro4566q4r) - interferon beta-1a 30 ug in 0.5 ml - avonex 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. avonex is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta, or any other component of the formulation [see warnings and precautions (5.3)] . the formerly available lyophilized vial formulation of avonex is contraindicated in patients with a history of hypersensitivity to albumin (human). risk summary data from a large population-based cohort study, as well as other published studies over several decades, have not identified a drug-associated risk of major birth defects with the use of interferon beta products during early pregnancy. findings regarding a potential risk for low birth weight or miscarriage with the use of interferon beta products in pregnancy have been inconsistent (see data). in a study in pregnant monkeys, administration of interfer

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

bayer australia ltd - interferon beta-1b, quantity: 0.25 mg/ml - injection, powder for - excipient ingredients: albumin; mannitol - betaferon is indicated for the treatment of: - ambulatory patients with relapsing-remitting multiple sclerosis (ms) characterised by at least two attacks of neurologic dysfunction over a two year period followed by complete or incomplete recovery. - betaferon is also indicated for the reduction of frequency and severity of clinical relapses, and for the slowing of progression of disease in patients with secondary progressive multiple sclerosis. - the treatment of patients with a single clinical event suggestive of multiple sclerosis and at least two clinically silent magnetic resonance imaging (mri) lesions characteristic of multiple sclerosis, if alternative diagnoses have been excluded.

New Zealand - English - Medsafe (Medicines Safety Authority)

bayer new zealand limited - interferon beta-1b 0.25mg (20% excess in quantity filled) - injection with diluent - 8 miu - active: interferon beta-1b 0.25mg (20% excess in quantity filled) excipient: albumin hydrochloric acid mannitol sodium hydroxide hydrochloric acid sodium chloride water for injection - betaferon is indicated for: · the treatment of patients with a single clinical event suggestive of multiple sclerosis and at least two clinically silent magnetic resonance imaging (mri) lesions characteristic of multiple sclerosis, if alternative diagnoses have been excluded, · the treatment of ambulatory patients, with relapsing-remitting multiple sclerosis characterised by at least two attacks of neurological dysfunction over a two year period followed by complete or incomplete recovery. · the reduction of frequency and severity of clinical relapses and for slowing the progression of disease in patients with secondary progressive multiple sclerosis

Israel - English - Ministry of Health

merck serono ltd - interferon beta 1a - solution for injection - interferon beta 1a 44 mcg/ml - interferon beta-1a - interferon beta-1a - rebif (interferone beta-1a) is indicated for the treatment of patients with relapsing forms of multiple sclerosis to decrease the frequency of clinical exacerbations and delay the accumulation of physical disability. efficacy of rebif in chronic progressive multiple sclerosis has not been established.

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

emd serono, inc. - interferon beta-1a (unii: xro4566q4r) (interferon beta-1a - unii:xro4566q4r) - interferon beta-1a 8.8 ug in 0.2 ml - rebif 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. rebif is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta, human albumin, or any other component of the formulation. risk summary data from a large population-based cohort study, as well as other published studies over several decades, have not identified a drug-associated risk of major birth defects with the use of interferon beta during early pregnancy. findings regarding a potential risk for low birth weight or miscarriage with the use of interferon beta in pregnancy have been inconsistent (see data) . it is unclear whether, as a class of products, administration of interferon beta therapies to pregnant animals at doses greater than those used clinically results in an increased rate of abortion. the potential for rebif to have adverse effects on em

European Union - English - EMA (European Medicines Agency)

bayer ag  - interferon beta-1b - multiple sclerosis - immunostimulants, - betaferon is indicated for the treatment ofpatients with a single demyelinating event with an active inflammatory process, if it is severe enough to warrant treatment with intravenous corticosteroids, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite multiple sclerosis;patients with relapsing-remitting multiple sclerosis and two or more relapses within the last two years;patients with secondary progressive multiple sclerosis with active disease, evidenced by relapses.