Israel - English - Ministry of Health

medison pharma ltd - interferon beta 1a - solution for injection - interferon beta 1a 30 mcg / 0.5 ml - interferon beta-1a - interferon beta-1a - treatment of relapsing forms of multiple sclerosis to slow the accumulation of physical disability and to decrease the frequency of clinical exacerbations. 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 diagnosis have been excluded, including the prescence of mri abnormalities characteristic of ms and if they are determined to be at high risk of developing clinically definite multiple sclerosis. safety and efficacy in patients with chronic progressive multiple sclerosis has not been evaluated.

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)

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

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)

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

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

genentech, inc. - peginterferon alfa-2a (unii: q46947fe7k) (peginterferon alfa-2a - unii:q46947fe7k) - peginterferon alfa-2a 180 ug in 1 ml - adult patients: pegasys, as part of a combination regimen with other hepatitis c virus (hcv) antiviral drugs, is indicated for the treatment of adults with chc and compensated liver disease. for information about the safe and effective use of other hcv antiviral drugs to be used in combination with pegasys, refer to their prescribing information. pegasys monotherapy is only indicated for the treatment of patients with chc and compensated liver disease if there are contraindications or significant intolerance to other hcv antiviral drugs. pediatric patients: pegasys in combination with ribavirin is indicated for the treatment of pediatric patients 5 years of age and older with chc and compensated liver disease. limitations of use : - pegasys alone or in combination with ribavirin without additional hcv antiviral drugs is not recommended for treatment of patients with chc who previously failed therapy with an interferon-alfa. - pegasys is not recommended for treatment of patients with chc who have had solid

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.

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

biogen australia pty ltd - peginterferon beta-1a, quantity: 94 microgram - injection, solution - excipient ingredients: arginine hydrochloride; water for injections; sodium acetate trihydrate; polysorbate 20; glacial acetic acid - plegridy is indicated for the treatment of relapsing forms of multiple sclerosis (ms) (see clinical trials).

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

biogen australia pty ltd - peginterferon beta-1a, quantity: 125 microgram - injection, solution - excipient ingredients: sodium acetate trihydrate; water for injections; glacial acetic acid; arginine hydrochloride; polysorbate 20 - plegridy is indicated for the treatment of relapsing forms of multiple sclerosis (ms) (see clinical trials).