New Zealand - English - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - interferon alfa-2a 4.5 miu - powder for injection - 4.5 miu - active: interferon alfa-2a 4.5 miu excipient: albumin sodium chloride water for injection

New Zealand - English - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - interferon alfa-2a 6 miu - powder for injection - 6 miu - active: interferon alfa-2a 6 miu excipient: albumin sodium chloride water for injection

New Zealand - English - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - interferon alfa-2a 9 miu - powder for injection - 9 miu - active: interferon alfa-2a 9 miu excipient: albumin sodium chloride water for injection

New Zealand - English - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - interferon alfa-2a 30 miu/ml (final fill volume, 0.72 ml, includes a 20 % fill overage); ribavirin 200mg;   - combination - 18 miu/0.6 ml, 200 mg - active: interferon alfa-2a 30 miu/ml (final fill volume, 0.72 ml, includes a 20 % fill overage) excipient: ammonium acetate benzyl alcohol glacial acetic acid polysorbate 80 sodium chloride sodium hydroxide water for injection active: ribavirin 200mg   excipient: ethylcellulose as aqueous dispersion (solids) hypromellose as component of opadry 03a14309 pink iron oxide red as component of opadry 03a14309 pink iron oxide yellow as component of opadry 03a14309 pink magnesium stearate maize starch microcrystalline cellulose purified talc as component of opadry 03a14309 pink sodium starch glycolate starch titanium dioxide as component of opadry 03a14309 pink triacetin

New Zealand - English - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - interferon alfa-2a 6 miu/ml; ribavirin 200mg;   - combination - 3miu/0.5ml, 200mg - active: interferon alfa-2a 6 miu/ml excipient: ammonium acetate benzyl alcohol glacial acetic acid polysorbate 80 sodium chloride sodium hydroxide water for injection active: ribavirin 200mg   excipient: ethylcellulose hypromellose as component of opadry 03a14309 pink iron oxide red as component of opadry 03a14309 pink iron oxide yellow as component of opadry 03a14309 pink magnesium stearate maize starch microcrystalline cellulose purified talc as component of opadry 03a14309 pink sodium starch glycolate starch titanium dioxide as component of opadry 03a14309 pink triacetin

New Zealand - English - Medsafe (Medicines Safety Authority)

merck sharp & dohme (new zealand) limited - interferon alfa-2b 15 miu/ml - solution for injection - 18 miu - active: interferon alfa-2b 15 miu/ml excipient: dibasic sodium phosphate disodium edetate dihydrate metacresol monobasic sodium phosphate monohydrate polysorbate 80 sodium chloride water for injection - intron a redipen is used in the treatment of: · hairy cell leukaemia in splenectomised or non-splenectomised patients; · chronic myelogenous leukaemia;

New Zealand - English - Medsafe (Medicines Safety Authority)

merck sharp & dohme (new zealand) limited - interferon alfa-2b 25 miu/ml - solution for injection - 30 miu - active: interferon alfa-2b 25 miu/ml excipient: dibasic sodium phosphate disodium edetate dihydrate metacresol monobasic sodium phosphate monohydrate polysorbate 80 sodium chloride water for injection - intron a redipen is used in the treatment of: · hairy cell leukaemia in splenectomised or non-splenectomised patients; · chronic myelogenous leukaemia;

New Zealand - English - Medsafe (Medicines Safety Authority)

merck sharp & dohme (new zealand) limited - interferon alfa-2b 50 miu/ml - solution for injection - 60 miu - active: interferon alfa-2b 50 miu/ml excipient: dibasic sodium phosphate disodium edetate dihydrate metacresol monobasic sodium phosphate monohydrate polysorbate 80 sodium chloride water for injection - intron a redipen is used in the treatment of: · hairy cell leukaemia in splenectomised or non-splenectomised patients; · chronic myelogenous leukaemia;

European Union - English - EMA (European Medicines Agency)

schering-plough europe - interferon alfa-2b - hepatitis c, chronic; hepatitis b, chronic - immunostimulants, - chronic hepatitis b: treatment of adult patients with chronic hepatitis b associated with evidence of hepatitis b viral replication (presence of hbv-dna and hbeag), elevated alanine aminotransferase (alt) and histologically proven active liver inflammation and/or fibrosis.chronic hepatitis c:adult patients:introna is indicated for the treatment of adult patients with chronic hepatitis c who have elevated transaminases without liver decompensation and who are positive for serum hcv-rna or anti-hcv (see section 4.4).the best way to use introna in this indication is in combination with ribavirin.chidren and adolescents:introna is intended for use, in a combination regimen with ribavirin, for the treatment of children and adolescents 3 years of age and older, who have chronic hepatitis c, not previously treated, without liver decompensation, and who are positive for serum hcv-rna. the decision to treat should be made on a case by case basis, taking into account any evidence of disease progression such as hepatic inflammation and fibrosis, as well as prognostic factors for response, hcv genotype and viral load. the expected benefit of treatment should be weighed against the safety findings observed for paediatric subjects in the clinical trials (see sections 4.4, 4.8 and 5.1).

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

mylan pharmaceuticals inc. - dalfampridine (unii: bh3b64okl9) (dalfampridine - unii:bh3b64okl9) - dalfampridine extended-release tablets are indicated as a treatment to improve walking in adult patients with multiple sclerosis (ms). this was demonstrated by an increase in walking speed [see clinical studies (14)]. the use of dalfampridine extended-release tablets is contraindicated in the following conditions: there are no adequate and well-controlled studies of dalfampridine in pregnant women. administration of dalfampridine to animals during pregnancy and lactation resulted in decreased offspring viability and growth at doses similar to the maximum recommended human dose (mrhd) of 20 mg/day. dalfampridine extended-release tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. in developmental toxicity studies in rats and rabbits, dalfampridine was administered orally at doses up to 10 and 5 mg/kg/day, respectively, during the period of organogenesis. these doses are approximately 5 times the mrhd on a body surface area (mg/m2 ) basis. no evidence