Ireland - English - HPRA (Health Products Regulatory Authority)

roche products limited - interferon alfa-2a - solution for injection - 6miu/ml %v/v

Ireland - English - HPRA (Health Products Regulatory Authority)

roche products limited - interferon alfa-2a - solution for injection - 3miu/0.5ml %v/v

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

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

horizon therapeutics usa, inc. - interferon gamma-1b (unii: 21k6m2i7ag) (interferon gamma-1b - unii:21k6m2i7ag) - interferon gamma-1b 100 ug in 0.5 ml - - actimmune is indicated for reducing the frequency and severity of serious infections associated with chronic granulomatous disease (cgd). - actimmune is indicated for delaying time to disease progression in patients with severe, malignant osteopetrosis (smo). actimmune is contraindicated in patients who develop or have known hypersensitivity to interferon gamma, e. coli derived products, or any component of the product. risk summary there are no adequate and well-controlled studies in pregnant women. actimmune should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. animal data actimmune has shown an increased incidence of abortions in primates when given from gestation day 20 to 80 in doses approximately 100 times the human dose. a study in pregnant primates treated with subcutaneous doses 2 – 100 times the human dose failed to demonstrate teratogenic activity for actimmune. female mice treated subcutaneously with recombinant murine ifn-interferon gamma (rmuifn-gamma) at 280 times the maximum recommended clinical dose of actimmune from shortly after birth through puberty but not during pregnancy had offspring which exhibited decreased body weight during the lactation period. the clinical significance of this finding observed following treatment of mice with rmuifn-gamma is uncertain. for lower doses, there is no evidence of maternal toxicity, embryotoxicity, fetotoxicity or teratogenicity in preclinical studies. risk summary it is not known whether actimmune is excreted in human milk. because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from actimmune, a decision should be made whether to discontinue nursing or to discontinue the drug, dependent upon the importance of the drug to the mother. infertility based on the information available, it cannot be excluded that the presence of higher levels of interferon gamma may impair male fertility and that in certain cases of female infertility increased levels of interferon gamma may have played a role [see nonclinical toxicology (13.1) ]. in younger patients, the long-term effect on fertility is also not known. the safety and effectiveness of actimmune has been established in pediatric patients aged 1 year and older in cgd patients and 1 month and older in smo patients [see clinical studies (14)]. there are no data available for pediatric patients below the age of 1 month. clinical studies of actimmune did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

roche products ltd - interferon alfa-2a - solution for injection - 18mega unit/1ml

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

roche products ltd - interferon alfa-2a - solution for injection - 12mega unit/1ml

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

roche products ltd - interferon alfa-2a - solution for injection - 6mega unit/1ml

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

roche products ltd - interferon alfa-2a - solution for injection - 9mega unit/1ml

Panama - English - Ministerio de Salud (Dirección Nacional de Farmacia Y Drogas)

bayer ag (leverkusen) - interferon beta 1-b - interferon beta 1-b....0.30 mg

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

roche products pty ltd - interferon alfa-2a -