Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Betaferon

Betaferon 250 microgram/ml, powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 9–10

HOS-085151 · Präparat HOS-083087

9  System Organ Very common Common Uncommon Rare Frequency Class ( 1/10) (  1/100 to ( 1/1,000 to (  1/10,000 to not known < 1/10) < 1/100) < 1/1,000) a ADRs derived only during post-marketing b Class label for interferon beta products (see section 4.4). c Class label for interferon products, see below Pulmonary arterial hypertension. d life-threatening and/or fatal cases have been reported. e laboratory abnormality f ‘Injection site reaction (various kinds)’ comprises all adverse events occurring at the injection site (except injection site necrosis), e.g. the following terms: injection site atrophy, injection site edema, injection site haemorrhage, injection site hypersensitivity, injection site infection, injection site inflammation, injection site mass, injection site pain and injection site reaction. g Flu-like symptom complex’ denotes flu syndrome and/or a combination of at least two Adverse Events from fever, chills, myalgia, malaise, sweating.

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