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Plegridy
Eintrag öffnenPlegridy · 4.1 Therapeutic indications · 1
Eintrag öffnenPlegridy · 4.3 Contraindications · 1
Eintrag öffnenPlegridy · 4.3 · - Hypersensitivity to natural or recombinant interferon beta or peginterferon or to any of the excipients list
Eintrag öffnenPlegridy · 4.4 Special warnings and precautions for use · 1
Eintrag öffnenPlegridy · 4.5 Interaction with other medicinal products and other forms of interaction · 1
Eintrag öffnenPlegridy · 4.5 · No interaction studies have been performed. The clinical studies indicate that multiple sclerosis patients can
Eintrag öffnenPlegridy · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenPlegridy · 4.8 Undesirable effects · 1
Eintrag öffnenPlegridy · 4.8 · 10 Hypersensitivity reactions Hypersensitivity events were reported in 16% of patients treated with peginterfe
Eintrag öffnenPlegridy · 4.8 · 8 - Rare (≥1/10,000 to <1/1,000) - Very rare (<1/10,000) - Not known (cannot be estimated from the available d
Eintrag öffnenPlegridy · 4.8 · 9 MedDRA system organ class Adverse reaction Frequency category Body temperature increased Platelet count decr
Eintrag öffnenPlegridy · 4.8 · Abnormal urine protein was reported in 1/130 (0.8%) for the SC arm and 4/131 (3.1%) in the IM group without an
Eintrag öffnenPlegridy · 4.8 · Description of selected adverse reactions via subcutaneous route of administration
Eintrag öffnenPlegridy · 4.8 · Flu-like symptoms Influenza -like illness was experienced by 47% of patients receiving peginterferon beta-1a 1
Eintrag öffnenPlegridy · 4.8 · Haematological disorders Decreases in white blood cell (WBC) counts of <3.0 x 109/L were observed in 7% of pat
Eintrag öffnenPlegridy · 4.8 · Hepatic transaminase abnormalities The incidence of hepatic transaminase increases was greater in patients rec
Eintrag öffnenPlegridy · 4.8 · Injection site reactions (ISRs) ISRs (e.g. injection site erythema, pain, pruritus, or oedema) were reported b
Eintrag öffnenPlegridy · 4.8 · Intramuscular route of administration An open-label, crossover study enrolled 136 subjects to assess the bioeq
Eintrag öffnenPlegridy · 4.8 · Paediatric population The safety of peginterferon beta-1a in paediatric patients aged 10 to less than 18 years
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