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NovoSeven · 4.8 · Clinical trials conducted in 484 patients (including 4297 treatment episodes) with haemophilia A and B, acquir
Eintrag öffnenNovoSeven · 4.8 · Clinical trials conducted in 61 patients with acquired haemophilia with a total of 100 treatment episodes, sho
Eintrag öffnenNovoSeven · 4.8 · For known contributing factors to thromboembolic risk associated with pregnancy and severe postpartum haemorrh
Eintrag öffnenNovoSeven · 4.8 · General disorders - Therapeutic response - Injection site reaction and decreased* including injection site adm
Eintrag öffnenNovoSeven · 4.8 · Immune system - Hypersensitivity (see - Anaphylactic reaction disorders sections 4.3 and 4.4)
Eintrag öffnenNovoSeven · 4.8 · In an open-label randomised clinical trial, venous thromboembolic events were reported in 2 of 51 patients tre
Eintrag öffnenNovoSeven · 4.8 · In clinical trials of patients with factor VII deficiency, formation of antibodies against NovoSeven and FVII
Eintrag öffnenNovoSeven · 4.8 · In post-marketing experience, there have been no reports of inhibitory antibodies against NovoSeven or FVII in
Eintrag öffnenNovoSeven · 4.8 · Inhibitory antibody formation
Eintrag öffnenNovoSeven · 4.8 · Investigations - Increased fibrin degradation products
Eintrag öffnenNovoSeven · 4.8 · MedDRA system Uncommon (≥1/1,000 to Rare (≥1/10,000 to <1/1,000) Frequency Not Known organ class <1/100)
Eintrag öffnenNovoSeven · 4.8 · Nervous system - Headache disorders
Eintrag öffnenNovoSeven · 4.8 · Other special populations
Eintrag öffnenNovoSeven · 4.8 · Patients with acquired haemophilia
Eintrag öffnenNovoSeven · 4.8 · Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows con
Eintrag öffnenNovoSeven · 4.8 · Safety and efficacy of NovoSeven have not been established outside the approved indications and therefore Novo
Eintrag öffnenNovoSeven · 4.8 · Skin and - Rash (including - Flushing subcutaneous allergic dermatitis and tissue disorders rash erythematous)
Eintrag öffnenNovoSeven · 4.8 · Summary of the safety profile
Eintrag öffnenNovoSeven · 4.8 · Table 1 Adverse reactions from clinical trials and spontaneous (post-marketing) reports
Eintrag öffnenNovoSeven · 4.8 · Table 1 lists adverse reactions reported during clinical trials and from spontaneous (post-marketing) reports.
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