Nebenwirkungen · NovoSeven
NovoSeven 1 mg (50 KIU) powder and solvent for solution for injection NovoSeven 2 mg (100 KIU) powder and solvent for solution for injection NovoSeven 5 mg (250 KIU) powder and solvent for solution for injection NovoSeven 8 mg (400 KIU) powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 9
HOS-085121 · Präparat HOS-083079
In clinical trials of patients with factor VII deficiency, formation of antibodies against NovoSeven and FVII is the only adverse drug reaction reported (frequency: common (≥ 1/100 to < 1/10)). In some cases, the antibodies showed inhibitory effect in vitro. Risk factors that may have contributed to antibody development including previous treatment with human plasma and/or plasma-derived factor VII, severe mutation of FVII gene, and overdose of NovoSeven, were present. Patients with factor VII deficiency treated with NovoSeven should be monitored for factor VII antibodies (see section 4.4).
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Version 2023-01-05T10:11:00Z · SHA-256 4cde9b1f299068eba5f867a596fb73966c9f4132d6fc783820f32def35917cf3 · Passage 2c89c6868e32c2f117523531f68964a3c48af87ac92e94a7453b5adac5fa38ea · Zeichen 5704–6301 im Abschnitt