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Hemlibra
Eintrag öffnenHemlibra · 4.1 Therapeutic indications · 1
Eintrag öffnenHemlibra · 4.3 Contraindications · 1
Eintrag öffnenHemlibra · 4.3 · Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Eintrag öffnenHemlibra · 4.4 Special warnings and precautions for use · 1
Eintrag öffnenHemlibra · 4.5 Interaction with other medicinal products and other forms of interaction · 1
Eintrag öffnenHemlibra · 4.5 · Clinical experience indicates a medicinal product interaction exists with emicizumab and aPCC (see sections 4.
Eintrag öffnenHemlibra · 4.5 · Experience with concomitant administration of anti-fibrinolytics with aPCC or rFVIIa in patients receiving Hem
Eintrag öffnenHemlibra · 4.5 · In case of thrombotic complication, the physician should consider discontinuing rFVIIa or FVIII and interrupt
Eintrag öffnenHemlibra · 4.5 · No adequate or well-controlled interaction studies have been conducted with emicizumab.
Eintrag öffnenHemlibra · 4.5 · There is a possibility for hypercoagulability with rFVIIa or FVIII with emicizumab based on preclinical experi
Eintrag öffnenHemlibra · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenHemlibra · 4.8 Undesirable effects · 1
Eintrag öffnenHemlibra · 4.8 · * An instance of aPCC treatment is defined as all doses of aPCC received by a patient, for any reason, until t
Eintrag öffnenHemlibra · 4.8 · 10 Table 2 Summary of adverse drug reactions from pooled HAVEN clinical studies and post- marketing surveillan
Eintrag öffnenHemlibra · 4.8 · 11 Characterization of the interaction between emicizumab and aPCC treatment in pivotal clinical studies
Eintrag öffnenHemlibra · 4.8 · ADRs from the phase III clinical studies and post-marketing surveillance are listed by MedDRA system organ cla
Eintrag öffnenHemlibra · 4.8 · Average cumulative amount of aPCC over 24 hours Duration of aPCC (U/kg/24 hours) treatment <50 50–100 >100 <24
Eintrag öffnenHemlibra · 4.8 · Blood and lymphatic system disorders Thrombotic microangiopathy Uncommon Nervous system disorders Headache Ver
Eintrag öffnenHemlibra · 4.8 · Description of selected adverse drug reactions
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