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Afstyla
Eintrag öffnenAfstyla · 4.1 Therapeutic indications · 1
Eintrag öffnenAfstyla · 4.3 Contraindications · 1
Eintrag öffnenAfstyla · 4.3 · Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Eintrag öffnenAfstyla · 4.3 · Known allergic reaction to hamster proteins.
Eintrag öffnenAfstyla · 4.4 Special warnings and precautions for use · 1
Eintrag öffnenAfstyla · 4.5 Interaction with other medicinal products and other forms of interaction · 1
Eintrag öffnenAfstyla · 4.5 · No interactions of human coagulation factor VIII products with other medicinal products have been reported.
Eintrag öffnenAfstyla · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenAfstyla · 4.8 Undesirable effects · 1
Eintrag öffnenAfstyla · 4.8 · Development of neutralizing antibodies (inhibitors) may occur in patients with haemophilia A treated with fact
Eintrag öffnenAfstyla · 4.8 · Frequencies have been evaluated on a per patient basis according to the following convention: very common (≥1/
Eintrag öffnenAfstyla · 4.8 · MedDRA Adverse reaction Frequency System Organ Class uncommon (PTPs)* Blood and lymphatic FVIII inhibition ver
Eintrag öffnenAfstyla · 4.8 · Paediatric population No age-specific differences in adverse reactions were observed between paediatric and ad
Eintrag öffnenAfstyla · 4.8 · Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorization of the medi
Eintrag öffnenAfstyla · 4.8 · Summary of the safety profile Hypersensitivity or allergic reactions (which may include angioedema, burning an
Eintrag öffnenAfstyla · 4.8 · Tabulated list of adverse reactions The table presented below is according to the MedDRA system organ classifi
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