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BeneFIX
Eintrag öffnenBeneFIX · 4.1 Therapeutic indications · 1
Eintrag öffnenBeneFIX · 4.3 Contraindications · 1
Eintrag öffnenBeneFIX · 4.3 · Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Eintrag öffnenBeneFIX · 4.3 · Known allergic reaction to hamster proteins.
Eintrag öffnenBeneFIX · 4.4 Special warnings and precautions for use · 1
Eintrag öffnenBeneFIX · 4.5 Interaction with other medicinal products and other forms of interaction · 1
Eintrag öffnenBeneFIX · 4.5 · No interactions of human coagulation factor IX (rDNA) products with other medicinal products have been reporte
Eintrag öffnenBeneFIX · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenBeneFIX · 4.8 Undesirable effects · 1
Eintrag öffnenBeneFIX · 4.8 · 7 System organ class Very Common Uncommon Frequency common ≥ 1/100 ≥ 1/1,000 to not known ≥ 1/10 to < 1/10 < 1
Eintrag öffnenBeneFIX · 4.8 · 8 Description of selected adverse reactions
Eintrag öffnenBeneFIX · 4.8 · Hypersensitivity/allergic reactions If any suspected hypersensitivity reaction takes place that is thought to
Eintrag öffnenBeneFIX · 4.8 · Inhibitor development A clinically relevant, low responding inhibitor was detected in 1 out of 65 BeneFIX pati
Eintrag öffnenBeneFIX · 4.8 · Paediatric population Allergic reactions might be experienced more frequently in children than in adults.
Eintrag öffnenBeneFIX · 4.8 · Patients with haemophilia B may develop neutralising antibodies (inhibitors) to factor IX. If such inhibitors
Eintrag öffnenBeneFIX · 4.8 · Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medi
Eintrag öffnenBeneFIX · 4.8 · Summary of the safety profile Hypersensitivity or allergic reactions (which may include angioedema, burning an
Eintrag öffnenBeneFIX · 4.8 · Tabulated list of adverse reactions The table presented below is according to the MedDRA system organ classifi
Eintrag öffnenBeneFIX · 4.8 · There are insufficient data to provide information on inhibitor incidence in PUPs (see also section 5.1).
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