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Refixia
Eintrag öffnenRefixia · 4.1 Therapeutic indications · 1
Eintrag öffnenRefixia · 4.3 Contraindications · 1
Eintrag öffnenRefixia · 4.3 · Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Eintrag öffnenRefixia · 4.3 · Known allergic reaction to hamster protein.
Eintrag öffnenRefixia · 4.4 Special warnings and precautions for use · 1
Eintrag öffnenRefixia · 4.5 Interaction with other medicinal products and other forms of interaction · 1
Eintrag öffnenRefixia · 4.5 · No interactions of human coagulation factor IX (rDNA) products with other medicinal products have been reporte
Eintrag öffnenRefixia · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenRefixia · 4.8 Undesirable effects · 1
Eintrag öffnenRefixia · 4.8 · 6 Very rarely development of antibodies to hamster protein with related hypersensitivity reactions has been ob
Eintrag öffnenRefixia · 4.8 · 7 and anaphylactic reaction occurred in 1/54 (2%) categorising these events as common. The case with anaphylac
Eintrag öffnenRefixia · 4.8 · A total of 115 previously treated patients (PTPs) and 54 previously untreated patients (PUPs) with moderate or
Eintrag öffnenRefixia · 4.8 · Blood and lymphatic system Factor IX inhibition Common* disorders
Eintrag öffnenRefixia · 4.8 · Cardiac disorders Palpitations Uncommon
Eintrag öffnenRefixia · 4.8 · Description of selected adverse reactions
Eintrag öffnenRefixia · 4.8 · Factor IX inhibition and anaphylactic reactions have not been observed in PTPs, and frequencies are therefore
Eintrag öffnenRefixia · 4.8 · Frequencies have been evaluated according to the following convention: very common (≥ 1/10); common (≥ 1/100 t
Eintrag öffnenRefixia · 4.8 · Frequency, type and severity of adverse reactions in children are expected to be similar as in adults. .
Eintrag öffnenRefixia · 4.8 · Gastrointestinal disorders Nausea Common
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