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Alprolix
Eintrag öffnenAlprolix · 4.1 Therapeutic indications · 1
Eintrag öffnenAlprolix · 4.3 Contraindications · 1
Eintrag öffnenAlprolix · 4.3 · Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Eintrag öffnenAlprolix · 4.4 Special warnings and precautions for use · 1
Eintrag öffnenAlprolix · 4.5 Interaction with other medicinal products and other forms of interaction · 1
Eintrag öffnenAlprolix · 4.5 · No interactions of ALPROLIX with other medicinal products have been reported. No interaction studies have been
Eintrag öffnenAlprolix · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenAlprolix · 4.8 Undesirable effects · 1
Eintrag öffnenAlprolix · 4.8 · 6 venous thrombosis and pulmonary embolism. The use of high purity factor IX is rarely associated with thrombo
Eintrag öffnenAlprolix · 4.8 · 7 Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the me
Eintrag öffnenAlprolix · 4.8 · Description of selected adverse reactions Throughout the clinical study program, one patient (previously untre
Eintrag öffnenAlprolix · 4.8 · Frequencies have been evaluated according to the following convention: very common (≥1/10); common (≥1/100 to
Eintrag öffnenAlprolix · 4.8 · Paediatric population Frequency, type and severity of adverse reactions in children are expected to be similar
Eintrag öffnenAlprolix · 4.8 · Patients with haemophilia B may develop neutralising antibodies (inhibitors) to factor IX. If such inhibitors
Eintrag öffnenAlprolix · 4.8 · Previously Untreated Patients (PUPs): A total of 33 patients with severe haemophilia B were observed in one cl
Eintrag öffnenAlprolix · 4.8 · Summary of the safety profile Hypersensitivity or allergic reactions (which may include angioedema, burning an
Eintrag öffnenAlprolix · 4.8 · Table 2 presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Eintrag öffnenAlprolix · 4.8 · Table 2: Adverse reactions reported for ALPROLIX MedDRA System Organ Class Adverse reactions Frequency categor
Eintrag öffnenAlprolix · 4.8 · Tabulated list of adverse reactions Previously Treated Patients (PTPs): A total of 153 patients with severe ha
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