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Privigen · 4.8 · 11 MedDRA System Adverse Reaction Frequency per Frequency per Organ Class (SOC) patient infusion General disor
Eintrag öffnenPrivigen · 4.8 · Adverse reactions such as chills, headache, dizziness, fever, vomiting, allergic reactions, nausea, arthralgia
Eintrag öffnenPrivigen · 4.8 · Cases of reversible aseptic meningitis and rare cases of transient cutaneous reactions (including cutaneous lu
Eintrag öffnenPrivigen · 4.8 · For safety with respect to transmissible agents and additional details on risk factors, see section 4.4.
Eintrag öffnenPrivigen · 4.8 · In Privigen clinical studies with paediatric patients, the frequency, nature and severity of adverse reactions
Eintrag öffnenPrivigen · 4.8 · Increase in serum creatinine level and/or acute renal failure have been observed.
Eintrag öffnenPrivigen · 4.8 · MedDRA System Adverse Reaction Frequency per Frequency per Organ Class (SOC) patient infusion Infections and A
Eintrag öffnenPrivigen · 4.8 · Paediatric Population
Eintrag öffnenPrivigen · 4.8 · Rarely human normal immunoglobulins may cause a sudden fall in blood pressure and, in isolated cases, anaphyla
Eintrag öffnenPrivigen · 4.8 · Reporting of suspected adverse reactions
Eintrag öffnenPrivigen · 4.8 · Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows con
Eintrag öffnenPrivigen · 4.8 · Reversible haemolytic reactions have been observed in patients, especially those with blood groups A, B, and A
Eintrag öffnenPrivigen · 4.8 · Seven clinical studies were performed with Privigen, which included patients with PID, ITP and CIDP. In the pi
Eintrag öffnenPrivigen · 4.8 · Summary of the safety profile
Eintrag öffnenPrivigen · 4.8 · Tabulated list of adverse reactions
Eintrag öffnenPrivigen · 4.8 · The following table shows an overview of the ADRs observed in the seven clinical studies categorized according
Eintrag öffnenPrivigen · 4.8 · Very rarely: Transfusion related acute lung injury (TRALI) and thromboembolic reactions such as myocardial inf
Eintrag öffnenSoliris · 4.5 · Concomitant use of eculizumab with intravenous immunoglobulin (IVIg) may reduce effectiveness of eculizumab. C
Eintrag öffnenUltomiris · 4.5 · Chronic intravenous human immunoglobulin (IVIg) treatment may interfere with the endosomal neonatal Fc recepto
Eintrag öffnenUltomiris · 4.5 · See section 4.2 for guidance in case of concomitant PE, PP, or IVIg treatment.
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