Active Substance: Coagulation factor IX.
Overview
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This medicine contains an important and useful components, as it consists of
Coagulation factor IXis available in the market in concentration
Coagulation Factor IX Human USP
Activity-neutralizing antibodies (inhibitors) have been detected in patients receiving factor IXcontaining products. As with all factor IX products, patients using (coagulation factor ix recombinant) should be monitored for the development of factor IX inhibitors . Patients with factor IX inhibitors may be at an increased risk of anaphylaxis upon subsequent challenge with factor IX. Patients experiencing allergic reactions should be evaluated for the presence of inhibitor. Preliminary information suggests a relationship may exist between the presence of major deletion mutations in a patient's factor IX gene and an increased risk of inhibitor formation and of acute hypersensitivity reactions. Patients known to have major deletion mutations of the factor IX gene should be observed closely for signs and symptoms of acute hypersensitivity reactions, particularly during the early phases of initial exposure to product. In view of the potential for allergic reactions with factor IX concentrates, the initial (approximately 10 - 20) administrations of factor IX should be performed under medical supervision where proper medical care for allergic reactions could be provided. Lactation: Not known if excreted in breast milk; use caution
Hemophilia B or Christmas disease
Patients with a known history of hypersensitivity to hamster protein.
>10% Headache (10.8%) 1-10% Dizziness (7.7%),Rash (1.6-7.7%),Injection site pain (6.2%),Nausea (6.2%),Urticaria (3.1-4.8%),Rhinitis (4.6%),Altered taste sense (4.6%),Dyspnea (3.2%),Fever (3.1%),Flushing (3.1%),Allergic reaction (1.5%) Frequency Not Defined Lethargy,Altered blood pressure (too rapid infusion),Thrombosis (large dose),Myocardial infarction (large dose),DIC (large dose),Chills,Tingling,Vomiting,Human-derived products: viral infection,Stinging at infusion site (large dose),Hives,Anaphylaxis
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Factor IX is used as replacement therapy in patients with haemophilia B whereby there is a genetic deficiency of factor IX.
Information not available
Information not available