سعر كوجينات اف اس 500 وحدة دولية فيال 2.5 مل 2022

Recombinant human coagulation factor VIII (octocog alfa) 500 IU vial for intravenous infusion after reconstitution with 2.5 ml (Kogenate-FS, Bayer).

• Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency); not indicated in von Willebrand disease.Population: Adults, adolescents and children of all agesEuropean Medicines Agency (EMA)

• Hypersensitivity or allergic reactions (e.g. urticaria, flushing, chest tightness, wheezing, hypotension), rarely progressing to anaphylaxis; factor VIII inhibitor development (very common in previously untreated, uncommon in previously treated patients); infusion-site reactions, febrile infusion reactions and dysgeusia.International label, same formulation · European Medicines Agency (EMA)

• Hypersensitivity to the active substance or any excipient; known allergic reactions to mouse or hamster protein.International label, same formulation · European Medicines Agency (EMA)

• Allergic-type hypersensitivity reactions including anaphylaxis are possible (product contains traces of mouse and hamster proteins); stop treatment and seek care if they occur.International label, same formulation · European Medicines Agency (EMA)
• Neutralising factor VIII inhibitors may develop, with highest risk in the first 20 exposure days; monitor clinically and with laboratory tests.International label, same formulation · European Medicines Agency (EMA)
• Patients with cardiovascular risk factors may face the same risk of cardiovascular events as non-haemophilic patients once clotting is normalised; evaluate and monitor cardiac risk factors.International label, same formulation · European Medicines Agency (EMA)

• Other medicinal productsNo interactions of Kogenate Bayer with other medicinal products have been reported.European Medicines Agency (EMA)

• No animal reproduction studies; because haemophilia A is rare in women, there is no experience in pregnancy; use during pregnancy only if clearly indicated.International label, same formulation · European Medicines Agency (EMA)
• No experience during breast-feeding; use only if clearly indicated.International label, same formulation · European Medicines Agency (EMA)

• Octocog alfa (recombinant coagulation factor VIII): Activated factor VIII acts as a cofactor for activated factor IX, accelerating conversion of factor X to Xa; replacement temporarily corrects the factor VIII deficiency (EU SmPC 5.1).