سعر نوفو ايت 250وحدة فيال للحقن الوريدي 2022

NovoEight 250 IU (Novo Nordisk): powder vial of turoctocog alfa (recombinant, B-domain truncated human coagulation factor VIII) with a pre-filled solvent syringe, for intravenous injection after reconstitution in haemophilia A.

• Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency); can be used in all age groups.Population: All age groupsEuropean Medicines Agency (EMA)
• Adults and children with hemophilia A: on-demand treatment and control of bleeding episodes, perioperative management and routine prophylaxis; not indicated for von Willebrand disease.Population: Adults and childrenDailyMed (U.S. National Library of Medicine)

• Hypersensitivity/allergic reactions are rare and may progress to severe anaphylaxis. Factor VIII inhibition: uncommon in previously treated patients, very common in previously untreated patients. Common: flushing, superficial thrombophlebitis, rash, haemarthrosis, muscle haemorrhage, cough, injection site reactions, pyrexia, increased hepatic enzymes, vomiting, incorrect dose administered, infusion-related reaction.International label, same product · European Medicines Agency (EMA)

• Hypersensitivity to the active substance or any excipient; known allergic reaction to hamster proteins.International label, same product · European Medicines Agency (EMA)
• Life-threatening hypersensitivity reactions, including anaphylaxis, to Novoeight or its components, including hamster proteins.International label, same formulation · DailyMed (U.S. National Library of Medicine)

• Allergic-type hypersensitivity reactions possible (contains traces of hamster proteins); stop immediately if hives, urticaria, chest tightness, wheezing, hypotension or anaphylaxis occur; treat shock per standard care.International label, same product · European Medicines Agency (EMA)
• Neutralising factor VIII inhibitors are a known complication (risk highest in the first 50 exposure days); monitor clinically and by laboratory tests; test for inhibitors if expected levels are not reached or bleeding is not controlled.International label, same product · European Medicines Agency (EMA)
• Factor VIII substitution may increase cardiovascular risk in patients with existing cardiovascular risk factors; consider central venous access device complications (infection, bacteraemia, catheter-site thrombosis).International label, same product · European Medicines Agency (EMA)

• Other medicines (general)No interactions of human coagulation factor VIII (rDNA) products 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 product · European Medicines Agency (EMA)
• As hemophilia mainly affects males, there are no adequate and well-controlled studies of Novoeight in pregnant women; animal reproduction studies have not been conducted.International label, same formulation · DailyMed (U.S. National Library of Medicine)
• No experience during breastfeeding; use during lactation only if clearly indicated.International label, same product · European Medicines Agency (EMA)

• Turoctocog alfa (human coagulation factor VIII, rDNA): Activated factor VIII acts as a cofactor for activated factor IX, accelerating conversion of factor X to activated factor X, which converts prothrombin to thrombin and fibrinogen to fibrin; replacement temporarily corrects the factor VIII deficiency (EU NovoEight SmPC 5.1).