Special Warning : אזהרת שימוש

4.4.    Special warnings and precautions for use
Severe allergic reactions to Recombinate have been reported. Patients with known hypersensitivity to bovine, mouse or hamster proteins should be treated with caution. Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis. If allergic or anaphylactic reactions occur, the injection/infusion should be stopped immediately. Facilities for the appropriate treatment of shock should be available.
If plasma AHF levels fail to reach expected levels or if bleeding is not controlled after adequate dosage, appropriate laboratory tests to detect the presence of an inhibitor should be performed.
The development of neutralising antibodies (inhibitors) to Factor VIII is a known complication in the management of individuals with haemophilia A. These inhibitors are usually IgG immunoglobulins directed against Factor VIII procoagulant activity, which are quantified in Bethesda Units (BU) per ml of plasma using the modified Bethesda assay. The risk of developing inhibitors is correlated to the extent of exposure to Factor VIII, the risk being highest within the first 20 exposure days, and to other genetic and environmental factors. Rarely, inhibitors may develop after the first 100 exposure days. Cases of recurrence of inhibitors (low titre) have been observed after switching from one recombinant factor VIII product to another in previously treated patients with more than 100 exposure days who have a history of inhibitor development.

Patients treated with recombinant coagulation factor VIII should be carefully monitored for the development of inhibitors by appropriate clinical observations and laboratory tests. See also section 4.8.
In the interest of patients, it is recommended that, whenever possible, every time that Recombinate is administered to them, the name and batch number of the product should be registered.
This medicinal product contains 1.5 mmol sodium per vial To be taken into consideration by patients on a controlled sodium diet.

Paediatric population
The warnings and precautions for use in paediatric patients do not differ from those for adult patients.

Recombinate Powder for Solution for Injection- BAXIJET ll,   26 2. 2015, RH 

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