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Human coagulation factor VIII 250IU
PRODUCT NAME
Octanate 250 IU
Human coagulation factor VIII
Powder and solvent for solution for intravenous injection
COMPOSITION
Active Ingredients: Human coagulation factor VIII
Octanate 250 IU is presented as powder and solvent for solution for injection containing nominally 250 IU human coagulation factor VIII per vial.
The product contains approximately 50 IU* per ml human coagulation factor VIII when reconstituted with 5 ml of solvent.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially `sodium-free` for 1 vial Octanate 250 IU.
Excipients:
– Sodium citrate, Sodium chloride, Calcium chloride, Glycine
– Solvent: Water for injections
*The potency (IU) is determined using the European Pharmacopoeia chromogenic assay. The mean specific activity of OCTANATE is ≥ 100 IU/mg protein.
THERAPEUTIC INDICATIONS
Treatment and prevention of bleeding episodes in patients with Hemophilia A (congenital or acquired FVIII deficiency), including previously treated patients (PTPs), previously untreated patients (PUPs) and patients undergoing major and minor surgical procedures.
PACKAGE SIZES
A set of 2 box:
- Box of: 1 vial of lyophilized powder for Octanate 250 IU.
- Box of: 1 Vial with 5 ml Water for Injections, 1 Disposable syringe, 1 Transfer set (1 Double-ended needle and 1 Filter needle), 1 Infusion set, 2 Alcohol swabs
MANUFACTURE
Octapharma AB
112 75 Stockholm, Sweden
Read the instructions for use carefully before using this medicinal product.
Please contact your doctor or pharmacist for further information.
Keep out of the reach of children.