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Human coagulation factor VIII 500IU
PRODUCT NAME
Octanate 500 IU
Human coagulation factor VIII
Powder and solvent for solution for intravenous injection
COMPOSITION
Active Ingredients: Human coagulation factor VIII
Octanate 500 IU is presented as powder and solvent for solution for injection containing nominally 500 IU human coagulation factor VIII per vial.
The product contains approximately 50 IU* per ml human coagulation factor VIII when reconstituted with 10 ml of solvent.
This medicinal product contains up to 1.75 mmol sodium (40 mg) per dose for 1 vial Octanate 500 IU. To be taken into consideration by patients on a controlled sodium diet.
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 500 IU
- Box of: 1 Vial with 10 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.