Haemoctin® SDH/ Factor VIII Biotest SDH
Human blood clotting factor VIII
Composition: One pierceable vial Haemoctin® SDH 250/500/1,000 contains 250/500/1,000 IU of human clotting factor VIII. After reconstitution the dry human clotting factor VIII. After reconstitution the dry substance in 5/10/10 ml of water for injection, each ml of product contains about 50/50/100 IU of human clotting factor VIII. The specific activity of Haemoctin® SDH 250/500/1,000 is about 50-170 IU/mg protein. Other ingredients: Glycine, Sodium, chloride, calcium chloride.
Indications: Prophylaxis and treatment of bleeding haemophilia A (congenital deficiency of factor VIII) and acquired factor VIII deficiency. Treatment of patients with factor VIII neutralising antibodies (=inhibitors).
Contra-indication : Haemoctin® SDH 250/500/1,000 should not be used in hypersensitivity to blood clotting factor VIII or to any other constituents.
Special Precautions for use: As with any intravenous protein product, allergic type hypersensitivity reactions are possible. The product contains traces of human proteins other than factor VIII. Patients should be informed of the early signs of hypersensitivity reactions including hives, Generalised urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis. If these symptoms accur, they should be advised to discontinue use of the product immediately and contact their physician.
Dosage instructions and duration of application: the dosage depends on the severity of the clotting disturbance, on the location and extent of the bleeding and on the clinical condition of the patients.
Interactions with other medicinal products: Interactions between Haemoctin® SDH 250/500/1000 and other medicinal products are unknown.
Method of administration: The product should be administered via the intravenous route. It is recommended not to administer more than 2-3 ml/min.
Special precaution for storage: Do not store above 25 oC. Do not freeze. Keep the container in the outer carton in order to protect from light.
Presentations: Haemoctin® SDH 250, Haemoctin® SDH 500 and Haemoctin®SDH 1,000