Haemoctin® SDH - Basic Information

Haemoctin® SDH 250/500/1000 Powder and solvent for solution for injection Active substance: FVIII of human plasma Composition: Powder: 1 vial.: 250, 500 or 1000 IU. Human plasma derived coagulation factor VIII (FVIII). Haemoctin® SDH 250/500/1000: reconstituted with 5 ml of water for injections ca. 50 IU/ml / 100 IU/ml / 200 IU/ml FVIII. Specific Activity ca. 100 IU/mg protein. Glycine, sodium chloride, sodium citrate, calcium chloride. Solvent: water for injections. Therapeutic indications: Treatm. and prophyl. of bleeding in patients with haemophilia A (congenital FVIII-deficiency). Does not contain von Willebrand factor in pharmacologically effective quantities, therefore not indicated in von Willebrand´s disease. Contraindications: Hypersensitivity to any excipient. Warnings: 1 vial contains up to 1.4 mmol (32.2 mg) sodium. To be taken into consideration by patients on a controlled sodium diet. Undesirable effects: Rare: Hypersensitivity or allergic reactions (e.g. angioedema, pain, burning and stinging at the injection site, chills, skin reactions, skin reddening, (gen.) urticaria, headache, rash, hypotension, lethargy, nausea, nerv. restlessness, tachycardia, chest tightness, tingling, vomiting, stridor, fever, wheezing). In some cases anaphyl. shock. Very rare: Exanthema, urticaria, erythema. FVIII inhibition (uncommon PTPs, very common PUPs) Storage: Do not store above 25 C. Do not freeze. Keep the vials in the outer carton in order to protect from light.

Biotest Pharma GmbH, Landsteinerstr. 5, 63303 Dreieich

Medical prescription. Information as of February 2019.