Haemoctin® SDH 250|500|1000
​​​​​​​powder and solvent to make an injection solution.

Active substance
Coagulation factor VIII of human plasma.

Composition
Powder: 1 vial: ­250, 500 or 1000 IU human 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 (congen.FVIII deficiency). Does not contain vW factor in pharmacolog. effective quantities, therefore not indicated in von Willebrand’s disease.

Contraindications
Hypersensitivity to any ingredient.

Warnings
1 vial contains up to 32.2­ mg sodium (equival. to 1.61 % of recomm. max. daily intake for an adult).

Undesirable e­ffects
​​​​​​​Hypersensitivity or allergic reactions, e.g. Quincke’s oedema, burning and stinging at the injection site, chills, skin reactions (such as skin reddening, itching, hives), (gen.) urticaria, headache, hypotension, lethargy, nausea, restlessness, tachycardia, chest tightness, tingling, vomiting, wheezing), severe anaphylaxis, anaphyl. shock, FVIII inhibition.

Biotest Pharma GmbH, Landsteinerstr. 5, 63303 Dreieich

Medical prescription.

Information as of November 2019.