Land: Malta
Språk: engelska
Källa: Medicines Authority
FACTOR VIII, HUMAN
Biotest Pharma GmbH Landsteinerstrasse 5, 63303 Dreieich, Germany
B02BD02
FACTOR VIII, HUMAN 50 IU/ml
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
FACTOR VIII, HUMAN 50 IU/ml
POM
ANTIHEMORRHAGICS
Authorised
2010-04-27
page 1/9 PACKAGE LEAFLET: INFORMATION FOR THE USER HAEMOCTIN SDH 250 HAEMOCTIN SDH 500 HAEMOCTIN SDH 1000 POWDER AND SOLVENT FOR SOLUTION FOR INJECTION HUMAN PLASMA DERIVED COAGULATION FACTOR VIII READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor, pharmacist or nurse. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Haemoctin SDH is and what it is used for 2. What you need to know before you use Haemoctin SDH 3. How to use Haemoctin SDH 4. Possible side-effects 5. How to store Haemoctin SDH 6. Contents of the pack and other information 1. WHAT HAEMOCTIN SDH IS AND WHAT IT IS USED FOR Haemoctin SDH is a medicine derived from human plasma. It contains the coagulation factor VIII, which is necessary for a normal course of blood coagulation. After reconstitution of the powder with water for injections the solution is ready for intravenous injection. Haemoctin SDH is used for treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). Haemoctin SDH does not contain von Willebrand factor in pharmacologically effective quantities, and is therefore not suitable for the treatment of von Willebrand's disease. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE HAEMOCTIN SDH DO NOT USE HAEMOCTIN SDH, • if you are allergic to coagulation factor VIII or to any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue. page 2/9 WARNINGS AND PRECAUTIONS The formation of inhibitors (antibodies) is a known com Läs hela dokumentet
Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS _ _ _ _ Page 2 of 11 1. NAME OF THE MEDICINAL PRODUCT Haemoctin SDH 250 Haemoctin SDH 500 Haemoctin SDH 1000 Powder and solvent for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Human plasma derived coagulation factor VIII One vial contains nominally 250, 500 or 1000 IU human plasma derived coagulation factor VIII. Haemoctin SDH 250 contains approximately 250 IU (50 IU/ml) human coagulation factor VIII after reconstitution. Haemoctin SDH 500 contains approximately 500 IU (100 IU/ml) human coagulation factor VIII after reconstitution. Haemoctin SDH 1000 contains approximately 1000 IU (200 IU/ml) human coagulation factor VIII after reconstitution. The potency (IU) is determined using the European Pharmacopoeia chromogenic factor VIII coagulation assay. The specific activity of Haemoctin SDH is approximately 100 IU/mg protein. Produced from the plasma of human donors. Excipient with known effect: One vial contains up to 32.2 mg sodium (1.4 mmol). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection. White powder and clear, colourless solvent for solution for injection. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). This preparation does not contain von Willebrand factor in pharmacologically effective quantities and is therefore not indicated in von Willebrand´s disease. Page 3 of 11 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be under the supervision of a physician experienced in the treatment of haemophilia. Treatment monitoring During the course of treatment, appropriate determination of factor VIII levels is advised to guide the dose to be administered and the frequency of repeated infusions. Individual patients may vary in their response to factor VIII, demonstrating different half-lives and recoveries. Dose based on bodyweight may require adjustment in u Läs hela dokumentet