Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
Human coagulation factor X
BPL Bioproducts Laboratory GmbH
B02BD13
human coagulation factor X
Vitamin K and other hemostatics, Antihemorrhagics, coagulation factor X
Factor X Deficiency
Coagadex is indicated for the treatment and prophylaxis of bleeding episodes and for perioperative management in patients with hereditary factor X deficiency. Coagadex is indicated in all age groups.
Revision: 9
Authorised
2016-03-16
27 B. PACKAGE LEAFLET 28 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT COAGADEX 250 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION COAGADEX 500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION human coagulation factor X 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. - This medicine has been prescribed for you only. 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 Coagadex is and what it is used for 2. What you need to know before you use Coagadex 3. How to use Coagadex 4. Possible side effects 5. How to store Coagadex 6. Contents of the pack and other information 1. WHAT COAGADEX IS AND WHAT IT IS USED FOR Coagadex is a concentrate of human coagulation factor X, a protein that is needed for blood to clot. The factor X in Coagadex is extracted from human plasma (the liquid part of blood). It is used to treat and prevent bleeding in patients with hereditary factor X deficiency, including during surgery. Patients with factor X deficiency do not have sufficient factor X for their blood to clot properly, leading to excessive bleeding. Coagadex replaces the missing factor X and allows their blood to clot normally. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE COAGADEX _ _ DO NOT USE COAGADEX: - if you are allergic to human coagulation factor X or any of the other ingredients of this medicine (listed in section 6). Check with your doctor if you think this applies to you. WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before using Coagadex: - if you have a larger or longer bleed than usual and the bleeding does not stop after an injection of Coagadex. - if you are taking a medicine to prevent Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Coagadex 250 IU powder and solvent for solution for injection Coagadex 500 IU powder and solvent for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Coagadex 250 IU powder and solvent for solution for injection Each vial contains nominally 250 IU human coagulation factor X. Coagadex contains approximately 100 IU/mL human coagulation factor X after reconstitution with 2.5 mL sterilised water for injections. Coagadex 500 IU powder and solvent for solution for injection Each vial contains nominally 500 IU human coagulation factor X. Coagadex contains approximately 100 IU/mL human coagulation factor X after reconstitution with 5 mL sterilised water for injections. Produced from the plasma of human donors. Excipients with known effect: Coagadex contains up to 0.4 mmol/mL (9.2 mg/mL) of sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection. Powder vial containing white or off-white powder. Solvent vial containing clear colourless liquid. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Coagadex is indicated for the treatment and prophylaxis of bleeding episodes and for perioperative management in patients with hereditary factor X deficiency. Coagadex is indicated in all age groups 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated under the supervision of a physician experienced in the treatment of rare bleeding disorders. Posology The dose and duration of the treatment depend on the severity of the factor X deficiency (i.e. the patient’s baseline factor X level), on the location and extent of the bleeding and on the patient’s clinical condition. Careful control of replacement therapy is especially important in cases of major surgery or life-threatening bleeding episodes. Not more than 60 IU/kg daily should be administered in any age group. 3 In adults and adolescents at least 12 years of age, the expected _in vivo_ peak i Прочетете целия документ