Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
Octocog alfa
Takeda Manufacturing Austria AG
B02BD02
octocog alfa
Antihemorrhagics
Hemophilia A
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor-VIII deficiency).Advate does not contain von Willebrand factor in pharmacologically effective quantities and is therefore not indicated in von Willebrand disease.
Revision: 32
Authorised
2004-03-02
247 B. PACKAGE LEAFLET 248 PACKAGE LEAFLET: INFORMATION FOR THE USER ADVATE 250 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION ADVATE 500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION ADVATE 1000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION ADVATE 1500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION ADVATE 2000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION ADVATE 3000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION octocog alfa (recombinant human 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. - 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. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What ADVATE is and what it is used for 2. What you need to know before you use ADVATE 3. How to use ADVATE 4. Possible side effects 5. How to store ADVATE 6. Contents of the pack and other information 1. WHAT ADVATE IS AND WHAT IT IS USED FOR ADVATE contains the active substance octocog alfa, human coagulation factor VIII produced by recombinant DNA technology. Factor VIII is necessary for the blood to form clots and stop bleedings. In patients with haemophilia A (inborn lack of factor VIII), it is missing or not working properly. ADVATE is used for the treatment and prevention of bleeding in patients of all age groups with haemophilia A (an inherited bleeding disorder caused by lack of factor VIII). ADVATE is prepared without the addition of any human- or animal-derived protein in the entire manufacturing process. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ADVATE DO NOT USE ADVATE - if you are allergic to octocog alfa or any of the other ingredients of this medicine (listed in section 6) - if you are al Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT ADVATE 250 IU powder and solvent for solution for injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains nominally 250 IU human coagulation factor VIII (rDNA), octocog alfa. ADVATE contains approximately 50 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution. The potency (International Units) is determined using the European Pharmacopoeia chromogenic assay. The specific activity of ADVATE is approximately 4 520-11 300 IU/mg protein. Octocog alfa (human coagulation factor VIII (rDNA)) is a purified protein that has 2332 amino acids. It is produced by recombinant DNA technology in Chinese hamster ovary (CHO) cells. Prepared without the addition of any (exogenous) human- or animal-derived protein in the cell culture process, purification or final formulation. Excipients with known effect This medicinal product contains 0.45 mmol sodium (10 mg) per vial. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection. Powder: White to off-white friable powder. Solvent: Clear and colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). ADVATE 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 haemophilia and with resuscitation support immediately available in case of anaphylaxis. Posology The dose and duration of the substitution therapy depend on the severity of the factor VIII deficiency, on the location and extent of the bleeding and on the patient’s clinical condition. The number of units of factor VIII is expressed in International Units (IU), which are related to the WHO standard for factor VIII products. Factor VIII activity in plasma is expressed either as a percentage (relative to nor Pročitajte cijeli dokument