País: Malta
Língua: inglês
Origem: Malta Medicines Authority
ANTITHROMBIN III
Baxalta Innovations GmbH Industriestrasse 67, 1221, Vienna, Austria
B01AB02
ANTITHROMBIN III 50 IU/ml
POWDER AND SOLVENT FOR SOLUTION FOR INFUSION OR INJECTION
ANTITHROMBIN III 50 IU/ml
POM
ANTITHROMBOTIC AGENTS
Authorised
2006-01-27
1 PACKAGE LEAFLET: INFORMATION FOR THE USER ANTITHROMBIN III BAXALTA 50 IU/ML, POWDER AND SOLVENT FOR SOLUTION FOR INFUSION Human plasma-derived antithrombin III 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. - If you get any side effects, talk to your doctor, pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. What ANTITHROMBIN III BAXALTA is and what it is used for 2. What you need to know before you use ANTITHROMBIN III BAXALTA 3. How to use ANTITHROMBIN III BAXALTA 4. Possible side effects 5. How to store ANTITHROMBIN III BAXALTA 6. Contents of the pack and other information 1. WHAT ANTITHROMBIN III BAXALTA IS AND WHAT IT IS USED FOR ANTITHROMBIN III BAXALTA is presented as pale yellow to pale green friable solid or powder and solvent for solution for infusion. ANTITHROMBIN III BAXALTA is available in pack sizes containing - 500 IU antithrombin III and 10 ml solvent - 1000 IU antithrombin III and 20 ml solvent ANTITHROMBIN III BAXALTA belongs to a pharmacotherapeutic group called antithrombotic agents. ANTITHROMBIN III BAXALTA is used for treatment of congenital or acquired antithrombin III deficiency, which may be within the framework of a large variety of clinical disorders. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ANTITHROMBIN III BAXALTA DO NOT USE ANTITHROMBIN III BAXALTA - If you are hypersensitive (allergic) to antithrombin III or to any of the other ingredients of ANTITHROMBIN III BAXALTA. - If you have a known history of heparin induced thrombocytopenia (i.e. a decrease of platelets). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using ANTITHROMBIN III BAXALTA. - Please tell your doctor immediately if you experience first signs of an allergic reaction (e.g. hives, generalized urticaria, tightness of the chest, wheezing, Leia o documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT ANTITHROMBIN III BAXALTA 50 IU/ml, powder and solvent for solution for injection or infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Human plasma-derived antithrombin III ANTITHROMBIN III BAXALTA is presented as lyophilised powder for injection or infusion containing nominally 50 IU * /ml human plasma-derived ANTITHROMBIN III per vial. * The potency International Unit (IU) is determined using the European Pharmacopoeial chromogenic assay. The specific activity of ANTITHROMBIN III BAXALTA is at least 3 IU AT/mg plasma protein. 500 IU/10 ml This medicinal product contains approximately 50 IU/ml (500 IU/10 ml) human plasma- derived antithrombin III when reconstituted with 10 ml of sterilised water for injections. 1000 IU/20 ml This medicinal product contains approximately 50 IU/ml (1000 IU/20 ml) human plasma- derived antithrombin III when reconstituted with 20 ml of sterilised water for injections. Excipient with known effect 500 IU/10 ml ANTITHROMBIN III BAXALTA contains 37.7 mg sodium per vial. 1000 IU/20 ml ANTITHROMBIN III BAXALTA contains 75.5 mg sodium per vial. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection or infusion. ANTITHROMBIN III BAXALTA is a lyophilised pale yellow to pale green, friable solid or a powder. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Antithrombin deficiency may be congenital or it may be acquired within the framework of a large variety of clinical disorders. An acquired deficiency of antithrombin may be due either to increased consumption or loss of protein, or to defective synthesis of antithrombin. The administration of ANTITHROMBIN III BAXALTA is indicated in patients with a plasma antithrombin activity below 70% of normal, for prophylaxis and treatment of thrombotic and thromboembolic disorders. Infusions of antithrombin may be particularly valuable in the following clinical situations: - surgical procedures, or pregnancy and deli Leia o documento completo