国: 欧州連合
言語: 英語
ソース: EMA (European Medicines Agency)
desirudin
Canyon Pharmaceuticals Ltd.
B01AE01
desirudin
Antithrombotic agents
Venous Thrombosis
Prevention of deep venous thrombosis in patients undergoing elective hip or knee replacement surgery.
Revision: 12
Withdrawn
1997-07-09
21 B. PACKAGE LEAFLET Medicinal product no longer authorised 22 PACKAGE LEAFLET: INFORMATION FOR THE USER REVASC 15MG/0.5ML POWDER AND SOLVENT FOR SOLUTION FOR INJECTION Desirudin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, nurse or your pharmacist. - If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse. IN THIS LEAFLET : 1. What Revasc is and what it is used for 2. Before you use Revasc 3. How to use Revasc 4. Possible side effects 5. How to store Revasc 6. Further information 1. WHAT REVASC IS AND WHAT IT IS USED FOR The common name of the active substance in Revasc is desirudin. Desirudin is a recombinant DNA product derived from yeast cells. Desirudin belongs to a group of medicines called anticoagulants, which prevent blood clots from forming in the blood vessels. Revasc is used to prevent blood clotting after elective hip or knee replacement surgery, as harmful blood clots can form in the blood vessels of the legs. It is often given for several days after operations because blood clots are most likely to form when you are resting in bed. 2. BEFORE YOU USE REVASC YOU MUST NOT BE GIVEN REVASC - if you are hypersensitive (allergic) to natural or synthetic hirudin, including desirudin or any of the other ingredients of Revasc - if you are bleeding a lot or have any serious bleeding disorder (e.g. haemophilia) - if you have serious kidney or liver disease - if you have a heart infection - if you have an uncontrolled high blood pressure - if you are pregnant. TAKE SPECIAL CARE WITH REVASC Make sure you tell your doctor if you are likely to have an increased risk of bleeding, which may be the case if you have, or have had: - bleeding disorders or a family history of bleeding disorder - stomach ulcers or any other bleeding disease of the gut - history of a stroke, or bleeding within the brain or eye - 完全なドキュメントを読む
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Revasc 15mg/0.5ml powder and solvent for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ Each vial contains 15 mg desirudin. After reconstitution one vial contains 15 mg** desirudin* per 0.5 ml Desirudin consists in a single chain polypeptide of 65 amino acid residues and 3 disulphide bridges. * produced by recombinant DNA technology in yeast cells. ** corresponding to approximately 270,000 antithrombin units (ATU) or 18,000 ATU per mg of desirudin with reference to the WHO Second International Standard for alpha-thrombin. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM White powder and clear, colourless solvent for solution for injection 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prevention of deep venous thrombosis in patients undergoing elective hip or knee replacement surgery. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Revasc should be initiated under the guidance of a physician with experience in coagulation disorders. Instructions for the preparation of Revasc are provided in section 6.6. Adult and elderly patients The recommended dose is 15 mg twice daily. The first injection should be initiated 5 to 15 minutes before surgery but after induction of regional block anaesthesia, if used. Treatment with desirudin is then continued twice daily post-operatively for 9 days up to a maximum of 12 days or until the patient is fully ambulant, whichever occurs first. Currently, there is no clinical experience to support the use of desirudin beyond 12 days. Administration is by subcutaneous injection, preferably at an abdominal site. Injections should be rotated between at least four different sites. Children There is no experience in children. Patients with renal impairment Desirudin is contraindicated in patients with severe renal impairment (creatinine clearance of less than 30ml/min corresponding to a serum creatinine > 2.5mg/dl o 完全なドキュメントを読む