국가: 유럽 연합
언어: 영어
출처: EMA (European Medicines Agency)
Antithrombin alfa
Laboratoire Francais du Fractionnement et des Biotechnologies
B01AB02
antithrombin alfa
Antithrombotic agents
Antithrombin III Deficiency
ATryn is indicated for the prophylaxis of venous thromboembolism in surgery of patients with congenital antithrombin deficiency. ATryn is normally given in association with heparin or low molecular weight heparin.
Revision: 16
Withdrawn
2006-07-28
18 B. PACKAGE LEAFLET Medicinal product no longer authorised 19 PACKAGE LEAFLET: INFORMATION FOR THE USER ATRYN 1750 IU POWDER FOR SOLUTION FOR INFUSION antithrombin alfa (rDNA) This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. 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. - 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 ATryn is and what it is used for 2. What you need to know before you use ATryn 3. How to use ATryn 4. Possible side effects 5. How to store ATryn 6. Contents of the pack and other information 1. WHAT ATRYN IS AND WHAT IT IS USED FOR ATryn contains antithrombin alfa which is similar to the naturally occurring human antithrombin. In the body, antithrombin blocks thrombin, a substance that plays a central role in the process of blood clotting. If you have an inborn deficiency of antithrombin, your blood level of antithrombin is lower than normal. This may result in a higher tendency to form clots in your blood vessels. This may be in the vessels of your legs (deep vein thrombosis) or in other vessels of your body (thromboembolism). Around major surgical procedures this tendency to clot is even more increased. Therefore, it is important that your antithrombin blood level be maintained at sufficient levels in these situations. This medicine is used in patients who have ‘congenital antithrombin deficiency’ (inherited low levels of the protein antithrombin). It is used when the patients are having surgery, to prevent problems due to the formation of blood clots in the vessels. It is normally given in association with heparin or l 전체 문서 읽기
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT ATryn 1750 IU powder for solution for infusion. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial contains nominally 1750 IU* antithrombin alfa**. After reconstitution, 1 ml of solution contains 175 IU antithrombin alfa. The specific activity of ATryn is approximately 7 IU/mg protein. * potency (IU) determined using European Pharmacopoeial chromogenic assay. ** recombinant human antithrombin produced in the milk of transgenic goats by recombinant DNA technology (rDNA). Excipient with known effect This medicine contains 38 mg (1.65 mmol) sodium per 10 ml vial. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for solution for infusion The powder is white to off-white. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ATryn is indicated for the prophylaxis of venous thromboembolism in surgery of adult patients with congenital antithrombin deficiency. It is normally given in association with heparin or low molecular weight heparin. _ _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated under the supervision of a physician experienced in the treatment of patients with congenital antithrombin deficiency. Posology Due to differences in pharmacokinetics of antithrombin alfa and plasma-derived antithrombin, treatment s h o u l d f o l l o w t h e s p e c i f i c dose r e c o m m e n d a t i o n s d e s c r i b e d b e l o w . I n t h e t r e a t m e n t o f c o n g e n i t a l antithrombin deficiency, the dose and duration of treatment should be individualised for each patient taking into account the family history with regard to thromboembolic events, the actual clinical risk factors, and the labor 전체 문서 읽기