Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
idarucizumab
Boehringer Ingelheim International GmbH
V03AB
idarucizumab
All other therapeutic products
Hemorrhage
Praxbind is a specific reversal agent for dabigatran and is indicated in adult patients treated with Pradaxa (dabigatran etexilate) when rapid reversal of its anticoagulant effects is required:for emergency surgery/urgent procedures;in life-threatening or uncontrolled bleeding.
Revision: 12
Authorised
2015-11-20
25 B. PACKAGE LEAFLET 26 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT AND USER PRAXBIND 2.5 G/50 ML SOLUTION FOR INJECTION/INFUSION idarucizumab READ ALL OF THIS LEAFLET CAREFULLY, BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. PLEASE NOTE THIS MEDICINE IS MAINLY USED IN EMERGENCY SITUATIONS AND THE DOCTOR WILL HAVE DECIDED THAT YOU NEEDED IT. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or nurse. - If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Praxbind is and what it is used for 2. What you need to know when you receive Praxbind 3. How to use Praxbind 4. Possible side effects 5. How to store Praxbind 6. Contents of the pack and other information 1. WHAT PRAXBIND IS AND WHAT IT IS USED FOR WHAT PRAXBIND IS Praxbind contains the active substance idarucizumab. Idarucizumab is a reversal agent specific for dabigatran (Pradaxa), a blood thinner medicine that blocks a substance in the body, which is involved in blood clot formation. Praxbind is used to rapidly trap dabigatran in order to inactivate its effect. WHAT PRAXBIND IS USED FOR Praxbind is used in adults in emergency situations where your doctor decides that rapid inactivation of the effect of Pradaxa is required: - For emergency surgery/urgent procedures; - In life-threatening or uncontrolled bleeding. 2. WHAT YOU NEED TO KNOW WHEN YOU RECEIVE PRAXBIND WARNINGS AND PRECAUTIONS Talk to your doctor or nurse before receiving Praxbind: - if you are allergic to idarucizumab or to any other of the substances listed in section 6. - if you have a genetic disease called hereditary fructose intolerance. In this case, the substance sorbitol contained in this medicine may cause serious adverse reactions. They will take this into account before treating you with Praxbind. This medicine will only remove dabigatran from your body. It will not remove other medicines used to prevent the Lue koko asiakirja
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Praxbind 2.5 g/50 mL solution for injection/infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of solution for injection/infusion contains 50 mg idarucizumab. Each vial contains 2.5 g idarucizumab in 50 mL. Idarucizumab is produced by recombinant DNA technology in Chinese hamster ovary cells. Excipients with known effect Each vial contains 2 g sorbitol and 25 mg sodium in 50 mL (see section 4.4). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection/infusion Clear to slightly opalescent, colourless to slightly yellow solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Praxbind is a specific reversal agent for dabigatran and is indicated in adult patients treated with Pradaxa (dabigatran etexilate) when rapid reversal of its anticoagulant effects is required: For emergency surgery/urgent procedures; In life-threatening or uncontrolled bleeding. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Restricted to hospital use only. Posology The recommended dose is 5 g idarucizumab (2 vials of 2.5 g/50 mL). In a subset of patients, recurrence of plasma concentrations of unbound dabigatran and concomitant prolongation of clotting tests have occurred up to 24 hours after administration of idarucizumab (see section 5.1). Administration of a second 5 g dose of idarucizumab may be considered in the following situations: recurrence of clinically relevant bleeding together with prolonged clotting times, or if potential re-bleeding would be life-threatening and prolonged clotting times are observed, or patients require a second emergency surgery/urgent procedure and have prolonged clotting times. Relevant coagulation parameters are activated partial thromboplastin time (aPTT), diluted thrombin time (dTT) or ecarin clotting time (ECT) (see section 5.1). 3 A maximum daily dose has not been investigated. _Restarting antithrombotic therapy_ Pradaxa (dabigatran etexilate) treatment Lue koko asiakirja