البلد: المملكة المتحدة
اللغة: الإنجليزية
المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)
Idarucizumab
Boehringer Ingelheim Ltd
V03AB37
Idarucizumab
50mg/1ml
Solution for infusion
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 02080400; GTIN: 5012816096189
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 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. Praxbind contains the active substance idarucizumab. 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 Tell your doctor or nurse • 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 formation of blood clots. After dabigatran has been removed from your body, you are not protected from the formation of blood clots. Your doctor will continue treating you with medicines used to prevent the formation of blood clots as soon as your medical condition allows. CHILDREN AND ADOLESCENTS There is no information on the use of Praxbind in children. OTHER MEDICINES AND PRAXBIND Tell your doctor if you are taking, have recently taken or might take any other medicines. This medicine has been designed to only bind to dabigatran. It is unlikely that Praxbind will influence the effect of other medicines or that other medicines اقرأ الوثيقة كاملة
OBJECT 1 PRAXBIND 2.5 G/50 ML SOLUTION FOR INJECTION/INFUSION Summary of Product Characteristics Updated 15-Dec-2017 | Boehringer Ingelheim Limited 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 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 50 mL vial contains 2 g sorbitol and 25 mg sodium (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 of Praxbind is 5 g (2x2.5 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 Praxbind 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 اقرأ الوثيقة كاملة