البلد: الاتحاد الأوروبي
اللغة: الإنجليزية
المصدر: EMA (European Medicines Agency)
cangrelor
Chiesi Farmaceutici S.p.A.
B01
cangrelor
Antithrombotic agents
Acute Coronary Syndrome; Vascular Surgical Procedures
Kengrexal, co-administered with acetylsalicylic acid (ASA), is indicated for the reduction of thrombotic cardiovascular events in adult patients with coronary artery disease undergoing percutaneous coronary intervention (PCI) who have not received an oral P2Y12 inhibitor prior to the PCI procedure and in whom oral therapy with P2Y12 inhibitors is not feasible or desirable.
Revision: 15
Authorised
2015-03-23
22 B. PACKAGE LEAFLET 23 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT KENGREXAL 50 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INJECTION/INFUSION cangrelor 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 Kengrexal is and what it is used for 2. What you need to know before you use Kengrexal 3. How to use Kengrexal 4. Possible side effects 5. How to store Kengrexal 6. Contents of the pack and other information 1. WHAT KENGREXAL IS AND WHAT IT IS USED FOR Kengrexal is an anti-platelet medicine that contains the active substance cangrelor. Platelets are very small cells in the blood that can clump together and help the blood to clot. Sometimes clots can form within a damaged blood vessel such as in an artery in the heart and this can be very dangerous as the clot can cut off the blood supply (a thrombotic event), causing a heart attack (myocardial infarction). Kengrexal diminishes the clumping of platelets and so reduces the chance of a blood clot forming. You have been prescribed Kengrexal because you have blocked blood vessels in your heart (coronary artery disease) and you need a procedure (called a percutaneous coronary intervention – PCI) to remove the blockage. During this procedure you may have a stent inserted in your blood vessel to help to keep it open. Using Kengrexal reduces the risk that this procedure will cause a clot to form and block the blood vessels again. Kengrexal is only for use in adults. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE KENGREXAL DO NOT USE KENGREXAL - If you are allergic to cangrelor or any of the other ingredients of this medicine (listed in section 6). - If you have a medical condition that is currently causing bleeding such as bleeding from اقرأ الوثيقة كاملة
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Kengrexal 50 mg powder for concentrate for solution for injection/infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains cangrelor tetrasodium corresponding to 50 mg cangrelor. After reconstitution 1 mL of concentrate contains 10 mg cangrelor. After dilution 1 mL of solution contains 200 micrograms cangrelor. Excipient with known effect Each vial contains 52.2 mg sorbitol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for concentrate for solution for injection/infusion. White to off-white lyophilised powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Kengrexal, co-administered with acetylsalicylic acid (ASA), is indicated for the reduction of thrombotic cardiovascular events in adult patients with coronary artery disease undergoing percutaneous coronary intervention (PCI) who have not received an oral P2Y12 inhibitor prior to the PCI procedure and in whom oral therapy with P2Y12 inhibitors is not feasible or desirable. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Kengrexal should be administered by a physician experienced in either acute coronary care or in coronary intervention procedures and is intended for specialised use in an acute and hospital setting. Posology The recommended dose of Kengrexal for patients undergoing PCI is a 30 micrograms/kg intravenous bolus followed immediately by 4 micrograms/kg/min intravenous infusion. The bolus and infusion should be initiated prior to the procedure and continued for at least two hours or for the duration of the procedure, whichever is longer. At the discretion of the physician, the infusion may be continued for a total duration of four hours, see section 5.1. Patients should be transitioned to oral P2Y12 therapy for chronic treatment. For transition, a loading dose of oral P2Y12 therapy (clopidogrel, ticagrelor or prasugrel) should be administered immediately following discontinuation of cangrelor infusion. Alternatively, a loadin اقرأ الوثيقة كاملة