البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
Milrinone
Wockhardt UK Limited
C01CE; C01CE02
Milrinone
1 milligram(s)/millilitre
Solution for injection/infusion
Product subject to prescription which may not be renewed (A)
Phosphodiesterase inhibitors; milrinone
Marketed
2016-09-16
CHANGE CONTROL : Version changes due to change in: Size/Layout Regulatory Non-Regulatory $IBOHFTJOEFUBJM t"EEFE*SFMBOEBEESFTT PACKAGE LEAFLET: INFORMATION FOR THE USER MILRINONE 1MG/ML SOLUTION FOR INJECTION/INFUSION MILRINONE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. t ,FFQUIJTMFBøFU:PVNBZOFFEUP SFBEJUBHBJO t *GZPVIBWFBOZGVSUIFSRVFTUJPOT BTLZPVSEPDUPS OVSTFPSQIBSNBDJTU t 5IJTNFEJDJOFIBTCFFO QSFTDSJCFEGPSZPVPOMZ%POPU QBTTJUPOUPPUIFST*UNBZIBSN UIFN FWFOJGUIFJSTJHOTPGJMMOFTT BSFUIFTBNFBTZPVST t *GZPVHFUBOZTJEFFòFDUT UBMLUPZPVSEPDUPS OVSTFPS QIBSNBDJTU5IJTJODMVEFTBOZQPTTJCMFTJEFFòFDUTOPUMJTUFEJO UIJTMFBøFU4FFTFDUJPO WHAT IS IN THIS LEAFLET: 8IBU.JMSJOPOFJTBOEXIBUJUJTVTFEGPS 8IBUZPVOFFEUPLOPXCFGPSFZPVBSFHJWFO.JMSJOPOF )PXZPVXJMMCFHJWFO.JMSJOPOF 1PTTJCMFTJEFFòFDUT )PXUPTUPSF.JMSJOPOF $POUFOUTPGUIFQBDLBOEPUIFSJOGPSNBUJPO 1. WHAT MILRINONE IS AND WHAT IT IS USED FOR 5IFOBNFPGZPVSNFEJDJOFJT.JMSJOPOFNHNM4PMVUJPOGPS JOKFDUJPOJOGVTJPO SFGFSSFEUPBT.JMSJOPOFUISPVHIPVUUIJT MFBøFU *UDPOUBJOTBNFEJDJOFDBMMFENJMSJOPOF5IJTCFMPOHTUP BHSPVQPGNFEJDJOFTDBMMFEQIPTQIPEJFTUFSBTFJOIJCJUPST*U XPSLTCZNBLJOHZPVSIFBSUNVTDMFDPOUSBDUNPSFTUSPOHMZBOE ZPVSCMPPEWFTTFMTCFDPNFXJEFS5IJTNFBOTCMPPEDBOøPX NPSFFBTJMZNBLJOHZPVSIFBSUQVNQCMPPENPSFTVDDFTTGVMMZ MILRINONE CAN BE USED IN ADULTS FOR: t 4IPSUUFSNUSFBUNFOUPGTFWFSFDPOHFTUJWFIFBSUGBJMVSF XIFSFUIFIFBSUDBOOPUQVNQFOPVHICMPPEUPUIFSFTUPG UIFCPEZ XIFOPUIFSNFEJDJOFTIBWFOPUXPSLFE t 5SFBUNFOUBGUFSBIFBSUPQFSBUJPOGPSXIFOZPVSIFBSUJT IBWJOHEJóDVMUZQVNQJOHCMPPEBSPVOEZPVSCPEZ MILRINONE CAN BE USED IN CHILDREN FOR t TIPSUUFSNUSFBUNFOU VQUPIPVST PGTFWFSFDPOHFTUJWF IFBSUGBJMVSF XIFSFUIFIFBSUDBOOPUQVNQFOPVHICMPPEUP UIFSFTUPGUIFCPEZ XIFOP اقرأ الوثيقة كاملة
Health Products Regulatory Authority 16 August 2019 CRN00918X Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Milrinone 1 mg/ml Solution for Injection/Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 10 ml ampoule contains 10 mg milrinone. Each ml of solution contains 1 mg milrinone. Excipient with known effect: Sodium (this medicinal product contains less than 1 mmol sodium (23 mg) per dose) For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection/infusion. Clear, colourless to pale yellow solution, practically free from particles. The pH of the solution is 3.2 - 4.0 and the osmolality is 261 – 319mOsm/Kg. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Milrinone Injection is indicated for the short-term treatment of severe congestive heart failure unresponsive to conventional maintenance therapy, and for the treatment of patients with acute heart failure, including low output states following cardiac surgery. In paediatric population milrinone is indicated for the short-term treatment (up to 35 hours) of severe congestive heart failure unresponsive to conventional maintenance therapy (glycosides, diuretics, vasodilators and/or angiotensin converting enzyme (ACE) inhibitors), and for the short-term treatment (up to 35 hours) of paediatric patients with acute heart failure, including low output states following cardiac surgery. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For intravenous administration. _Adults_: Milrinone Injection should be given as a loading dose of 50μg/kg administered over a period of 10 minutes usually followed by a continuous infusion at a dosage titrated between 0.375microgram(s)/kg/min and 0.75microgram(s)/kg/min according to haemodynamic and clinical response, but should not exceed 1.13mg/kg/day total dose. For instructions on dilution of the product before administration and a guide to maintenance infusion delivery rates, see section 6.6. Solutions of different concentrations may be used according to patient اقرأ الوثيقة كاملة