Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
Milrinone
Pinewood Laboratories Ltd
C01CE; C01CE02
Milrinone
1 milligram(s)/millilitre
Solution for injection/infusion
Phosphodiesterase inhibitors; milrinone
Marketed
2016-09-16
P ACKAGE LEAFLET: INFORMATION FOR THE USER MILRINONE 1 MG/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. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor, nurse or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Milrinone is and what it is used for 2. What you need to know before you are given Milrinone 3. How you will be given Milrinone 4. Possible side effects 5. How to store Milrinone 6. Contents of the pack and other information 1. WHAT MILRINONE IS AND WHAT IT IS USED FOR The name of your medicine is Milrinone 1 mg/ml Solution for Injection/Infusion (referred to as Milrinone throughout this leaflet). It contains a medicine called milrinone. This belongs to a group of medicines called phosphodiesterase inhibitors. It works by making your heart muscle contract more strongly and your blood vessels become wider. This means blood can flow more easily making your heart pump blood more successfully. MILRINONE CAN BE USED IN ADULTS FOR: • Short-term treatment of severe congestive heart failure (where the heart cannot pump enough blood to the rest of the body) when other medicines have not worked • Treatment after a heart operation for when your heart is having difficulty pumping blood around your body MILRINONE CAN BE USED IN CHILDREN FOR: • short term treatment (up to 35 hours) of severe congestive heart failure (where the heart cannot pump enough blood to the rest of the body) when other medicines have not worked • short term treatment (up to 35 hours) of acute heart failure after a heart operation i.e. when your heart is hav Đọc toàn bộ tài liệu
Health Products Regulatory Authority 10 June 2022 CRN00CGCR 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 ml of solution contains 1 mg milrinone. Each 10 ml ampoule contains 10 mg milrinone. 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 – 319 mOsm/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 50 microgram(s)/kg administered over a period of 10 minutes usually followed by a continuous infusion at a dosage titrated between 0.375 microgram(s)/kg/min and 0.75 microgram(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 fluid requirements. The duration of therapy should depend upon the patient's response. In congestive Đọc toàn bộ tài liệu