Ország: Egyesült Királyság
Nyelv: angol
Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)
Milrinone
Sanofi
C01CE02
Milrinone
1mg/1ml
Solution for infusion
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 02010200; GTIN: 5000283606888
PACKAGE LEAFLET: INFORMATION FOR THE USER PRIMACOR 1MG/ML SOLUTION FOR INJECTION Milrinone IS THIS LEAFLET HARD TO SEE OR READ? PHONE 0845 372 7101 FOR HELP READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE • 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Primacor is and what it is used for 2. What you need to know before you take Primacor 3. How to take Primacor 4. Possible side effects 5. How to store Primacor 6. Contents of the pack and other information 1. WHAT PRIMACOR IS AND WHAT IT IS USED FOR The name of your medicine is Primacor 1mg/ml Solution for Injection (called Primacor in this leaflet). Primacor 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. Primacor can be used 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 Primacor 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 having difficulty pumping blood around your body. 2. WHAT YOU NEED TO KNOW B Olvassa el a teljes dokumentumot
OBJECT 1 PRIMACOR 1MG/ML SOLUTION FOR INJECTION Summary of Product Characteristics Updated 29-Jan-2016 | SANOFI 1. Name of the medicinal product Primacor 1mg/ml Solution for Injection 2. Qualitative and quantitative composition Each ampoule contains 1mg/ml of the active substance Milrinone. For a full list of excipients, see section 6.1. 3. Pharmaceutical form Solution for Injection. Clear, colourless to pale yellow liquid. 4. Clinical particulars 4.1 Therapeutic indications Primacor 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 Primacor 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_: Primacor 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 0.375µg/kg/min and 0.75µg/kg/min according to haemodynamic and clinical response, but should not exceed 1.13mg/kg/day total dose. The following provides a guide to maintenance infusion delivery rate based upon a solution containing milrinone 200µg/ml prepared by adding 40ml diluent per 10ml ampoule (400ml diluent per 100ml Primacor Injection). 0.45% saline, 0.9% saline or 5% glucose may be used as diluents. PRIMACOR INJECTION DOSE (ΜG /KG/MIN) INFUSION DELIVERY RATE (ML/KG/HR) 0.375 0.11 0.400 0.500 0.600 0.700 0.750 0.12 0.15 0.18 0.21 0.22 Solutions of different concentrations may be used according to patient Olvassa el a teljes dokumentumot