Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
Furosemide
Mercury Pharmaceuticals (Ireland) Ltd
C03CA; C03CA01
Furosemide
50 mg/5ml
Solution for injection
Product subject to prescription which may not be renewed (A)
Sulfonamides, plain; furosemide
Marketed
1990-05-28
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT FUROSEMIDE 20MG IN 2ML SOLUTION FOR INJECTION FUROSEMIDE 50MG IN 5ML SOLUTION FOR INJECTION FUROSEMIDE 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 further questions, please ask your doctor or nurse. - If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. This product will be referred to as Furosemide Injection from here onwards. WHAT IS IN THIS LEAFLET 1. What Furosemide Injection is and what it is used for 2. What you need to know before you are given Furosemide Injection 3. How Furosemide Injection is given to you 4. Possible side effects 5. How to store Furosemide Injection 6. Contents of the pack and other information 1. WHAT FUROSEMIDE INJECTION IS AND WHAT IT IS USED FOR Furosemide is a strong diuretic. Diuretics help you to pass more water (urine). Furosemide Injection may be used to help you pass more water, promptly and effectively. Excess fluid can build up in certain conditions which affect the heart, lungs, kidneys and liver. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN FUROSEMIDE INJECTION YOU SHOULD NOT BE GIVEN FUROSEMIDE IF - you are allergic to Furosemide or any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue -you are allergic to amiloride, sulfonamides or sulphonamide derivatives, such as sulfadiazine or co-trimoxazole -you have a low blood volume or are dehydrated (with or without accompanying low blood pressure) -you have too little potassium or sodium in your blood (shown in blood test) -you have severe liver problems (cirrhosis) -you have already taken Furosemide in the past to treat failure to pass urine or kidney failure or if you have kidney failure that is due to medicines Olvassa el a teljes dokumentumot
Health Products Regulatory Authority 16 November 2020 CRN009W5D Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Furosemide 50mg in 5ml Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1ml of sterile solution for injection contains Furosemide 10mg. Each 5ml ampoule contains Furosemide 50mg. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. Clear, colourless or almost colourless sterile solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Furosemide is a potent diuretic and is recommended for use when prompt and effective diuresis is required Furosemide Injection 50mg/5ml is appropriate for use in emergencies or where oral therapy is not feasible. The indications include cardiac, pulmonary, hepatic and renal oedema. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults: Initially, doses of 20 - 50mg may be administered by the intramuscular route, or by slow intravenous injection at a rate not exceeding 4mg/minute. The diuretic effect of furosemide is proportional to the dosage and, if larger doses are required, they should be given as a controlled infusion at a rate not exceeding 4mg/minute and titrated according to the response. Elderly: Elimination of furosemide is generally slower in the elderly. Dosage should be titrated until the required effect is achieved. _Paediatric population: _Dosages for children range from 0.5 - 1.5mg/kg weight daily up to a maximum total daily dose of 20mg Method of administration Furosemide Injection 50mg/5ml are for intramuscular or for intravenous administration and must always be given slowly. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Hypersensitivity to amiloride, sulphonamides or sulphonamide derivatives. Hypovolaemia and dehydration (with or without accompanying hypotension) (see section 4.4). Severe hypokalaemia: severe hyponatraemia (see section 4.4). Comatose or pre-comatose Olvassa el a teljes dokumentumot