Country: Malta
Language: English
Source: Medicines Authority
BUMETANIDE
KARO Pharma AB Box 16184, 103 24, Stockholm, Sweden
C03CA02
BUMETANIDE 0.5 mg/ml
SOLUTION FOR INJECTION
BUMETANIDE 0.5 mg/ml
POM
DIURETICS
Authorised
2012-11-23
PACKAGE LEAFLET: INFORMATION FOR THE USER BURINEX ® 0.5 MG/ML, SOLUTION FOR INJECTION Bumetanide 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, pharmacist or nurse. • 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. • In this leaflet Burinex 0.5mg/mL solution for injection will be called Burinex. WHAT IS IN THIS LEAFLET 1. What Burinex is and what it is used for 2. What you need to know before you use Burinex 3. How to take Burinex 4. Possible side effects 5. How to store Burinex 6. Contents of the pack and other information 1. WHAT BURINEX ® IS AND WHAT IT IS USED FOR Burinex is available as a solution for injection, containing 0.5 mg bumetanide per ml. Burinex ® belongs to a group of medicine called diuretics. Burinex ® works by removing any excess water from your body. It will make you go to the toilet more. Burinex is used: • To treat high blood pressure, fluid retention (oedema) in the body, _e.g_ . if you have disturbed heart function, if you have impared renal function or if, for some other reason you need to increase the production of urine. • To treat drug poisoning with salicylates (painkillers) or barbiturates (hypnotics). 2. WHAT YOU NEED TO KNOW BEFORE YOU USE BURINEX ® DO NOT USE BURINEX • if you are allergic to bumetanide, formaldehyde or any of the other ingredients in this medicine (listed in section 6). • if you have been told that you have very low levels of potassium, sodium or chloride in your blood. • if you cannot make urine at all. • if you have severe liver problems or are in a coma caused by this (hepatic encephalopathy). WARNINGS Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Burinex 0.5 mg/ml, solution for injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Burinex ampoule contains 0.5 mg bumetanide per millilitre. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Burinex 0.5 mg/ml, solution for injection is indicated in the management of acute oedema due to congestive heart failure, including pulmonary oedema, cirrhosis of the liver and renal disease including nephrotic syndrome in adults. Drug intoxication where forced diuresis is desirable in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology If oral administration is not feasible, of if a rapid effect is desired, bumetanide may be administered intramuscularly or intravenously. Usual dose is 0.5-1 mg. Pulmonary oedema: In less serious cases 0.5 mg intravenously. Repeat, if necessary, after 20 minutes. In acute cases 2 mg intravenously. Repeat, if necessary, 2 to 3 times at 20 minute intervals. _Paediatric population: _ The medicinal product is not recommended for children as there is limited information on the safety, efficacy and dosage in children. _Elderly _ Due to changed pharmaco-kinetics and pharmaco-dynamics the diuretic effect may decrease in elderly, increasing the risk of side effects. Therefore, the dosage must be determined in accordance with the efficiency and any adverse reactions to the medicinal product. _Patients with hepatic or renal impairment _ Page 1 of 9 Due to changed pharmaco-kinetics and/or pharmaco-dynamics the diuretic effect may decrease in patients with hepatic or renal insufficiency, increasing the risk of side effects. Therefore, the dosage must be determined in accordance with the efficiency and any adverse reactions to the medicinal product. _Renal impairment: _ 2-5 mg, repeat, if necessary, every 6 to 8 hours, or 2-5 mg in 500 ml solution for infusion administered over 30 to 60 minutes. Repe Read the complete document