Страна: Малта
Език: английски
Източник: Medicines Authority
FUROSEMIDE
Mercury Pharmaceuticals (Ireland) Limited 4045 Kingswood Road, City West Business Park, Co, Dublin, Ireland
C03CA01
FUROSEMIDE 10 mg/ml
SOLUTION FOR INFUSION OR INJECTION
FUROSEMIDE 10 mg/ml
POM
DIURETICS
Withdrawn
2006-11-28
Package leaflet: Information for the patient Furosemide 250mg in 25ml Solution for Injection/Infusion 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, 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/Infusion from here onwards. What is in this leaflet 1. What Furosemide Injection/Infusion is and what it is used for 2. What you need to know before you are given Furosemide Injection /Infusion 3. How Furosemide Injection/Infusion is given to you 4. Possible side effects 5. How to store Furosemide Injection/Infusion 6. Contents of the pack and other information 1. What Furosemide Injection/Infusion is and what it is used for Furosemide is a strong diuretic. Diuretics help you to pass more water (urine). Furosemide Injection/Infusion may be used to help you to pass more water when your kidneys are not producing enough urine. 2. What you need to know before you are given Furosemide Injection /Infusion 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 cotrimoxazole -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 or chemicals that are prone to cause ki Прочетете целия документ
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Furosemide 250mg in 25ml Solution for Injection/Infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1ml of solution contains Furosemide 10mg. Each 25ml ampoule contains Furosemide 250mg Excipient with known effect: Each 25ml contains 91 mg (4mmol) sodium For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for Injection/Infusion. Clear, colourless or almost colourless sterile solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Furosemide Injection 250mg/25ml is for use in the management of oliguria due to acute or chronic renal insufficiency with a glomerular filtration rate below 20ml/minute. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Doses of 20 to 50 mg intramuscularly or intravenously may be given initially. If larger doses are required, they should be given increasing by 20 mg increments and not given more often than every two hours. If doses greater than 50 mg are required it is recommended that they be given by slow intravenous infusion. The recommended maximum daily dose of furosemide administration is 1,500 mg. The recommended initial dose is one 25ml ampoule (250mg) diluted in 225ml Sodium Chloride Injection BP or Ringer’s solution for injection, administered over one hour. If urine output is insufficient within the next hour, a dose of two 25ml ampoules (500mg) in an appropriate infusion fluid may be given over two hours. The total volume of the infusion should be governed by the patient’s state of hydration. If a satisfactory urine output has still not been achieved within one hour of the end of the second infusion, a third infusion containing four 25ml ampoules (1,000mg) may be given. The rate of infusion should not exceed 4mg/minute. In oliguric or anuric patients with significant fluid overload, the injection may be given without dilution directly into the vein, using a constant-rate infusion pump with a micrometer screw- gauge adjustment; the rate of administration should st Прочетете целия документ