Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
FUROSEMIDE
Pfizer Healthcare Ireland
10 Mg/Ml
Solution for Injection
2011-12-21
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Furosemide Pfizer 10mg/ml Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1ml solution contains 10mg furosemide. Each 2 ml ampoule contains 20 mg of furosemide (20 mg/2 ml) Each 5 ml ampoule contains 50 mg of furosemide (50 mg/5 ml) Excipients Sodium 0.3mmol per 2ml. For a full list of excipients, see section 6 3 PHARMACEUTICAL FORM Solution for injection. A clear and colourless solution, essentially free from visible particles. pH of the solution is between 8.00 and 9.30. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS When a prompt diuresis is required. Use in emergencies or when oral therapy is precluded. Indications include: _- Oedema and/or ascites caused by cardiac or hepatic diseases_ - _Oedema caused by renal diseases (in case of nephrotic syndrome, treatment of the underlying disease is essential)_ _- Pulmonary oedema (e.g. in case of acute heart failure)_ - _Hypertensive crisis (in addition to other therapeutic measures)_ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration: intravenous or (in exceptional cases) intramuscular General: The parenteral administration of furosemide is indicated in cases where oral administration is not feasible or not efficient (for example in case of reduced intestinal absorption) or when a quick effect is required. To achieve optimum efficacy and suppress counter-regulation, a continuous furosemide infusion is generally to be preferred to repeated bolus injections. Where continuous furosemide infusion is not feasible for follow-up treatment after one or several acute bolus doses, a follow-up regimen with low doses given at short intervals (approx. 4 hours) is to be preferred to a regimen with higher bolus doses at longer interval Read the complete document