Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
FRUSEMIDE/FUROSEMIDE
IMEKS PHARMA SDN. BHD.
FRUSEMIDE/FUROSEMIDE
2ml10Units mL
Mefar Ilac Sanayii A.S.
SUMMARY OF PRODUCT CHARACTERISTICS FUROSEMIDE-HAMELN 10 MG/ML SOLUTION FOR INJECTION HAMELN 1. NAME OF THE MEDICINAL PRODUCT Furosemide-hameln 10 mg/ml solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2 ml of solution contains 20 mg furosemide (10 mg/ml). Excipient(s) with know effect: This medicinal product contains a maximum 4 mg sodium per 1 ml of solution. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Furosemide-hameln is clear colourless solution, free from vis- ible particles. pH 8.0-9.3 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Furosemide-hameln is a diuretic indicated for use when a prompt and effective diuresis is required. The intravenous for- mulation is appropriate for use in emergencies or when oral therapy is precluded. Indications include cardiac, pulmonary, hepatic and renal oedema. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults_ 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 admin- istration is 1,500 mg. _Elderly_ The dosage recommendations for adults apply, but in the el- derly furosemide is generally eliminated more slowly. Dosage should be titrated until the required response is achieved. _Paediatric population_ Parenteral doses for children range from 0.5 to 1.5 mg/kg body weight daily up to a maximum total daily dose of 20 mg. Method of administration Furosemide-hameln is administered intravenously or intramus- cularly. Intravenous furosemide must be injected or infused slowly; a rate of 4 mg per minute must not be exceeded. In patients with severe impairment of renal function (serum creatinine>5 mg/ dl), it is recommended that an infusion rate of 2.5 mg per min- ute is not exceeded. In Baca dokumen lengkap