Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
FUSIDATE SODIUM
Leo Laboratories Limited
500 Milligram
Pdr+Solv for soln for Inf
1991-02-27
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fucidin 500mg Powder and Solvent for Concentrate for Solution for I.V. Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of powder contains 500 mg of Sodium Fusidate. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Powder and solvent for concentrate for solution for infusion A white to off-white crystalline powder accompanied by a clear and colourless buffer solution as solvent for reconstitution. The reconstituted product is further diluted with the appropriate infusion fluid prior to administration by intravenous infusion. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the treatment of systemic infections due to micro-organisms sensitive to this anti-infective. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults only: (Weighing more than 50kg) The usual total daily dose is 1,500 - 2,000mg in divided doses, i.e. given three to four times daily. Add the fusidate/buffer solution to 500ml of infusion and infuse slowly over a period of at least 2 to 4 hours into a wide bore vein with good blood flow. If a superficial vein is employed a more prolonged period of at least 6 hours is advisable. Since Fucidin is excreted in the bile, no dosage modifications are needed in renal impairment. The dosage in patients undergoing haemodialysis needs no adjustment as Fucidin is not significantly dialysed. Children (and adults weighing less than 50kg). The usual total daily dose is 20mg/kg body weight daily divided into 3 equal doses. Each dose corresponds to 0.13ml of the fusidate buffer solution per kg bodyweight. This volume should be further diluted at least ten fold with the appropriate infusion fluid. 4.3 CONTRAINDICATIONS Use in patients hypersensitive to the active ingredient. IRISH MEDICINES Read the complete document