Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
GENTAMICIN SULFATE
Sanofi-Aventis Ireland Limited
80 Mg/Ml
Solution for Injection
2003-03-09
License Part II Summary of Product Characteristics 1 NAME OF THE MEDICINAL PRODUCT Cidomycin Adult 80 mg/2 ml Solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial (2ml) contains Gentamicin Sulphate equivalent to 80 mg Gentamicin base (40mg/ml). For excipients, see 6.1. 3 PHARMACEUTICAL FORM Solution for injection Clear colourless solution in a vial. 4 CLINICAL PARTICULARS 4.1 Therapeutic Indications Gentamicin injection is indicated for the treatment of serious systemic infections including those of the central nervous system due to organisms sensitive to this anti-infective. 4.2 Posology and method of administration ADULTS: Serious infections: If renal function is not impaired, 5mg/kg/daily in divided doses at six or eight hourly intervals. The total daily dose may be subsequently increased or decreased as clinically indicated. Systemic infections: If renal function is not impaired, 3-5mg/kg/day in divided doses according to severity of infection, adjusting according to clinical response and body weight. Urinary tract infections: As “Systemic infections”. Or, if renal function is not impaired, 160mg once daily may be used. Renal Impairment: Gentamicin is excreted by simple glomerular filtration and therefore reduce Read the complete document