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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 ampoule (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 easy open ampoules.
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 reduced dosage is necessary
where renal function is impaired. Nomograms are available for the calculation of dose, which depends on the patient’s
age, weight and renal function. The following table may be useful when treating adults.
The recommended dose and precautions for intramuscular and intravenous administration are identical. Gentamicin
when given intravenously should be injected directly into a vein or into the drip set tubing over no less than three
minutes. If administered by infusion, this should be over no longer than 20 m
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