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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dalacin C Phosphate 150 mg/ml Concentrate for Solution for Infusion or Solution for Injection, 4ml
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains clindamycin phosphate equivalent to 150 mg clindamycin giving 600 mg clindamycin per
ampoule.
Excipient:
Benzyl alcohol
9 mg/ml
For full list of excipients, _see section 6.1._
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion or solution for injection
Clear, colourless, sterile solution with a pH of 5.5-7.0
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the management of serious infections due to organisms susceptible to this anti-infective.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Parenteral (IM or IV Administration). Dalacin C Phosphate MUST be diluted prior to IV administration and should be
infused over at least 10-60 minutes.
_Adults including the elderly:_
The usual daily adult dosage of Dalacin C Phosphate for infections of the intra-abdomial area, female pelvis, and other
complicated or serious infections is 1800-2700 mg given in 2, 3, or 4 equal doses. Less complicated infections due to
more susceptible microorganisms may respond to lower doses such as 1200-1800 mg/day administered in 3 or 4 equal
doses. Doses of up to 4800 mg daily have been used successfully.
Single IM injections of greater than 600 mg are not recommended nor is administration of more than 1.2 g in a single
one-hour infusion.
Alternatively, the drug may be administered in the form of a single rapid infusion of the first dose followed by
continuous IV Infusion.
_Children (over 1 month of age)_: Serious infections: 15-25 mg/kg/day in three or four equal doses.
More severe infections: 25-40 mg/kg/day in three or four equal doses. In severe
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