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CLINDAMYCIN Solution for Injection or Infusion (2018)

Active ingredients: Clindamycin

Product Name and Form

Clindamycin 150mg/ml Solution for Injection or Infusion.

Pharmaceutical form

Solution for Injection or Infusion.

Clear, colourless, solution.

Qualitative and Quantitative Composition

Each 1ml of solution contains clindamycin phosphate equivalent to 150mg clindamycin.

Each 2ml ampoule contains 300mg clindamycin.

Each 4ml ampoule contains 600mg clindamycin.

Excipients: Sodium 6.57mg per ml (prior to dilution).

For a full list of excipients, see section 6.1.

Chemical substance
Description
Clindamycin

Clindamycin is a lincosamide antibiotic with a primarily bacteriostatic action against Gram-positive aerobes and a wide range of anaerobic bacteria. Lincosamides such as clindamycin bind to the 50S subunit of the bacterial ribosome and inhibit the early stages of protein synthesis.

List of excipients

Disodium edetate
Sodium hydroxide (for pH adjustment)
Water for injections

Pack sizes and Marketing

Type 1 flint glass ampoule containing 2ml or 4ml sterile, aqueous solution, packed in cardboard carton, together with a leaflet. 1 or 5 ampoules in each pack.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

Focus Pharmaceuticals Ltd, Capital House, 85 King William Street, London, EC4N 7BL, United Kingdom

11/01/2010

Marketing authorization number:

PL 20046/0072