CIPROFLOXACIN Solution for infusion

Active ingredients: Ciprofloxacin

Product name and form

Ciprofloxacin 2mg/ml solution for infusion.

Pharmaceutical Form

Solution for infusion.

Clear, colourless solution.

Qualitative and quantitative composition

Each bag contains 2 mg/ml ciprofloxacin (as lactate).

The 50 ml bag contains 100 mg ciprofloxacin (as lactate).

The 100 ml bag contains 200 mg ciprofloxacin (as lactate).

The 200 ml bag contains 400 mg ciprofloxacin (as lactate).

Excipients:

50 ml bag: The sodium chloride content is 450 mg (7.7 mmol).

100 ml bag: The sodium chloride content is 900 mg (15.4 mmol).

200 ml bag: The sodium chloride content is 1800 mg (30.8 mmol).

For a full list of excipients, see section 6.1.

Active Ingredient
Description

Ciprofloxacin is a fluoroquinolone antibacterial agent. The bactericidal action of ciprofloxacin results from the inhibition of both type II topoisomerase (DNA-gyrase) and topoisomerase IV, required for bacterial DNA replication, transcription, repair and recombination.

List of Excipients

Lactic acid solution
Sodium chloride
Water for injection

Pack sizes and marketing

50ml, 100ml or 200ml PVC bag contained in a polypropylene/polyester- aluminium/polyester pouch. Pack sizes of 5 or 10 bags.

Marketing authorization holder

Villerton Invest SA, Rue Edward Steichen 14, 2540 Luxembourg

Marketing authorization dates and numbers

PL 24780/0001

07/01/2009