AVELOX Solution for infusion Ref.[7000] Active ingredients: Moxifloxacin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Bayer plc, 400 South Oak Way, Reading RG2 6AD

Product name and form

Avelox 400 mg/250 ml solution for infusion.

Pharmaceutical Form

Solution for infusion.

Clear, yellow solution.

Qualitative and quantitative composition

1 bottle or 1 bag of 250 ml contains 400 mg moxifloxacin (as hydrochloride).

1 ml contains 1.6 mg moxifloxacin (as hydrochloride).

Excipient with known effect: 250 ml of solution for infusion contains 787mg (34 mmol) sodium.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Moxifloxacin

Moxifloxacin, a fourth-generation fluoroquinolone, has in vitro activity against a wide range of Gram-positive and Gram-negative pathogens. The bactericidal action of moxifloxacin results from the inhibition of both type II topoisomerases (DNA gyrase and topoisomerase IV) required for bacterial DNA replication, transcription and repair.
List of Excipients

Sodium chloride
Hydrochloric acid 1N (for pH-adjustment)
Sodium hydroxide solution 2N (for pH-adjustment)
Water for injections

Pack sizes and marketing

Polyolefine bags with polypropylene port sealed in aluminium foil overwrap. 250 ml pack available in cartons of 5 and 12 bags.

Colourless glass bottles (type 2) with a chlorobutyl or bromobutyl rubber stopper as closure. The 250 ml bottle is available in packs of 1 bottle and in multipacks containing 5 bottles (5 packs of 1 bottle).

Not all pack sizes may be marketed.

Marketing authorization holder

Bayer plc, 400 South Oak Way, Reading RG2 6AD

Marketing authorization dates and numbers

PL 00010/0613

First authorisation: 12th November 2009

Drugs

Drug Countries
AVELOX Austria, Cyprus, Ecuador, Estonia, Finland, Hong Kong, Ireland, Japan, Lithuania, Malta, Mexico, Nigeria, New Zealand, Romania, Singapore, Turkey, United Kingdom
 
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