Source: Health Products Regulatory Authority (IE) Revision Year: 2025 Publisher: Fresenius Kabi Deutschland GmbH, Else-Kroener Strasse 1, Bad Homburg v.d.H 61352, Germany
Moxifloxacin 400 mg/250 ml Solution for Infusion, KabiPac bottles.
| Pharmaceutical Form |
|---|
|
Solution for infusion. Clear yellow solution. pH of solution is between 5.0 and 6.0. Osmolality of solution: 260–330 mOsm. |
Each bottle of 250 ml contains 400 mg moxifloxacin (as hydrochloride).
Each ml contains 1.6 mg moxifloxacin (as hydrochloride).
Excipient with known effect:
250 ml of solution for infusion contains 54.4 mmol sodium.
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
|
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 acetate trihydrate |
Moxifloxacin is packed in:
Low-density polyethylene bottles (KabiPac) as primary packaging closed with a cap containing a rubber disc to allow insertion of the needle.
Pack sizes:
Polyethylene bottle (KabiPac): 1, 10, 20, 25 and 40.
Not all pack sizes may be marketed.
Fresenius Kabi Deutschland GmbH, Else-Kroener Strasse 1, Bad Homburg v.d.H 61352, Germany
PA2059/013/001
Date of first authorisation: 17th January 2014
Date of last renewal: 27th November 2018
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