Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Ibigen S.r.l., Via Fossignano, 2, 04011 Aprilia (LT), Italy
Levofloxacin Ibigen 5 mg/ml solution for infusion.
| Pharmaceutical Form |
|---|
|
Solution for infusion. Clear greenish-yellow isotonic solution. |
Each 50 ml vial (5 mg/ml solution) contains 250 mg of levofloxacin as levofloxacin hemihydrate.
Each 100 ml vial (5 mg/ml solution) contains 500 mg of levofloxacin as levofloxacin hemihydrate.
Excipients with known effect:
50 ml of solution for infusion contain 7.7 mmol (177 mg) sodium.
100 ml of solution for infusion contain 15.4 mmol (354 mg) sodium.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Levofloxacin |
Levofloxacin is a synthetic antibacterial agent of the fluoroquinolone class. As a fluoroquinolone antibacterial agent, levofloxacin acts on the DNA – DNA-gyrase complex and topoisomerase IV. |
| List of Excipients |
|---|
|
Sodium chloride |
50ml, type 1 glass vial with flanged aluminium cap and bromobutyl rubber stopper.
Each vial contains 50 ml solution for infusion. Pack sizes of 1 and 10 vials.
100ml, type 1 glass vial with flanged aluminium cap and bromobutyl rubber stopper.
Each vial contains 100 ml solution for infusion. Pack sizes of 1 and 10 vials.
Not all pack sizes may be marketed.
Ibigen S.r.l., Via Fossignano, 2, 04011 Aprilia (LT), Italy
PL 31745/0012
20/01/2012
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