In vitro, moxifloxacin revealed cardiac electrophysiological properties that can cause prolongation of the QT interval, even though at high concentrations.

After intravenous administration of moxifloxacin to dogs (30 mg/kg infused over 15, 30 or 60 minutes) the degree of QT prolongation was clearly depending on the infusion rate, i.e. the shorter the infusion time the more pronounced the prolongation of the QT interval. No prolongation of the QT interval was seen when a dose of 30 mg/kg was infused over 60 minutes.

Reproductive studies performed in rats, rabbits and monkeys indicate that placental transfer of moxifloxacin occurs. Studies in rats (p.o. and i.v.) and monkeys (p.o.) did not show evidence of teratogenicity or impairment of fertility following administration of moxifloxacin. A slightly increased incidence of vertebral and rib malformations was observed in foetuses of rabbits but only at a dose (20 mg/kg i.v.) which was associated with severe maternal toxicity. There was an increase in the incidence of abortions in monkeys and rabbits at human therapeutic plasma concentrations.

Quinolones, including moxifloxacin, are known to cause lesions in the cartilage of the major diarthrodial joints in immature animals.

6. Pharmaceutical particulars
6.1 List of excipients
Sodium chloride

Hydrochloric acid (for pH-adjustment)

Sodium hydroxide (for pH-adjustment)

Water for injections

6.2 Incompatibilities
The following solutions are incompatible with moxifloxacin solution for infusion:

Sodium chloride 10% and 20% solutions

Sodium bicarbonate 4.2% and 8.4% solutions

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

6.3 Shelf life

Polyolefine bag:  3 years 
Glass bottle:  5 years 

Use immediately after first opening and/or dilution.

6.4 Special precautions for storage
Do not store below 15°C.

6.5 Nature and contents of container
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.

6.6 Special precautions for disposal and other handling
This product is for single use only. Any unused solution should be discarded.

The following co-infusions were found to be compatible with moxifloxacin 400 mg solution for infusion:

Water for injections, Sodium chloride 0.9%, Sodium chloride 1 molar, Glucose 5%/10%/40%, Xylitol 20%, Ringer's solution, Compound Sodium Lactate Solution (Hartmann's Solution, Ringer-Lactate Solution).

Moxifloxacin solution for infusion should not be co-infused with other drugs.

Do not use if there are any visible particulate matter or if the solution is cloudy.

At cool storage temperatures precipitation may occur, which will re-dissolve at room temperature. It is therefore recommended not to store the infusion solution below 15°C.

7. Marketing authorisation holder
Bayer plc, Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA, United Kingdom.

8. Marketing authorisation number(s)
PL 00010/0613

9. Date of first authorisation/renewal of the auth