MOXIFLOXACIN Solution for infusion Ref.[116545] Active ingredients: Moxifloxacin

Posology

The recommended dose is 400 mg moxifloxacin, infused once daily.

Initial intravenous treatment may be followed by oral treatment with moxifloxacin 400 mg tablets, when clinically indicated.

In clinical studies most patients switched to oral therapy within 4 days (CAP) or 6 days (cSSSI). The recommended total duration of intravenous and oral treatment is 7-14 days for CAP and 7-21 days for cSSSI.

Renal/hepatic impairment

No adjustment of dosage is required in patients with mild to severely impaired renal function or in patients on chronic dialysis i.e. haemodialysis and continuous ambulatory peritoneal dialysis (see section 5.2 for more details).

There is insufficient data in patients with impaired liver function (see section 4.3).

Other special populations

No adjustment of dosage is required in the elderly and in patients with low bodyweight.

Paediatric population

Moxifloxacin is contraindicated in children and growing adolescents. Efficacy and safety of moxifloxacin in children and adolescents have not been established (see sections 4.3, 4.4 and 5.3).

Method of administration

For intravenous use; constant infusion over 60 minutes (see also section 4.4).

If medically indicated the solution for infusion can be administered via a T-tube, together with compatible infusion solutions (see section 6.6).

No specific countermeasures after accidental overdose are recommended. In the event of overdose, symptomatic treatment should be implemented. ECG monitoring should be undertaken, because of the possibility of QT interval prolongation. Concomitant administration of charcoal with a dose of 400 mg oral or intravenous moxifloxacin will reduce systemic availability of the drug by more than 80% or 20% respectively. The use of charcoal early during absorption may be useful to prevent excessive increase in the systemic exposure to moxifloxacin in cases of oral overdose.

3 years.

Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C.

From a microbiological point of view, unless the method of opening/reconstitution/dilution precludes the risk of microbial contamination, the product should be used immediately.

If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

Do not refrigerate or freeze.

Keep the bottle in the outer carton in order to protect from light.

For storage conditions of the opened/diluted medicinal product, see section 6.3.

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.

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/250 ml solution for infusion:

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

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

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 8°C.