1. Name of the medicinal product
Avelox 400 mg/250 ml solution for infusion

2. 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 34 mmol sodium.

For the full list of excipients, see section 6.1.

3. Pharmaceutical form
Solution for infusion

250 ml glass bottle or 250 ml polyolefine flexible bag filled with minimum 250 ml clear, yellow solution.

4. Clinical particulars
4.1 Therapeutic indications
Avelox is indicated for the treatment of:

- Community acquired pneumonia (CAP)

- Complicated skin and skin structure infections (cSSSI)

Moxifloxacin should be used only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of these infections.

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

4.2 Posology and method of administration
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 section 4.3).

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).

4.3 Contraindications
- Hypersensitivity to moxifloxacin, other quinolones or to any of the excipients listed in section 6.1.

- Pregnancy and lactation (see section 4.6).

- Patients below 18 years of age.

- Patients with a history of tendon disease/disorder related to quinolone treatment.

Both in preclinical investigations and in humans, changes in cardiac electrophysiology have been observed following exposure to moxifloxacin, in the form of QT prolongation. For reasons of drug safety, moxifloxacin is therefore contraindicated in patients with:

- Congenital or documented acquired QT prolongation

- Electrolyte disturbances, particularly in uncorrected hypokalaemia

- Clinically relevant bradycardia

- Clinically relevant heart failure with reduced left-ventricular ejection fraction

- Previous history of symptomatic arrhythmias

Moxifloxacin should not be used concurrently with other drugs t