AVELOX SOLUTION FOR INFUSION 400 mg/250 ml

BAYER (SOUTH EAST ASIA) PTE LTD

BAYER (SOUTH EAST ASIA) PTE LTD

Therapeutic

Prescription Only

INJECTION

**4.2 Dosage and method of administration** **4.2.1 Method of administration** Solution for Infusion: The infusion solution should be infused intravenously over 60 minutes. The solution for infusion can be administered directly or via a T-tube together with compatible infusion solutions. The following coinfusions were found to form stable mixtures over a period of 24 hours at room temperature with Avelox infusion solution, and can therefore be considered as compatible with Avelox solution for infusion: - Water for Injections - Sodium Chloride 0.9% - Sodium Chloride 1 molar - Glucose 5% - Glucose 10% - Glucose 40% - Xylitol 20% - Ringer’s Solution - Lactated Ringer’s Solution If Avelox infusion solution is to be given with another drug, each drug should be given separately (see “Pharmaceutical Particulars, Incompatibilities” – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Only clear solutions are to be used. **4.2.2 Dosage regimen** **Dose (adults):** The recommended dose for Avelox is 400 mg once-daily (250 mL solution for infusion) for the above-mentioned indication and should not be exceeded. **Duration of treatment:** The duration of treatment should be determined by the severity of the indication or clinical response. The following general recommendations for the treatment of upper and lower respiratory tract infections and skin infections are made: Therapy may be initial intravenous administration, followed by oral administration of film-coated tablets. When switching from intravenous to oral dosage administration, no dosage adjustment is necessary. Patients whose therapy is started with Avelox IV may be switched to Avelox Tablets when clinically indicated at the discretion of the physician. Pneumonia: community acquired pneumonia: The recommended total treatment duration for sequential administration (intravenous followed by oral) is 7–14 days. Complicated skin and skin structure infections total treatment duration for sequential therapy (intravenous followed by oral therapy), 7 – 21 days. The recommended duration of treatment for the indication being treated should not be exceeded. Avelox 400 mg film-coated tablets and Avelox 400 mg solution for infusion have been studied in clinical trials for up to 21 days (in complicated skin and skin structure infections). **4.2.3 Missed dose** If a dose is missed it should be taken anytime but not later than 8 hours prior to the next scheduled dose. If less than 8 hours remain before the next dose, the missed dose should not be taken and treatment should be continued as prescribed with the next scheduled dose. Double doses should not be taken to compensate for a missed dose. **4.2.4 Additional information on special populations** **4.2.4.1 Children and adolescents** Efficacy and safety of Avelox in children and adolescents have not been established (see “Contraindications”). **4.2.4.2 Geriatric patients** No adjustment of dosage is required in elderly. **4.2.4.3 Ethnic differences** No adjustment of dosage is required in ethnic groups. **4.2.4.4 Patients with hepatic impairment** No dosage adjustment is required in patients with mild or moderate impaired liver function. The use of moxifloxacin is not recommended in patients with severe hepatic impairment (Child Pugh C) (see “Special warnings and precautions for use” in Child Pugh C patients – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **4.2.4.5 Patients with renal impairment** No dose adjustment is required in patients with any degree of renal impairment (including creatinine clearance ≤ 30 mL/min/1.73m2) and in patients on chronic dialysis i.e. haemodialysis and continuous ambulatory peritoneal dialysis.