מדינה: מלטה
שפה: אנגלית
מקור: Medicines Authority
MOXIFLOXACIN
Bayer Limited 1st Floor The Grange Offices The Grange Brewery Road Stillorgan Co. Dublin, A94 H2K7 , Ireland
J01MA14
MOXIFLOXACIN 400 mg
SOLUTION FOR INFUSION
MOXIFLOXACIN 400 mg
POM
ANTIBACTERIALS FOR SYSTEMIC USE
Withdrawn
2010-08-05
BP22036_REC30610 1 PACKAGE LEAFLET: INFORMATION FOR THE USER AVELOX 400 MG/250 ML SOLUTION FOR INFUSION For use in adults. Moxifloxacin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor, pharmacist or nurse. • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Avelox is and what it is used for 2. What you need to know before you are administered Avelox 3. How to use Avelox 4. Possible side effects 5. How to store Avelox 6. Contents of the pack and other information 1. WHAT AVELOX IS AND WHAT IT IS USED FOR Avelox contains the active substance moxifloxacin which belongs to a group of antibiotics called fluoroquinolones. Avelox works by killing bacteria that cause infections if they are caused by bacteria that are susceptible to moxifloxacin. Avelox is used in adults for treating the following bacterial infections: • Infection of the lungs (pneumonia) acquired outside the hospital • Infections of the skin and soft tissue 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE ADMINISTERED AVELOX Contact your doctor if you are not sure if you belong to a patient group described below. DO NOT USE AVELOX • If you are allergic to the active substance moxifloxacin, any other quinolone antibiotics or any of the other ingredients of this medicine (listed in section 6). • If you are pregnant or breast-feeding. • If you are under 18 years of age. • If you have a history of tendon disease or disorder which was related to treatment with quinolone antibiotics (see sections _Warnings and precautions _ and _ 4. Possible side effects_ ). • If you were born with or have had any condition with abnormal heart rhythm (seen on ECG, electrical recording of the heart), have salt imbalance in the blood (especially low level of קרא את המסמך השלם
Page 1 of 15 BP22036_REC30610 1. NAME OF THE MEDICINAL PRODUCT Avelox 400 mg/250 ml solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 bottle 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 787 mg (34 mmol) sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for infusion 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 s קרא את המסמך השלם