Страна: Малайзія
мова: англійська
Джерело: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
MOXIFLOXACIN HCL
BAYER CO. (MALAYSIA) SDN. BHD.
MOXIFLOXACIN HCL
5Tablet Tablets
BAYER HEALTHCARE MANUFACTURING S.R.L
AVELOX ® Moxifloxacin (400 mg film-coated tablets) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What _Avelox_ is used for 2. How _Avelox_ works 3. Before you use _Avelox_ 4. How to use _Avelox_ 5. While you are using it 6. Side effects 7. Storage and Disposal of _Avelox_ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial Number WHAT _AVELOX_ IS USED FOR Avelox is used for treating the following bacterial infections when caused by bacteria against which moxifloxacin is active: - Infections of the respiratory tract: Sudden worsening of long term inflammation of the airways (chronic bronchitis), infection of the lungs (pneumonia) acquired outside the hospital, or acute infection of the sinuses - Mild to moderate infections of the female upper genital tract (pelvic inflammatory disease), including infections of the fallopian tubes and infections of the uterus mucous membrane. - Severe infections of the skin and associated soft tissues (e.g. major abscesses, infected burns and ulcers, infected bite wounds, diabetic foot infections) - Severe infections of the abdominal cavity such as abscesses HOW _AVELOX_ WORKS Avelox contains the active substance moxifloxacin which belongs to a group of antibiotics called fluoroquinolones. Avelox works by killing bacteria that cause infections. BEFORE YOU USE _AVELOX _ - When you must not use it DO NOT TAKE _AVELOX_ - If you are allergic to the active substance moxifloxacin, any other quinolone antibiotics or any of the other ingredients of this medicine - If you are pregnant or breast- feeding. DO NOT TAKE AVELOX AND TELL YOUR DOCTOR if any of these apply to you. - Before you start to use it You should not take fluoroquinolone antibacterial medicines, including Avelox, if you have experienced any serious adverse reaction in the past when taking a fluoroquinolone (see section Things to be careful of and Side effects). In this situation, you should inform your healthcare providers as soon as possibl Прочитайте повний документ
Reference : Moxifloxacin/ Film-coated Tablets / Solution for Infusion / CCDS / Version 23 /January 2021 AVELOX ® NAME OF THE MEDICINAL PRODUCT Avelox 400 mg film-coated tablets Avelox 400 mg solution for infusion QUALITATIVE AND QUANTITATIVE COMPOSITION Film-coated tablet 1 film-coated tablet contains 400 mg moxifloxacin (as hydrochloride). Solution for infusion 1 bottle or bag contains 250 mL solution for infusion containing 400 mg moxifloxacin (as hydrochloride). PHARMACEUTICAL FORM Film-coated tablet Dull red film-coated tablet with an oblong, convex shape with facet, a dimension of 17x7 mm with 10 mm radius of curvature and a weight of 693.8-699.8mg.“Bayer”on one side and “M 400” on the other side. Dull red film-coated tablet with an oblong, convex shape with facet, a dimension of 17x7 mm with 10 mm radius of curvature and a weight of 693.8-699.8mg.“blanc”on one side and “M 400” on the other side. Solution for infusion 250 mL polyolefine flexible bag filled with minimum 250 mL clear, yellow solution. 250 mL glass bottle with clear, yellow solution filled with minimum 250 mL. INDICATIONS Avelox tablets are indicated for the treatment of adults (> 18 years of age) with the following bacterial infections caused by susceptible strains: • Acute sinusitis • Acute exacerbations of chronic bronchitis _ _ • Community acquired pneumonia • Mild to moderately severe inflammatory pelvic diseases (i.e. Infections of the upper female genital tract, including salpingitis and endometritis), without an associated tubo-ovarian or pelvic abscess. Avelox 400 mg film-coated tablets are not recommended for monotherapy of mild to moderately severe inflammatory pelvic diseases. Preferably, they should be administered in combination with another suited antibiotic (such as cephalosporin), due to the increasing resistance of _Neisseria gonorrhoeae_ to Reference : Moxifloxacin/ Film-coated Tablets / Solution for Infusion / CCDS / Version 23 /January 2021 moxifloxacin; that is, unless moxifloxacin-resistant _Neiss Прочитайте повний документ