Страна: Малайзия
Език: английски
Източник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
MOXIFLOXACIN HCL
MEDISPEC (M) SDN.BHD
MOXIFLOXACIN HCL
1 x 5 Tablets; 1 x 7 Tablets; 1 x10 Tablets; 2 x 7 Tablets; 3 x 10 Tablets; 12 x 10 Tablets; 5 x 10 Tablets
Sunshine Lake Pharma Co., Ltd.
MOXIFLOXACIN HEC 400MG FILM-COATED TABLET Moxifloxacin (400mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What _Moxifloxacin HEC_ is used for 2. How _Moxifloxacin HEC_ works 3. Before you use _Moxifloxacin HEC_ 4. How to use _Moxifloxacin HEC_ 5. While you are using it 6. Side effects 7. Storage and Disposal of _Moxifloxacin HEC_ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT _MOXIFLOXACIN HEC_ IS USED FOR _Moxifloxacin HEC_ is used in patients 18 years of age and older for treatment of bacterial infections caused by bacteria susceptible to moxifloxacin. HOW _MOXIFLOXACIN HEC_ WORKS _Moxifloxacin HEC _ works by killing bacteria that cause infections. BEFORE YOU USE _MOXIFLOXACIN HEC_ - _When you must not use it _ Do not take _Moxifloxacin-HEC_ : If you are allergic to moxifloxacin, any other quinolone antibiotics or any of the other ingredients of this medicine. If you are under 18 years of age. If you have previously had problems with your tendons related to treatment with quinolone antibiotics If you were born with or have any condition with abnormal heart rhythm, a salt imbalance in the blood (especially low levels of potassium in the blood), a very slow heart rhythm, heart failure, a history of abnormal heart rhythms, or you are taking other medicines that result in abnormal ECG changes. If you have a severe liver disease or increased liver enzymes. _ _ _ _ - _Pregnancy and lactation _ Do not take _Moxifloxacin HEC_ if you are pregnant, trying to get pregnant or think you may be pregnant. Do not take _Moxifloxacin HEC_ if you are breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine. _ _ - _Before you start to use it _ Talk to your doctor before taking _Moxifloxacin-HEC_ If you have any heart rhythm conditions. If you suffer from epilepsy or a condition which makes you likely to have convulsions. If you have or have ever had any mental health problems. If you Прочетете целия документ
PRODUCT NAME Moxifloxacin HEC 400 mg film-coated tablets COMPOSITION Each film-coated tablet contains 400 mg moxifloxacin (as hydrochloride monohydrate). DOSAGE FORM Film-coated tablet. PRODUCT DESCRIPTION White or off-white oblonged film-coated tablets, debossed “S9” on one side while blank on the other. PHARMACODYNAMICS Pharmacotherapeutic group: Quinolone antibacterials, fluoroquinolones, ATC code: J01MA14 Mechanism of action _ _ Moxifloxacin is _ _ activity against a wide range of Gram-positive and Gram-negative pathogens. The bactericidal action of moxifloxacin results from the inhibition of both type II topoisomerases (DNA gyrase and topoisomerase IV) required for bacterial DNA replication, transcription and repair. It appears that the C8-methoxy moiety contributes to enhanced activity and lower selection of resistant mutants of Gram-positive bacteria compared to the C8-H moiety. The presence of the bulky bicycloamine substituent at the C-7 position prevents active efflux, associated with the _nor_ A or _pmr_ A genes seen in certain Gram-positive bacteria. Moxifloxacin exhibits a concentration dependent killing rate. Mechanism of resistance Resistance mechanisms that inactivate penicillins, cephalosporins, aminoglycosides, macrolides and tetracyclines do not interfere with the antibacterial activity of moxifloxacin. Other resistance mechanisms such as permeation barriers (common in _Pseudomonas _ _aeruginosa_ ) and efflux mechanisms may also effect susceptibility to moxifloxacin. Moxifloxacin is a poor substrate for active efflux mechanisms in Gram-positive organisms. Moxifloxacin inhibits both topoisomerase II and IV with similar activity in some Gram- positive bacteria, such bacteria may be resistant to other quinolones, but susceptible to moxifloxacin. _ _ Microbiological Susceptibility _ _ The prevalence of acquired resistance may vary geographically and with time for selected species and local information of resistance is desirable, particularly when treating severe infections. As necessary, expert Прочетете целия документ