Krajina: Malajzia
Jazyk: angličtina
Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
MOXIFLOXACIN HCL
Duopharma Marketing Sdn. Bhd.
MOXIFLOXACIN HCL
1x5 Tablets; 2x5 Tablets
DUOPHARMA MANUFACTURING (BANGI) SDN BHD
FLONOXIN 400MG TABLET Moxifloxacin (400mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What Flonoxin is used for 2. How Flonoxin works 3. Before you use Flonoxin 4. How to use Flonoxin 5. While you are using it 6. Side effects 7. Storage and Disposal of Flonoxin 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT FLONOXIN IS USED FOR Flonoxin is used in patients aged 18 years and above to treat infections caused by certain bacteria which include: • Infections of the sinuses. • Sudden worsening of long-term inflammation of the airways • Infection of the lower respiratory tract (pneumonia) acquired outside hospital. • Mild to moderate infections of the female upper genital tract (pelvic inflammatory disease), including infections of the fallopian tubes and uterus mucous membrane. Flonoxin is not sufficient on its own for treating this kind of infection hence another antibiotic in addition to Flonoxin should be prescribed by your doctor for treatment of these infections. • Infection of the skin, soft tissue and infection occurring within the abdomen. HOW MAXIFLOXACIN WORKS Flonoxin works by killing bacteria that cause infections. BEFORE YOU USE FLONOXIN - _When you must not take it _ Do not take this medicine • If you have an allergy to Flonoxin, other quinolone antibiotics or any of the other ingredients listed at the end of this leaflet • If you are pregnant or breast-feeding • If you are under 18 years of age • If you previously had problems with your tendons related to treatment with quinolone antibiotics • If you are born with or have - Any condition with abnormal heart rhythm (as in ECG) - Salt imbalance in the blood (especially low levels of potassium in the blood) - A very slow heart rhythm (bradycardia) - A weak heart (heart failure) - A history of abnormal heart rhythms or if you are taking other medicines that result in abnormal ECG changes. • If you have severe liver disease or increased liver enzymes (t Prečítajte si celý dokument
DESCRIPTION: FLONOXIN 400MG TABLET: Dull red, 17 mm oblong shaped, plain on both sides, film-coated tablet. COMPOSITION: Each film coated tablet contains 400 mg Moxifloxacin. PHARMACODYNAMICS: Moxifloxacin is a DNA gyrase inhibitor and also inhibits topoisomerase IV. DNA gyrase (topoisomerase II) is an essential bacterial enzyme that maintains the superhelical structure of DNA. DNA gyrase is required for DNA replication and transcription, DNA repair, recombination and transposition; inhibition is bactericidal. PHARMACOKINETICS: Moxifloxacin is well-absorbed with a bioavailability of 90%. Its absorption is not affected by high-fat meal or yogurt. The volume of distribution is approximately 1.7-2.7 L/kg with tissue concentration often exceeding plasma concentrations in respiratory tissues, alveolar macrophages, abdominal tissues/ fluids, uterine tissue (endometrium, myometrium), and sinus tissues. Moxifloxacin is approximately 30-50% bound to proteins. 52% of the dose is hepatically metabolised via glucuronide and sulfate conjugation. The half-life elimination of a single oral dose is 12-16 hours. Moxifloxacin is excreted via urine (as unchanged druged and glucuronide conjugates) and feces (as unchanged drug and sulfate conjugates). INDICATIONS: Moxifloxacin tablets are indicated for treatment of adults (≥18 years of age) with the following bacterial infections caused by susceptible strains: • Acute bacterial rhinosinusitis* • Acute exacerbations of chronic obstructive pulmonary disease including chronic bronchitis* •Nosocomial pneumonia/Hospital-acquired pneumonia* •Acute otitis media* •External otitis* •Endocarditis* •Infection of cerebrospinal fluid* •Meningitis* •Septicaemia* •Uncomplicated acute cystitis / uncomplicated cystitis* •Prevention of exacerbations in women with recurring urinary tract infections* •Prevention of infection in surgical procedures in the urogenital system*,# •Pre-operative preparations for chronic cholesteatomatous otitis and chronic otitis spreading to bone* Prečítajte si celý dokument