Country: Malasía
Tungumál: enska
Heimild: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LEVOFLOXACIN HEMIHYDRATE
IMEKS PHARMA SDN. BHD.
LEVOFLOXACIN HEMIHYDRATE
50Tablet Tablets; 100Tablet Tablets; 500Tablet Tablets; 30Tablet Tablets
T.O. CHEMICALS (1979) LTD.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ OLFOVEL 500 ® TABLET Levofloxacin hemihydrate (512.5mg) _ _ 1 WHAT IS IN THE LEAFLET 1. What Olfovel is used for 2. How Olfovel works 3. Before you use Olfovel 4. How to use Olfovel 5. While you are using it 6. Side effects 7. Storage and Disposal of Olfovel 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT OLFOVEL IS USED FOR Olfolvel is used to treat: • Pneumonia (inflammation of the lung) • Acute exacerbation of chronic bronchitis (breathing difficulty due to airway narrowing) • Acute sinusitis (inflammation of sinus) • Skin and skin structure infections • Chronic bacterial prostatitis (recurring infections in the prostate) • Acute pyelonephritis (sudden and severe kidney infection) • Urinary tract infection HOW OLFOVEL WORKS Levofloxacin is an antimicrobial agent. It inhibits the enzymes that required for growth of microorganisms. It is active against many microorganisms. BEFORE YOU USE OLFOVEL_ _ _ _ - _When you must not use it_ Do not take Olfolvel, if you: • Are allergic to levofloxacin, any other quinolone antibiotic or any of the other ingredients of this medicine • Have ever had epilepsy • Have ever had a problem with your tendons such as tendonitis that was related to treatment with a ‘quinolone antibiotic’. • Are a child or a growing teenager • Are pregnant, might become pregnant or think you may be pregnant • Are breast-feeding - _Before you start to use it _ Talk to your doctor or pharmacist if you • Are 60 years old or older • Are using corticosteroids • Have ever had a fit (seizure) • Have kidney problems • Have something known as ‘glucose-6- phosphate dehydrogenase deficiency’ • Have ever had mental health problems • Are diabetic • Have ever had liver problems • Have myasthenia gravis • Are born with or have family history of abnormal heart rate • Have salt imbalance in the blood (low level of potassium or magnesium in the blood) • Have a hist Lestu allt skjalið
CONTENTS Each tablet contains Levofloxacin Hemihydrate 512.5 mg equivalent to Levofloxacin 500.0 mg DESCRIPTION Pale orange, long round biconvex film coated tablets with bisec-line and letter B, L on one side and figure 500 on the other side. PHARMACODYNAMICS Levofloxacin is a broad spectrum quinolone antimicrobial agent. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone with the pure (-)-(S)- enantiomer of the racemic drug substance ofloxacin. The mechanism of action of levofloxacin involves inhibition of DNA gyrase and bacterial topoisomerase IV. Both of the enzymes are grouped as type II topoisomerases that required for DNA replication, transcription, repair and recombination. IN VITRO ANTIMICROBIAL ACTIVITY Levofloxacin is often bactericidal at concentration equal to or slightly greater than inhibitory concentration. It has also been shown to be active against most strains of the following microorganisms: Aerobic gram-positive microorganisms Enterococcus faecalis (many strains are only moderately susceptible), _Staphylococcus _ _aureus_ (methicilin-susceptible strains), Staphylococcus coagulase negative (methicilin-susceptible strains), _ Staphylococcus epidermidis_ (methicilin-susceptible strains), _Staphylococcus _ _saprophyticus_, _Streptococcus _ _pneumoniae_ (including multi-drug resistant strains [MDRSP]*), _Streptococcus _ _pyogenes_, _Streptococcus_ _agalactiae_ . *MDRSP (Multi-drug resistant _ Streptococcus pneumoniae_) isolates are strains resistant to two or more of the following antibiotics: penicillin (MIC=2µg/ml), 2 nd generation cephalosporins, e.g., cefuroxime, macrolides, tetracyclines and trimethoprim / sulfamethoxazole. Aerobic gram-negative microorganisms _Enterobacter _ _cloacae_, _Enterobacter _ _aerogenes_, _Enterobacter _ _agglomerans_, _Escherichia coli_, _ Haemophilus influenza_, _ Haemophilus parainfluenzae_, _ Klebsiella _ _pneumonia_, _ Klebsiella oxytoca_, _ Legionella pneumophila_, _ Moraxella catarrhalis_, _Proteus _ _mirabilis_, _Proteus _ _vulgaris_, _Providenc Lestu allt skjalið