Šalis: Malaizija
kalba: anglų
Šaltinis: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LEVOFLOXACIN HEMIHYDRATE
Glenmark Pharmaceuticals (Malaysia) Sdn. Bhd.
LEVOFLOXACIN HEMIHYDRATE
5Tablet Tablets
GLENMARK PHARMACEUTICALS LTD
GLEVO TABLETS Levofloxacin Tablets (250mg, 500mg) 1 _Consumer Medication Information Leaflet (RiMUP)_ WHAT IS IN THIS LEAFLET 1. What Glevo is used for 2. How Glevo _ _ works 3. Before you use Glevo 4. How to use Glevo 5. While you are using it 6. Side effects 7. Storage and Disposal of Glevo 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT GLEVO_ _IS USED FOR Glevo is used for the treatment of the following infections: -Acute sinusitis (inflammation of a nasal sinus.) -Acute exacerbation (increase in the severity) of chronic bronchitis -Community-acquired pneumonia -Uncomplicated skin and soft tissue infections -Urinary tract infections including acute pyelonephritis (inflammation of the substance of the kidney) -Chronic bacterial prostatitis (inflammation of the prostate gland) HOW GLEVO_ _WORKS Bactericidal effects of Levofloxacin are induced via inhibition of DCA gyrase activity. BEFORE YOU USE GLEVO_ _ - _When you must not use it _ Do not use this product if you are allergic to any excipients of this product _. _ _ _ _Pregnancy and lactation _ Do not take Glevo if you are pregnant, trying to get pregnant or think you may be pregnant. Do not take Glevo if you are breast- feeding. Ask your doctor or pharmacist for advice before taking any medicine. _ _ _ _ - _Before you start to use it _ - Tell your healthcare providers if you have been diagnosed with an enlargement or “bulge” of a large blood vessel (aortic aneurysm or large vessel peripheral aneurysm). _ _ - Tell your healthcare providers if you _ _ have experienced a previous episode of aortic dissection (a tear in the aorta wall). - Tell your healthcare providers if you have a family history of aortic aneurysm or aortic dissection or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome, or vascular Ehlers- Danlos syndrome, or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behcet´s disease, high blood pressure, or known atheroscleros Perskaitykite visą dokumentą
SAME SIZE ARTWORK LEAFLET SIZE : 264 mm x 186 mm _For the use only of a Registered Medical Practitioner _ _or a Hospital or a Laboratory. _ Levofloxacin Tablets 250 mg / 500 mg TABLETS Glevo 250 / 500 25 mm 25 mm 24 mm PE00000 MY PANTONE BLACK PROCESS C SUPERSEDES ARTWORK CODE PE37786 PANTONE SHADE ICONGRAPHICS CODE: PHARMACODE: SPACE FOR PHARMACODE SPACE FOR PHARMACODE SPACE FOR PHARMACODE SPACE FOR PHARMACODE COMPOSITION : GLEVO 250 TABLETS Each film coated tablet contains: Levofloxacin Hemihydrate equivalent to Levofloxacin 250 mg COLOURS: Red Oxide of Iron & Titanium Dioxide BP DESCRIPTION: Brick red round biconvex film coated tablets with break line on one side. GLEVO 500 TABLETS Each film coated tablet contains: Levofloxacin Hemihydrate equivalent to Levofloxacin 500 mg COLOURS: Red Oxide of Iron, Yellow Oxide of Iron & Titanium Dioxide BP DESCRIPTION: Orange capsule shaped film coated tablets with break line on one side. THERAPEUTIC CLASS : S0610 PHARMACOLOGY MECHANISM OF ACTION : Like Ofloxacin and other fluoroquinolones, bactericidal effects of Levofloxacin are induced via inhibition of DNA gyrase activity. In comparison with racemic Ofloxacin, the activity of Levofloxacin may be more specific for bacterial DNA gyrase than mammalian topoisomerase II. Levofloxacin is reportedly 8 to 128 times more potent than R(+)-ofloxacin (DR-3354), and twice as potent as racemic Ofloxacin. _SPECTRUM OF ANTIBACTERIAL ACTIVITY _ Levofloxacin has been shown to be active against most strains of the following microorganisms both in vitro and in clinical infections: Aerobic gram-positive microorganisms: Enterococcus faecalis, Staphylococcus aureus (methicillin-susceptible), Staphylococcus haemolyticus (methicillin-susceptible), Staphylococcus saprophyticus, Streptococcus pneumoniae (including penicillin-resistant strains), Streptococcus pyogenes, and Streptococci (Groups C and G). Intermediate susceptibility: Staphylococcus haemolyticus (methicillin-resistant). Aerobic gram-negative microorganisms: Enterobacter cloacae, Esch Perskaitykite visą dokumentą