Country: Malasja
Lingwa: Ingliż
Sors: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Gemifloxacin Mesylate
PAHANG PHARMACY SDN. BHD.
Gemifloxacin Mesylate
5tablet Tablets; 7tablet Tablets
LG CHEM LTD
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ FACTIVE FILM-COATED TABLET _GEMIFLOXACIN MESYLATE (320 MG) _ 1 Confidential ⓒ 2023 LG Chem, Ltd. All rights reserved. WHAT IS IN THIS LEAFLET 1. What FACTIVE is used for 2. How FACTIVE works 3. Before you use FACTIVE 4. How to use FACTIVE 5. While you are using it 6. Side effects 7. Storage and Disposal of FACTIVE 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT FACTIVE IS USED FOR FACTIVE is a fluoroquinolone antibiotic medicine used to treat certain infections caused by certain germs called bacteria in adults 18 years or older. HOW FACTIVE WORKS FACTIVE works by inhibiting topoisomerase IV and topoisomerase II (DNA gyrase) enzymes that are involved in the uncoiling and supercoiling of DNA during replication. BEFORE YOU USE FACTIVE - _When you must not use it_ _ _ _DO NOT TAKE FACTIVE_ _IF YOU_: - have ever had a severe allergic reaction to an antibiotic known as a fluoroquinolone, or are allergic to any of the ingredients in FACTIVE (listed in Product Description) - are PREGNANT OR PLANNING to become pregnant - are breast-feeding or planning to breast-feed - are children or adolescents, less than 18 years of age - have a history of fluoroquinolone- associated tendonitis and tendon rupture - _Before you start to use it_ _ _ Tell your healthcare provider about all your medical conditions, including if you: - have tendon problems - have a disease that causes muscle weakness (myasthenia gravis) - have tendon problems have central nervous system problems (such as epilepsy) - have nerve problems - have or anyone in your family has an irregular heartbeat, especially a condition called “QT prolongation” - have been diagnosed with an enlargement or “bulge” of a large blood vessel (aortic aneurysm or large vessel peripheral aneurysm). - have experienced a previous episode of aortic dissection (a tear in the aorta wall). - have a family history of aortic aneurysm or aortic dissection or other risk factors or predis Aqra d-dokument sħiħ
FACTIVE ® 320MG GEMIFLOXACIN MESYLATE FILM-COATED TABLET _PACKAGE INSERT _ 1/20 ⓒ 2023 LG Chem, Ltd. All rights reserved. 1. NAME OF THE MEDICINAL PRODUCT Factive F ilm-coated tablet 320 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains gemifloxacin mesylate equivalent to 320 mg gemifloxacin. 3. PHARMACEUTICAL FORM A white to off-white oval-shaped film-coated tablet with breaklines on both faces debossed with LG 320 on both faces. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Consideration should be given to official guidance on the appropriate use of antibacterial agents. Factive is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below. COMMUNITY-ACQUIRED PNEUMONIA (of mild to moderate severity) caused by _ Streptococcus _ _pneumoniae_ (including multi-drug resistant strains [MDRSP])*, _ Haemophilus influenzae, _ _Moraxella _ _catarrhalis, _ _Mycoplasma _ _pneumoniae, _ _Chlamydia _ _pneumonia, _ _or _ _Klebsiella _ _pneumonia. _ *MDRSP: multi-drug resistant _Streptococcus _ _pneumoniae,_ includes isolates previously known as PRSP (penicillin resistant _ Streptococcus pneumonia_), and_ _ are strains resistant to two or more of the following antibiotics: penicillin (MIC ≥ 2 ㎍ /mL), 2 nd generation cephalosporins (e.g., cefuroxime), macrolides, tetracyclines and trimethoprim/sulfamethoxazole. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Factive and other antibacterial drugs, Factive should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy, In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. 4.2 DOSAGE AND ADMINISTRATION Factive can be taken with or without food and should be swallowed whole with a l Aqra d-dokument sħiħ