국가: 말레이시아
언어: 영어
출처: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CLARITHROMYCIN
KOMEDIC SDN BHD
CLARITHROMYCIN
14 Tablets; 700 Tablets; 98 Tablets
MEDOCHEMIE (FAR EAST) LTD - ORAL FACILITY
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ KLERIMED TABLET Clarithromycin (250mg, 500mg) ________________________________________________________________________________________________ 1 WHAT IS IN THIS LEAFLET 1. What Klerimed is used for 2. How Klerimed works 3. Before you use Klerimed 4. How to use Klerimed 5. While you are using it 6. Side effects 7. Storage and disposal of Klerimed 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT KLERIMED IS USED FOR Klerimed is used for: • respiratory tract infection • skin and soft tissue infections • helicobacter pylori infection associated with duodenal ulcer HOW KLERIMED WORKS Klerimed contains active ingredient clarithromycin. Clarithromycin is an antibiotic belonging to a group called the macrolides. Klerimed works by killing certain bacteria that cause infection. BEFORE YOU USE KLERIMED _- When you must not use it _ Do not take Klerimed if you: • are hypersensitive (allergic) to clarithromycin, other macrolide antibtiotics such as erythromycin or azithromycin, or any of the other ingredients of Klerimed (listed in Product description). • are taking ergotamine or dihydroergotamine tablets • are taking terfenadine or astemizole ( for hay fever or allergies) or cisapride(for heartburn) or pimozide (antipsychotic medicine) tablets • are taking domperidone (used for nausea & vomiting) _ _ _- Before you start to use it _ Take special care with Klerimed and tell your doctor or pharmacist if you: • have any kidney problems • have liver problems _ _ _Pregnancy and breast-feeding _ This medicine may cause harm to your fetus. Please consult your doctor or pharmacist if you are pregnant, planning for pregnancy or breast-feeding before using any medicine. _ _ _ _ _- Taking other medicines _ Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, herbal and complementary medicines including: • digoxin, disopyr 전체 문서 읽기
KLERIMED – PACKAGE INSERT 1. TRADE NAME OF THE MEDICINAL PRODUCT KLERIMED 250MG TABLET KLERIMED 500MG TABLET 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each KLERIMED tablet contains 250mg or 500mg of clarithromycin 3. PHARMACEUTICAL FORM Film coated tablets for oral administration. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS For the treatment of infections caused by one or more susceptible organisms. The indications include: - initial therapy in community acquired respiratory infections - upper respiratory tract infection, including pharyngitis and sinusitis - lower respiratory tract infection, including acute and chronic bronchitis and pneumonia - skin and soft tissue infections of mild to moderate seriousness - eradication of _ Helicobacter pylori_ in duodenal ulcer patients when used in the presence of acid suppression induced by omeprazole. The activity is greater at neutral pH than at acid pH. Clarithromycin is usually active, _in vitro_, against the following organisms: Gram-positive bacteria: _Staphylococcus_ (methicillin susceptible), _Streptococcus _ _pyogenes_ (Group A ß haemolytic streptococci), ά haemolytic streptococci (viridans group), _Streptococcus _ _pneumoniae,_ _Streptococcus agalactiae, Listeria monocytogenes_ Gram-negative bacteria: _Bordatella pertussis, Campylobacter jejuni, Haemophilus influenzae,_ _Haemophilus _ _parainfluenzae, _ _Helicobacter _ _pylori, _ _Legionella _ _pneumophila, _ _Moraxella _ _catarrhalis _ and _Neisseria _ _gonorrhoeae._ Mycoplasma: _Mycoplasma pneumoniae, Ureaplasma urealyiticum._ Anaerobes: _Bacteroides _ _fragilis_ (macrolide susceptible), _Clostridium _ _perfringens, _ _Peptococcus _ _sp.,_ _Peptostreptococcus sp., Propionibacterium acnes._ Other organisms: _Chlamydia trachomatis, Mycobacterium avium, Mycobacterium chelonae,_ _Mycobacterium _ _fortuitum, Mycobacterium intracellulare, Mycobacterium kansasaii Mycobacterium leprae._ The activity is bactericidal against several bacterial strains, including _ Campylobacter sp.,_ _ Haemophilus _ _influ 전체 문서 읽기