البلد: أستراليا
اللغة: الإنجليزية
المصدر: Department of Health (Therapeutic Goods Administration)
roxithromycin
Sandoz Pty Ltd
Roxithromycin
Registered
_ _ _Roxithromycin AN tablets – Consumer Medicine Information _ _ _ _Doc ID: 71.AN.M.1.0 _ _ _ _ _ _Page 1 _ ROXITHROMYCIN AN FILM-COATED TABLETS _ROXITHROMYCIN _ CONSUMER MEDICINE INFORMATION WHAT IS THIS LEAFLET This leaflet answers some common questions about Roxithromycin AN. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you taking this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT ROXITHROMYCIN AN IS USED FOR This medicine is used to treat various infections caused by bacteria such as: acute pharyngitis (sore throat and discomfort when swallowing) tonsillitis sinusitis acute bronchitis (infection of the bronchi causing coughing) pneumonia (lung infection characterised by fever, malaise, headache) skin and soft tissue infections non gonococcal urethritis impetigo (bacterial infection causing sores on the skin). It contains the active ingredient roxithromycin. Roxithromycin belongs to a group of medicines called macrolides. It works by killing or stopping the growth of the bacteria that are causing the infection. However, Roxithromycin AN does not have any effect on viral infections such as the flu. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is not addictive. This medicine is available only with a doctor’s prescription. BEFORE YOU TAKE ROXITHROMYCIN AN _ _ _WHEN YOU MUST NOT TAKE _ _IT _ DO NOT TAKE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: roxithromycin, the active ingredient, or to any of the other ingredients listed at the end of this leaflet under Product Description. any other macrolide antibiotic (such as azithromycin, clarith اقرأ الوثيقة كاملة
_Roxithromycin AN tablets Product Information _ _ _ _ _ 167.AN.P.1.1 Page 1 of 9 ROXITHROMYCIN AN _ _ _(ROXITHROMYCIN TABLETS) _ _ _ PRODUCT INFORMATION _ _ NAME OF THE MEDICINE Roxithromycin CHEMICAL NAME_:_ Erythromycin-[O-[(2-methoxyethoxy)-methyl]oxime] MOLECULAR FORMULA_: _ C 41 H 76 N 2 O 15 MOLECULAR WEIGHT_:_ 837.1 CAS REGISTRY NUMBER : [ _80214-83-1_ ] DESCRIPTION It is a white crystalline powder. Roxithromycin AN tablets also contain inactive ingredients: microcrystalline cellulose, povidone, croscarmellose sodium, silicon dioxide, lactose, hypromellose, titanium dioxide, magnesium stearate, macrogol 4000, poloxamer 188. PHARMACOLOGY Roxithromycin is a semisynthetic macrolide antibiotic. Microbiology At plasma concentrations achieved with the recommended therapeutic doses, roxithromycin has been demonstrated to have _in vitro_ and clinical activity against the following microorganisms: _Streptococcus _ _pneumoniae, _ _Strep. _ _pyogenes, _ _Mycoplasma _ _pneumoniae, _ _Moraxella _ _catarrhalis, _ _Ureaplasma urealyticum_ and Chlamydia sp. _Roxithromycin AN tablets Product Information _ _ _ _ _ 167.AN.P.1.1 Page 2 of 9 Roxithromycin has been demonstrated to have clinical activity against the following microorganisms which are partially sensitive _in vitro_ to roxithromycin: _Haemophilus influenzae_ and _Staphylococcus aureus_ , except methicillin resistant _Staph. aureus_ (MRSA). The following strains of microorganisms are resistant: Multiresistant _Staph. aureus_ , Enterobacteriaceae, Pseudomonas sp. and Acinetobacter sp. DISC SUSCEPTIBILITY TESTING _ _ Dilution or diffusion techniques – either quantitative (MIC) or breakpoint, should be used following a regularly updated, recognised and standardised method (eg. NCCLS). Standardised susceptibility test procedures require the use of laboratory control microorganisms to control the technical aspects of the laboratory procedures. A report of “Susceptible” indicates that a pathogen is likely to be inhibited if the antimicrobial compound in the blood r اقرأ الوثيقة كاملة