Χώρα: Αυστραλία
Γλώσσα: Αγγλικά
Πηγή: Department of Health (Therapeutic Goods Administration)
Roxithromycin
Sandoz Pty Ltd
Medicine Registered
ROXITHROMYCIN SANDOZ ® 1 ROXITHROMYCIN SANDOZ ® _roxithromycin film-coated tablets _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Roxithromycin Sandoz. 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 SANDOZ 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) • exacerbation of chronic bronchitis • 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 Sandoz 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 SANDOZ Διαβάστε το πλήρες έγγραφο
_Product Information _ _Roxithromycin Sandoz 150 and 300 mg film-coated tablets _ _06/2013 _ _1 _ _Sandoz Pty Ltd _ PRODUCT INFORMATION ROXITHROMYCIN SANDOZ 150MG AND 300MG FILM-COATED TABLETS NAME OF THE MEDICINE Roxithromycin DESCRIPTION _Chemical name:_ Erythromycin-[O-[(2-methoxyethoxy)-methyl]oxime] CAS: 80214-83-1 Molecular formula_: _C 41 H 76 N 2 O 15 MW_:_ 837.1 It is a white crystalline powder. Roxithromycin Sandoz tablets also contain inactive ingredients: microcrystalline cellulose, povidone, croscarmellose sodium, silicon dioxide, lactose, hypromellose, titanium dioxide, magnesium stearate, macrogol 4000, poloxamer 188. PHARMACOLOGY PHARMACOKINETICS Roxithromycin is a semisynthetic macrolide antibiotic. Microbiology Roxithromycin is bacteriostatic at low concentrations and bactericidal at high concentrations. It binds to the 50S subunit of the 70S ribosome, thereby disrupting bacterial protein synthesis. A prolonged postantibiotic effect has been observed with roxithromycin. Whilst the clinical significance of this remains uncertain, it supports the rationale for once daily dosing. Although clinical data have demonstrated the efficacy and safety of once daily dosing in adults, these have not been demonstrated in children. _Product Information _ _Roxithromycin Sandoz 150 and 300 mg film-coated tablets _ _06/2013 _ _2 _ _Sandoz Pty Ltd _ 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 has been demonstrated to have clinical activity against the following microorganisms which are partially sens Διαβάστε το πλήρες έγγραφο