Pajjiż: Awstralja
Lingwa: Ingliż
Sors: Department of Health (Therapeutic Goods Administration)
Roxithromycin
Apotex Pty Ltd
Medicine Registered
APO-ROXITHROMYCIN _Contains the active ingredient roxithromycin_ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_ WHAT IS IN THIS LEAFLET READ THIS LEAFLET CAREFULLY BEFORE TAKING YOUR MEDICINE. This leaflet answers some common questions about Roxithromycin. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the last page. More recent information on this medicine may be available. ASK YOUR DOCTOR OR PHARMACIST: • if there is anything you do not understand in this leaflet, • if you are worried about taking your medicine, or • to obtain the most up-to-date information. You can also download the most up to date leaflet from www.apotex.com.au. All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you. Pharmaceutical companies cannot give you medical advice or an individual diagnosis. Keep this leaflet with your medicine. You may want to read it again. WHAT THIS MEDICINE IS USED FOR The name of your medicine is APO- Roxithromycin. It contains the active ingredient roxithromycin. It is used to treat: • acute pharyngitis (sore throat and discomfort when swallowing) • tonsillitis • sinusitis • acute bronchitis (infection of the bronchi causing coughing) • worsening of chronic bronchitis • pneumonia (lung infection characterised by fever, malaise, headache) • skin and soft tissue infections • non gonoccocal urethritis • impetigo (bacterial infection causing sores on the skin). Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed this medicine for another reason. This medicine is available only with a doctor's prescription. _HOW IT WORKS_ Roxithromycin is an antibiotic that belongs to a group of medicines called macrolides. These antibiotics Aqra d-dokument sħiħ
Product Information – Australia APO-Roxithromycin tablets Page 1 APO-ROXITHROMYCIN TABLETS NAME OF THE MEDICINE ACTIVE INGREDIENT: Roxithromycin Chemical names:_ _ (3_R_, 4_S_, 5_S_, 6_R_, 7_R_, 9_R_, 11_S_, 12_R_, 13_S_, 14_R_)-4-[(2,6-dideoxy-3-_C_-methyl-3-O-methyl- α- L -_ribo_- hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-10-[(_E_)-[(2-methoxyethoxy)-methoxy]imino]- 3,5,7,9,11,13,-hexamethyl-6-[(3,4,6-trideoxy-3-(dimethylamino)- β- D -_xylo_-hexopyranosyl)oxy]- oxacyclotetradecan-2-one. STRUCTURAL FORMULA: _ _ MOLECULAR FORMULA: C 41 H 76 N 2 O 15 . MOLECULAR WEIGHT: 837.07 CAS REGISTRY NUMBER: 80214-83-1 _ _ DESCRIPTION Roxithromycin is a semi-synthetic macrolide antibiotic. Each Roxithromycin film-coated tablet contains either 150 mg or 300 mg of roxithromycin as the active ingredient. GenRx ROXITHROMYCIN tablets also contain the following inactive ingredients: maize starch, hydroxypropylcellulose, silica – colloidal anhydrous, sodium starch glycollate, poloxamer, povidone, magnesium stearate, talc – purified, propylene glycol, glucose, titanium dioxide and hypromellose. PHARMACOLOGY 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 Product Information – Australia APO-Roxithromycin tablets Page 2 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. At plasma concentrations achieved with the recommended therapeutic doses, roxithrom Aqra d-dokument sħiħ