Nazione: Nuova Zelanda
Lingua: inglese
Fonte: Medsafe (Medicines Safety Authority)
Roxithromycin 150mg;
Teva Pharma (New Zealand) Limited
Roxithromycin 150 mg
150 mg
Coated tablet
Active: Roxithromycin 150mg Excipient: Colloidal silicon dioxide Glucose Hyprolose Hypromellose Magnesium stearate Maize starch Povidone Propylene glycol Purified talc Titanium dioxide Water
Blister pack, PVC/PVDC/Al foil, 10 tablets
Prescription
Prescription
Kopran Limited
Adults Roxithromycin is indicated for the treatment of the following types of mild to moderately severe infections caused by or likely to be caused by susceptible micro-organisms: · upper respiratory tract infection - acute pharyngitis, tonsillitis and sinusitis · dental infections · lower respiratory tract infection - acute bronchitis; acute exacerbations of chronic bronchitis and community acquired pneumonia · skin and skin structure infections · non-gonococcal urethritis. Children Roxithromycin 150 mg tablets are indicated for the treatment of the following mild to moderately severe infections in children caused by or likely to be caused by susceptible micro-organisms: acute pharyngitis, acute tonsillitis and impetigo. Appropriate culture and sensitivity tests should be performed when necessary to determine organism susceptibility and thus treatment suitability. Therapy with roxithromycin may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued.
Package - Contents - Shelf Life: Blister pack, PVC/PVDC/Al foil - 10 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC/Al foil - 50 tablets - 24 months from date of manufacture stored at or below 25°C
2006-06-24
CONSUMER MEDICINE INFORMATION ARROW - ROXITHROMYCIN Roxithromycin 150 mg and 300 mg tablets WHAT IS IN THIS LEAFLET This leaflet answers some common questions about ARROW - ROXITHROMYCIN. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking ARROW - ROXITHROMYCIN against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. Keep this leaflet with your medicine. You may need to read it again. WHAT ARROW - ROXITHROMYCIN IS USED FOR ARROW - ROXITHROMYCIN Tablets are used to treat infections in different parts of the body 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-gonoccocal urethritis • impetigo (bacterial infection causing sores on the skin). ARROW - ROXITHROMYCIN is an antibiotic that belongs to a group of medicines called macrolides. These antibiotics work by killing or stopping the growth of the bacteria that are causing your infection. ARROW - ROXITHROMYCIN, like other antibiotics, does not work against viral infections such as flu. Your doctor may have prescribed ARROW - ROXITHROMYCIN for another reason. Ask your doctor if you have any questions about why ARROW - ROXITHROMYCIN has been prescribed for you. There is no evidence that ARROW - ROXITHROMYCIN Tablets is addictive. ARROW - ROXITHROMYCIN is available only with a doctor's prescription. BEFORE YOU TAKE ARROW - ROXITHROMYCIN _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE ARROW - ROXITHROMYCIN IF YOU ARE ALLERGIC TO MEDICINES CONTAINING ROXITHROMYCIN, ANY OTHER MACROLIDES ANTIBIOTIC EG, AZITHROMYCIN, CLARITHROMYCIN, ERYTHROMYCIN OR ANY OF THE INGREDIENTS LISTED AT THE Leggi il documento completo
Version 1.0 1 NEW ZEALAND DATA SHEET 1. PRODUCT NAME Arrow – Roxithromycin 150, 150 mg, coated tablets Arrow – Roxithromycin 300, 300 mg, coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 150 mg or 300 mg of roxithromycin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM White, round, coated tablets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Adults_ Roxithromycin is indicated for the treatment of the following types of mild to moderately severe infections caused by or likely to be caused by susceptible micro-organisms: • upper respiratory tract infection - acute pharyngitis, tonsillitis and sinusitis • dental infections • lower respiratory tract infection - acute bronchitis; acute exacerbations of chronic bronchitis and community acquired pneumonia • skin and skin structure infections • non-gonococcal urethritis. _Children _ Roxithromycin 150 mg tablets are indicated for the treatment of the following mild to moderately severe infections in children caused by or likely to be caused by susceptible micro-organisms: acute pharyngitis, acute tonsillitis and impetigo. Appropriate culture and sensitivity tests should be performed when necessary to determine organism susceptibility and thus treatment suitability. Therapy with roxithromycin may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued. 4.2 DOSE AND METHOD OF ADMINISTRATION This product may not be interchangeable with other products containing this ingredient in the New Zealand's market. The bioequivalence with Rulide ® marketed in Australia has been demonstrated. Roxithromycin should be taken at least 15 minutes before food or on an empty stomach (i.e. more than three hours after a meal). The film coated tablets must be swallowed whole with a drink. _Adults _ The recommended dosage is 300 mg per day, which may be taken according to one of the following dosage regimens. Usual dosage: Roxithromycin 300 mg tablet Leggi il documento completo