País: Austrália
Língua: inglês
Origem: Department of Health (Therapeutic Goods Administration)
roxithromycin, Quantity: 300 mg
Arrotex Pharmaceuticals Pty Ltd
Roxithromycin
Tablet, film coated
Excipient Ingredients: titanium dioxide; poloxamer; colloidal anhydrous silica; purified talc; povidone; sodium starch glycollate type B; hyprolose; magnesium stearate; hypromellose; sodium starch glycollate type A; glucose; maize starch; propylene glycol
Oral
5 tablets
(S4) Prescription Only Medicine
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 microorganisms: Upper respiratory tract infection: acute pharyngitis, tonsillitis and sinusitis. Lower respiratory tract infection: acute bronchitis and acute exacerbations of chronic bronchitis; community acquired pneumonia. Skin and skin structure infections. Nongonococcal urethritis. 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.
Visual Identification: White to off-white, round, convex film coated tablets.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2008-04-10
APO-ROXITHROMYCIN _Roxithromycin_ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_ WHAT IS IN THIS LEAFLET 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. 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. 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. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may want to read it again. WHAT THIS MEDICINE IS USED FOR Roxithromycin is used to treat different infections caused by bacteria, which include: • 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 gonococcal urethritis • impetigo (bacterial infection causing sores on the skin) _HOW IT WORKS_ 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. Roxithromycin, like other antibiotics, does not work against 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 this medicine for another reason. This medicine is available only with a doctor's prescription. This medicine is not addictive. This medicine is not recommended for use in children weighing less th Leia o documento completo
APO- Roxithromycin tablets Page 1 1 AUSTRALIAN PRODUCT INFORMATION – APO-ROXITHROMYCIN (ROXITHROMYCIN) 1 NAME OF THE MEDICINE Roxithromycin 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 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. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM 150 MG TABLETS White to off-white, round, convex and film-coated tablets. 300 MG TABLETS White to off-white, round, convex and film-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 in adults caused by or likely to be caused by susceptible microorganisms: • Upper respiratory tract infection: acute pharyngitis, tonsillitis and sinusitis. • Lower respiratory tract infection: acute bronchitis and acute exacerbations of chronic bronchitis; 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 microorganisms: • Acute pharyngitis • Acute tonsillitis • Impetigo. Appropriate culture and sensitivity tests should be performed when necessary to determine an organism’s 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. APO- Roxithromycin tablets Page 2 2 4.2 DOSE AND METHOD OF ADMINISTRATION For oral administration. ADULTS 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 recommended dosage is 300 mg per day which may be taken according to one of the following dosage regimens: Roxithromyci Leia o documento completo