국가: 오스트레일리아
언어: 영어
출처: Department of Health (Therapeutic Goods Administration)
roxithromycin, Quantity: 300 mg
Arrotex Pharmaceuticals Pty Ltd
Roxithromycin
Tablet, film coated
Excipient Ingredients: glucose; propylene glycol; colloidal anhydrous silica; hyprolose; maize starch; povidone; hypromellose; magnesium stearate; titanium dioxide; purified talc
Oral
5 tablets
(S4) Prescription Only Medicine
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 exacerbation of chronic bronchitis; community acquired pneumonia. Skin and skin structure infections. Nongonococcal 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. Impetigo. Appropriate culture and susceptibility 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 biconvex film-coated tablet plain on both side; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2005-12-16
ROXAR- Consumer Medicine Information Page 1 of 4 Roxar roxithromycin CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about ROXAR. It does not contain all 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 ROXAR against the benefits they expect it will have for you. TALK TO YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE. Keep this leaflet with your medicine. You may need to read it again. WHAT ROXAR IS USED FOR ROXAR is 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-gonococcal urethritis • impetigo (bacterial infection causing sores on the skin). ROXAR 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. ROXAR, like other antibiotics, does not work against viral infections such as the flu. Your doctor may have prescribed ROXAR for another reason. Ask your doctor if you have any questions about why ROXAR has been prescribed for you. This medicine is available only with a doctor's prescription. There is no evidence that ROXAR is addictive. BEFORE YOU TAKE IT When you must not take it DO NOT TAKE THIS MEDICINE IF YOU ARE ALLERGIC TO: • roxithromycin • any other macrolide antibiotic eg, azithromycin, clarithromycin or erythromycin • any of the ingredients listed at the end of this leaflet. Symptoms of an allergic reaction may include skin rash, itching, difficulty breathing or swelling. DO NOT TAKE ROXAR IF YOU HAVE SEVERE LIVER PROBLEMS. DO NOT TAKE ROXAR IF YOU 전체 문서 읽기
1 AUSTRALIAN PI – ROXAR (ROXITHROMYCIN) 1 NAME OF THE MEDICINE Roxithromycin 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ROXAR 150 tablets contain 150mg of roxithromycin. ROXAR 300 tablets contain 300mg of roxithromycin. PHYSICAL AND CHEMICAL CHARACTERISTICS: Roxithromycin is a white, crystalline powder. It is very slightly soluble in water and freely soluble in acetone, alcohol and methylene chloride. EXCIPIENTS: For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM ROXAR 150 tablets are white to off white round biconvex film-coated tablet plain on both sides. ROXAR 300 tablets are white to off white round biconvex film-coated tablet plain on both sides. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC 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. 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 micro-organisms: acute pharyngitis, acute tonsillitis, impetigo. 2 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 D OSE AND METHOD OF ADMINISTRATION 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. Usual 전체 문서 읽기