Land: Australien
Sprog: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
roxithromycin, Quantity: 300 mg
Sanofi-Aventis Australia Pty Ltd
Tablet, film coated
Excipient Ingredients: purified talc; colloidal anhydrous silica; hypromellose; titanium dioxide; magnesium stearate; povidone; hyprolose; glucose; maize starch; propylene glycol; poloxamer
Oral
5, 1 tablets (sample)
(S4) Prescription Only Medicine
For the treatment of mild to moderately severe infections in adults caused by or likely to be caused by susceptible micro-organisms in; Acute pharyngitis, tonsillitis, and sinusitis. Acute bronchitis and acute exacerbations of chronic bronchitis; Community acquired pneumonia (including atypical pneumonia). Skin and soft tissue infections and non-gonococcal urethritis
Visual Identification: Biconvex, cylindrical white tablet, 11mm in diameter, with 164J debossed on one surface.; Container Type: Blister Pack; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Registered
1994-06-03
BIAXSIG ® TABLETS B I A X S I G ® CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING BIAXSIG? Biaxsig contains the active ingredient roxithromycin. Biaxsig is used to treat infections in different parts of the body caused by bacteria. For more information, see Section 1. Why am I using Biaxsig? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE BIAXSIG? Do not use if you have ever had an allergic reaction to roxithromycin or any of the ingredients listed at the end of the CMI. Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I use Biaxsig? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Biaxsig and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE BIAXSIG? • The recommended adult dosage is 300 mg per day • The recommended dosage for children more than 40 kg is one 150 mg tablet twice daily. More instructions can be found in Section 4. How do I use Biaxsig? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING BIAXSIG? THINGS YOU SHOULD DO • Remind any doctor or dentist you visit that you are using Biaxsig. • If the symptoms of your infection do not improve within a few days, or if they become worse, tell your doctor. • If you get severe diarrhoea tell your doctor, pharmacist or nurse immediately. Do this even if it occurs several weeks after Biaxsig has been stopped. • If you get a sore, white mouth or tongue while taking, or soon after stopping Biaxsig, tell your doctor or pharmacist. • Tell your doctor or pharmacist if you get vaginal itching or discharge. • If you are about to start taking any new medicine, tell your doctor and pharmacist that you are taking Biaxsig T Læs hele dokumentet
bia-ccdsv7-piv10-23sep20_ _ Page 1 of 13 AUSTRALIAN PRODUCT INFORMATION – BIAXSIG ® (ROXITHROMYCIN) 1 NAME OF THE MEDICINE Roxithromycin 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 300 mg and 150 mg tablets contain 300 mg and 150 mg of roxithromycin per tablet respectively. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Biaxsig 300 mg Tablets: white biconvex, cylindrical, 11 mm in diameter, film-coated tablets. Contains glucose (in film coating). Biaxsig 150 mg Tablets: white biconvex, cylindrical, 9 mm in diameter, film-coated tablets. Contains glucose (in film coating). 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ADULTS Biaxsig 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 micro-organisms: • Upper Respiratory Tract Infections: Acute pharyngitis, tonsillitis, sinusitis • Lower Respiratory Tract Infections: Acute bronchitis and acute exacerbations of chronic bronchitis; community acquired pneumonia • Skin and skin structure infections • Non-gonococcal urethritis CHILDREN Biaxsig is 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 bia-ccdsv7-piv10-23sep20_ _ Page 2 of 13 • 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 Biaxsig 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 ADULTS Biaxsig should be taken at least 15 minutes before food or on an empty stomach (i.e. more than 3 hours after a meal). The recommended dosage for adults, the elderly and patients with impaired renal function is 300 mg per day taken as either one 150 mg tablet twice daily, or as Læs hele dokumentet