देश: ऑस्ट्रेलिया
भाषा: अंग्रेज़ी
स्रोत: Department of Health (Therapeutic Goods Administration)
moxifloxacin, Quantity: 400 mg (Equivalent: moxifloxacin hydrochloride, Qty 436.8 mg)
Bayer Australia Ltd
Tablet, film coated
Excipient Ingredients: titanium dioxide; microcrystalline cellulose; hypromellose; ferric oxide; croscarmellose sodium; lactose monohydrate; magnesium stearate; macrogol 400
Oral
5 tablets, 1 tablet
(S4) Prescription Only Medicine
AVELOX (moxifloxacin hydrochloride) tablets are indicated for the treatment of adults with infections caused by susceptible organisms in the conditions. Acute bacterial sinusitis, Community acquired pneumonia, Acute exacerbations of chronic bronchitis. AVELOX IV (moxifloxacin hydrochloride) intravenous solutions are indicated for treatment of adults who require initial IV therapy for the treatment of infections in the conditions. Community acquired pneumonia (caused by susceptible organisms). Acute exacerbations of chronic bronchitis when caused by organisms bacteriologically proven to be resistant to other classes of antibiotics or when there is intolerance to other antibiotics. AVELOX IV (moxifloxacin hydrochloride) intravenous solutions are indicated for treatment of adults with severe and complicated skin and skin structure infections who require initial parenteral therapy, and who have intolerance to alternative agents. (especially penicillin allergy), and when caused by organisms known to be susceptible to moxifloxacin. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to moxifloxacin. Therapy with moxifloxacin may be initiated. in some conditions, before results of these tests are known. Once results become available, therapy should be continued with the most appropriate antibiotic therapy.
Visual Identification: Dull red, oblong, convex film coated tablet with BAYER on one side and M400 on the other.; Container Type: Blister Pack; Container Material: PP/Al; Container Life Time: 5 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2000-12-21
210621 AVELOX ® TABLETS CMI 1 AVELOX ® TABLETS (AV·E·LOX) _moxifloxacin hydrochloride _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Avelox tablets. 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 risks and benefits. Your doctor has weighed the risks of you taking Avelox against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT AVELOX IS USED FOR Avelox tablets are used in adults for the treatment of infections of the lungs, airways and sinuses. In certain infections, you may require treatment with Avelox IV injection followed by a course of Avelox tablets e.g. severe and complicated skin and skin structure infections. Even if you have read the Consumer Medicine Information for Avelox IV, you should read this leaflet as well as it contains information specific to the tablets. Avelox tablets contain the active ingredient, moxifloxacin, which is an antibiotic belonging to a group of medicines called quinolones. These antibiotics work by killing the bacteria that are causing your infection. Avelox tablets will not work against infections caused by viruses such as colds or the flu. Avelox tablets are available by prescription only. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. BEFORE YOU TAKE AVELOX _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE AVELOX TABLETS IF YOU HAVE AN ALLERGY TO: • moxifloxacin, the active ingredient in Avelox • any of the ingredients listed at the end of this leaflet • other medicines belonging to the quinolone family (e.g. ciprofloxacin, norfloxacin, nalidixic acid) Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • पूरा दस्तावेज़ पढ़ें
Avelox PI VX1.0; CCDS 23 1 AUSTRALIAN PRODUCT INFORMATION – AVELOX (MOXIFLOXACIN HYDROCHLORIDE) TABLET AND IV SOLUTION FOR INFUSION 1 NAME OF THE MEDICINE Moxifloxacin hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 436.8 mg moxifloxacin hydrochloride, equivalent to 400 mg moxifloxacin. Each 250 mL solution for infusion contains 436.8 mg moxifloxacin hydrochloride, equivalent to 400 mg moxifloxacin in 0.8% sodium chloride. The solution for infusion (250 mL) contains 34 mmoL sodium. 3 PHARMACEUTICAL FORM Avelox 400 mg tablets are dull red, oblong, convex film-coated tablets with BAYER on one side and M 400 on the other. Avelox 400mg tablets contains lactose monohydrate. Avelox IV is a sterile, preservative free aqueous solution of moxifloxacin hydrochloride with pH ranging from 4.1 to 4.6. The appearance of the intravenous solution is yellow. The colour does not affect, nor is it indicative of, product stability. For the full list of excipients, see Section 6.1 List of excipients. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Avelox (moxifloxacin hydrochloride) tablets are indicated for the treatment of adults with infections caused by susceptible organisms in the conditions: - Acute bacterial sinusitis - Community acquired pneumonia - Acute exacerbations of chronic bronchitis Avelox IV (moxifloxacin hydrochloride) intravenous solutions are indicated for treatment of adults who require initial IV therapy for the treatment of infections in the conditions: - Community acquired pneumonia (caused by susceptible organisms) - Acute exacerbations of chronic bronchitis when caused by organisms bacteriologically proven to be resistant to other classes of antibiotics or when there is intolerance to other antibiotics Avelox PI VX1.0; CCDS 23 2 - Avelox IV (moxifloxacin hydrochloride) intravenous solutions are indicated for treatment of adults with severe and complicated skin and skin structure infections who require initial parenteral therapy, and who have intolerance to alternative पूरा दस्तावेज़ पढ़ें