Země: Austrálie
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
moxifloxacin hydrochloride monohydrate, Quantity: 436.33 mg (Equivalent: moxifloxacin, Qty mg)
Arrotex Pharmaceuticals Pty Ltd
Tablet, film coated
Excipient Ingredients: lactose; povidone; lactose monohydrate; croscarmellose sodium; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose; iron oxide red; macrogol 400
Oral
5
(S4) Prescription Only Medicine
Moxifloxacin APO (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,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 APO 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.,Consideration should be given to available official guidance on the appropriate use of antibacterial agents.
Visual Identification: Moxifloxacin 400 mg tablets are dull red coloured, caplet shaped, film coated tablets, debossed with M on one side and 400 on other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2019-08-09
MOXIFLOXACIN APO TABLETS 1 MOXIFLOXACIN APO _Contains the active ingredient moxifloxacin (as hydrochloride monohydrate) _ 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 this medicine. 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 taking this medicine 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 THIS MEDICINE IS USED FOR This medicine contains 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. Moxifloxacin will not work against infections caused by viruses such as colds or the flu. It is used to treat infections of the lungs, airways and sinuses in adults. In certain infections, you may require treatment with moxifloxacin injection followed by a course of moxifloxacin tablets e.g. severe and complicated skin and skin structure infections. Even if you have read the Consumer Medicine Information for moxifloxacin injection, you should read this leaflet as well as it contains information specific to the tablets. 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. There is no evidence that this medicine is addictive. This medicine should not be used in children and adolescents under 18 years of age. BEFORE YOU TAKE THIS MEDICINE _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: • moxifloxacin or other medicines belonging to the quinolone family (e.g. cipr Přečtěte si celý dokument
1 AUSTRALIAN PRODUCT INFORMATION – MOXIFLOXACIN APO (MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE) 1 NAME OF THE MEDICINE Moxifloxacin hydrochloride monohydrate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film coated tablet contains 400 mg moxifloxacin (as hydrochloride monohydrate). EXCIPIENTS WITH KNOWN EFFECTS: lactose. For the full list of excipients, see Section 6.1 List of Excipients. 3 PHARMACEUTICAL FORM Dull red coloured, caplet shaped, film coated tablets, debossed with “M” on one side and “400” on other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Moxifloxacin is 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 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. Consideration should be given to available official guidance on the appropriate use of antibacterial agents. 4.2 DOSE AND METHOD OF ADMINISTRATION This medicine is available as a 400 mg film coated tablet for oral administration. _Moxifloxacin injection is unavailable in this brand however is available in other brands. _ _Where correct dosing requires moxifloxacin injection formulation, refer to the specific product _ _information for this formulation for their complete dosage and administration instructions. _ DOSAGE The usual dose of moxifloxacin is 400 mg orally or intravenously every 24 hours. The recommended dose should not be exceeded. The duration of therapy depends on the type of infection as described below. 2 INFECTION DAILY DOSE USUAL DURATION Acute bacterial sinusitis 400 mg 10 days (oral therapy) Acu Přečtěte si celý dokument