Land: Australia
Språk: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
moxifloxacin, Quantity: 1.6 mg/mL (Equivalent: moxifloxacin hydrochloride, Qty 1.744 mg/mL)
Bayer Australia Ltd
Injection, intravenous infusion
Excipient Ingredients: hydrochloric acid; sodium chloride; water for injections; sodium hydroxide
Intravenous
5 bottles, 1 bottle
(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: Clear yellow solution; Container Type: Bottle; Container Material: Glass Type I Clear; Container Life Time: 5 Years; Container Temperature: Store below 30 degrees Celsius
Registered
2002-01-31
200428 AVELOX ® IV CMI 1 AVELOX ® IV (AV·E·LOX) _moxifloxacin hydrochloride_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Avelox IV. It does not contain all of the available information on Avelox IV. 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 receiving Avelox IV against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT RECEIVING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET IN A SAFE PLACE, EVEN AFTER YOUR TREATMENT IS FINISHED. You may need to read it again. WHAT AVELOX IV IS USED FOR Avelox IV is a sterile intravenous antibiotic used in adults for the treatment of serious infections of the lungs and airways. It can also be used to treat severe, complicated skin and skin structure infections. Avelox IV is used to start the treatment and then your doctor may prescribe tablets to complete the course. Remember to read the Consumer Medicine Information for Avelox tablets, if you receive them, because it may contain additional information specific to the tablets. Avelox IV 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. Avelox IV will not work against infections caused by viruses such as colds or the flu. Avelox IV is available by prescription only, and is used in a hospital environment 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 ARE GIVEN AVELOX IV _WHEN YOU MUST NOT BE _ _GIVEN IT _ YOU MUST NOT BE GIVEN AVELOX IV 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, norfloxaci Les hele dokumentet
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 Les hele dokumentet