Երկիր: Ավստրալիա
Լեզու: անգլերեն
Աղբյուրը: Department of Health (Therapeutic Goods Administration)
moxifloxacin hydrochloride, Quantity: 1.75 mg/mL
Fresenius Kabi Australia Pty Ltd
moxifloxacin hydrochloride
Injection, intravenous infusion
Excipient Ingredients: sodium sulfate; sulfuric acid; sodium acetate trihydrate; water for injections
Intravenous
1, 10, 20, 25 and 40
(S4) Prescription Only Medicine
Moxifloxacin Kabi 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,- Moxifloxacin Kabi 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 Kabi 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: The appearance of the intravenous solution is yellow.; Container Type: Bottle; Container Material: Plastic; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2016-05-09
CMI for Moxifloxacin Kabi Jul 2018 Page 1 of 4 MOXIFLOXACIN KABI Moxifloxacin Hydrochloride CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Moxifloxacin Kabi. 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 receiving Moxifloxacin Kabi 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 MOXIFLOXACIN KABI IS USED FOR Moxifloxacin Kabi 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. Moxifloxacin Kabi 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 Moxifloxacin tablets, if you receive them, because it may contain additional information specific to the tablets. Moxifloxacin Kabi 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 Kabi will not work against infections caused by viruses such as colds or the flu. Moxifloxacin Kabi 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 MOXIFLOXACIN KABI _WHEN YOU MUST NOT BE GIVEN IT _ YOU MUST NOT BE GIVEN MOXIFLOXACIN KABI IF YOU HAVE AN ALLERGY TO: • moxifloxacin, the active ingredient in Moxifloxacin Kabi • any of the ingredients listed at the end of this leafl Կարդացեք ամբողջական փաստաթուղթը
Page 1 of 28 AUSTRALIAN PRODUCT INFORMATION- MOXIFLOXACIN KABI (MOXIFLOXACIN HYDROCHLORIDE) 1. NAME OF MEDICINE Moxifloxacin hydrochloride. 2. QUANTITATIVE AND QUALITATIVE COMPOSITION Moxifloxacin Kabi is available in ready-to-use 250 mL (containing 400 mg of moxifloxacin) FREE_flex_ _®_ bags or KabiPac infusion bottles, as a sterile, preservative free aqueous solution of moxifloxacin hydrochloride with pH ranging from 5.0 to 6.0. The appearance of the intravenous solution is yellow. The colour does not affect, nor is it indicative of, product stability. The inactive ingredients are sodium acetate trihydrate, sodium sulfate, sulfuric acid and Water for Injections. For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Moxifloxacin Kabi (moxifloxacin hydrochloride) is a synthetic broad spectrum antibacterial agent and is available as Moxifloxacin Kabi IV infusion solution for intravenous administration. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Moxifloxacin Kabi 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 − Moxifloxacin Kabi 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 Kabi may be initiated, in some conditions, before results of Կարդացեք ամբողջական փաստաթուղթը