Country: Australia
Bahasa: Inggeris
Sumber: Department of Health (Therapeutic Goods Administration)
moxifloxacin hydrochloride, Quantity: 1.74 mg/mL
Baxter Healthcare Pty Ltd
moxifloxacin hydrochloride
Injection, intravenous infusion
Excipient Ingredients: sodium hydroxide; hydrochloric acid; water for injections; sodium chloride
Intravenous Infusion
1 x 250 mL
(S4) Prescription Only Medicine
MOXIFLOXACIN-BAXTER is indicated for treatment of adults who require initial I.V. 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-BAXTER is 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-BAXTER 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, greenish yellow solution, essentially free from visible particles; Container Type: Bottle; Container Material: Glass Type II Clear; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius
Licence status A
2016-08-30
MOXIFLOXACIN-CLARIS _moxifloxacin hydrochloride _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about MOXIFLOXACIN-CLARIS It does not contain all of the available information on MOXIFLOXACIN-CLARIS. 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- CLARIS 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-CLARIS IS USED FOR MOXIFLOXACIN-CLARIS 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-CLARIS is used to start the treatment and then your doctor may prescribe tablets to complete the course. MOXIFLOXACIN-CLARIS 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-CLARIS will not work against infections caused by viruses such as colds or the flu. MOXIFLOXACIN-CLARIS 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-CLARIS _WHEN YOU MUST NOT BE GIVEN IT _ YOU MUST NOT BE GIVEN MOXIFLOXACIN-CLARIS IF YOU HAVE AN ALLERGY TO: • moxifloxacin, the active ingredient in MOXIFLOXACIN-CLARIS • 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 includ Baca dokumen lengkap
PRODUCT INFORMATION MOXIFLOXACIN-CLARIS CLARIS LIFESCIENCES AUSTRALIA PTY LTD NAME OF THE MEDICINE Moxifloxacin (as hydrochloride) 400 mg/250 mL solution for infusion. T h e c h e m i c a l n a m e i s 1-cyclopropyl-7-{(_S,S_)-2,8- diaza-bicyclo[4.3.0]non-8-yl}-6-fluoro-8- methoxy-1,4-dihydro-4-oxo-3-quinolinecarboxylic acid hydrochloride and t h e chemical structure is: The CAS number is 186826-86-8 The empirical formula is C 21 H 23 FN 3 O 4 .HCl The molecular weight is 437.9 DESCRIPTION Moxifloxacin hydrochloride is a light yellow or yellow powder or crystals. Moxifloxacin-Claris is a sterile, clear, greenish-yellow aqueous solution containing moxifloxacin hydrochloride equivalent to moxifloxacin 400 mg/250 mL with sodium chloride in water for injections. The pH is adjusted to 4.1 – 4.6 with hydrochloric acid or sodium hydroxide. PHARMACOLOGY Oral moxifloxacin is unavailable in this brand however is available in other brands. Pharmacokinetic information obtained using oral moxifloxacin is also included in the following sub-sections for completion and for information of the prescribers. PHARMACOKINETICS Absorption Following oral administration, moxifloxacin is absorbed rapidly and almost completely with an absolute bioavailability of approximately 90%. Concomitant administration of moxifloxacin together with food slightly prolongs the time to reach peak concentrations by approximately 2 hours and slightly reduced peak concentrations by approximately 16%. Extent of absorption remained unchanged. As AUC/MIC is most predictive for antimicrobial efficacy of quinolones, this effect is clinically not relevant. Therefore, moxifloxacin can be administered independent from meals. The mean (+SD) C max and AUC values following single and multiple doses of 400 mg moxifloxacin given orally or by 1 hour I.V. infusion are summarised below. C MAX (MG/L) AUC HALF-LIFE (HR) Single Dose Oral Healthy (n = 372) 3.1 + 1.0 36.1 + 9.1 11.5 - 15.6* Single Dose I.V. Healthy young (n = 56) Patients (n = 118) Male (n = 64) Female (n = 5 Baca dokumen lengkap