Kraj: Australia
Język: angielski
Źródło: Department of Health (Therapeutic Goods Administration)
Ofloxacin
Allergan Australia Pty Ltd
Medicine Registered
OCUFLOX® OFLOXACIN EYE DROPS – CMI VERSION 2.0 PAGE 1 OF 4 CONSUMER MEDICINE INFORMATION OCUFLOX ® EYE DROPS (ofloxacin 3 mg/mL) _The information in this leaflet is ONLY a summary and is not a complete statement about OCUFLOX_ _®_ _ eye _ _drops. Your doctor has more detailed information relating to you, your medical history and the product and _ _should be consulted so that you will be informed about all aspects of OCUFLOX_ _®_ _ eye drops as it relates to you. _ PLEASE READ THIS LEAFLET CAREFULLY BEFORE USING OCUFLOX ® EYE DROPS AND KEEP THIS LEAFLET HANDY WHILE YOU ARE ON THE MEDICATION. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. All medicines have benefits and risks. Your doctor has weighed the risks of you using OCUFLOX ® eye drops against the benefits they expect it will have for you. 1. PRODUCT DESCRIPTION WHAT ARE OCUFLOX ® EYE DROPS? These eye drops contain the drug ofloxacin and are used to treat certain eye infections. WHAT IS IN OCUFLOX ® EYE DROPS? Each bottle contains ofloxacin, which is an antibiotic, as the active ingredient. Other ingredients are benzalkonium chloride 0.05 mg/mL, sodium chloride 9 mg/mL and purified water. WHAT DO THEY LOOK LIKE? The eye drops are in a 5 mL sterile plastic bottle. 2. WHAT OCUFLOX ® EYE DROPS ARE USED FOR HOW OCUFLOX ® EYE DROPS WORK OCUFLOX ® eye drops act by killing a wide range of bacteria that cause certain eye infections such as conjunctivitis (inflamed eyes) and corneal ulcers (infection on the surface of the eye). AVAILABILITY OCUFLOX ® eye drops are available only on prescription at pharmacies. This product has been approved in Australia for the use listed above. However, your doctor may prescribe this medicine for another use. If you want more information, ask your doctor. CONTENTS This leaflet answers some commo Przeczytaj cały dokument
OCUFLOX ® Product Information Version 2.0 Page 1 of 5 OCUFLOX ® Ofloxacin 3 mg/mL eye drops. NAME OF THE DRUG The active constituent of OCUFLOX ® eye drops is ofloxacin. _(STRUCTURE OF OFLOXACIN) _ CAS Registry No. J01MA01 DESCRIPTION Ofloxacin is a white to yellow crystalline powder which is soluble in glacial acetic acid, sparingly soluble in chloroform and slightly soluble in water, methanol, ethanol or acetone. Its melting point is 260 ° - 270°C with decomposition. CHEMICAL NAME: (±)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H- pyrido [1, 2, 3-de]-1, 4 benzoxazine-6-carboxylic acid. OCUFLOX ® eye drops contain 3 mg/mL ofloxacin and are formulated as an isotonic solution using 9 mg/mL sodium chloride preserved with 0.05 mg/mL benzalkonium chloride. The pH of OCUFLOX ® eye drops range from 6.0 - 7.0. PHARMACOLOGY Ofloxacin is a third generation fluorinated 4-quinolone having broad spectrum _in vitro_ bactericidal activity against certain aerobic gram-positive, gram-negative and some anaerobic bacteria. Ofloxacin appears to have more than one mechanism contributing to its bactericidal action. The primary mechanism of action is believed to be the inhibition of bacterial DNA gyrase, the enzyme responsible for inserting negative supercoils into bacterial DNA. Apparently, this enzyme inhibition leads to bacterial death through a complex process in which DNA synthesis is arrested and regulation of normal gene expression is disrupted. Ofloxacin, unlike most of the other quinolones, possesses an additional bactericidal mechanism which is not dependent on protein or RNA synthesis. It is bactericidal in both the replicating and nonreplicating stages of bacterial growth. Ofloxacin, _in vitro_ maintains an inhibitor Przeczytaj cały dokument