Nchi: Australia
Lugha: Kiingereza
Chanzo: Department of Health (Therapeutic Goods Administration)
Ciprofloxacin
Hospira Australia Pty Ltd
Medicine Registered
DBL ™ Ciprofloxacin Injection for Intravenous Infusion CMI page 1 DBL ™ CIPROFLOXACIN INJECTION FOR INTRAVENOUS INFUSION Ciprofloxacin _(Sip-roe-FLOX-a-sin)_ CONSUMER MEDICINE INFORMATION _Date of dispensing _ _Consumer Name _ _Pharmacist Name _ _Consumer Address _ _Pharmacist Address _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about DBL ™ Ciprofloxacin Injection for Intravenous Infusion. 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 being given DBL ™ Ciprofloxacin Injection for Intravenous Infusion against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET._ _ You may need to read it again. WHAT DBL ™ CIPROFLOXACIN INJECTION FOR INTRAVENOUS INFUSION IS USED FOR This medicine is used to treat: • lung infections • infections of skin • infections of bone and joints • kidney and bladder infections • infections in the blood • inhalation of anthrax (post- exposure) This medicine belongs to a group of medicines called fluoroquinolones. It works by killing many kinds of bacteria which cause infections in the body. Ciprofloxacin will not work against infections caused by viruses such as cold and flu. 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. This medicine is not addictive. It is available only with a doctor’s prescription. BEFORE YOU ARE GIVEN DBL ™ CIPROFLOXACIN INJECTION FOR INTRAVENOUS INFUSION _WHEN YOU MUST NOT BE _ _GIVEN IT _ YOU MUST NOT BE Soma hati kamili
Product Information - Australia Version 5.0 Page 1 DBL™ CIPROFLOXACIN INJECTION FOR INTRAVENOUS INFUSION NAME OF THE MEDICINE Ciprofloxacin The chemical structure is shown below: Molecular formula: C 17 H 18 FN 3 O 3 Molecular weight: 331.35 CAS Registry Number: 85721-33-1 DESCRIPTION DBL™ Ciprofloxacin Injection for Intravenous Infusion is a synthetic carboxyquinolone derivative with broad spectrum antimicrobial activity for intravenous (IV) administration. Ciprofloxacin, a fluoroquinolone, is a 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3- quinolinecarboxylic acid. Ciprofloxacin is a white to pale yellow crystalline powder. DBL™ Ciprofloxacin Injection for Intravenous Infusion is available as a ciprofloxacin (as lactate) 100 mg/50 mL, 200 mg/100 mL and 400mg/200mL infusion solution. It also contains the excipients lactic acid (as a solubilising agent), glucose (as monohydrate, 50 mg/mL) and water for injections. Hydrochloric acid is added as necessary to adjust the pH. DBL™ Ciprofloxacin Injection for Intravenous Infusion is a clear, colourless or slightly yellow solution. PHARMACOLOGY PHARMACOKINETICS _Distribution _ Immediately following a 30 minute intravenous infusion of 200 mg ciprofloxacin, serum concentrations average 3 microgram/mL. During the first hour after completion of infusion, serum concentration decreases to approximately 30% of the peak value, but thereafter serum concentrations decline with a half life of approximately four hours. Mean concentrations observed after a 200 mg dose are given below: CIPROFLOXACIN SERUM CONCENTRATIONS (MICROGRAM/ML) AFTER A 30 MINUTE INFUSION DOSE END OF INFUSION 0.5 HR 1 HR 3 HR 6 HR 8 HR 12 HR 200 mg 3.18 1.4 1.0 0.5 0.3 0.2 0.1 The pharmacokinetics of intravenously administered ciprofloxacin are near linear over the dosage range of 100 mg to 300 mg, Soma hati kamili