Country: Ավստրալիա
language: անգլերեն
source: Department of Health (Therapeutic Goods Administration)
cefepime
Pfizer Australia Pty Ltd
Cefepime
Registered
DBL ™ Cefepime cmi page 1 DBL ™ CEFEPIME POWDER FOR INJECTION _Cefepime dihydrochloride (SEF-eh-pim) _ CONSUMER MEDICINE INFORMATION _Date of dispensing_ _Patient Name _ _Pharmacist Name _ _Patient address _ _Pharmacist Address _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about DBL ™ Cefepime Powder for Injection. It does not contain all the available information. It does not take the place of talking to your doctor and pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking DBL ™ Cefepime Powder for Injection against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT DBL ™ CEFEPIME POWDER FOR INJECTION IS USED FOR DBL ™ Cefepime Powder for Injection belongs to a group of antibiotics called cephalosporins. It is used to treat infections in different parts of the body caused by bacteria. These antibiotics work by killing the bacteria that are causing your infection. DBL ™ Cefepime Powder for Injection is an injectable antibiotic used for serious infections in adults caused by bacteria: • in the lungs (pneumonia and bronchitis), • in the kidney and bladder (urinary tract infections), • in the skin, • inside the abdomen (peritonitis and biliary tract infections), • in the womb or vagina, or • in the blood (septicaemia). DBL ™ Cefepime Powder for Injection is also used to prevent infections before, during and after surgery. It may be given before surgery or if you have a lack of white blood cells with fever. DBL ™ Cefepime Powder for Injection is also used for serious infections in children over 2 months of age caused by bacteria: • in the lungs (pneumonia), • in the kidney and bladder (urinary tract infections), • in the skin; • in the blood; or • if the child has a lack of white blood cells with fever. DBL ™ Cefepime Powder for Injection will not wo read_full_document
Product Information - Australia Version 3.0 Page 1 of 14 DBL ™ CEFEPIME POWDER FOR INJECTION NAME OF THE MEDICINE Cefepime (as hydrochloride monohydrate) powder for solution for injection Molecular Formula: C 19 H 25 N 6 O 5 S 2 Cl.HCl.H 2 O Molecular Weight: 571.5 CAS Registry No.: 123171-59-5 ARC code: J01DE01 DESCRIPTION Cefepime hydrochloride is a semi-synthetic broad spectrum cephalosporin antibiotic for parenteral administration. The chemical name is: Pyrrolidinium, 1-[[7-[[2-amino-4- thiazolyl)(methoxyimino)acetyl]-amino]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en- 3-yl]methyl]-1-methyl-,chloride, monohydrochloride, monohydrate, [6R- [6 , 7 (Z)]]. Cefepime hydrochloride is a white to pale yellow powder. It is highly soluble in water. It has a pH of between 4.0 and 6.0. DBL ™ Cefepime Powder for Injection is a sterile lyophilised powder for injection containing the inactive ingredient L-arginine to control the pH of the reconstituted solution at 4.0 to 6.0. Following reconstitution with Water for Injection as directed in labelling, it results in a pale yellow to amber coloured, clear solution. Each 20 mL vial contains either 1.914 g or 3.828 g of sterile cefepime – L-arginine powder, which is equivalent to 1 g or 2 g of cefepime and approximately 725 mg of arginine per gram of cefepime. It contains no antimicrobial preservative and is for use in one patient only. PHARMACOLOGY MECHANISM OF ACTION Cephalosporins act by interfering with bacterial cell-wall synthesis, leading to lysis of the infectious organism. PHARMACOKINETICS _In Adults _ _ _ Average plasma concentrations of cefepime observed in normal adult males at various times following single 30-minute infusions of 1 g and 2 g are summarised in Table 1. Following intramuscular (IM) administration, cefepime is completely absorbed. The average plasma concentrations of cefepime at various times following a single IM injection are summarised in Table 1. Product Information - Australia Version 3.0 Page 2 of 14 TABLE 1: MEAN PLASMA CONCE read_full_document