Maa: Australia
Kieli: englanti
Lähde: Department of Health (Therapeutic Goods Administration)
cefepime
Omegapharm
Cefepime
Registered
OMEGAPHARM CEFEPIME FOR INJECTION 1 G AND 2 G CONSUMER MEDICINE INFORMATION OMEGAPHARM CEFEPIME FOR INJECTION 1 G AND 2 G CEFEPIME (AS CEFEPIME HYDROCHLORIDE) CONSUMER MEDICINE INFORMATION _ _ OMEGAPHARM CEFEPIME FOR INJECTION 1 g and 2 g Page 1 of 3 WHAT IS IN THIS LEAFLET? The medicine which your doctor has prescribed for you is called Omegapharm Cefepime for Injection. The information in this leaflet answers some questions you may have about Omegapharm Cefepime for Injection. This leaflet does not contain all the information about Omegapharm Cefepime for Injection. Your doctor or pharmacist has been provided with full information, and can answer any questions you may have. Follow your doctor's advice, even if it differs from what is in this leaflet. You should read this leaflet carefully before Omegapharm Cefepime for Injection is given to you. Keep this leaflet in a safe place, you may need to read it again. WHAT OMEGAPHARM CEFEPIME FOR INJECTION IS USED FOR: Omegapharm Cefepime for Injection contains cefepime which belongs to a group of antibiotics called cephalosporins. These antibiotics work by killing the bacteria that are causing the infection. Omegapharm Cefepime 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). It may be given before surgery or if you have a lack of white blood cells with fever. Omegapharm Cefepime 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), or in the skin; or in the blood; or if the child has a lack of white blood cells with fever. There may be other reasons why your doctor has prescribed Omegapharm Cefepime for Injection. Ask your doctor why Omegapharm Cefepime for Injection has Lue koko asiakirja
Product Information: Omegapharm Cefepime for Injection 1 g and 2 g Page 1 of 15 PRODUCT INFORMATION OMEGAPHARM CEFEPIME FOR INJECTION 1 G AND 2 G NAME OF THE MEDICINE Cefepime as Cefepime hydrochloride 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-[6α,7β(Z)]], which corresponds to the following structural formula: Cefepime hydrochloride is a white to pale yellow powder, which is highly soluble in water. MOLECULAR FORMULA: C 19 H 25 ClN 6 O 5 S 2 •HCl•H 2 O MOLECULAR WEIGHT: 571.50 CAS REGISTRY NUMBER: 123171-59-5 Omegapharm Cefepime for Injection contains Arginine as an excipient. PHARMACOLOGY _ _ _PHARMACOKINETICS (IN ADULTS)_ _ _ Average plasma concentrations of cefepime observed in normal adult males at various times following single 30-minute infusions of 500 mg, 1 g and 2 g are summarised in Table 1. Following intramuscular 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: Omegapharm Cefepime for Injection 1 g and 2 g Page 2 of 15 TABLE 1 MEAN PLASMA CONCENTRATIONS OF CEFEPIME (MICROGRAM/ML) IN MALE SUBJECTS WITH NORMAL RENAL FUNCTION TIME AFTER DOSE (HOURS) DOSE 0.5 1 2 4 8 12 INTRAVENOUS INFUSION 500 mg 33.6 18.9 11.3 4.6 1.0 0.6 1 g 66.9 41.8 25.3 11.0 2.8 0.8 2 g 127.6 81.7 45.4 20.1 4.6 1.2 INTRAMUSCULAR INJECTION 500 mg 8.2 12.5 12.0 6.9 1.9 0.7 1 g 14.8 25.9 26.3 16.0 4.5 1.4 2 g 36.1 49.9 51.3 31.5 8.7 2.3 Concentrations of cefepime achieved in specific tissues and body fluids are listed in Table 2. TABLE 2 MEAN CONCENTRATIONS OF CEFEPIME IN VARIOUS BODY FLUIDS (MICROGRAM/ML) AND TISSUES (MICROGRAM/G) TISSUE OR FLUID INTRAVENOUS DOSE (G) AVERAGE TIME OF SAMPLE AFTER Lue koko asiakirja