Land: Australien
Sprache: Englisch
Quelle: Department of Health (Therapeutic Goods Administration)
cefepime hydrochloride monohydrate, Quantity: 2378.5 mg (Equivalent: cefepime, Qty 2 g)
Fresenius Kabi Australia Pty Ltd
Cefepime hydrochloride monohydrate
Injection, powder for
Excipient Ingredients: arginine
Intramuscular, Intravenous
10, 50, 1
(S4) Prescription Only Medicine
Adults: Cefepime Kabi is indicated in the treatment of the infections listed below when caused by susceptible bacteria.,- Lower respiratory tract infections, including pneumonia and bronchitis. - Urinary tract infections, both complicated, including pyelonephritis, and uncomplicated infections. - Skin and skin structure infections. - Intra-abdominal infections, including peritonitis and biliary tract infections. - Gynaecological infections. - Septicaemia. - Empiric treatment in febrile neutropenic patients (See PRECAUTIONS).,Cefepime Kabi is also indicated for surgical prophylaxis in patients undergoing intra-abdominal surgery. In this indication it is essential that metronidazole also be administered.,Paediatrics: Cefepime Kabi is indicated in paediatric patients over 2 months of age for the treatment of the infections listed below when caused by susceptible bacteria: - Pneumonia. - Urinary tract infections, both complicated, including pyelonephritis, and uncomplicated infections. - Skin and skin structure infections. - Septicaemia. - Empiric treatment in febrile neutropenic patients (See PRECAUTIONS).,Culture and susceptibility studies should be performed when appropriate to determine susceptibility of the causative organism(s) to cefepime. Empiric therapy with Cefepime Kabi may be instituted before results of susceptibility studies are known; however, once these results become available, the antibiotic treatment should be adjusted accordingly.,Because of its broad spectrum of bactericidal activity against gram-positive and gram-negative bacteria, Cefepime Kabi can be used appropriately as monotherapy prior to identification of the causative organisms(s). In the treatment of febrile neutropenia, consideration should be given to the need for other antibiotics in combination with Cefepime Kabi. In patients who are at risk of mixed aerobic-anaerobic infection, including infections in which Bacterioides fragilis may be present, concurrent initial therapy with an anti-anaerobic agent is recommended before the causative organism(s) is known.
Visual Identification: White to pale yellow powder; Container Type: Vial; Container Material: Glass Type II Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2015-09-07
Feb, 2016 Filename: CefCMI290216-clean Page 1 of 3 Change: Address change CEFEPIME KABI _Powder for Injection _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Cefepime Kabi. 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 being given Cefepime Kabi against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT CEFEPIME KABI IS USED FOR Cefepime Kabi 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. Cefepime Kabi 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. It will not work against infections caused by viruses such as colds or the flu. Cefepime Kabi 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). Cefepime Kabi 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. Your doctor may have prescribed Cefepime Kabi for another reason. Ask your doctor if you have any questions about why Cefepime Kabi has been prescribed for you. BEFORE YOU ARE GIVEN CEFEPIME KABI _WHEN YOU MUST NOT BE _ _GIVEN IT _ _ _ YOU MUST NOT Lesen Sie das vollständige Dokument
Page 1 of 22 AUSTRALIAN PRODUCT INFORMATION CEFEPIME KABI Cefepime (as hydrochloride) 1g and 2g Powder for Injection 1 NAME OF MEDICINE Cefepime hydrochloride monohydrate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Cefepime Kabi Powder for Injection is a sterile powder for injection available in 20 mL vials containing cefepime hydrochloride monohydrate equivalent to 1 g or 2 g cefepime. For the list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Powder for Injection. Cefepime hydrochloride monohydrate is a white to pale yellow powder. It is highly soluble in water. Following reconstitution with Water for Injections, it is a pale yellow to amber coloured solution with a pH between 4.0 and 6.0. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adults Cefepime Kabi is indicated in the treatment of the infections listed below when caused by susceptible bacteria. • Lower respiratory tract infections, including pneumonia and bronchitis. • Urinary tract infections, both complicated, including pyelonephritis, and uncomplicated infections. • Skin and skin structure infections. • Intra-abdominal infections, including peritonitis and biliary tract infections. • Gynaecological infections. • Septicaemia. Page 2 of 22 • Empiric treatment in febrile neutropenic patients (See Section 4.4 Special Warnings and Precautions for Use). Cefepime Kabi is also indicated for surgical prophylaxis in patients undergoing intra- abdominal surgery. In this indication it is essential that metronidazole also be administered. Paediatrics Cefepime Kabi is indicated in paediatric patients over 2 months of age for the treatment of the infections listed below when caused by susceptible bacteria: • Pneumonia • Urinary tract infections, both complicated, including pyelonephritis, and uncomplicated infections • Skin and skin structure infections • Septicaemia • Empiric treatment in febrile neutropenic patients (See Section 4.4 Special Warnings and Precautions for Use) Culture and susceptibility studies s Lesen Sie das vollständige Dokument