CEFEPIME DEMOGEN (Demogen Australia Pty Ltd trading as DEMOGEN Pharmaceuticals)

Adults

CEFEPIME DEMOGEN 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 Special warning and precautions for use).

CEFEPIME DEMOGEN is also indicated for surgical prophylaxis in patients undergoing intraabdominal surgery. In this indication it is essential that metronidazole also be administered.

Paediatrics

CEFEPIME DEMOGEN 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 Special warning and precautions for use).

Culture and susceptibility studies should be performed when appropriate to determine susceptibility of the causative organism(s) to cefepime. Empiric therapy with CEFEPIME DEMOGEN 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 gramnegative bacteria, CEFEPIME DEMOGEN 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 DEMOGEN. 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.