Cefepime-AFT

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Cefepime dihydrochloride monohydrate 595mg equivalent to cefepime 500 mg

Available from:

AFT Pharmaceuticals Ltd

INN (International Name):

Cefepime dihydrochloride monohydrate 595 mg (= cefepime 500 mg)

Dosage:

500 mg

Pharmaceutical form:

Powder for injection

Composition:

Active: Cefepime dihydrochloride monohydrate 595mg equivalent to cefepime 500 mg Excipient: Arginine

Prescription type:

Prescription

Manufactured by:

Qilu Antibiotics Pharmaceutical Co Ltd

Therapeutic indications:

Adults: Cefepime-AFT is indicated for the treatment of the indications 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 · Septicaemia · Empiric treatment in febrile neutropenic patients.

Product summary:

Package - Contents - Shelf Life: Vial, glass, Type 1 glass with rubber stopper - 1 dose units - 24 months from date of manufacture stored at or below 25°C protect from light - Vial, glass, Type 1 glass with rubber stopper - 5 dose units - 24 months from date of manufacture stored at or below 25°C protect from light - Vial, glass, Type 1 glass with rubber stopper - 10 dose units - 24 months from date of manufacture stored at or below 25°C protect from light

Authorization date:

2013-08-09

Summary of Product characteristics

Page 1 of 15
NEW ZEALAND DATA SHEET
1.
CEFEPIME-AFT POWDER FOR INJECTION
Cefepime-AFT 500 mg powder for injection.
Cefepime-AFT 1 g powder for injection.
Cefepime-AFT 2 g powder for injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cefepime-AFT 500 mg: each vial contains 500 mg cefepime (as
dihydrochloride monohydrate).
Cefepime-AFT 1 g: each vial contains 1 g cefepime (as dihydrochloride
monohydrate).
Cefepime-AFT 2g: each vial contains 2 g cefepime (as dihydrochloride
monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for injection.
White to pale yellow powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Adults
Cefepime-AFT 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.
•
Septicaemia
•
Empiric treatment in febrile neutropenic patients (see section 4.4).
Culture and susceptibility studies should be performed when
appropriate to determine susceptibility of
the causative organism(s) to cefepime. Empiric therapy with
Cefepime-AFT 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-AFT can be used appropriately as monotherapy prior to
identification of the causative
Page 2 of 15
organisms(s). In the treatment of febrile neutropenia, consideration
should be given to the need for other
antibiotics in combination with Cefepime-AFT. In patients who are at
risk of mixed aerobic-anaerobic
infection, including infections in which
_Bacterioides fragilis _
may be present, concurrent init