Cefepime-AFT cefepime hydrochloride monohydrate equivalent to cefepime 500 mg, powder for injection, vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

cefepime hydrochloride monohydrate, Quantity: 595 mg (Equivalent: cefepime, Qty 500 mg)

Available from:

AFT Pharmaceuticals Pty Ltd

INN (International Name):

Cefepime hydrochloride monohydrate

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: arginine

Administration route:

Intramuscular, Intravenous

Units in package:

1 vial, 5 vials, 10 vials

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

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. ? Gynaecological infections. ? Septicaemia ? Empiric treatment in febrile neutropenic patients (See PRECAUTIONS) Cefepime-AFT 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-AFT 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-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 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 initial therapy with an anti-anaerobic agent is recommended before the causative organism(s) is known.

Product summary:

Visual Identification: White to off white powder; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2013-02-13

Patient Information leaflet

Page 1 of 4
CEFEPIME-AFT
Cefepime (as hydrochloride monohydrate) 500 mg, 1g and 2 g powder for
injection
Consumer Medicine Information
What is in this leaflet
The medicine which your doctor has prescribed for you is called
Cefepime-AFT. The information in this leaflet answers some
questions you may have about Cefepime-AFT.
This leaflet does not contain all the information about Cefepime-AFT.
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 Cefepime-AFT is given to
you. Keep this leaflet in a safe place; you may need to
read it again.
What Cefepime-AFT
is used for
Cefepime-AFT contains cefepime which belongs to a group of antibiotics
called cephalosporins. These antibiotics work by
killing the bacteria that are causing the infection.
Cefepime-AFT 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.
Cefepime-AFT 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
Cefepime-AFT. Ask your doctor why Cefepime-AFT has been
prescribed for you.
Before you are given Cefepime-AFT
When you must not be given Cefepime-AFT
You should not be given Cefepime-AFT if -
•
You have an allergy to Cefepime-AFT, or to other cephalosporins or to
any ingredient listed at the end of this leaflet.
Symptoms of a severe allergic reaction may include chills, feve

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION - CEFEPIME-AFT
(CEFEPIME HYDROCHLORIDE MONOHYDRATE)
1
NAME OF THE MEDICINE
Cefepime hydrochloride monohydrate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cefepime hydrochloride monohydrate is a semi-synthetic, broad spectrum
cephalosporin antibiotic for
parenteral administration.
Cefepime hydrochloride monohydrate is a white to pale yellow powder.
It is highly soluble in water.
Cefepime-AFT powder for injection is a sterile dry mixture of Cefepime
hydrochloride monohydrate
and L-arginine. It is supplied in vials containing Cefepime
hydrochloride monohydrate equivalent to
Cefepime 500 mg, 1 g and 2 g.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Powder for Injection.
Cefepime-AFT powder for injection containing cefepime (as
hydrochloride monohydrate) 500 mg
AUST R 196281.
Cefepime-AFT powder for injection containing cefepime (as
hydrochloride monohydrate) 1 g AUST R
196279.
Cefepime-AFT powder for injection containing cefepime (as
hydrochloride monohydrate) 2 g AUST R
196280.
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.
•
Gynaecological infections.
•
Septicaemia.
2
•
Empiric treatment in febrile neutropenic patients (See Special warning
and precautions for use).
Cefepime-AFT is also indicated for surgical prophylaxis in patients
undergoing intraabdominal surgery.
In this indication it is essential that metronidazole also be
administered.
_PAEDIATRICS _
Cefepime-AFT is indicated in paediatric patients over 2 months of age
for the treatment of the infections
listed below when caused by susceptible bacteria:
•
Pneumonia.
•
Ur