CEFEPIME ALPHAPHARM cefepime (as hydrochloride) 2g powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

cefepime

Available from:

Alphapharm Pty Ltd

INN (International Name):

Cefepime

Authorization status:

Registered

Patient Information leaflet

CEFEPIME
ALPHAPHARM
_contains the active ingredient cefepime hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Cefepime
Alphapharm. It does not contain all
the available information. It does not
take the place of talking to your
doctor or pharmacist.
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.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Cefepime
Alphapharm against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT CEFEPIME
ALPHAPHARM IS USED
FOR
Cefepime Alphapharm contains
cefepime which belongs to a group of
antibiotics called cephalosporins.
These antibiotics work by killing the
bacteria that are causing the
infection.
Cefepime Alphapharm 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 Alphapharm 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.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
BEFORE YOU ARE GIVEN
CEFEPIME ALPHAPHARM
_WHEN YOU MUST NOT BE GIVEN_
_CEFEPIME ALPHAPHARM_
YOU SHOULD NOT BE GIVEN CEFEPIME
ALPHAPHARM IF YOU HAVE AN ALLERGY
TO:
•
you have an all

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
CEFEPIME ALPHAPHARM
_Cefepime (as hydrochloride) Powder for injection _
1
++NAME OF THE MEDICINE
Cefepime (as hydrochloride).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cefepime hydrochloride is a white to pale yellow powder, which is
highly soluble in water.
Cefepime Alphapharm is supplied in vials containing 1 g and 2 g of
cefepime (as hydrochloride). Each vial
contains cefepime (as hydrochloride) and arginine as the excipient.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Powder for injection.
Cefepime Alphapharm Powder for Injection is a sterile powder for
injection. The 1 mg strength is available in
20 mL vials, and the 2 mg strength is available in 50 mg vials,
containing cefepime (as hydrochloride).
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ADULT
Cefepime Alphapharm 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
SECTION 4.4
SPECIAL WARNINGS AND
PRECAUTIONS FOR USE)
Cefepime Alphapharm is also indicated for surgical prophylaxis in
patients undergoing intra-abdominal
surgery. In this indication it is essential that metrodinazole also be
administered.
PAEDIATRICS
Cefepime Alphapharm 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 WARN