Cefepime Kabi

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Cefepime dihydrochloride monohydrate 1.1892 g equivalent to cefepime 1g

Available from:

Fresenius Kabi New Zealand Limited

Dosage:

1 g

Pharmaceutical form:

Powder for injection

Composition:

Active: Cefepime dihydrochloride monohydrate 1.1892 g equivalent to cefepime 1g Excipient: Arginine

Prescription type:

Prescription

Therapeutic indications:

Adults: Cefepime Kabi 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 II clear glass vial with halobutyl rubber stopper - 1 dose units - 24 months from date of manufacture stored at or below 25°C protect from light - Vial, glass, Type II clear glass vial with halobutyl rubber stopper - 10 dose units - 24 months from date of manufacture stored at or below 25°C protect from light - Vial, glass, Type II clear glass vial with halobutyl rubber stopper - 50 dose units - 24 months from date of manufacture stored at or below 25°C protect from light

Authorization date:

2018-01-08

Patient Information leaflet

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 blood (septicaemia).
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 BE GIVEN CEFEPIME
KABI IF:
•
YOU HAVE AN ALLERGY TO
CEFEPIME KABI, OTHER
CEPHALOSPORINS OR ANY OF THE
INGREDIENTS LISTED AT THE END
OF THIS LEAFLET.
Some of the symptoms of an
allergic reaction may include
skin rash, itching, difficulty
breathing, dizziness, flushing,
sweating and swelling of the
face, tongue or other parts of
the body.
•
YOU HAVE HAD A SERIOUS
ALLERGIC REACTION TO BETA-
LACTAM OR PENICILLIN
ANTIBIOTI

Summary of Product characteristics

NEW ZEALAND DATA SHEET
1.
CEFEPIME KABI POWDER FOR INJECTION
Cefepime Kabi, 1g Cefepime (as hydrochloride monohydrate) powder for
injection
Cefepime Kabi, 2g Cefepime (as hydrochloride monohydrate) powder for
injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cefepime Kabi, 1g Cefepime (as hydrochloride monohydrate) powder for
injection:
Each vial contains 1189.2 of cefepime hydrochloride monohydrate
(equivalent to 1 g of
cefepime)
Cefepime Kabi, 2g Cefepime (as hydrochloride monohydrate) powder for
injection:
Each vial contains 2378.5 of cefepime hydrochloride monohydrate
(equivalent to 1 g of
cefepime)
For the full list of excipients, see SECTION 6.1.
3.
PHARMACEUTICAL FORM
Cefepime Kabi is a sterile powder for injection available in 20 mL
vials containing cefepime
hydrochloride monohydrate equivalent to 1 g or 2 g cefepime. 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.
•
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 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
pr