BINDOZEF INJECTION 1g cefepime (as hydrochloride) 1 g powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

cefepime, Quantity: 1000 mg

Available from:

Strides Pharma Science Pty Ltd

INN (International Name):

Cefepime

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: arginine

Administration route:

Intramuscular, Intravenous, Intravenous Infusion

Units in package:

1 vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Adults:. Cefepime 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;. - Empirical treatment in febrile neutropenic patients (see Precautions).. Cefepime 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 is indicated in paediatric patients over 2 months of age for the treatment of the infections listed below when caused by susceptible bacteria. . - Urinary tract infections, both complicated, including pyelonephritis, and uncomplicated infections;. - Skin and skin structure infections;. - Septicaemia;. - Empirical 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. Empirical therapy with Cefepime 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 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. 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 pale yellow powder filled in clear glass vials, stoppered with rubber stoppers & sealed with aluminium seals with light orange colour PP disc; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2011-09-13

Patient Information leaflet

BINDOZEF INJECTION 1 G AND 2 G
CONSUMER MEDICINE INFORMATION
Ver 1.1
BINDOZEF INJECTION 1 G AND 2 G
CEFEPIME (AS CEFEPIME HYDROCHLORIDE)
CONSUMER MEDICINE INFORMATION
_ _
BINDOZEF INJECTION 1 g & 2 g Page 1 of 3
WHAT IS IN THIS LEAFLET?
The medicine which your doctor has
prescribed
for
you
is
called
BINDOZEF
INJECTION.
The
information
in
this
leaflet
answers
some questions you may have about
BINDOZEF INJECTION.
This leaflet does not contain all the
information
about
BINDOZEF
INJECTION.
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
BINDOZEF
INJECTION
is
given to you. Keep this leaflet in a
safe place, you may need to read it
again.
WHAT BINDOZEF
INJECTION IS USED FOR:
BINDOZEF
INJECTION
contains
cefepime which belongs to a group of
antibiotics
called
cephalosporins.
These antibiotics work by killing the
bacteria
that
are
causing
the
infection.
BINDOZEF
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 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.
BINDOZEF INJECTION 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
BINDOZEF
INJECTION. Ask your doctor why
BINDOZEF
INJECTION
has
been
prescribed for you.
BEFORE YOU ARE GIVEN
BINDOZEF INJECTION
_When you must not take BINDOZEF _
_INJECTION _
_ _
YOU
SHOULD
NOT
BE
GIVEN
BINDOZEF INJECTION IF –
z
you
have
an
allergy

Summary of Product characteristics

Product Information:
BINDOZEF INJECTION (Cefepime for Injection 1 g and 2 g)
Ver 1.4
Page 1 of 15
PRODUCT INFORMATION
BINDOZEF INJECTION 1G (1 G CEFEPIME AS CEFEPIME HYDROCHLORIDE)
POWDER FOR INJECTION
BINDOZEF INJECTION 2G (2 G CEFEPIME AS CEFEPIME HYDROCHLORIDE)
POWDER FOR INJECTION
NAME OF THE MEDICINE
Cefepime as Cefepime hydrochloride
DESCRIPTION
Cefepime hydrochloride is a semi-synthetic broad-spectrum
cephalosporin antibiotic for parenteral
administration.
The
chemical
name
is
Pyrrolidinium,
1-[[7-[[(2-amino-4-
thiazolyl)(methoxyimino)acetyl]amino]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3-
yl]methyl]-1-methyl-,chloride,
monohydrochloride,
monohydrate,
[6R-[6α,7ß(Z)]],
which
corresponds to the following structural formula:
Cefepime hydrochloride is a white to pale yellow powder, which is
highly soluble in water.
MOLECULAR FORMULA:
C
19
H
25
ClN
6
O
5
S
2
•HCl•H
2
O
MOLECULAR WEIGHT:
571.50
CAS REGISTRY NUMBER:
123171-59-5
BINDOZEF INJECTION contains Arginine as an excipient.
PHARMACOLOGY
_PHARMACOKINETICS (IN ADULTS) _
Average plasma concentrations of cefepime observed in normal adult
males at various times
following single 30-minute infusions of 500 mg, 1 g and 2 g are
summarised in Table 1. Following
intramuscular administration, cefepime is completely absorbed. The
average plasma concentrations
of cefepime at various times following a single IM injection are
summarised in Table 1.
TABLE 1
Product Information:
BINDOZEF INJECTION (Cefepime for Injection 1 g and 2 g)
Ver 1.4
Page 2 of 15
MEAN PLASMA CONCENTRATIONS OF CEFEPIME (MICROGRAM/ML) IN
MALE SUBJECTS WITH NORMAL RENAL FUNCTION
TIME AFTER DOSE (HOURS)
DOSE
0.5
1
2
4
8
12
INTRAVENOUS INFUSION
500 mg
33.6
18.9
11.3
4.6
1.0
0.6
1 g
66.9
41.8
25.3
11.0
2.8
0.8
2 g
127.6
81.7
45.4
20.1
4.6
1.2
INTRAMUSCULAR INJECTION
500 mg
8.2
12.5
12.0
6.9
1.9
0.7
1 g
14.8
25.9
26.3
16.0
4.5
1.4
2 g
36.1
49.9
51.3
31.5
8.7
2.3
Concentrations of cefepime achieved in specific tissues and body
fluids are listed in Table 2.
TABLE 2
MEAN CONCENTRATIONS OF CE