HOSPIRA CEFTAZIDIME POWDER FOR INJECTION ceftazidime (as pentahydrate) 1 g powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ceftazidime pentahydrate

Available from:

Pfizer Australia Pty Ltd

INN (International Name):

ceftazidime pentahydrate

Authorization status:

Registered

Patient Information leaflet

HOSPIRA™ CEFTAZIDIME POWDER FOR
INJECTION
ceftazidime (as pentahydrate) (_kef-TAZ-e-deem_)
CONSUMER MEDICINE INFORMATION
_ Date of Dispensing_
_Consumer Name _
_ Pharmacist Name _
_Consumer Address _
_ Pharmacist Address _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about HOSPIRA™
Ceftazidime Powder for Injection. 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
HOSPIRA™ Ceftazidime Powder
for Injection against the benefits
this medicine is expected to have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK
YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET IN A SAFE PLACE.
You may need to read it again.
WHAT HOSPIRA™
CEFTAZIDIME POWDER FOR
INJECTION IS USED FOR
Ceftazidime is an antibiotic used to
treat infections in different parts of
the body caused by bacteria.
Ceftazidime will not work against
infections caused by viruses such
as colds or the flu.
Ceftazidime belongs to a group of
antibiotics called cephalosporins
(cef-a-loe-SPOR-ins). These
antibiotics
work by killing the
bacteria that are causing your
infection.
Your doctor may have prescribed
ceftazidime for another reason.
ASK YOUR DOCTOR IF YOU HAVE
ANY
QUESTIONS ABOUT WHY CEFTAZIDIME
HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only with
a doctor’s prescription.
BEFORE YOU ARE GIVEN
HOSPIRA™
CEFTAZIDIME POWDER FOR
INJECTION
_WHEN YOU MUST NOT BE _
_GIVEN IT _
_ _
HOSPIRA™ CEFTAZIDIME POWDER
FOR INJECTION SHOULD NOT BE GIVEN
TO YOU IF YOU HAVE AN ALLERGY TO:
•
ceftazidime
•
other cephalosporins
•
any of the ingredients listed at
the end of this leaflet.
•
lignocaine
Symptoms of an allergic reaction
may include:
•
shortness of breath, wheezing
or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the
skin.
CEFTAZIDIME SHOULD NOT BE GIVEN
TO YOU IF YOU HAVE HA

Summary of Product characteristics

Product Information - Australia
HOSPIRA™
CEFTAZIDIME, POWDER FOR INJECTION
NAME OF THE MEDICINE
Ceftazidime (as ceftazidime pentahydrate)
CAS No. 78439-06-2
Molecular Weight: 636.6
Molecular formula: C
22
H
22
N
6
O
7
S
2
, 5H
2
O
Chemical name:
(6
_R_
,7
_R_
)-7-[[(2
_Z_
)-2-(2-Aminothiazol-4-yl)-2-[(1-carboxy-1
methylethoxy)imino]acetyl]amino]-8-oxo-3-[(1-pyridinio)methyl]-5-thia-1-azabicyclo
[4.2.0]oct-2-ene-2-carboxylate pentahydrate.
DESCRIPTION
Hospira™ Ceftazidime Powder for Injection is a cephalosporin
antibiotic for use by injection
only. It is supplied as a white to cream coloured crystalline powder
in vials containing 1 g
and 2 g ceftazidime (as pentahydrate) with sodium carbonate anhydrous
(117 mg per gram of
ceftazidime). On the addition of Water for Injections, Hospira™
Ceftazidime Powder for
Injection dissolves with effervescence to produce a light yellow to
amber coloured solution
for injection.
Ceftazidime pentahydrate is slightly soluble in water and in methanol,
practically insoluble in
acetone and in ethanol (96 per cent). It dissolves in acid and alkali
solutions. Ceftazidime
pentahydrate decomposes at about 150 °C
.
Ceftazidime
penthahydrate
is
hygroscopic
and
crystalline
in
nature
.
No
potential
polymorphism is reported.
Hospira™ Ceftazidime Powder for Injection contains approximately 51
mg (2.17 mEq) of
sodium per gram of ceftazidime. 116 mg ceftazidime pentahydrate is
equivalent to 100 mg
ceftazidime
anhydrous.
For
laboratory
tests
associated
with
ceftazidime
administration,
ceftazidime pentahydrate should be used.
PHARMACOLOGY
PHARMACOKINETICS
Absorption
of
ceftazidime
after
oral
administration
is
negligible,
therefore
Hospira™
Ceftazidime Powder for Injection is intended for parenteral use only.
Version 2.0 Page 1
Product Information - Australia
In humans, after a single intramuscular administration of 500 mg and 1
g, mean peak serum
levels of 18 and 37 mg/L respectively are achieved at 1 hour, falling
to 8 and 2 mg/L and 20
and 5 mg/L at four and eight hours respectively for