ZETAF 2g ceftazidime (as pentahydrate) 2g powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ceftazidime pentahydrate, Quantity: 2349 mg (Equivalent: ceftazidime, Qty 2000 mg)

Available from:

Strides Pharma Science Pty Ltd

INN (International Name):

Ceftazidime

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: sodium carbonate

Administration route:

Intravenous

Units in package:

1 vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Ceftazidime for Injection is indicated for the treatment of single and mixed infections caused by susceptible aerobic organisms with suspected or documented resistance to other antimicrobials, but not to ceftazidime, and as an alternative to aminoglycosides in pseudomonal infection in patients in whom aminoglycoside toxicity is a cause for concern and other pseudomonal antibiotics cannot be used. ,Indications include the following:,Severe infections in general: ,For example: septicaemia including neonatal sepsis, bacteraemia; and in patients in intensive care units with specific problems, e.g., infected burns.,Respiratory tract infections: ,For example: pneumonia, broncho-pneumonia, infected pleurisy, infected bronchiectasis and bronchitis.,Severe ear, nose and throat infections: ,For example: otitis media, mastoiditis.,Urinary tract infections: ,For example: acute and chronic pyelonephritis, pyelitis, cystitis, urethritis (bacterial only), and infections associated with bladder and renal stones.,Skin and soft tissue infections: ,For example, erysipelas, abscesses, cellulitis, infected burns and wounds, mastitis.,Gastrointestinal and abdominal infections: ,For example: intra-abdominal abscesses, enterocolitis.,Bone and joint infections: ,For example: osteitis, osteomyelitis, septic arthritis, infected bursitis.

Product summary:

Visual Identification: White or pale yellow coloured powder filled in clear glass vials, stoppered with rubber stoppers & sealed with aluminium seal with german blue PP disc; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2012-01-09

Patient Information leaflet

ZETAF 1G AND 2G
CONSUMER MEDICINE INFORMATION
Ver 1.2
ZETAF 1G & 2G
Ceftazidime (as pentahydrate)
CONSUMER MEDICINE INFORMATION
_ _
ZETAF Page 1 of 3
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ZETAF. 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 ZETAF
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 ZETAF IS USED FOR
Ceftazidime is an antibiotic used to
treat infections in different parts of
the body caused by bacteria.
Ceftazidime is also used to prevent
infections
before,
during
and
after
surgery.
Ceftazidime
will
not
work
against
infections caused by viruses such as
colds or the flu.
Ceftazidime belongs to a group of
antibiotics
called
cephalosporins.
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
ZETAF
WHEN YOU MUST NOT BE GIVEN
IT
ZETAF SHOULD NOT BE GIVEN TO YOU
IF YOU HAVE AN ALLERGY TO:
•
ceftazidime
•
other cephalosporins
•
lignocaine
•
any of the ingredients listed at
the end of this leaflet.
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
HAD
A
MAJOR
ALLERGIC REACTION TO PENICILLINS.
CEFTAZIDIME SHOULD NOT BE MIXED
WITH LIGNOCAINE AND GIVEN TO YOU IF
YOU HAVE HAD AN ALLERGIC REACTION
TO LIGNOCAINE.
Sometimes ceftazidime is mixed with
lignocaine hydroch

Summary of Product characteristics

Product Information:
ZETAF 1g & 2g (Ceftazidime for Injection 1g & 2g)
Ver 1.2
Page 1 of 11
PRODUCT INFORMATION
ZETAF 1G (1G CEFTAZIDIME AS CEFTAZIDIME PENTAHYDRATE)
ZETAF 2G (2G CEFTAZIDIME AS CEFTAZIDIME PENTAHYDRATE)
NAME OF THE MEDICINE
The name of medicine is Ceftazidime as Ceftazidime pentahydrate
CHEMICAL
NAME:
(6R,7R)-7[[(2Z)-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.
MOLECULAR FORMULA:
C
22
H
22
N
6
O
7
S
2
.5H
2
0
CAS REGISTRY NUMBER:
72558-82-8
MOLECULAR WEIGHT
: 636.6
DESCRIPTION
ZETAF is a cephalosporin antibiotic for use by injection only. It is
supplied as a white or almost
white, crystalline powder in vials containing 1 g and 2 g ceftazidime
(as pentahydrate) with sodium
carbonate anhydrous (118 mg per gram of ceftazidime). On the addition
of Water for Injections,
ZETAF dissolves with effervescence to produce a clear, colourless
solution for injection.
ZETAF contains approximately 51 mg (2.2 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
MICROBIOLOGY
Ceftazidime is bactericidal in action, exerting its effect on target
cell wall proteins and causing
inhibition of cell wall synthesis. It is stable to most
beta-lactamases produced by Gram-positive and
Gram-negative organisms and consequently is active against many
ampicillin- and cephalothin-
resistant strains (but not methicillin-resistant strains). Ceftazidime
has been shown to have
_in vitro _
activity against the following organisms:
_ _
Product Information:
ZETAF 1g & 2g (Ceftazidime for Injection 1g & 2g)
Ver 1.2
Page 2 of 11
_GRAM-NEGATIVE: _
_Pseudomonas aeruginosa _
Pseudomonas species (other)
_Klebsiella pneumoniae _
Klebsiella species (other)
_Proteus mirabilis _
_Proteus vulgaris _
_Morganella morganii _
(formerly
_Proteus morga