CEFTAZIDIME SANDOZ ceftazidime 1g (as pentahydrate) powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ceftazidime pentahydrate, Quantity: 1164.8 mg (Equivalent: ceftazidime, Qty 1000 mg)

Available from:

Sandoz Pty Ltd

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: sodium carbonate

Administration route:

Intravenous, Intramuscular

Units in package:

5 vials, 10 vials, 1 vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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

Product summary:

Visual Identification: Clear glass vial with aluminium cap and plastic "flip-offs" containing a white to cream powder.; Container Type: Vial; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2003-06-05

Patient Information leaflet

CEFTAZIDIME SANDOZ
®
190129-cmi
1
CEFTAZIDIME SANDOZ
®
_ceftazidime pentahydrate powder for injection _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Ceftazidime Sandoz.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using Ceftazidime
Sandoz against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT CEFTAZIDIME
SANDOZ IS USED FOR
The name of your medicine is
Ceftazidime Sandoz. It contains the
active ingredient ceftazidime
pentahydrate.
Ceftazidime Sandoz is an antibiotic
used to treat infections in different
parts of the body caused by bacteria.
Ceftazidime Sandoz 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 Sandoz for another
reason. Ask your doctor if you have
any questions about why Ceftazidime
Sandoz has been prescribed for you.
Ceftazidime Sandoz is available only
with a doctor's prescription.
Ceftazidime Sandoz is not addictive.
BEFORE YOU ARE GIVEN
CEFTAZIDIME SANDOZ
_WHEN YOU MUST NOT BE GIVEN _
_IT _
DO NOT USE CEFTAZIDIME SANDOZ IF:
1.
YOU HAVE AN ALLERGY TO
CEFTAZIDIME, ANY OF THE
INGREDIENTS LISTED AT THE END OF
THIS LEAFLET, OR ANY OTHER
CEPHALOSPORINS
Some of the symptoms of an
allergic reaction may include
wheezing, shortness of breath,
swelling of the face, lips or
tongue which may cause
difficulty in swallowing or
breathing, skin rash, itching or
hives.
2.
YOU HAVE HAD A SERIOUS ALLERGIC
REACTION TO ANY PENICILLINS
You may be more likely to have
an allergic reaction to
Ceftazidime Sandoz if you are
allergic to penicillin medicines.
DO NOT USE CEFTAZIDIME SANDOZ IF
THE PACKAGING IS TORN OR SHOWS
SIGNS OF TA

Summary of Product characteristics

190129-Ceftazidime Sandoz -pi
Page 1 of 12
AUSTRALIAN PRODUCT INFORMATION
CEFTAZIMIDE SANDOZ
® 1G POWDER FOR INJECTION (CEFTAZIMIDE
PENTAHYDRATE)
1
NAME OF THE MEDICINE
Ceftazidime (as pentahydrate)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ceftazidime Sandoz
®
is a cephalosphorin antibiotic containing ceftazidime pentahydrate, a
white to faintly yellow crystalline powder, soluble in acid and alkali
solution; slightly soluble
in water and in methanol; practically insoluble in acetone and in
alcohol. On addition of water
for injections, Ceftazidime Sandoz
®
dissolves with effervescence to produce a solution for use
by injection only.
For laboratory tests associated with ceftazidime administration,
ceftazidime pentahydrate
should be used.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Vial (powder for reconstitution): 1 g (for IM or IV use)
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Treatment of single and mixed infections caused by susceptible aerobic
organisms with
suspected or documented resistance to other antimicrobials, but not to
ceftazidime; as an
alternative to aminoglycosides in pseudomonal infection in patients in
whom aminoglycoside
toxicity is a cause for concern and other antipseudomonal antibiotics
cannot be used.
Ind
ications include the following:
•
_SEVERE INFECTIONS IN GENERAL_
(e.g.
_ _
septicaemia including neonatal sepsis, bacteraemia;
in patients in intensive care units with specific problems, e.g.
infected burns)
_. _
•
_RESPIRATORY TRACT_
(e.g. pneumonia, bronchopneumonia, infected pleurisy, infected
bronchiectasis and bronchitis)
_. _
•
_SEVERE EAR, NOSE AND THROAT INFECTIONS_
(e.g.
_ _
otitis media, mastoiditis).
_ _
•
_URINARY TRACT _
(e.g.
_ _
acute and chronic pyelonephritis, pyelitis, cystitis, urethritis -
bacterial only; infections associated with bladder and renal stones).
•
_SKIN AND SOFT TISSUE_
(e.g. erysipelas, abscesses, cellulitis, infected burns and wounds,
mastitis).
•
_GASTROINTESTINAL AND ABDOMINAL_
(e.g