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

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ceftazidime pentahydrate, Quantity: 1.16 g

Available from:

AFT Pharmaceuticals Pty Ltd

INN (International Name):

ceftazidime pentahydrate

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: sodium carbonate

Administration route:

Intravenous, Intramuscular

Units in package:

1 vial, 10 vials, 5 vials

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Ceftazidime-AFT 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: ? Severe infections in general: for example septicaemia, including neonatal sepsis, bacteraemia, and in patients in intensive care units with specific problems, eg, 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 almost white crystalline powder; Container Type: Vial; Container Material: Glass; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2017-09-22

Patient Information leaflet

Ceftazidime-AFT
_Ceftazidime Powder for Injection 1g and 2g _
_Consumer Medicine Information _
WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully before you use Ceftazidime-AFT.
This leaflet answers some common questions about Ceftazidime-AFT. It
does not contain all
of the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Sometimes new risks are found
even when a medicine
has been used for many years. Your doctor has weighed the expected
benefits of you taking
Ceftazidime-AFT against the risks this medicine could have for you.
If you have any concerns about taking this medicine, ask your doctor
or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
WHAT IS CEFTAZIDIME-AFT USED FOR?
Ceftazidime-AFT belongs to a group of medicines called cephalosporins.
Ceftazidime-AFT is used to treat a wide range of infections caused by
bacteria. These
infections may affect the chest (bronchitis or pneumonia), ears, nose,
throat, bladder and
urinary tract, skin and soft tissue, stomach or bones.
Ceftazidime-AFT works by killing the bacteria that cause these
infections.
Your doctor may have prescribed Ceftazidime-AFT for another reason.
There is no evidence that Ceftazidime-AFT injection is addictive.
BEFORE YOU ARE GIVEN CEFTAZIDIME-AFT
WHEN YOU MUST NOT BE GIVEN IT:
You must not be given Ceftazidime-AFT if:
•
you have ever had an allergic reaction to cephalosporins, penicillins
or any of the
ingredients listed toward the end of this leaflet. (See "Ingredients")
•
the expiry date (EXP) printed on the pack has passed.
•
the packaging is torn or shows signs of tampering
TELL YOUR DOCTOR IF:
You must tell your doctor if:
•
you are allergic to foods, dyes, preservatives or any other medicines
(in particular
cephalosporins, penicillins, chloramphenicol or lignocaine)
•
you
are
taking
any
other
medicines,
including
medicines
you
buy
without
a
prescription
•
you are taking oral contraceptives (birth control p

Summary of Product characteristics

Page 1 of 14
AUSTRALIAN PRODUCT INFORMATION
CEFTAZIDIME-AFT (CEFTAZIMIDE PENTAHYDRATE) POWDER
FOR INJECTION
1.
NAME OF THE MEDICINE
Ceftazidime (as pentahydrate)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ceftazidime-AFT 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,
Ceftazidime-AFT Injection dissolves with effervescence to produce a
solution for injection.
Ceftazidime-AFT
Injection
contains
approximately
52
mg
(2.3
mEq)
of
sodium
per
gram
of
ceftazidime. 1.16 g ceftazidime pentahydrate is equivalent to 1g
ceftazidime free acid. For laboratory
tests associated with ceftazidime administration, ceftazidime
pentahydrate should be used.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
The drug product is white or almost white crystalline powder.
Powder for injection
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ceftazidime-AFT 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:
•
_SEVERE INFECTIONS IN GENERAL_
: for example septicaemia, including neonatal sepsis, bacteraemia,
and in patients in intensive care units with specific problems, eg,
infected burns.
•
_RESPIRATORY TRACT INFECTIONS_
: for example, pneumonia, broncho-pneumonia, infected pleurisy,
infected bronchiectasis and bronchitis.
Page 2 of 14
•
_SEVERE EAR, NOSE AND THROAT INFECTIONS_
: for example, otitis media, mastoiditis.
•
_URINARY TRACT INFECTIONS_
: for example, acute and chronic pyelonephritis, pyelitis, cystitis,
urethritis (bacterial