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

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Toimeaine:

ceftazidime pentahydrate, Quantity: 1164.8 mg (Equivalent: ceftazidime, Qty 1 g)

Saadav alates:

Fresenius Kabi Australia Pty Ltd

INN (Rahvusvaheline Nimetus):

ceftazidime pentahydrate

Ravimvorm:

Injection, powder for

Koostis:

Excipient Ingredients: sodium carbonate

Manustamisviis:

Intramuscular, Intravenous Bolus

Ühikuid pakis:

5, 10, 1

Retsepti tüüp:

(S4) Prescription Only Medicine

Näidustused:

Ceftazidime 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: - Sever infections in general: for expample septicaemia (including neonatal sepsis), bacteraemia, patients in intensive care units with specific problems, e.g infected burns. - Respiratory tract infections: for example, pneumonia, broncho-pneumonia, infected pleurisy, infected bronchiectasis, bronchitis. - Sever ear, nose and throat infections: for example, otitis media, mastoiditis. - Urinary tract infections: for example, acute and chronic pyelonephritis, pyelitis, cystitis, urethritis (bacterial only), 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.

Toote kokkuvõte:

Visual Identification: Sterile, white to pale yellow powder; Container Type: Vial; Container Material: Glass Type II Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Volitamisolek:

Licence status A

Loa andmise kuupäev:

2015-07-02

Infovoldik

Page 1 of 3
CEFTAZIDIME KABI
Ceftazidime (as pentahydrate)
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Ceftazidime Kabi.
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 taking Ceftazidime
Kabi
against
the
benefits
they
expect it will 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 CEFTAZIDIME KABI
IS USED FOR
Ceftazidime Kabi 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.
This medicine belongs to a group
of medicines called cephalosporins.
It works by killing the bacteria that
cause these infections.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS
ABOUT
WHY
THIS
MEDICINE
HAS
BEEN
PRESCRIBED
FOR YOU.
Your doctor may have prescribed it
for another reason.
Ceftazidime Kabi is available only
with a doctor's prescription.
Ceftazidime Kabi is not addictive.
BEFORE
YOU
ARE
GIVEN
CEFTAZIDIME KABI
_WHEN YOU MUST NOT BE GIVEN IT _
YOU
MUST
NOT
BE
GIVEN
CEFTAZIDIME
KABI
IF
YOU
HAVE
EVER HAD AN ALLERGIC REACTION TO:
•
any
medicine
containing
cephalosporins or penicillins
• any of the ingredients listed at the
end of this leaflet.
Some
of
the
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.
YOU
MUST
NOT
BE
GIVEN
THIS
MEDICINE
AFTER
THE
EXPIRY
DATE
PRINTED
ON
THE
PACK
OR
IF
THE
PACKAGING
IS
TORN
OR
SHOWS
SIGNS OF TAMPERING.
IF YOU ARE NOT SURE WHETHER YOU
SHOULD BE GIVEN THIS MEDICINE,
TALK TO YOUR DOCTOR.
_BEFORE YOU ARE GIVEN IT _
TELL
YOUR
DOCTOR
IF
YOU
HAVE
ALLERGIES TO ANY OTHER MEDIC

Toote omadused

AUSTRALIAN PRODUCT INFORMATION- CEFTAZIDIME KABI
(CEFTAZIDIME AS PENTAHYDRATE)
Page 1 of 14
1 NAME OF MEDICINE
Ceftazidime (as pentahydrate)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
CEFTAZIDIME KABI powder for injection contains either 1 g or 2 g of
ceftazidime (as
pentahydrate).
Ceftazidime Kabi contains approximately 52.5 mg (2.3 mEq) of sodium
per gram of
ceftazidime. 1.164g ceftazidime pentahydrate is equivalent to 1 g
ceftazidime free acid.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3 PHARMACEUTICAL FORM
Powder for injection.
Supplied as a white to pale yellow powder. On the addition of Water
for Injections,
Ceftazidime Kabi dissolves with effervescence to produce a solution
for injection.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ceftazidime 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, patients in intensive care units with specific problems,
e.g. infected burns.

RESPIRATORY TRACT INFECTIONS: for example, pneumonia,
broncho-pneumonia, infected
pleurisy, infected bronchiectasis, 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), 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, osteom