CEFTAZIDIME JUNO ceftazidime (as pentahydrate) 2g powder for injection vial

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Toimeaine:

ceftazidime pentahydrate, Quantity: 2.328 g (Equivalent: ceftazidime, Qty 2 g)

Saadav alates:

Juno Pharmaceuticals Pty Ltd

INN (Rahvusvaheline Nimetus):

ceftazidime pentahydrate

Ravimvorm:

Injection, powder for

Koostis:

Excipient Ingredients: sodium carbonate

Manustamisviis:

Intravenous

Ühikuid pakis:

Single Pack

Retsepti tüüp:

(S4) Prescription Only Medicine

Näidustused:

CEFTAZIDIME JUNO 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 ceftazidime, and as an alternative to aminoglycosides in pseudomonal infection in patients in whom aminoglycoside toxicity is a cause for concern and other 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, 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.

Toote kokkuvõte:

Visual Identification: White or cream coloured powder supplied in 50 mL capacity colourless, Type III glass vials, and sealed with Helvoet Pharma FM257/2 dark grey bromobutyl rubber stopper and dark green aluminium flip-off cap.; Container Type: Vial; Container Material: Glass Type III Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Volitamisolek:

Licence status A

Loa andmise kuupäev:

2006-09-19

Infovoldik

Page 1
CEFTAZIDIME JUNO
Ceftazidime (as pentahydrate) (ke-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
Ceftazidime
Juno.
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
Ceftazidime
Juno
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 CEFTAZIDIME
JUNO 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
CEFTAZIDIME JUNO
_WHEN YOU MUST NOT BE _
_GIVEN IT_
_ _
CEFTAZIDIME JUNO IF YOU HAVE
AN ALLERGY TO:
•
ceftazidime
• other cephalosporins
• any of the ingredients listed at
the end of this leaflet.
• lignocaine
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 IF YOU HAVE HAD A
SERIOUS ALLERGIC REACTION TO
PENICILLIN ANTIBIOTICS.
CEFTAZIDIME SHOULD NOT BE
MIXED WITH LIGNOCAINE AND
GIVEN TO YOU IF YOU HAVE HAD AN
ALLERGIC REACTION TO

Toote omadused

Juno Pharmaceuticals Pty Ltd
Australian Product Information
Page | 1
AUSTRALIAN PRODUCT INFORMATION
CEFTAZIDIME JUNO _(CEFTAZIDIME (AS PENTAHYDRATE)) _
_ _
1 NAME OF THE MEDICINE
Ceftazidime (as pentahydrate)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Ceftazidime Juno powder for injection is a cephalosporin antibiotic
for use by injection only.
Ceftazidime pentahydrate is slightly soluble in water and in methanol,
practically insoluble in
acetone and in ethanol. It dissolves in acid and alkali solutions.
Ceftazidime Juno is in vials containing 1 g and 2 g ceftazidime (as
pentahydrate). For the full
list of excipients, see Section 6.1 List of excipients.
For laboratory tests associated with ceftazidime administration,
ceftazidime pentahydrate
should be used.
3 PHARMACEUTICAL FORM
Ceftazidime Juno is a powder for injection and is a white or cream
coloured powder.
On the addition of water for injections, Ceftazidime Juno powder for
injection dissolves with
effervescence to produce a clear, colourless solution for injection.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ceftazidime Juno powder 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:
•
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 onl