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

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

מרכיב פעיל:

ceftazidime pentahydrate, Quantity: 2.328 g

זמין מ:

Alphapharm Pty Ltd

INN (שם בינלאומי):

ceftazidime pentahydrate

טופס פרצבטיות:

Injection, powder for

הרכב:

Excipient Ingredients: sodium carbonate

מסלול נתינה (של תרופות):

Intravenous Infusion, Intravenous Bolus

יחידות באריזה:

Packs of 10 vials, Packs of 1 vial

סוג מרשם:

(S4) Prescription Only Medicine

סממני תרפויטית:

Ceftazidime Viatris 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.

leaflet_short:

Visual Identification: White or almost white, crystalline powder.; Container Type: Vial; Container Material: Glass Type III Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

מצב אישור:

Licence status A

תאריך אישור:

2010-05-21

עלון מידע

CEFTAZIDIME
ALPHAPHARM
_ceftazidime (as pentahydrate)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
This leaflet answers some common
questions about CEFTAZIDIME
Alphapharm.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you being given
CEFTAZIDIME Alphapharm against
the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, TALK TO
YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT CEFTAZIDIME
ALPHAPHARM IS USED
FOR?
CEFTAZIDIME Alphapharm 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 Alphapharm is
available only with a doctor's
prescription.
CEFTAZIDIME Alphapharm is not
addictive.
BEFORE YOU ARE GIVEN
CEFTAZIDIME
ALPHAPHARM
_WHEN YOU MUST NOT BE GIVEN_
_IT_
YOU MUST NOT BE GIVEN
CEFTAZIDIME ALPHAPHARM 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 DO

מאפייני מוצר

AUSTRALIAN PRODUCT INFORMATION
CEFTAZIDIME ALPHAPHARM
_Ceftazidime pentahydrate powder for injection _
1
NAME OF THE MEDICINE
Ceftazidime pentahydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ceftazidime Alphapharm is supplied in vials containing 1 g and 2 g of
ceftazidime (as pentahydrate).
116.4 mg ceftazidime pentahydrate is equivalent to 100 mg ceftazidime
free acid.
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
Ceftazidime Alphapharm is a powder for injection and is a white or
almost white, crystalline powder.
On the addition of water for injections, Ceftazidime Alphapharm
dissolves with effervescence to produce a
solution for injection. Ceftazidime Alphapharm containing 1 g of
ceftazidime (as pentahydrate) is for
intramuscular or intravenous use. Ceftazidime Alphapharm containing 2
g ceftazidime (as pentahydrate) is for
intravenous use.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ceftazidime Alphapharm 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
only), and infections associated with bladder and renal stones.
SKIN AND SOFT TISSUE INFECTIONS:
for example, erysipelas, abscesses, cellulitis, infected burns and
woun