DBL CEFOTAXIME SODIUM for injection 1g vial

País: Austràlia

Idioma: anglès

Font: Department of Health (Therapeutic Goods Administration)

ingredients actius:

cefotaxime sodium, Quantity: 1.048 g

Disponible des:

Pfizer Australia Pty Ltd

formulario farmacéutico:

Injection, powder for

Composición:

Excipient Ingredients:

Vía de administración:

Intravenous, Intramuscular

Unidades en paquete:

10 vials, 1 vial

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

INDICATIONS: Cefotaxime is indicated for the treatment of the following types of injection when caused by susceptible micro-organisms: Infections of the respiratory tract (upper and lower). Infections of the urinary tract. Septicaemia - concomitant therapy with an aminoglycoside may be instituted prior to isolation of the causative organism. Intra-abdominal infection. Gonorrhoea (including gonorrhoea caused by beta lactamase producing strains of N. gonorrhoeae). Ear, nose and throat infections. Skin and skin structure infections. Bone and joint infections. Meningitis - cefotaxime should be combined with an appropriate alternative antibiotic (ampicillin, chloramphenicol or pencillin G) for initial therapy in children, (excluding neonates) pending the availability of culture and sensitivity results. In adults, the empirical use of cefotaxime should be restricted to patients suspected of having meningitis caused by Gram negative enteric bacilli. Cefotaxime may be used for the prevention of post-operative infection in obstetrical surgery, vaginal and abdominal hysterectomy and biliary surgery. In serious cases, cefotaxime may be used, if considered appropriate,before the results of sensitivity tests become available. The emergency of resistance to cefotaxime may complicate treatment.

Resumen del producto:

Visual Identification: Clear glass vial containing a white to pale yellow crystalline powder.; Container Type: Vial; Container Material: Glass Type III Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Estat d'Autorització:

Licence status A

Data d'autorització:

2001-08-22

Informació per a l'usuari

DBL CEFOTAXIME SODIUM™
1
DBL™ CEFOTAXIME
SODIUM
_cefotaxime sodium (kef-oh-TACK-sim SO-dee-uhm) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about DBL Cefotaxime
Sodium. 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 DBL
Cefotaxime Sodium 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 DBL CEFOTAXIME
SODIUM IS USED FOR
DBL Cefotaxime Sodium is an
antibiotic used to treat infections of
the:
•
kidneys and bladder
•
blood (septicaemia)
•
skin and flesh immediately under
the skin
•
bones
•
heart valves
•
brain (meningitis)
•
abdomen (peritonitis)
•
some sexually transmitted
infections (gonorrhoea).
It is also used to prevent infections
before, during and after surgery.
Cefotaxime will not work against
infections caused by viruses such as
colds or the flu.
Cefotaxime belongs to a group of
antibiotics called cephalosporins
(kef-a-loe-SPOR-ins). These
antibiotics work by killing the
bacteria that are causing your
infection.
Your doctor may have prescribed
cefotaxime for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY CEFOTAXIME
HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
DBL Cefotaxime Sodium is not
addictive.
BEFORE YOU ARE GIVEN
DBL CEFOTAXIME
SODIUM
_WHEN YOU MUST NOT BE GIVEN _
_IT _
DBL CEFOTAXIME SODIUM SHOULD
NOT BE GIVEN TO YOU IF YOU HAVE AN
ALLERGY TO:
•
cefotaxime
•
any similar medicines known as
cephalosporins
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.
CEFOTAXIME SHOULD NOT BE GIVEN TO

Fitxa tècnica

Version: pfpcefov11120
Supersedes: pfpcefov10619
Page 1 of 16
AUSTRALIAN
PRODUCT
INFORMATION
–
DBL
™
CEFOTAXIME SODIUM FOR INJECTION
(CEFOTAXIME SODIUM)
1.
NAME OF THE MEDICINE
Cefotaxime sodium.
2.
QUALITATIVE AND QUANTITATIVE COMPOSTION
Each vial of DBL Cefotaxime Sodium contains 1 or 2 g cefotaxime
sodium.
Each gram of cefotaxime contains approximately 48 mg (2.09 mmol) of
sodium.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Powder for injection.
DBL Cefotaxime Sodium is a white to pale yellow crystalline powder.
The reconstituted product is a pale yellow solution. Raising the pH
(by addition of strong base)
will result in an intense yellow colour and possible degradation.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
DBL Cefotaxime Sodium is indicated for the treatment of the following
types of infection when
caused by susceptible micro-organisms:
•
infections of the respiratory tract (upper and lower)
•
infections of the urinary tract
•
septicaemia - concomitant therapy with an aminoglycoside may be
instituted prior to
isolation of the causative organism
•
intra-abdominal infection
•
gonorrhoea (including gonorrhoea caused by beta lactamase producing
strains of
_N. _
_gonorrhoeae_
)
•
ear, nose and throat infections
•
skin and skin structure infections
•
bone and joint Infections
•
meningitis. Cefotaxime should be combined with an appropriate
alternative antibiotic
(ampicillin, chloramphenicol or penicillin G) for initial therapy in
children (excluding
neonates) pending the availability of culture and sensitivity results.
In adults, the empirical
use of cefotaxime should be restricted to patients suspected of having
meningitis caused by
Gram negative enteric bacilli.
Version: pfpcefov11120
Supersedes: pfpcefov10619
Page 2 of 16
Cefotaxime may be used for the prevention of post operative infection
in obstetrical surgery,
vaginal and abdominal hysterectomy and biliary surgery.
In serious cases, cefotaxime may be used, if considered appr