CEFAZOLIN SANDOZ cefazolin 2g (as sodium) powder for injection infusion bottle

País: Austràlia

Idioma: anglès

Font: Department of Health (Therapeutic Goods Administration)

ingredients actius:

cefazolin sodium, Quantity: 2096 mg (Equivalent: cefazolin, Qty 2000 mg)

Disponible des:

Sandoz Pty Ltd

formulario farmacéutico:

Injection, powder for

Composición:

Excipient Ingredients:

Vía de administración:

Oral

Unidades en paquete:

1 infusion bottle, 10 infusion bottles, 5 infusion bottles

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

Treatment of the following serious infections due to susceptible organisms: Respiratory tract infections due to Strep. pneumoniae, Klebsiella sp., H. influenzae, Staph. aureus (penicillin sensitive and penicillin resistant) and group A beta-haemolytic streptococci. Injectable benzathine penicillin is considered to be the drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephazolin is effective in the eradication of streptococci from the nasopharynx; however, data establishing the efficacy of cephazolin in the subsequent prevention of rheumatic fever are not available at present. Genitourinary tract infections due to E. coli, P. mirabilis, and klebsiella sp. and some strains of enterobacter and enterococci. Skin and skin structure infections due to Staph. aureus (penicillin sensitive and penicillin resisant) and group A beta-haemolytic streptococci and other strains of streptococci. Bone and joint infections due to Staph. aureus. Septicaemia due to Strep. pneumoniae, Staph. aureus (penicillin sensitive and penicillin resistant), E. coli, P. mirabilis, and klebsiella sp. Endocarditis due to staph. aureus (penicillin sensitive and penicillin resistant) and group A beta-haemolytic streptococci. NOTE: Appropriate culture and susceptibility studies should be preformed to determine susceptibility of the causative organism to cephazolin.

Resumen del producto:

Visual Identification: Clear glass infusion bottle containing a white to slightly yellowish powder.; Container Type: Bottle; Container Material: Glass Type II Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Estat d'Autorització:

Registered

Data d'autorització:

2004-05-05

Informació per a l'usuari

CEFAZOLIN SANDOZ
®
_Cephazolin sodium powder for injection_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Cefazolin Sandoz.
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 using Cefazolin
Sandoz against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT CEFAZOLIN
SANDOZ IS USED
FOR
The name of your medicine is
Cefazolin Sandoz. It contains the
active ingredient cephazolin sodium.
Cefazolin Sandoz is an antibiotic
used to treat infections in different
parts of the body caused by bacteria.
Cefazolin Sandoz belongs to a group
of antibiotics called cephalosporins.
These antibiotics work by killing the
bacteria that are causing your
infection.
Your doctor may have prescribed
Cefazolin Sandoz for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY CEFAZOLIN
SANDOZ HAS BEEN PRESCRIBED FOR
YOU.
Cefazolin Sandoz is available only
with a doctor's prescription. It is not
addictive.
BEFORE YOU ARE
GIVEN CEFAZOLIN
SANDOZ
_WHEN YOU MUST NOT BE GIVEN_
_CEFAZOLIN SANDOZ_
DO NOT USE CEFAZOLIN SANDOZ IF:
1.
YOU HAVE AN ALLERGY TO THE
ACTIVE INGREDIENT, CEPHAZOLIN
SODIUM, OR TO ANY OTHER
CEPHALOSPORINS
Some of the symptoms of an
allergic reaction may include
asthma, wheezing, shortness of
breath, swelling of the face, lips
or tongue which may cause
difficulty in swallowing or
breathing, skin rash, itching or
hives.
2.
YOU HAVE HAD A SERIOUS ALLERGIC
REACTION TO ANY PENICILLINS.
You may be more likely to have
an allergic reaction to Cefazolin
Sandoz if you are allergic to
penicillin medicines.
DO NOT USE CEFAZOLIN SANDOZ IF THE
PACKAGING IS TORN OR SHOWS SIGNS OF
TAMPERING.
DO NOT USE CEFAZOLIN SANDOZ AFTER
THE EXPIRY DATE ON THE PACK HAS
PASSED.
IF YOU ARE NOT S

Fitxa tècnica

_Product Information (Registered Version) _
_ _
_Page 1 _
_Cefazolin Sandoz 1g & 2g powder for injection _
_03/2012 _
_Sandoz Pty Ltd _
_ _
_Version 05 _
_ _
_ _
_ _
_ _
_ _
_CEFAZOLIN SANDOZ_
_®_
_ _
NAME OF THE MEDICINE
_Active_: Cephazolin sodium; sodium content is 48.3mg/g of cephazolin
sodium
_Chemical structure of cephazolin sodium _
_Chemical name_:
(_6R,7R_)-3-[(5-methyl-1,3,4-thiadiazol-2-yl)thiomethyl]-8-oxo-7-[2-(1_H_-tetrazol-1-yl)
acetamido]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate.
_Molecular formula: _
C
14
H
13
N
8
NaO
4
S
3
_Molecular weight: _
476.5
_CAS: _
_ _
_ _
27164-46-1_ _
_ _
DESCRIPTION
Cephazolin sodium is a white to off-white crystalline powder with a
solubility in water of
greater
than
or
equal
to
100mg/mL.
Cefazolin
Sandoz
powder
for
injection
contains
cephazolin sodium as a single ingredient.
PHARMACOLOGY
_PHARMACODYNAMICS _
Semi-synthetic cephalosporin for parenteral administration.
Microbiology
_In vitro_ tests demonstrate that the bactericidal action of
cephalosporins results from inhibition
of
cell
wall
synthesis.
Cephazolin
is
active
against
the
following
organisms
_in _
_vitro_:
_Staphylococcus aureus_ (penicillin sensitive and penicillin
resistant); group A beta-haemolytic
streptococci and other strains of streptococci (many strains of
enterococci are resistant);
_Streptococcus pneumoniae_, _ Escherichia coli_, _ Proteus mirabilis,_
Klebsiella sp., _ Enterobacter _
_aerogenes_, _Haemophilus influenzae_. Most strains of _Enterobacter
cloacae_ and indole-positive
proteus (_P. vulgaris, P. morganii, P. rettgeri_) are resistant.
Methicillin resistant staphylococci,
serratia, pseudomonas, _ Acinetobacter calcoaceticus_ (formerly Mima
and Herellea sp.) are
almost uniformly resistant to cephazolin.
_Susceptibility tests _
Dilution or diffusion techniques – either quantitative (MIC) or
breakpoint, should be used
following
a
regularly
updated,
recognised
and
standardised
method
(e.g.
NCCLS).
Standardised
susceptibility
test
procedures
require
the
use
of
laboratory
control