CEFAZOLIN JUNO cefazolin (as sodium) 1g powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

cefazolin sodium, Quantity: 1048 mg (Equivalent: cefazolin, Qty 1000 mg)

Available from:

Juno Pharmaceuticals Pty Ltd

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients:

Administration route:

Intravenous, Intramuscular

Units in package:

5 vials, 10 vials

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Cephazolin Sodium Injection is indicated in the treatment of the following serious infections due to susceptible organisms: 1. Respiratory tract infections due to S. pneumoniae, Klebsiella species, 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 Sodium is effective in the eradication of streptococci from the nasopharynx; however, data establishing the efficacy of cephazolin sodium in the subsequent prevention of rheumatic fever are not available at present 2. Gentinourinary tract infections due to Esch. coli, Pr. mirabilis, Klebsiella species and some strains of Enterobacter and enterococci. 3. Skin and soft-tissue infections due to Staph. aureus (penicillin-sensitive and penicillin-resistant) and group A beta-haemolytic streptococci and other strains of streptococci. 4. Bone and joint infections due to Staph. aureus. 5. Septicaemia due to S. pneumoniae, Staph. aureus (penicillin-sensitive and penicillin- resistant), Pr. mirabilia, Esch. coli and Klebsiella species. 6. Endocarditis due to Staph. aureus (penicillin-sensitive and penicillin-resistant) and Group A beta-haemolytic streptococci. Appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organism to cephazolin sodium.

Product summary:

Visual Identification: A white or slightly yellow powder; Container Type: Vial; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1996-08-05

Patient Information leaflet

Page 1
CEFAZOLIN JUNO
Cefazolin Sodium (ke-f
ä
-z
ö
-lin)
_)_
_ _
_ _
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
Cefazolin Juno Powder for
Injection. 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 being given
cefazolin against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK
YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT CEFAZOLIN
JUNO IS
USED FOR
Cefazolin is an antibiotic used to
treat infections in different parts
of the body caused by bacteria.
Cefazolin will not work against
infections caused by viruses
such as colds or the flu.
This medicine belongs to a group
of antibiotics called
cephalosporins _(ke-fä-lö-spörins). _
_ _
It works by killing the bacteria
causing your infection or by
stopping its growth.
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.
This medicine is not addictive.
It is available only with a doctor’s
prescription.
BEFORE YOU ARE GIVEN
CEFAZOLIN JUNO
_WHEN YOU MUST NOT BE _
_GIVEN IT_
_ _
CEFAZOLIN JUNO IF YOU HAVE AN
ALLERGY TO:
• any medicine containing
cefazolin
• any other cephalosporin
antibiotics.
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.
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
ANY TYPES OF ALL

Summary of Product characteristics

Cefazolin Juno powder for injection
CEFAZOLIN JUNO POWDER FOR INJECTION
NAME OF THE MEDICINE
Cefazolin sodium
The molecular formula of cefazolin sodium is C
14
H
13
N
8
NaO
4
S
3
and the molecular weight is
476.5. The structural formula is shown below:
H
H
CH
2
CONH
N
O
S
COONa
CH
2
S
N
N
S
N
N
N
N
CH
3
Cefazolin sodium is the sodium salt of
3-[(5-Methyl-1,3,4-thiadiazol-2-yl)thiomethyl]-7-
(tetrazol-1-ylacetamido)-3-cephem-4-carboxylic acid.
CAS Registry Number 27164-46-1
DESCRIPTION
Cefazolin sodium is a semisynthetic cephalosporin antibiotic.
Cefazolin sodium occurs as a white to slightly yellow powder which may
have a faint odour.
The drug is freely soluble in water, 0.9% sodium chloride solution and
glucose solutions and
very slightly soluble in alcohol. A 10% solution in water has a pH of
4.5 to 6.0. When the
pH of a solution exceeds 8.5 there may be hydrolysis and when it is
below 4.5 insoluble
cefazolin may be precipitated.
Cefazolin Juno powder for injection is a powder for parenteral
administration following
reconstitution. Each vial contains cefazolin sodium equivalent to 500_
_mg of cefazolin or
cefazolin sodium equivalent of 1 g of cefazolin.
1.05_ _g of cefazolin sodium is approximately equivalent to 1_ _g of
cefazolin . Each gram of
cefazolin sodium contains 48.3_ _mg of sodium.
PHARMACOLOGY
Microbiology
_In vitro_ tests demonstrate that the bactericidal action of
cephalosporins results from
inhibition of cell wall synthesis. Cefazolin sodium 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).
Cefazolin Juno powder for injection
Streptococcus pneumoniae
Klebsiella species
Escherichia coli
Enterobacter aerogenes
Proteus mirabilis
Haemophilus influenzae
Most strains of Enterobacter cloacae and indole-positive Proteus (Pr.
vulgaris, Pr. morganii,
Pr. rettgeri) are resistant. Methicillin-resistant staphylococci,
Se