CEFAZOLIN-AFT cefazolin sodium 0.5 g powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

cefazolin sodium, Quantity: 0.524 g

Available from:

AFT Pharmaceuticals Pty Ltd

INN (International Name):

cefazolin sodium

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients:

Administration route:

Intramuscular, Intravenous

Units in package:

10 vials, 1 vial, 5 vials

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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. Cefazolin is effective in the eradication of Streptococci from the nasopharynx; however, data establishing the efficacy of cefazolin in the subsequent prevention of rheumatic fever are not available at present; - Genitourinary tract infections due to E. coli, P. mirabilis, Klebsiella sp. and some strains of Enterobacter and enterococci; - Skin and skin structure infections due to Staph. aureus (penicillin sensitive and penicillin resistant), 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), P. mirabilis, E. coli and Klebsiella sp.; - 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 cefazolin.

Product summary:

Visual Identification: White to almost-white powder; Container Type: Vial; Container Material: Glass Type II Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2011-11-24

Patient Information leaflet

1
Cefazolin-AFT 500 mg and 1 g powder for injection vials
Cefazolin sodium
CONSUMER MEDICINE INFORMATION
What is in this leaflet
This leaflet answers some common questions about Cefazolin-AFT.
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-AFT 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-AFT is used for
Cefazolin-AFT is an antibiotic used to treat infections in different
parts of the body
caused by bacteria.
Cefazolin-AFT will not work against infections caused by viruses such
as colds or the
flu.
Cefazolin-AFT belongs to a group of antibiotics called cephalosporins.
These
antibiotics work by killing the bacteria that are causing your
infection.
Ask your doctor if you have any questions about why Cefazolin-AFT has
been
prescribed for you. Your doctor may have prescribed Cefazolin-AFT for
another
reason.
Cefazolin-AFT is available only with a doctor's prescription. It is
not addictive.
Before you are given Cefazolin-AFT
When you must not be given Cefazolin-AFT
Do not use Cefazolin-AFT if:
1.
you have an allergy to the active ingredient, cefazolin 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-AFT
if you are
allergic to penicillin medicines.
2
Do not use Cefazolin-AFT if the packaging is torn or shows signs of
tampering.
Do not use Cefazolin-AFT after the expiry date on the pack has passed.
If you are not sure whether you should be given Cefazol

Summary of Product characteristics

Page 1 of 13
AUSTRALIAN PRODUCT INFORMATION
CEFAZOLIN-AFT (CEFAZOLIN SODIUM) POWDER FOR
INJECTION
1.
NAME OF THE MEDICINE
Cefazolin sodium
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cefazolin sodium is a white to off-white crystalline powder with a
solubility in water of greater than or
equal to 100mg/mL. Cefazolin-AFT powder for injection contains
cefazolin sodium as a single
ingredient.
The sodium content is 48 mg/g of cefazolin sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
White to almost white powder for injection which reconstitutes with
Sterile Water for Injection to give
a colourless solution.
This powder for injection is supplied in vials containing cefazolin
sodium equivalent to 500 mg and 1g
cefazolin.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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. Cefazolin
is effective in the eradication of Streptococci from the nasopharynx;
however, data establishing
the efficacy of cefazolin in the subsequent prevention of rheumatic
fever are not available at
present.
•
Genitourinary tract infections due to E. coli, P. mirabilis,
Klebsiella sp. and some strains of
Enterobacter and enterococci.
Page 2 of 13
•
Skin and skin structure infections due to Staph. aureus (penicillin
sensitive and penicillin
resistant) 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), P. mirabilis, E. coli and Klebsiella sp.
•
Endocarditis due to Staph. aureus (penicillin sen