CEFAZOLIN-AFT cefazolin sodium 2 g powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

cefazolin sodium, Quantity: 2.097 mg

Available from:

AFT Pharmaceuticals Pty Ltd

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients:

Administration route:

Intramuscular, Intravenous

Units in package:

1 Vial, 5 Vials, 10 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: The drug product is white or almost white, very hygroscopic.; Container Type: Vial; Container Material: Glass Type II Clear; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2022-02-07

Patient Information leaflet

Cefazolin-AFT
1
CEFAZOLIN-AFT
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING CEFAZOLIN-AFT?
Cefazolin-AFT contains the active ingredient cefazolin sodium.
Cefazolin-AFT is an antibiotic used to treat infections in different
parts of the body caused by bacteria
For more information, see Section 1. Why am I using Cefazolin-AFT? in
the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE CEFAZOLIN-AFT?
Do not use if you have ever had an allergic reaction to Cefazolin-AFT
or any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Cefazolin-AFT? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Cefazolin-AFT and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE CEFAZOLIN-AFT?
Cefazolin-AFT must only be given by a doctor or nurse. Your doctor
will decide what dose and how long you will receive
Cefazolin-AFT.
More instructions can be found in Section 4. How do I use
Cefazolin-AFT? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING CEFAZOLIN-AFT?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Cefazolin-AFT.
•
If you get a sore white mouth or tongue or if you get a severe
diarrhoea, tell your doctor, pharmacist
or nurse immediately.
DRIVING OR USING
MACHINES
•
Cefazolin-AFT may cause dizziness in some people. Make sure you know
how you react to Cefazolin-
AFT before you drive a car, operate machinery or do anything else that
may be dangerous if you are
affected.
LOOKING AFTER
YOUR MEDICINE

Cefazolin-AFT will be stored in the pharmacy or on the ward. The
powder for injection is kept in a
cool, dr

Summary of Product characteristics

Page 1 of 14
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 almost white crystalline powder with a
solubility in water of greater than
or equal to 100 mg/mL. Cefazolin-AFT powder for injection contains
cefazolin sodium as a single
ingredient.
The sodium content is 50 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 2 g 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 14
•
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