Consumer medicine information

Cefazolin-AFT 2 g Powder for injection

Cefazolin

BRAND INFORMATION

Brand name

Cefazolin-AFT 2 g

Active ingredient

Cefazolin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Cefazolin-AFT 2 g Powder for injection.

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, dry place, protected from light, where the temperature stays below 25°C (Cefazolin-AFT 500 mg and 1 g) or 30°C (Cefazolin-AFT 2 g).

For more information, see Section 5. What should I know while using Cefazolin-AFT? in the full CMI.

6. Are there any side effects?


The common side effects of Cefazolin-AFT are oral thrush, vaginal thrush, diarrhoea, nausea and vomiting. The more serious side effects of Cefazolin-AFT are skin rash, itching or hives, swelling of the face, lips or tongue which may cause difficulty swallowing or breathing, wheezing or shortness of breath, bleeding or bruising more easily than normal, severe abdominal cramps or stomach cramps, watery and severe diarrhoea, which may also be bloody and signs of frequent infections such as fever, severe chills, sore throat or mouth ulcers.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

BRAND INFORMATION

Brand name

Cefazolin-AFT 2 g

Active ingredient

Cefazolin

Schedule

S4

 

1 Name of Medicine

Cefazolin sodium.

2 Qualitative and Quantitative Composition

Cefazolin-AFT is supplied in vials containing cefazolin sodium equivalent to 500 mg, 1 g and 2 g cefazolin.
The sodium content is 50 mg/g of cefazolin sodium.
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.
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.

4 Clinical Particulars

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).
Signs and symptoms. Toxic signs and symptoms following an overdose of cefazolin may include pain, inflammation and phlebitis at the injection site.
The administration of inappropriately large doses of parenteral cephalosporins may cause dizziness, paraesthesias and headaches. Seizures may occur following overdosage with some cephalosporins, particularly in patients with renal impairment, in whom accumulation is likely to occur.
Laboratory abnormalities may include elevations in creatinine, serum urea, liver enzymes and bilirubin, a positive Coombs' test, thrombocytosis, thrombocytopenia, eosinophilia, leucopenia and prolongation of the prothrombin time.
Treatment. In managing overdosage, the possibility of multiple drug overdoses, interaction among drugs and unusual drug kinetics should be considered.
If seizures occur, the drug should be discontinued promptly; anticonvulsant therapy may be administered if clinically indicated. Protect the patient's airway and support ventilation and perfusion. Meticulously monitor and maintain, within acceptable limits, the patient's vital signs, blood gases, serum electrolytes, etc.
In cases of severe overdosage, especially in a patient with renal failure, combined haemodialysis and haemoperfusion may be considered if response to more conservative therapy fails. However, no data supporting such therapy are available.

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. No data available.
Carcinogenicity. Long-term studies in animals to determine the carcinogenic potential of cefazolin have not been performed.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSCEFASO.gif Chemical name: sodium (6R, 7R)-3-[[5-methyl-1,3,4- thiadiazol-2-yl)sulphanyl]methyl]-8- oxo-7-[(1H-tetrazol-1-ylacetyl)amino]-5- thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate.
Molecular formula: C14H13N8NaO4S3.
Molecular weight: 476.5.
CAS number. 27164-46-1.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/CEFAFTST.gif