Consumer medicine information

Ceftriaxone-AFT 500 mg Powder for injection

Ceftriaxone

BRAND INFORMATION

Brand name

Ceftriaxone-AFT

Active ingredient

Ceftriaxone

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Ceftriaxone-AFT 500 mg Powder for injection.

1. Why am I given Ceftriaxone-AFT?


Ceftriaxone-AFT contains the active ingredient ceftriaxone sodium. Ceftriaxone-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 given Ceftriaxone-AFT? in the full CMI.

2. What should I know before I am given Ceftriaxone-AFT?


You should not be given Ceftriaxone-AFT if you have ever had an allergic reaction to ceftriaxone sodium or penicillin.
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 am given Ceftriaxone-AFT? in the full CMI.

3. What if I am taking other medicines?


Some medicines and Ceftriaxone-AFT may interfere with each other.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How Ceftriaxone-AFT is Given?


Ceftriaxone-AFT will be given by either a doctor or nurse. It can be given either as a slow injection into a vein or as an injection into a large muscle. More instructions can be found in Section 4. How Ceftriaxone-AFT is given? in the full CMI.

5. What should I know while I am given Ceftriaxone-AFT?

Things you should do
  • If the symptoms of your infection do not improve within a few days or if they become worse, tell your doctor.
  • If you get severe diarrhea tell your doctor, nurse or pharmacist immediately even if occurs several weeks after Ceftriaxone-AFT has stopped.
  • Tell your doctor if you get a sore or white furry mouth or tongue or if you get vaginal itching or discharge. You may have a fungal infection called thrush.
Things you should not do
  • If you have diarrhea, do not take any medicine to stop the diarrhea without first checking with your doctor. Diarrhea may mean you have a serious condition affecting your bowel.
Driving or using machines
  • Be careful before you drive or use any machines or tools until you know how Ceftriaxone-AFT affects you. Ceftriaxone-AFT generally does not cause any problems with your ability to drive or operate machinery. However, Ceftriaxone-AFT may cause dizziness in some people.

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

6. Are there any side effects?


Like all medicines, Ceftriaxone-AFT can cause side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects. 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

Ceftriaxone-AFT

Active ingredient

Ceftriaxone

Schedule

S4

 

1 Name of Medicine

Ceftriaxone sodium, powder for injection.

2 Qualitative and Quantitative Composition

Ceftriaxone-AFT 500 mg: each vial contains ceftriaxone sodium equivalent to ceftriaxone 500 mg.
Ceftriaxone-AFT 1 g: each vial contains ceftriaxone sodium equivalent to ceftriaxone 1 g.
Ceftriaxone-AFT 2 g: each vial contains ceftriaxone sodium equivalent to ceftriaxone 2 g.
Ceftriaxone sodium is a white to yellowish orange crystalline powder which is readily soluble in water, sparingly soluble in methanol and very slightly soluble in ethanol. The pH of a 5% aqueous solution is approximately 6-8. The colour of ceftriaxone sodium solutions ranges from light yellow to amber, depending on the length of storage, concentration and diluent used.
Ceftriaxone-AFT contains approximately 83 mg (3.6 mEq) of sodium per gram of ceftriaxone activity.
For the full list of excipients, see Section 6.1.

3 Pharmaceutical Form

Powder for injection.

4 Clinical Particulars

4.9 Overdose

In the case of overdosage, drug concentration would not be reduced by haemodialysis or peritoneal dialysis.
There is no specific antidote. Treatment of overdosage should be symptomatic.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Genetic toxicity tests including the Ames test, a micronucleus test and a test for chromosomal aberrations in human lymphocytes cultured in vitro with ceftriaxone. Ceftriaxone showed no potential for mutagenic activity in these studies.
Carcinogenicity. Carcinogenicity studies with ceftriaxone in animals to determine the toxicity and carcinogenic potential of ceftriaxone have not been performed. The maximum duration of animal toxicity studies was 6 months.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. Ceftriaxone sodium has the chemical name sodium (Z)-(6R,7R)-7-[2-(2-amino- 1,3-thiazol-4-yl)-2-(methoxy-imino) acetamido]-8-oxo-3-[(2,5-dihydro-2-methyl-6-oxido-5-oxo-1,2,4-triazin-3-yl) thiomethyl]-5-thia-1-azabicyclo{4.2.0}oct-2-ene-2- carboxylate,hydrate (2:7). The structural formula is:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSCEFSOD.gif It has the chemical formula C18H16N8Na2O7S3, 3.5 H2O with a molecular weight of 661.6.
CAS number. The CAS number is 104376-79-6.

7 Medicine Schedule (Poisons Standard)

S4-Prescription Only Medicine.

Summary Table of Changes

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