Consumer medicine information

Ceftriaxone Viatris 2 g Powder for injection

Ceftriaxone

BRAND INFORMATION

Brand name

Ceftriaxone Viatris

Active ingredient

Ceftriaxone

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Ceftriaxone Viatris 2 g Powder for injection.

1. Why am I given CEFTRIAXONE VIATRIS?


CEFTRIAXONE VIATRIS contains the active ingredient ceftriaxone sodium. CEFTRIAXONE VIATRIS 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 VIATRIS? in the full CMI.

2. What should I know before I am given CEFTRIAXONE VIATRIS?


You should not be given CEFTRIAXONE VIATRIS 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 VIATRIS? in the full CMI.

3. What if I am taking other medicines?


Some medicines and CEFTRIAXONE VIATRIS 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 VIATRIS is given?


CEFTRIAXONE VIATRIS 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 VIATRIS is given? in the full CMI.

5. What should I know while I am given CEFTRIAXONE VIATRIS?

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 diarrhoea tell your doctor, nurse or pharmacist immediately even if occurs several weeks after CEFTRIAXONE VIATRIS 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 diarrhoea, 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 VIATRIS affects you. CEFTRIAXONE VIATRIS generally does not cause any problems with your ability to drive or operate machinery. However, CEFTRIAXONE VIATRIS may cause dizziness in some people.

For more information, see Section 5. What should I know while I am given CEFTRIAXONE VIATRIS? in the full CMI.

6. Are there any side effects?


Like all medicines, CEFTRIAXONE VIATRIS 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 Viatris

Active ingredient

Ceftriaxone

Schedule

S4

 

1 Name of Medicine

Ceftriaxone sodium.

2 Qualitative and Quantitative Composition

Each Ceftriaxone Viatris powder for injection vial contains ceftriaxone sodium equivalent to either 1000 mg or 2000 mg of ceftriaxone as a single ingredient.
Ceftriaxone sodium contains approximately 83 mg (3.6 mEq) of sodium per gram of ceftriaxone activity.
The product contains no excipients or preservatives.

3 Pharmaceutical Form

Ceftriaxone Viatris 1000 mg. For IM injection, IV injection and IV infusion. A white to slightly yellow crystalline powder for injection vial.
Ceftriaxone Viatris 2000 mg. For IV infusion. A white to slightly yellow crystalline powder for injection vial.
The colour of ceftriaxone sodium solutions ranges from light yellow to amber, depending on the length of storage, concentration and diluent used.

4 Clinical Particulars

4.9 Overdose

Excessive serum concentrations of ceftriaxone cannot be reduced by haemodialysis or peritoneal dialysis. Treatment of overdosage should be symptomatic and consist of general supportive measures. In the case of overdose; nausea, vomiting and diarrhoea can occur. There is no specific antidote for ceftriaxone overdose.
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 toxicology tests included 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 have not been performed. The maximum duration of animal toxicity studies was six months.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSCEFSOD.gif Chemical name: disodium(Z)-(6R, 7R)-7-[2-(2-amino-1, 3-thiazol-4-yl)-2-(methoxyimino) 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 hemiheptahydrate.
Molecular formula: C18H16N8Na2O7S3, 3.5H2O.
Molecular weight: 661.59.
Ceftriaxone Viatris contains ceftriaxone sodium, an almost white to yellowish crystalline powder which is freely soluble in water, sparingly soluble in methanol and very slightly soluble in ethanol. The pH of a 12% aqueous solution is approximately 6.0 to 8.0.
CAS number. 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/CEFALPST.gif