Consumer medicine information

1. Why am I being given Teicoplanin Sandoz?

Teicoplanin Sandoz contains the active ingredient teicoplanin. Teicoplanin Sandoz is an antibiotic. It is used to kill bacteria responsible for infections which can occur in your bones, blood, or joints. For more information, see Section 1. Why am I being given Teicoplanin Sandoz? in the full CMI.

2. What should I know before I use Teicoplanin Sandoz?

Do not use if you have ever had an allergic reaction to Teicoplanin Sandoz 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 Teicoplanin Sandoz? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Teicoplanin Sandoz 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 will I be given Teicoplanin Sandoz?

Teicoplanin Sandoz should be prepared and administered by a qualified health professional (doctor, pharmacist, or nurse).
More instructions can be found in Section 4. How will I be given Teicoplanin Sandoz? in the full CMI.

5. What should I know while being given Teicoplanin Sandoz?

6. Are there any side effects?

Mild side effects include local pain and redness at the injection site, rash, dizziness, nausea, headache and stiffness. Very serious side effects which may indicate a serious allergic reaction include swelling of the face, lips, mouth or throat, which may cause difficulty in swallowing or breathing, and hives or welts on the skin. Other serious side effects include blistering of your skin, mouth, eyes or genitals, a red scaly widespread rash with bumps under the skin and blisters accompanied by a fever, flu-like symptoms and a rash on your face followed by an extended rash with a fever, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes, and kidney problems (shown in tests).
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.

1 Name of Medicine

Teicoplanin.

2 Qualitative and Quantitative Composition

Teicoplanin Sandoz 400 mg injection containing a white to pale yellow, sterile lyophilised powder, equivalent to 400 mg teicoplanin. It is freely soluble in water and on reconstitution gives a clear solution.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Teicoplanin Sandoz 400 mg injection is presented as a sterile, lyophilised white to light yellow powder for reconstitution with water for injections.

4 Clinical Particulars

4.9 Overdose

In an observational post-authorisation safety study, patients receiving more than 5 high loading doses of 12 mg/kg twice a day, followed by a maintenance dose of 12 mg/kg once daily, had an observed cumulative rate of nephrotoxicity from the start of treatment up to 60 days after the last administration of 27% (95% CI = [20.7%; 35.3%]).
Cases of excessive doses administered in error to paediatric patients have been reported. In one report, agitation occurred in a 29 day-old newborn given 400 mg I.V. (95 mg/kg). In the other cases, there were no symptoms or laboratory abnormalities associated with teicoplanin.
Treatment. In case of overdose, treatment should be supportive and symptomatic. Teicoplanin is not removed by haemodialysis or peritoneal dialysis.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Teicoplanin was negative in assays evaluating the potential to cause gene mutations, but assays to evaluate the potential to cause chromosome damage have not been performed.
Carcinogenicity. Long-term studies in animals to evaluate the carcinogenic potential of teicoplanin have not been performed.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. The chemical structure of teicoplanin is:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSTEICOP.gif CAS number. 61036-62-2.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes

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