Consumer medicine information

1. Why am I using Teicoplanin Medsurge?

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

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

Do not use if you have ever had an allergic reaction to teicoplanin 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, are pregnant or plan to become pregnant, or are breastfeeding or planning to breastfeed.
For more information, see Section 2. What should I know before I use Teicoplanin Medsurge? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with teicoplanin 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 Teicoplanin Medsurge?

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

5. What should I know while using Teicoplanin?

6. Are there any side effects?

Mild side effects include local pain and redness at the injection site, rash, dizziness, nausea, headache and stiffness. 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 fever, vomiting, diarrhoea, balance problems, ringing in the ears, problems hearing, anything that makes you think you might have a second infection, blistering of your skin, mouth, eyes or genitals, a red scaly widespread rash with bumps under the skin (including your skin folds, chest, abdomen (including stomach), back and arms) 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.

Notes

Distributed by Medsurge Healthcare

1 Name of Medicine

Teicoplanin Medsurge.

2 Qualitative and Quantitative Composition

Each vial contains lyophilised teicoplanin 400 mg and sodium chloride 24.8 mg with an accompanying ampoule containing water for injections 3.2 mL*.
* An overfill is included to allow withdrawal of the correct dose.
The reconstituted solution contains:
For a 400 mg vial: 400 mg/3.0 mL of teicoplanin.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Powder for injection.
Sterile, pyrogen-free ivory white powder for reconstitution with water for injections. It is freely soluble in water and on reconstitution gives a clear solution.

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 of overdosage should be symptomatic. Teicoplanin is not removed by haemodialysis or peritoneal dialysis.
For information on the management of overdose, contact the Poisons 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

Teicoplanin is a glycopeptide-antibiotic produced by Actinoplanes teichomyceticus.
Chemical structure. No data available.
CAS number. 61036-62-2.

7 Medicine Schedule (Poisons Standard)

Prescription Only Medicine (Schedule 4).

Summary Table of Changes

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