Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about Charcotrace. It does not contain all the available information. It does not take the place of talking to your doctor.

All medicines have risks and benefits. Your doctor has weighed the risks of you being given Charcotrace against the benefits they expect it will have for you.

If you have any concerns about being given this medicine, ask your doctor.

Keep this leaflet in a safe place. You may need to read it again.

What Charcotrace is used for

Charcotrace is used to assist the surgeon in locating small lesions of the breast after the position has been determined by the radiologist.

Following the determination of the position of a breast lesion by ultrasound or other methods, Charcotrace is used to mark a pathway from the lesion to the external skin for later removal.

Charcotrace is a sterile injection of a suspension of fine charcoal particles in water.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.

Before you are given Charcotrace

When you must not be given it

You should not be given Charcotrace if you have an allergy to:

• any medicine containing charcoal
• any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include:

• shortness of breath
• wheezing or difficulty breathing
• swelling of the face, lips, tongue or other parts of the body
• rash, itching or hives on the skin.

You should not be given this medicine if the solution is discoloured. The solution is normally a black suspension of fine particles.

You should not be given this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If you are given this medicine after the expiry date has passed, it may not work as well.

If you are not sure whether you should be given this medicine, talk to your doctor.

Before you are given it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding. Your doctor can discuss with you the risks and benefits involved.

If you have not told your doctor about any of the above, tell him/her before you are given Charcotrace.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket, health food shop, naturopath or herbalist.

How Charcotrace is given

Charcotrace must only be given by a doctor. The vial will be shaken before use in order to suspend the fine particles.

Following the determination of the position of a breast lesion by ultrasound or other methods, an injection of Charcotrace is used to mark a fixed black track from the lesion to the skin.

The pathway may not be visible to you because it is within the breast tissue except for the spot where the path ends at the surface of the skin.

The pathway remains in the tissue until the time of surgery, which may be up to six months later.

At the time of the operation, the surgeon follows this direct path from the external skin to the lesion and removes the lesion along with the carbon track.

If you are given too much (overdose)

Charcotrace must only be given by a doctor so an overdose is not likely to occur.

If a larger than necessary amount of Charcotrace is used there may be leakage of charcoal suspension from the injection site.

Side effects

Tell your doctor as soon as possible if you do not feel well while you are being given Charcotrace. This medicine helps most people but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Ask your doctor to answer any questions you may have.

Tell your doctor if you notice any of the following and they worry you:

• local pain or stinging at the injection site.

The above list includes the more common side effects of your medicine. They are usually mild and short-lived.

If it has been 6 months or more since Charcotrace was injected into your breast tissue, tell your doctor as soon as possible if you notice the following:

• swelling, heat, pain and/or redness at the injection site.

The above list includes serious side effects that may require medical attention.

Tell your doctor if you notice anything that is making you feel unwell.

Other side effects not listed above may also occur in some people.

After being given Charcotrace

Storage

Charcotrace will be stored in the surgery, pharmacy or ward of a hospital. The injection is kept in a cool dry place where the temperature stays below 25°C.

Charcotrace will be opened for use on you. It will be used only once and then it will be discarded. It will never be stored after it is opened, nor used for more than one person.

Product description

What it looks like

Charcotrace is a black suspension of fine black charcoal particles in a clear glass vial with a plastic top.

Charcotrace is available as a 3 mL suspension in a 7 mL vial.

Ingredients

Charcotrace contains 40 mg/mL activated charcoal as the active ingredient.

It also contains:

• sodium chloride
• water for injections.

Hydrochloric acid and sodium hydroxide are used for pH adjustment when and if required.

This medicine does not contain lactose, sucrose, gluten, tartrazine, or other azo dyes or preservatives.

Manufacturer

Charcotrace is made and supplied in Australia by:

Phebra Pty Ltd
19 Orion Road
Lane Cove West, NSW 2066
Australia

Charcotrace activated charcoal injection120 mg in 3 mL
3 mL in a 7 mL vial.

AUST R 100313

Phebra product code- INJ107

Date of most recent amendment: May 2020.

Charcotrace, Phebra and the Phi symbol are trademarks of Phebra Pty Ltd.

Published by MIMS June 2020

1 Name of Medicine

Activated charcoal.

2 Qualitative and Quantitative Composition

Charcotrace contains activated charcoal 120 mg in water for injections to 3 mL.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Charcotrace is a sterile suspension.

4 Clinical Particulars

4.1 Therapeutic Indications

As an aid in stereotactic or ultrasonic localisation of small impalpable lesions of the breast for later surgical excision.

4.2 Dose and Method of Administration

Roll gently before use.
Following stereotactic or ultrasound location of the lesion, Charcotrace (about 0.3 mL to 1 mL) should be injected using an 18 G needle close to the lesion and the injection continued while slowly withdrawing the needle with a to-and-fro movement to form a visible track. The barrel of the syringe should be kept horizontal while injecting to minimise any large particles entering the bore of the needle.
Use in one patient on one occasion only and discard.

4.3 Contraindications

For injection by the subcutaneous route only; contraindicated in all other routes of injection.

4.4 Special Warnings and Precautions for Use

Only small volumes (0.3 mL to 1 mL) of Charcotrace need to be injected to form a visible track.
Charcotrace should only be administered for localisation of breast lesions when there is high expectation of subsequent surgical resection. In cases where injection of activated charcoal has not been followed by excision, carbon granulomas, presenting as breast masses, have been reported in some patients within 6 months.
Use of larger than recommended volumes of Charcotrace may result in leakage from the injection sites or spread into tissues outside the breast.

Use in special populations.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

None.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Local pain and stinging may be experienced at the injection site. Other adverse reactions are uncommon (≥ 0.1% and < 1%).
Granuloma and foreign body reactions have been reported on occasions if carbon particles are left in situ for more than six months.

Reporting suspected adverse effects.

4.9 Overdose

Overdosage has not been reported. If too much Charcotrace has been used, it should be removed by the surgeon.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Metabolism.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Sodium chloride, water for injections to 3 mL, and sodium hydroxide and hydrochloric acid are used for pH adjustment when required. Contains no antimicrobial preservative.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG)¹. The expiry date can be found on the packaging.
¹ AUST R 100313.

6.4 Special Precautions for Storage

Store below 25°C.

6.5 Nature and Contents of Container

Charcotrace is presented as 3 mL of suspension in a 7 mL glass vial in a pack of 10 vials.
Phebra product code - INJ107.
The vial stopper is not made with natural rubber latex.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

The molecular weight of the compound is 12 and the molecular formula is C.

Chemical structure.

CAS number.

References

Azavedo E, Svane G, Auer G. Stereotactic fine-needle biopsy in 2594 mammographically detected non-palpable lesions. Lancet 1989 May; 1033-1035.
Langlois SL, Carter ML. Carbon localisation of impalpable mammographic abnormalities. Australas Radiol 1991 Aug;35(3):237-41.
Mullen DJ, Eisen RN, Newman RD, Perrone PM, Wilsey JC. The Use of Carbon Marking after Stereotactic Large-Core-Needle Breast Biopsy. Radiology 2001 Jan; 218: 255-260.
Moss HA, Barter SJ, Nayagam M, Lawrence D, Pittam M. The use of carbon suspension as an adjunct to wire localisation of impalpable breast lesions. Clin Radiol; 2002 Oct; 57(10):937-44.
Rose A, Collins JP, Neerhut P, Bishop CV, Mann GB. Carbon localisation of impalpable breast lesions. The Breast 2003;12: 264-269.
Svane G. A stereotactic technique for preoperative marking of non-palpable breast leasions. Acta Radiologica Diagnosis 1983 24(2):145-151.

7 Medicine Schedule (Poisons Standard)

Unscheduled.

Summary Table of Changes