CHARCOTRACE activated charcoal 120 mg/3 mL injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

activated charcoal, Quantity: 40 mg/mL

Available from:

Phebra Pty Ltd

INN (International Name):

activated charcoal

Pharmaceutical form:

Injection, suspension

Composition:

Excipient Ingredients: hydrochloric acid; sodium chloride; sodium hydroxide; water for injections

Administration route:

Subcutaneous

Units in package:

3 mL (in 5 mL-capacity vials), cartons of 10 vials

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

Aid to the stereotactic or ultrasonic localising of small lesions of the breast for later surgical excision.

Product summary:

Visual Identification: Fine black powder suspension; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2005-07-20

Patient Information leaflet

Charcotrace
®
Page 1 of 2
Version 07
CHARCOTRACE
®
ACTIVATED CHARCOAL INJECTION 120 MG IN 3 ML
_activated charcoal _
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

Summary of Product characteristics

PRODUCT INFORMATION
Product Information- Charcotrace
®
activated charcoal injection 120 mg in 3 mL
Page 1 of 6
Version 05
CHARCOTRACE
® INJECTION
(ACTIVATED CHARCOAL120 MG IN 3 ML)
1
NAME OF THE 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
T
HERAPEUTIC INDICATIONS
As an aid in stereotactic or ultrasonic localisation of small
impalpable lesions of the breast for later surgical excision.
4.2
D
OSE 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
C
ONTRAINDICATIONS
For injection by the subcutaneous route only; contraindicated in all
other routes of injection.
4.4
S
PECIAL 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
None.
PRODUCT INFORMATION
CHARCOTRACE
®
Australian Product Information- Charcotrace
®
activated charcoal injection 12