CARDIOLITE Powder for injection

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

tetrakis(2-methoxyisobutylisonitrile) copper(1) tetrafluoroborate, Quantity: 1 mg

Available from:

Global Medical Solutions Australia Pty Limited T/A Radpharm Scientific

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: cysteine hydrochloride; stannous chloride dihydrate; sodium citrate dihydrate; mannitol

Administration route:

Intravenous

Units in package:

2, 5 and 30

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

Technetium (99mTc) sestamibi is indicated for use in conjunction with stress testing as an adjunct in the diagnosis of ischaemic heart disease. In these patients additional information about ventricular function may be derived by using the first pass technique. INDICATIONS AS AT 23 NOVEMBER 1999: Technetium [99mTc] Sestamibi is indicated for use in conjunction with stress testing as an adjunct in the diagnosis of ischaemic heart disease. In these patients additional information about ventricular function may be derived by using the first pass technique. Technetium [99mTc] Sestamibi is indicated as a second line diagnostic aid to assist in the evaluation of patients for whom mammography is inconclusive.

Product summary:

Visual Identification: White powder or plug.; Container Type: Vial; Container Material: Glass; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1994-10-18

Patient Information leaflet

CARDIOLITE

1
CARDIOLITE

KIT FOR PREPARATION OF TECHNETIUM (99MTC)
SESTAMIBI INJECTION
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
This medicine is new or being used differently. Please report side
effects. See the full CMI for further details.
1.
WHY AM I USING [MEDICINE NAME]?
CARDIOLITE

contains the active ingredient tetrakis(2-methoxyisobutylisonitrile)
copper(1) tetrafluoroborate. CARDIOLITE

is
used show the blood flow inside your heart during exercise and rest
and the presence and size of any breast cancer.
For more information, see Section 1. Why am I using [medicine name]?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE CARDIOLITE

?
Do not use if you have ever had an allergic reaction to CARDIOLITE

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 AND ARE BREASTFEEDING OR PLAN TO BREASTFEED.
For more information, see Section 2. What should I know before I use
[medicine name]? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with CARDIOLITE

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 CARDIOLITE

?
•
Your doctor will decide how much you will be given. This depends on
your condition and other factors, such as weight.
•
CARDIOLITE

is given as an injection into a vein.
More instructions can be found in Section 4. How do I use [medicine
name]?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING CARDIOLITE

?
THINGS YOU
SHOULD DO
•
Remind any doctor you visit that you are allergic Cardiolite or any of
the ingredients listed at the end
of this leaflet.
•
Tell your doctor if you have heart disease.
•
Tell your doctor as soon as possible if you do not feel well during
the inject

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – CARDIOLITE KIT FOR
PREPARATION OF TECHNETIUM (99MTC) SESTAMIBI INJECTION VIAL
[TETRAKIS(2-METHOXYISOBUTYLISONITRILE) COPPER(1)
TETRAFLUOROBORATE] INTRAVENOUS INJECTION POWDER
1
NAME OF THE MEDICINE
Tetrakis (2-Methoxyisobutylisonitrile) Copper (1) Tetrafluoroborate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains a non-radioactive sterile, non-pyrogenic,
lyophilized powder of Tetrakis (2-
methoxyisobutyl isonitrile) Copper (I) Tetrafluoroborate, It contains
no preservative. Prior to
lyophilization the pH is 5.3 to 5.9.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
White powder or plug for the preparation of technetium (99mTc)
sestamibi intravenous injection.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
a)
Technetium [
99m
Tc] Sestamibi is indicated for use in conjunction with stress testing
as an
adjunct in the diagnosis of ischemic heart disease. In these patients
additional information
about ventricular function may be derived by using the first pass
technique.
b)
Technetium [
99m
Tc] Sestamibi is indicated as a second line diagnostic aid to assist
in the
evaluation of patients for whom mammography is inconclusive.
4.2
D
OSE AND METHOD OF ADMINISTRATION
This drug is administered by intravenous injection for diagnostic use
after reconstitution with sterile,
non-pyrogenic, oxidant-free Sodium Pertechnetate 99mTc Injection.
a)
Dose for Cardiac Imaging:
The suggested dose range for I.V. administration to be employed in the
average patient (70
Kg) is:
370-1110 MBq
For diagnosis of ischemic heart disease, two injections (exercise and
rest) are required in
order to differentiate transiently from persistently reduced
myocardial uptake. After the
injection, exercise if used should be encouraged for an additional one
to two minutes.
2
The patient dose should be measured by a suitable radioactivity
calibration system
immediately prior to patient administration. Radiochemical purity
should be checked prior
to patient admin