TECHNESCAN SESTAMIBI kit for the preparation of technetium [99m Tc] sestamibi injection

Country: Australia

Bahasa: Inggeris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

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

Boleh didapati daripada:

Landauer Radiopharmaceuticals Pty Ltd

INN (Nama Antarabangsa):

Tetrakis(2-methoxyisobutylisonitrile) copper(1) tetrafluoroborate

Borang farmaseutikal:

Injection, powder for

Komposisi:

Excipient Ingredients: stannous chloride dihydrate; cysteine hydrochloride monohydrate; sodium citrate dihydrate; mannitol; hydrochloric acid; sodium hydroxide

Laluan pentadbiran:

Intravenous

Unit dalam pakej:

5 vials

Jenis preskripsi:

Not scheduled. Not considered by committee

Tanda-tanda terapeutik:

Technetium [99m Tc] 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 [99m Tc] Sestamibi is indicated as a second line diagnostic aid to assist in the evaluation of patients for whom mammography is inconclusive.

Ringkasan produk:

Visual Identification: White to almost white lyophilised powder or pellet; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Status kebenaran:

Registered

Tarikh kebenaran:

2011-09-13

Risalah maklumat

Technescan
®
Sestamibi
1/4
TECHNESCAN
®
SESTAMIBI
KIT FOR THE PREPARATION OF TECHNETIUM [
99M
TC] SESTAMIBI INJECTION
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the common questions about TECHNESCAN
®
SESTAMIBI. It
does not contain all of the available information about TECHNESCAN
®
SESTAMIBI. It does
not replace talking to your doctor.
All medicines have risks and benefits. Your doctor has weighed the
risks of you or your child
receiving TECHNESCAN
®
SESTAMIBI against the benefits he or she expects it will have.
IF YOU HAVE ANY CONCERNS ABOUT HAVING THIS MEDICINE, ASK YOUR DOCTOR.
KEEP THIS LEAFLET. You may need to read it again.
WHAT IS TECHNESCAN
®
SESTAMIBI
TECHNESCAN
®
SESTAMIBI
is a kit for radiopharmaceutical preparation.
This kit contains an active ingredient (non-radionuclide) called
tetrakis (2-methoxyisobutyl isonitrile) copper (I) tetrafluoroborate
to which a solution containing
another ingredient called a radionuclide is added to give the final
radiopharmaceutical
preparation, TECHNETIUM [
99m
Tc] SESTAMIBI INJECTION. The radiopharmaceutical
preparation is administered to you as an injection.
A radionuclide is radioactive. The radionuclide in TECHNETIUM [
99m
Tc] SESTAMIBI
INJECTION is called pertechnetate (
99m
Tc).
WHAT IS TECHNESCAN
®
SESTAMIBI USED FOR
TECHNESCAN
®
SESTAMIBI is used to show the blood flow inside your heart during
exercise
and rest. It can be used to show the presence and size of any breast
cancer.
Your doctor may have prescribed
TECHNESCAN
®
SESTAMIBI for an
other purpose. Ask your
doctor if you have any questions about why
TECHNESCAN
®
SESTAMIBI
has been prescribed for
you. If you have any concerns, you should discuss these with your
doctor.
This medicine is only available with a doctors prescription.
Technescan
®
Sestamibi
2/4
BEFORE YOU ARE GIVEN TECHNESCAN
®
SESTAMIBI
Before you are given
TECHNESCAN
®
SESTAMIBI
your doctor will explain to you the procedure
you are about to undergo, and the radioactive medicine you will be

Ciri produk

TECHNESCAN
®
SESTAMIBI
1(18)
AUSTRALIAN PRODUCT INFORMATION
TECHNESCAN
®
SESTAMIBI
(TETRAKIS (2-METHOXYISOBUTYLISONITRILE) COPPER(1) TETRAFLUOROBORATE)
1
NAME OF THE MEDICINE
Tetrakis (2-methoxyisobutylisonitrile) copper (I) tetrafluoroborate.
The abbreviated notation is [Cu(MIBI)
4
]BF
4
(where MIBI is 2-methoxyisobutylisonitrile).
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
TECHNESCAN
®
SESTAMIBI is a kit for radiopharmaceutical preparation of Technetium
[
99m
Tc] Sestamibi Injection. Each vial contains 1 mg of tetrakis
(2-methoxyisobutylisonitrile)
copper (I) tetrafluoroborate.
TECHNESCAN
®
SESTAMIBI is a sterile, nonpyrogenic, lyophilised white powder. After
reconstitution of the radiopharmaceutical kit with sterile,
non-pyrogenic, oxidant free Sodium
Pertechnetate (
99m
Tc) Injection, the solution for injection is clear and colourless and
a complex
of the MIBI and Technetium-99m forms yielding Technetium [
99m
Tc] Sestamibi ([Tc-99m
(MIBI)
6
]
+
Cl
-
).
The pH of the reconstituted product is 5.5 (5.0 to 6.0). No
bacteriostatic preservative is present.
The contents of the vial are stored under nitrogen.
For the full list of excipients, see section 6.1 List of Excipients
_PHYSICAL CHARACTERISTICS _
Technetium (
99m
Tc) decays by isomeric transition with a physical half-life of 6
hours. Photons
associated with this transition which are useful for detection and
imaging studies are listed in
Table 1.
_Table 1. Principal Radiation Emission Data_
_1_
_ _
PRINCIPAL RADIATION
M
MEAN %/DISINTEGRATION
MEAN ENERGY
(KEV)
Gamma-2
87.2
140.5
1
Browne E., Firestone R.B., and Shirley V.S., (Ed.) Table of
Radioactive Isotopes, 1986, J. Wiley
keV=Kilo Electron Volt
_ _
TECHNESCAN
®
SESTAMIBI
2(18)
_Table 2. Physical Decay Chart; _
_99m_
_Tc Half-Life 6 Hours _
HOURS
FRACTION REMAINING
HOURS
FRACTION REMAINING
0*
1.000
7
0.445
1
0.891
8
0.397
2
0.794
9
0.354
3
0.707
10
0.315
4
0.630
11
0.281
5
0.561
12
0.250
6
0.500
_*Calibration time _
_EXTERNAL RADIATION _
The specific gamma ray constant for
99m
Tc is 0.19 milligray
(
mGy