ANSTO Health Thallous(201Tl) chloride 125MBq/mL injection multidose vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

thallous(201Tl) chloride, Quantity: 125 MBq/mL

Available from:

Australian Nuclear Science and Technology Organisation T/A ANSTO

INN (International Name):

thallous(201Tl) chloride

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: water for injections; sodium chloride; benzyl alcohol

Administration route:

Intravenous

Units in package:

125MBq/1mLx1 vial, 750MBq/6mLx1 vial, 500MBq/4mLx1 vial, 250MBq/2mLx1 vial, 1000MBq/8mLx1 vial

Class:

Medicine Registered

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

Thallous chloride (201Tl) may be useful in myocardial perfusion imaging for the diagnosis and localization of myocardial infarction. It may also be useful in conjunction with exercise stress testing as an adjunct in the diagnosis of ischaemic heart disease (atherosclerotic coronary artery disease).

Product summary:

Visual Identification: A clear colourless solution; Container Type: Vial; Container Material: Glass; Container Life Time: 5 Days; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-10-15

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
Thallous Chloride (
201
TI) Injection
What is in this leaflet
This leaflet answers some common questions about Thallous Chloride (
201
TI)
Injection. It does not contain all the available information. It does
not take the
place of you talking to your nuclear medicine specialist.
All medicines and diagnostic agents have risks and benefits. Your
referring
doctor, in consultation with the nuclear medicine specialist, has
weighed the
small risks of you having a procedure where you are given Thallous
Chloride
(
201
TI) Injection against the benefits they expect the procedure will have
for
you.
If you have any concerns about being given this injection, discuss
them
with your nuclear medicine specialist.
Keep this leaflet. You many need to read it again.
What Thallous Chloride (
201
TI) Injection is used for
Thallous Chloride (
201
TI) Injection is used mainly to assess blood flow to the
heart. It is also used to assess how your heart behaves under stress.
Thallous
Chloride
(
201
TI)
Injection
contains
Thallium-201
as
the
active
ingredient. Thallium-201 is a radiotracer. It contains a very low dose
of
radiation which emits a small amount of energy, similar to an X-ray.
This
energy can be detected by a special camera, called a gamma camera, and
produces an image known as a scan. The tiny amount of Thallium in this
product is not poisonous and will have no effect on your body.
A Thallium-201 scan will help your specialist to examine the blood
supply to
your heart muscle.
Your nuclear medicine specialist may be giving you Thallium-201 to
help
diagnose other conditions. Ask your nuclear medicine specialist if you
have
any questions about why Thallium-201 is being given to you or why you
have
been referred for a scan.
For more information, ask for a copy of the booklet Nuclear Medicine
–
Answering your Questions, available from the hospital, clinic or
supplier.
Before you are given it
Tell your nuclear medicine specialist or technologist if:
1.
you are pregnant or intend to become pregnant wit

Summary of Product characteristics

DESCRIPTION
Thallous Chloride (
201
Tl) Injection is a sterile
solution of thallous chloride (
201
Tl) in isotonic
saline with pH 4.0 to 7.0. The radioactivity
at calibration time is 125 MBq per mL. It is
essentially carrier free and contains less than
2.0% of
200
Tl and
202
Tl; greater than 97% of
201
Tl and less than 0.25% lead-203, from supply
to customer until expiry. It contains 1.0%
benzyl alcohol as a preservative.
PHYSICAL CHARACTERISTICS
Thallium-201 decays by electron capture with
a half-life of 73.1 hours to stable Mercury-201.
Photons that are useful for detection and
imaging are listed in Table 1. The lower
energy X-rays obtained from the Mercury-201
daughter of Thallium-201 are recommended
for imaging.
TABLE 1: PRINCIPAL RADIATION EMISSION DATA
D A Weber, K E Eckerman, L T Dillman and
J C Ryman. “MIRD: Radionuclide Data
and Decay Schemes”. The Society of Nuclear
Medicine Inc., New York, 1989.
TABLE 2: PHYSICAL DECA Y CHART FOR
201
TL
External Radiation
The specific gamma ray constant for
201
Tl is
120
μ
Gy/MBq-hr at 1 cm. Attenuation by lead
is given in Table 3.
TABLE 3: RADIATION ATTENUTION BY
LEAD SHIELDING
ACTIONS
Carrier-free thallous chloride (
201
Tl) has been
found to accumulate in viable myocardium in
a manner analogous to potassium. Experiments
employing labelled microspheres in human
volunteers have shown that the myocardial
distribution of thallous chloride (
201
Tl)
THALLOUS CHLORIDE [
201
TI] INJECTION
RADIATION
MEAN % PER
MEAN ENERGY (KEV)
DISINTE GRATION
Gamma-6
2.7
135.3
Gamma-8
10.0
167.4
Mercury X-rays
93.8
69-83
HOURS
FRACTION
HOURS FRACTION
REMAINING
REMAINING
0
1.000
84
0.451
12
0.892
96
0.402
24
0.797
108
0.359
36
0.711
120
0.321
48
0.634
132
0.286
60
0.566
144
0.255
72
0.505
SHIELD
COEFFICIENT
OF ATTENUATION
THICKNESS(MM)LEAD
0.23
0.5
0.83
0.1
1.9
0.01
3.1
0.001
_PI_
P
RODUCT
I
NFORMATION
correlates well with regional perfusion. In
clinical studies, thallium images have been
found to visualize areas of infarction confirmed
by electrocardiographic and enzyme changes.
Regio