ARI SODIUM IODIDE(I123) 1-12 MBq DIAGNOSTIC CAPSULE

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sodium iodide(123I), Quantity: 1 MBq

Available from:

Australian Nuclear Science and Technology Organisation T/A ANSTO

INN (International Name):

sodium iodide(123I)

Pharmaceutical form:

Capsule

Composition:

Excipient Ingredients: dibasic sodium phosphate heptahydrate; sodium bicarbonate; sodium thiosulfate pentahydrate; sodium hydroxide; purified water; sunset yellow FCF; quinoline yellow; titanium dioxide; brilliant blue FCF; carmoisine; Gelatin; ethanol; Shellac; Pharmaceutical glaze; carbon black

Administration route:

Oral

Units in package:

1 capsule

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

Sodium Iodide [123] Diagnostic Capsules are for diagnostic imaging of thyroid tissue.

Product summary:

Visual Identification: Capsules - "ari" is printed on a buff opaque body. A radiation symbol is printed on the maroon cap. The print ink is black.; Container Type: Vial; Container Material: Glass; Container Life Time: 48 Hours; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2005-05-31

Patient Information leaflet

WHAT IS IN THIS LEAFLET
This leaflet answers some common questions
about Sodium Iodide[
123
I] Diagnostic Capsules.
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 a
Sodium Iodide[
123
I] Diagnostic Capsule against
the benefits they expect the procedure will
have for you.
IF YOU HAVE CONCERNS ABOUT BEING GIVEN
THIS CAPSULE, DISCUSS THEM WITH YOUR
NUCLEAR MEDICINE SPECIALIST.
KEEP THIS LEAFLET. You may need to read it again.
PRODUCT DESCRIPTION
Each Sodium Iodide[
123
I] Diagnostic Capsule
contains sodium iodide[
123
I], in a solution of
sodium thiosulphate, sodium bicarbonate and
sodium hydroxide absorbed onto disodium
hydrogen phosphate filler in a maroon gelatine
capsule about 19 mm long and 6 mm thick.
WHAT A SODIUM IODIDE[
123
I]
DIAGNOSTIC CAPSULE IS USED FOR
Sodium Iodide[
123
I] Diagnostic Capsules are
used to measure the performance of the thyroid
gland. This gland controls the body’s physical
and chemical processes.
Iodine-123 is a radiotracer. After swallowing,
it is taken up by your thyroid gland where it
emits small amounts of radiation energy similar
to X-rays. This radiation can be detected by
a special camera, called a “gamma camera”,
and produces an image known as a scan. This
scan enables the nuclear medicine specialist
to determine how your thyroid gland is
functioning.
Ask your nuclear medicine specialist if you have
any questions about why a Sodium Iodide[
123
I]
Diagnostic Capsule is being given to you or
why you have been referred for a scan.
BEFORE YOU ARE GIVEN IT
Tell your nuclear medicine specialist or
technologist if:
YOU ARE PREGNANT OR INTEND TO BECOME
PREGNANT
It is known that this capsule may be harmful
to an unborn baby when administered to a
pregnant woman. Sodium iodide[
123
I] wil

Summary of Product characteristics

Sodium Iodide[
123
I] Diagnostic Capsules
are supplied for oral administration as dark
maroon gelatin capsules containing sodium
iodide[
123
I] stabilised by sodium thiosulphate
in a sodium bicarbonate solution. The capsule
contains the sodium iodide[
123
I] solution
adsorbed on an inert filler of di-sodium
hydrogen phosphate (429 – 569 mg) and
are supplied with activities in the range 1 to
12 MBq or 100 to 750 MBq at the time of
calibration.
Each capsule is contained in a glass serum vial
sealed with a rubber stopper and aluminium
seal. The vial is supplied in a suitably shielded
lead pot.
Iodine-123 has a physical half-life of 13.2 hours,
and has 83.6% disintegrations at an energy level
of 159 keV. The specific gamma ray constant for
iodine-123 is 7.478E-5 mSv/h per MBq at 1.0
m. The mass attenuation coefficient (µ) in lead
is 1.4109 cm
-2
/g,
1
and the attenuation factors
for lead are as follows: THICKNESS OF LEAD (CM)
FACTOR
0.0433
0.5
0.1439
0.1
0.2876
0.01
To correct for the effect of decay multiply the
activity on the calibration time and date by the
appropriate factor from the table below.
_PI_
P
RODUCT
I
NFORMATION
HOURS
FACTOR
HOURS FACTOR
1
0.949
9
0.623
2
0.900
10
0.591
3
0.854
11
0.561
4
0.811
12
0.533
5
0.769
13
0.505
6
0.730
14
0.479
7
0.692
15
0.455
8
0.657
16
0.432
SODIUM IODIDE [
123
1] DIAGNOSTIC CAPSULES
DESCRIPTION
PHYSICAL CHARACTERISTICS OF IODINE-123
PHARMACOLOGY
PHARMACODYNAMIC PROPERTIES
At doses used in diagnostic investigations,
sodium iodide has not been observed to exert
any pharmacodynamic effects.
PHARMACOKINETIC PROPERTIES
Absorption of iodide after capsule
administration is virtually complete after 1 – 2
hours, but may be delayed if food is present
in the stomach, which in turn will alter the
radiation dose pattern. Sodium iodide is
rapidly absorbed from the gastrointestinal tract
into the bloodstream and distributed in the
extracellular fluid. A proportion is concentrated
by thyroid tissue. Some iodine is also trapped
by the stomach and salivary glands. Most of
the remaind