Sodium Iodide (I-131) 200MBq/mL Therapy Solution oral liquid BP vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sodium iodide(131I), Quantity: 50 MBq

Available from:

Australian Nuclear Science and Technology Organisation T/A ANSTO

INN (International Name):

Sodium iodide(131I)

Pharmaceutical form:

Oral Liquid, solution

Composition:

Excipient Ingredients: sodium thiosulfate pentahydrate; water for injections; sodium bicarbonate

Administration route:

Oral

Units in package:

from 0.25mL to 6mL (50 to 1200 MBq per vial)

Class:

Medicine Registered

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

Sodium Iodide (131I) solution BP (for therapy) is indicated in the treatment of hyperthyroidism's and the detection and ablation of residual functioning thyroid tissue in differentiated thyroid carcinoma

Product summary:

Visual Identification: A clear colourless solution; Container Type: Vial; Container Material: Glass; Container Life Time: 14 Days; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-10-15

Patient Information leaflet

10019/10234-
Sodium Iodide [
131
I] Therapy Solution, oral liquid -
ANSTO-cmi
1
CONSUMER MEDICINE INFORMATION (CMI)
SODIUM IODIDE [131-I] THERAPY SOLUTION, ORAL LIQUID
1
MEDICINE NAME
Sodium Iodide [
131
I]
2
SPECIAL ADVISORY
Radiopharmaceuticals should be used only by physicians who are
qualified by specific training in the safe
use and handling of radionuclides produced by a nuclear reactor or
particle accelerator, and whose
experience and training have been approved by the appropriate
government agency authorised to license
the use of radionuclides.
Care should be taken to minimise radiation exposure to patients,
consistent with proper patient
management. As with other radioactive drugs, Sodium Iodide [
131
I] must be handled with care and
appropriate safety measures should be used to minimise radiation
exposure to clinical personnel.
3
WHY AM I USING SODIUM IODIDE [
131
I] THERAPY SOLUTION?
You are being given the Sodium Iodide [
131
I] Therapy Solution, oral liquid for the treatment of treatment
of hyperthyroidism, and the detection, treatment and ablation of
residual functioning thyroid tissue in
differentiated thyroid carcinoma.
Sodium Iodine (
131
I) is a radioisotope which emits high energy electrons (beta
particles). When
administered orally the Iodine-131 is
rapidly absorbed from the gastrointestinal tract into the bloodstream
and distributed in the extracellular fluid. A proportion is
concentrated by thyroid tissue, where beta
radiation from the Iodine-131 help reduce the activity of the tissue
in proportion to the amount of Iodine-
131 absorbed.
If you have any concerns about being given this solution, discuss them
with your nuclear medicine
specialist.
4
WHAT SHOULD I KNOW BEFORE I USE SODIUM IODIDE [
131
I] THERAPY SOLUTION?
All medicines and diagnostic agents have risks and benefits associated
with their usage. Your nuclear
medicine physician or specialist has weighed the small risk of your
being treated with a Sodium Iodide
(
131
I) therapy Solution against the benefits it is expected you will
re

Summary of Product characteristics

10019/10234-SODIUM IODIDE (
131
I) THERAPY SOLUTION, ORAL LIQUID - ANSTO-pi 1
AUSTRALIAN PRODUCT INFORMATION
SODIUM IODIDE [131-I] THERAPY SOLUTION, ORAL LIQUID
1
NAME OF THE MEDICINE
Sodium Iodide [
131
I]
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
DESCRIPTION
Sodium Iodide [
131
I] Therapy Solution is supplied for oral administration as a
colourless solution
containing sodium iodide [
131
I]. A range of Iodine-131 content is available from 50 MBq to 16,000
MBq at the time of calibration at 0900 hrs (Sydney time) each Monday.
The solution is contained in a 10ml glass serum vial sealed with a
rubber stopper and aluminium
seal. The vial is in turn contained in a lead pot. The product is
designed for therapy use.
For the full list of excipients, see Section 6.1 List of Excipients.
PHYSICAL CHARACTERISTICS FOR [
131
I]
Iodine-131 decays by beta and gamma emission with a physical half-life
of 8.04 days. The principal
beta emissions and gamma photons are listed in Table 1.
TABLE 1: PRINCIPAL RADIATION EMISSION DATA.
PRINCIPAL RADIATION
MEAN % PER
DISINTEGRATION
MEAN ENERGY (KEV)
Beta - 1
2.1
69.4 (Avg.)
Beta - 3
7.3
96.6 (Avg.)
Beta - 4
89.4
191.5 (Avg.)
Gamma - 7
6.1
284.3
Gamma - 14
81.2
364.5
Gamma - 17
7.3
637.0
Gamma - 19
1.8
722.9
Reference: Weber D A, Eckerman K F, Dillman L T and Ryman J C, MIRD:
Radionuclide Data and Decay Schemes, The
Society of Nuclear Medicine, 1989.
10019/10234-SODIUM IODIDE (
131
I) THERAPY SOLUTION, ORAL LIQUID - ANSTO-pi 2
TABLE 2: PHYSICAL DECAY PROFILE FOR
131
I.
DAYS
FRACTION REMAINING
DAYS
FRACTION REMAINING
0
1.000
15
0.274
1
0.917
16
0.252
2
0.842
17
0.231
3
0.772
18
0.212
4
0.708
19
0.194
5
0.650
20
0.178
6
0.596
21
0.164
7
0.547
22
0.150
8
0.502
23
0.138
9
0.460
24
0.126
10
0.422
25
0.116
11
0.387
26
0.106
12
0.355
27
0.098
13
0.326
28
0.089
14
0. 299
EXTERNAL RADIATION
The specific gamma ray constant for iodine-131 is 0.61 mGy per MBq
-h
at 1 cm. The first half-value
thickness of lead for iodine-131 is 0.26 cm. Attenuation by lead is
given in Table 3.
TABLE 3: COEFFICIENT OF A