ANSTO Health Sodium Iodide (131-I) Therapy Capsules 50MBq

Страна: Австралия

Язык: английский

Источник: Department of Health (Therapeutic Goods Administration)

Активный ингредиент:

sodium iodide(131I), Quantity: 50 MBq

Доступна с:

Australian Nuclear Science and Technology Organisation T/A ANSTO

ИНН (Международная Имя):

Sodium iodide(131I)

Фармацевтическая форма:

Capsule, hard

состав:

Excipient Ingredients: dibasic sodium phosphate; titanium dioxide; iron oxide yellow; water for injections; sodium bicarbonate; sodium thiosulfate pentahydrate; Gelatin; sodium lauryl sulfate; silicon dioxide; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; ethanol; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide

Администрация маршрут:

Oral

Штук в упаковке:

1 capsule

класс:

Medicine Registered

Тип рецепта:

Not scheduled. Not considered by committee

Терапевтические показания :

.

Обзор продуктов:

Visual Identification: Yellow coloured gelatin capsule printed with "ANSTO Health' and a radioactive logo; Container Type: Vial; Container Material: Glass; Container Life Time: 14 Days; Container Temperature: Store below 25 degrees Celsius

Статус Авторизация:

Registered

Дата Авторизация:

1991-10-15

тонкая брошюра

10020/10233- Sodium Iodide [
131
I] 50 – 6000 MBq Therapy Capsule - ANSTO-cmi
1
CONSUMER MEDICINE INFORMATION (CMI)
SODIUM IODIDE [IODINE-131] THERAPY CAPSULE
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 CAPSULE?
You are being given the Sodium Iodide (
131
I) Therapy Capsule for the 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 from the capsules is taken up by
the thyroid gland tissue. 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 capsule, discuss them
with your nuclear medicine
specialist.
4
WHAT SHOULD I KNOW BEFORE I USE SODIUM IODIDE [
131
I] THERAPY CAPSULE?
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 capsule against the benefits it is expected you will
receive from it.
Before you are given Sodium Iodide [
131
I] Therapy Capsule, it is important to tell your nuclear medicine
specialist or technologist

Характеристики продукта

10020/10233-
SODIUM IODIDE [
131
I] 50 - 6000MBQ THERAPY CAPSULE - ANSTO-pi 1
AUSTRALIAN PRODUCT INFORMATION
SODIUM IODIDE [IODINE-131] THERAPY CAPSULE
1
NAME OF THE MEDICINE
Sodium Iodide [
131
I]
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
DESCRIPTION
Sodium Iodide [
131
I] Therapy Capsules are supplied for oral administration as pale
yellow gelatin
capsules containing sodium iodide [
131
I] solution adsorbed on an inert filler (di-sodium hydrogen
phosphate). A range of iodine-131 content is available, from 50 MBq to
6000 MBq at the time of
calibration at 0900 hrs (Sydney time) each Monday.
Each capsule is contained in a glass serum vial sealed with a rubber
stopper and red aluminium
seal. The vial is in turn contained in an appropriate lead container.
A special lead shielded
decapping pot and decapping pliers are supplied free with the initial
order.
For the full list of excipients, see Section 6.1 List of Excipients.
PHYSICAL CHARACTERISTICS FOR
131
I
Iodine-131 with a physical half-life of 8.04 days, decays by beta
emission (average energy 182
keV) with associated gamma emission. Stable xenon-131 is formed in
98.9% of decays and
radioactive xenon -131m (half-life 11.9 days) in 1.1% of decays. 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.
10020/10233-
SODIUM IODIDE [
131
I] 50 - 6000MBQ THERAPY CAPSULE - 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