ANSTO Health Sodium Iodide(131I) 200MBq/mL injection multidose vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sodium iodide(131I), Quantity: 200 MBq/mL

Available from:

Australian Nuclear Science and Technology Organisation T/A ANSTO

INN (International Name):

Sodium iodide(131I)

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: sodium thiosulfate pentahydrate; sodium chloride; water for injections; dibasic sodium phosphate heptahydrate; monobasic sodium phosphate dihydrate

Administration route:

Intravenous

Units in package:

1x3mL (600MBq) in 10mL vial, 1x5mL (1000MBq) in 10mL vial, 1x4mL (800MBq) in 10mL vial, 1x7mL (1400MBq) in 10mL vial, 1x6mL (120

Class:

Medicine Registered

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

Hyperthyroidisms. 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 Type I Clear; Container Life Time: 14 Days; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-10-15

Summary of Product characteristics

10018-SODIUM IODIDE (
131
I) INJECTION - ANSTO-pi 1
AUSTRALIAN PRODUCT INFORMATION
SODIUM IODIDE [131-I] INJECTION
1
NAME OF THE MEDICINE
Sodium Iodide [
131
I]
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
DESCRIPTION
Sodium Iodide (
131
I) Injection is supplied as a clear, colourless, sterile,
non-pyrogenic isotonic solution.
The injection solution consists of Sodium Iodide at an activity
concentration of 200MBq/ml and sodium
thiosulfate at a concentration of 3.35 mg / GBq of I-131 in a
phosphate buffered sodium chloride solution.
The pH of the injection solution is 7.0 - 8.5. A range of Iodine-131
content is available from 200 to 1600
MBq at the time of calibration at 0900 (Sydney time) on the day of
calibration given on the product label.
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 182keV) with
associated gamma emission.
131
I has a major gamma emission [γ-ray] at 364 keV, although somewhat
higher than ideal. The principal beta and gamma photon emissions 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.
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 is 0.26 cm and a lead thickness of 2.6cm will
produce an attenuation factor of 10
-2
. A
range of values for the relative attenuation of the radiation
resulting from the interposition of various
thickness of lead [Pb] is shown in Table 2.
10018-SODIUM IODIDE (
131
I) INJECTION - ANSTO-pi 2
TABLE 2: COEFFICIENT OF ATTENUATION OF GAMMA RAYS FROM
131
I