ANSTO - Sodium Iodide [131I] Therapy Capsules (50 to 6000 MBq)

Χώρα: Σιγκαπούρη

Γλώσσα: Αγγλικά

Πηγή: HSA (Health Sciences Authority)

Δραστική ουσία:

Sodium Iodide [I-131]

Διαθέσιμο από:

TRANSMEDIC PTE LTD

Φαρμακολογική κατηγορία (ATC):

V10XA01

Φαρμακοτεχνική μορφή:

CAPSULE

Σύνθεση:

Sodium Iodide [I-131] 50 to 6000 MBq/capsule

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

Prescription Only

Κατασκευάζεται από:

ANSTO

Καθεστώς αδειοδότησης:

ACTIVE

Ημερομηνία της άδειας:

2021-03-08

Αρχείο Π.Χ.Π.

ANSTO - SODIUM IODIDE [131I] THERAPY CAPSULES (50 TO 6000 MBQ)
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 (anhydrous di-sodium
hydrogen phosphate). Other excipients include sodium bicarbonate
solution and water for Injection.
A range of iodine-131 content is available, from 50 MBq to 6000MBq 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.
PHYSICAL CHARACTERISTICS OF [
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)
Beta1
2.1
69.4 (Avg.)
Beta3
7.3
96.6 (Avg.)
Beta4
89.4
191.5 (Avg.)
Gamma7
6.1
284.3
Gamma14
81.2
364.5
Gamma17
7.3
637.0
Gamma19
1.8
722.9
_Reference: Weber DA, Eckerman KF, Dillman LTand Ryman J C, MIRD:
Radionuclide Data and _
_Decay Schemes, The Society of Nuclear Medicine,1989. _
TABLE2: PHYSICAL DECAY CHART FOR[
131
I]
DAYS
FRACTION REMAINING
DAYS
FRACTION REMAINING
0
1.000
8
0.502
1
0.917
9
0.460
2
0.842
10
0.422
3
0.772
11
0.387
4
0.708
12
0.355
5
0.650
13
0.326
6
0.596
14
0.299
7
0.547
SODIUM IODIDE [131I] THERAPY CAPSULES
2
EXTERNAL RADIATION
The specific gamma ray constant for iodine-131 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 about 10
-2.
Attenuation
by lead is given in Table 3.
TABLE 3: PRINCIPAL RADIATI