Sodium Iodide [131I] Diagnostic Capsules GE Healthcare 3.7 MBq

Land: Norge

Språk: norsk

Kilde: Statens legemiddelverk

Aktiv ingrediens:

Natriumjodid (131I)

Tilgjengelig fra:

GE Healthcare Buchler GmbH & Co. KG

ATC-kode:

V09FX03

INN (International Name):

Natriumjodid (131I)

Dosering :

3.7 MBq

Legemiddelform:

Kapsel, hard

Enheter i pakken:

Beholder av plast med skumpolster i blybeskyttelse 10 stk

Resept typen:

C

Autorisasjon status:

Markedsført

Autorisasjon dato:

2004-10-06

Preparatomtale

_ _
SUMMARY OF PRODUCT CHARACTERISTICS
FOR
SODIUM IODIDE (
131
I) DIAGNOSTIC CAPSULES, GE HEALTHCARE
1.
NAME OF THE MEDICINAL PRODUCT
Sodium Iodide (
131
I) Diagnostic Capsules, GE Healthcare
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium iodide(
131
I) Diagnostic Capsules are presented as a white capsule. Each capsule
contains 3.7 MBq (100

Ci) at the first reference date. At subsequent reference dates, at
weekly intervals, the nominal activity per capsule is shown in the
table below -
Reference date
Days after first reference
Activity, MBq (

Ci)
1
0
3.7
(100)
2
7
2.02
(55)
3
14
1.10
(30)
4
21
0.603
(16)
5
28
0.329 (9)
Iodine-131 is produced by fission of Uranium-235 or by neutron
bombardment of stable
tellurium in a nuclear reactor. Iodine-131 has a half-life of 8.02
days. It decays by emission
of gamma radiations of 365 keV (81.7%), 637 keV (7.2%) and 284 keV
(6.1%) and beta
radiations of maximal energy of 606 keV to stable Xenon-131.
Excipients with known effect:
Sodium: 85.28 mg/capsule. This needs to be taken into consideration by
patients on a
sodium controlled diet.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsules, hard.
White, opaque gelatine capsules
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
Sodium iodide may be given as a “tracer” dose to study radioiodine
kinetics. An estimation
of the thyroid uptake and effective half life obtained with a tracer
dose can be used to
calculate the activity required for radioiodine therapy.
In the management of thyroid carcinoma, sodium iodide is used to
identify thyroid
remnants and metastases (after ablation).
_ _
Thyroid scanning for benign conditions with iodine-131 can be
performed but only when
radiopharmaceuticals with more favourable dosimetry, e.g. iodine-123
or technetium-99m
are not available.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_Adults _
The recommended activities for an adult patient (70 kg) are as
follows:

For thyroid uptak