Sodium Iodide [131I] Injection GE Healthcare 74 MBq/ ml

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 :

74 MBq/ ml

Legemiddelform:

Injeksjonsvæske, oppløsning

Enheter i pakken:

Hetteglass 740 MBq

Resept typen:

C

Autorisasjon status:

Markedsført

Autorisasjon dato:

2004-10-06

Preparatomtale

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SUMMARY OF PRODUCT CHARACTERISTICS
FOR
SODIUM (
131
I) IODIDE, INJECTION, GE HEALTHCARE
1.
NAME OF MEDICINAL PRODUCT
Sodium (
131
I) Iodide Injection, GE Healthcare
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium (
131
I) Iodide: 37-740 MBq/vial (74 MBq/ml) at the activity reference date
0.925-9.25 GBq/vial (925 MBq/ml) at the activity reference date
Iodine-131 is produced by fission of Uranium-235 or by neutron
bombardment of stable
tellurium in a nuclear reactor. It decays by emission of gamma
radiations of 365 keV
(81.7 %), 637 keV (7.2 %) and 284 (6.1 %) and beta radiations of
maximal energy of
0.606 MeV to stable Xenon-131. Iodine-131 has a half-life of 8.02
days.
Excipients with known effect:
This medicinal product contains 5.9 mg/ml sodium. To be taken into
consideration by
patients on a controlled sodium diet.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Diagnostic indications
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
amount can be used to
calculate the activity required for radioiodine therapy.
In the management of thyroid carcinoma, sodium iodide is used to
identify thyroid remnant
and metastases (after ablation).
Thyroid scanning for benign conditions with sodium (
131
I) iodide can be performed but
only where circumstances do not allow for radiopharmaceuticals with
more favourable
dosimetry to be used.
Therapeutic indications
Radioiodide thyroid therapy is indicated for:

Treatment of Graves’ disease, toxic multinodular goitre or
autonomous nodules

Treatment of papillary and follicular thyroid carcinoma including
metastatic disease.
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Sodium (
131
I) iodide therapy is often combined with surgical intervention and
with
antithyroid medications.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Diagnostic use
Adults
The reco