Sodium Iodide [131I] Capsules T Curiumpharma -

Pays: Norvège

Langue: norvégien

Source: Statens legemiddelverk

Ingrédients actifs:

Natriumjodid (131I)

Disponible depuis:

Curium Netherlands B.V.

Code ATC:

V09FX03

DCI (Dénomination commune internationale):

Natriumjodid (131I)

forme pharmaceutique:

Kapsel, hard

Unités en paquet:

Beholder av plast med blyemballasje 7400 MBq

Type d'ordonnance:

C

Statut de autorisation:

Markedsført

Date de l'autorisation:

2005-05-18

Résumé des caractéristiques du produit

2022
1/17
SUMMARY OF PRODUCT CHARACTERISTICS
FOR
SODIUM IODIDE (I131) CAPSULES T CURIUMPHARMA, 37-7400 MBQ HARD CAPSULE
1.
NAME OF THE MEDICINAL PRODUCT
Sodium Iodide (I131) Capsules T Curiumpharma 37-7400 MBq hard capsule
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One hard capsule contains 37-7400 MBq sodium iodide (
131
I) at the time of calibration.
Iodine-131 is produced by fission of uranium-235 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 _
One hard capsule contains 63.5 mg sodium and 23 mg of sucrose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
Transparent hard gelatine capsule containing a white to light brown
powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Radioiodine thyroid therapy is indicated in adults and children for:

Hyperthyroidism: Treatment of Graves’ disease, toxic multinodular
goitre or autonomous nodules.

Treatment of papillary and follicular thyroid carcinoma including
metastatic disease.
Sodium iodide (
131
I) therapy is often combined with surgical intervention and with
antithyroid
medicinal products.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
This medicinal product should be administered only by authorised
healthcare professionals in
designated clinical settings (see section 6.6).
Posology
The activity to be administered is a matter of clinical judgement. The
therapeutic effect is only
achieved after several weeks. The activity of the capsule should be
determined before use.
_Adults _
_Treatment of hyperthyroidism _
In case of failure or impossibility to pursue the medical treatment,
radioactive iodide may be
administered to treat the hyperthyroidism.
Patients should be rendered euthyroid medically whenever possible
before giving radioiodine
treatment for hyperthyroidism.
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2/17
The activity to be administe