Capsion Sodium Iodide [131I] Capsules For Therapy 50 MBq

Land: Norge

Språk: norsk

Kilde: Statens legemiddelverk

Aktiv ingrediens:

Natriumjodid (131 I)

Tilgjengelig fra:

Cis bio international

ATC-kode:

V10XA01

INN (International Name):

Sodium iodide (131 I)

Dosering :

50 MBq

Legemiddelform:

Kapsel, hard

Enheter i pakken:

Hetteglass i blyemballasje 3700 MBq

Resept typen:

C

Autorisasjon status:

Markedsført

Autorisasjon dato:

2007-08-01

Preparatomtale

1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
CAPSION 50-3,700 MBq capsule, hard.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 50 to 3,700 MBq sodium iodide (
131
I) at calibration date.
Iodine-131 is produced by fission of uranium-235 and by neutron
bombardment of stable
tellurium in a nuclear reactor. Iodine-131 has a half-life of 8.04
days. It decays by emission of
gamma radiation of 365 keV (81.2 %), 637 keV (7.3 %) and 284 keV (6.1
%) and beta radiations
of maximal energy of 606 keV to stable xenon-131.
Excipient with known effect:
Each capsule contains 110 mg of sodium.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule hard.
Capsule green and orange.
4.
CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Radioiodine 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.
Sodium iodide (
131
I) therapy is often combined with surgical intervention and with
antithyroid
medications.
2
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The activity administered is a matter for clinical judgment. The
therapeutic effect is only
achieved after several weeks.
·
FOR THE TREATMENT OF HYPERTHYROIDISM
Patients should be rendered euthyroid medically whenever possible
before giving radioiodine
treatment for hyperthyroidism. The dose required depends on the
diagnosis, the size of the
gland, thyroid uptake and iodine clearance.
The range of activities currently prescribed, irrespective of the
method used, vary in the range
200–800 MBq, but repeated treatment may be necessary. Re-treatment
after six months is
indicated for persisting hyperthyroidism.
The following target organ doses may be used for posology calculation:
autonomous nodule
300 – 400 Gy absorbed dose to target organ
toxic multinodular goitre
150 – 200 Gy absorbed dose to target organ
Graves’ disease
200 Gy absorbed dose to target or