Theracap 131TM -

Maa: Norja

Kieli: norja

Lähde: Statens legemiddelverk

Aktiivinen ainesosa:

Natriumjodid (131I)

Saatavilla:

GE Healthcare Buchler GmbH & Co. KG

ATC-koodi:

V10XA01

INN (Kansainvälinen yleisnimi):

Natriumjodid (131I)

Lääkemuoto:

Kapsel, hard

Kpl paketissa:

Beholder av plast med blyemballasje 1x50 MBq

Prescription tyyppi:

C

Valtuutuksen tilan:

Markedsført

Valtuutus päivämäärä:

2006-07-14

Valmisteyhteenveto

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF MEDICINAL PRODUCT
THERACAP
131 TM
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
THERACAP is presented as a single yellow capsule containing sodium
iodide (
131
I) in
the following dosage range; 37 MBq - 5.55 GBq at the activity
reference date. Each
capsule contains a maximum of 20 µg of sodium iodide (
131
I).
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.
Excipient(s) with known effect:
One hard capsule contains: 50 mg sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule hard.
Yellow gelatine capsule.
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 authorized
healthcare
professionals in designated clinical settings (see section 6.6).
Posology
2
The activity to be administered is a matter for 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.
The activity to be administered depends on the diagnosis