Moniyot-131 Capsule T 37-7400 MB kapsler, hårde

Država: Danska

Jezik: danski

Izvor: Lægemiddelstyrelsen (Danish Medicines Agency)

Aktivni sastojci:

Natriumiodid (131-I)

Dostupno od:

Monrol Europe S.R.L.

ATC koda:

V10XA01

INN (International ime):

Sodium iodide (131-I)

Doziranje:

37-7400 MB

Farmaceutski oblik:

kapsler, hårde

Datum autorizacije:

2013-03-06

Svojstava lijeka

15 JULY 2019
SUMMARY OF PRODUCT CHARACTERISTICS
FOR
MONIYOT-131 CAPSULE T, HARD CAPSULES
1.
NAME OF THE MEDICINAL PRODUCT
Moniyot-131 Capsule T
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One hard capsule contains 37-7400 MBq sodium iodide (
131
I) at time of calibration.
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 129.68 mg sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsules
Transparent hard gelatine capsules containing a white to light brown
powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Radioiodide 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).
_dk_hum_02244_spc.doc_
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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.
The activity to be administered depends on the diagnosis,