SODIUM IODIDE NA131I POLATOM CAPSULE

Страна: Сингапур

Език: английски

Източник: HSA (Health Sciences Authority)

Активна съставка:

Sodium iodide Na131I, solution

Предлага се от:

QUANTUM TECHNOLOGIES GLOBAL PTE. LTD.

АТС код:

V10XA01

Лекарствена форма:

CAPSULE

Композиция:

Sodium iodide Na131I, solution 37-5500 MBq

Начин на приложение:

ORAL

Вид предписание :

Prescription Only

Произведено от:

Narodowe Centrum Badan Jadrowych

Статус Оторизация:

ACTIVE

Дата Оторизация:

2018-04-23

Листовка

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Sodium iodide Na
131
I POLATOM, capsules for therapeutic use
37-5500 MBQ, HARD CAPSULES
_Natrii iodidi (_
_131_
_I) capsulae ad usum therapeuticum_
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your nuclear medicine doctor
who will supervise the
procedure.
-
If you get any side effects, talk to your nuclear medicine doctor.
This includes any possible side
effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET:
1.
What
Sodium iodide Na
131
I POLATOM, capsules for therapeutic use
is and what it is
used for
2.
What
you
need
to
know
before
Sodium
iodide
Na
131
I
POLATOM,
capsules
for
therapeutic use
is used
3.
How
Sodium iodide Na
131
I POLATOM, capsules for therapeutic use
is used
4.
Possible side effects
5.
How
Sodium iodide Na
131
I POLATOM, capsules for therapeutic use
is stored
6.
Contents of the pack and other information
1.
WHAT
SODIUM IODIDE NA
131
I POLATOM, CAPSULES FOR THERAPEUTIC USE IS AND WHAT IT IS
USED FOR
This medicine is a radiopharmaceutical product for therapy only.
The
capsules
containing
different
amount
(activity)
of
radioactive
sodium
iodide
(
131
I)
are
administrated orally for thyroid diseases treatment.
Sodium iodide (
131
I) is used for benign thyroid diseases treatment as listed below:
-
treatment of thyroid nodular goitre
-
treatment of Graves-Basedow’s disease
-
treatment of toxic multinodular goitre or autonomic nodule
It is also used in differentiated thyroid carcinoma treatment in the
following indications:
-
destruction of remaining tissues after surgery treatment (thyroid
ablation)
-
treatment of iodine-accumulating thyroid carcinoma metastases
The use of
Sodium iodide Na
131
I POLATOM, capsules for therapeutic use
does involve exposure
to ionising radiation. Your doctor and the nuclear medicine doctor
have considered that the clinical
benefit that you will obtain

Данни за продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Sodium iodide Na
131
I POLATOM, capsules for therapeutic use
Hard capsules, 37-5500 MBq
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Single hard capsule contains sodium iodide (
131
I)
_Natrii iodidi (_
_131_
_I) _
in the following activities range [37 -
5500 MBq]
Iodine-131 is produced by neutron bombardment of stable tellurium in a
nuclear reactor or by fission of
uranium. Iodine-131 has a half life of 8.02days. It decays to stable
xenon-131, by emission of gamma
radiations of 365 keV (81.7%), 637 keV (7.2%) and 284 keV (6.1 %) and
beta radiation of maximal
energy of 606 keV.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Hard capsules
_ _
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This product is used in the treatment of: thyroid nodular goitre,
hyperthyroidism in the Graves-
Basedow’s disease, autonomic nodule and the toxic multinodular
goitre. It is used for the thyroid
residue
ablation
after
surgery
of
differentiated
thyroid
tumours
and
in
the
treatment
of
iodine-
accumulating metastases.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Sodium iodide Na
131
I POLATOM, capsules for therapeutic use is a medicinal product with
varying
radioactivity, for oral administration.
The recommended therapeutic dose is a matter for clinical judgement.
This dose should be established
individually for each patient.
Adults:
Treatment of hyperthyroidism and nodular goitre:
The activity administered is usually in the range of 200 – 800 MBq
but repeated treatment may be
necessary.
The dose required depends on the diagnosis, the size of the gland,
thyroid uptake and iodine clearance.
Patients should be rendered euthyroid medically whenever possible
before giving radioiodine treatment
for hyperthyroidism.
For thyroid ablation and treatment of metastases:
The administered activities following total or sub total thyroidectomy
to ablate remaining thyroid tissue
are in the range of 1850 – 3700 MBq. It depends on the remnant size
and