ThyroTop D 0.5-37 MBq hard capsule capsules hard

Pajjiż: Armenja

Lingwa: Ingliż

Sors: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredjent attiv:

131I sodium iodide

Disponibbli minn:

Institute of Isotopes Co. Ltd. Konkoly Thege Miklos str.29-33

Kodiċi ATC:

V09F

INN (Isem Internazzjonali):

131I sodium iodide

Dożaġġ:

0.5-37MBq

Għamla farmaċewtika:

capsules hard

Unitajiet fil-pakkett:

(10) in glass vial

Tip ta 'preskrizzjoni:

Prescription

L-istatus ta 'awtorizzazzjoni:

Registered

Data ta 'l-awtorizzazzjoni:

2019-10-21

Fuljett ta 'informazzjoni

OGYÉI/16933/2016 (2. versio)
PACKAGE LEAFLET: INFORMATION FOR THE USER
THYROTOP D 0.5 – 37 MBQ HARD CAPSULE
131
I sodium iodide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE THIS MEDICINE IS USED FOR
YOUR
EXAMINATION 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 doctor.
-
If you get any side effects, talk to your doctor. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What ThyroTop D 0.5 – 37 MBq hard capsule is and what it is
used for
2.
What you need to know before you take ThyroTop D 0.5 – 37
MBq hard capsule
3.
How to take ThyroTop D 0.5 – 37 MBq hard capsule
4.
Possible side effects
5.
How to store ThyroTop D 0.5 – 37 MBq hard capsule
6.
Contents of the pack and other information
1.
WHAT THYROTOP D 0.5 – 37 MBQ HARD CAPSULE IS AND WHAT IT
IS USED FOR
ThyroTop D 0.5 -37 MBq hard capsule is a radioactive medicine, which
can be used to design the individual patient dose of radionuclide
therapy
and
for
determination
of
thyroidal
uptake
of
radioiodine
and
its
saturation curve. This medicine can be used only in nuclear medicine
departments.
The gelatine capsule itself is colourless and contains white powder.
After oral administration of the capsule,
131
I-sodium iodide gets into the
blood stream and reaches the thyroid, the salivary glands, placenta,
gastric
mucosa and plexus
chorioideus
and
breast
milk
in
case of
lactation.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE THYROTOP D 0.5 – 37
MBQ HARD CAPSULE
DO NOT TAKE THYROTOP D 0.5 – 37 MBQ HARD CAPSULE
-
if you are allergic to any of the other ingredients of this medicine
(listed in section 6).
-
if you are pregnant, or breastfeeding
-
if you do not consent to the nuclear medicine examination
-
if you are not capable to follow the instructions on post treatment
radiation protections
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking ThyroTop D 0.5 – 37 MBq hard
capsule
In
case
of
pat

Karatteristiċi tal-prodott

OGYÉI/16933/2016 (2. versio)
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
THYROTOP D 0.5-37 MBQ HARD CAPSULE
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains
131
I in form of
131
I sodium iodide. Activity
range: 0,5-37 MBq at reference date.
Iodine-131 has a half-life of 8.02 days. It decays by emission of
gamma
radiations of 365 keV (81%), 637 keV (7.3%) and 284 keV (6.0%) and
beta radiations of maximal energy of 606 keV to stable Xenon-131.
Excipient(s) with known effect: ca. 143 mg sodium per hard capsule
3.
PHARMACEUTICAL FORM
Hard capsule
Size “0”, colourless, transparent, CONI-SNAP type gelatine capsule
Radioactive pharmaceutical containing
131
I-labelled sodium iodide active
substance, for oral administration
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
Thyroid diagnostics
Examination
of
radioiodine
uptake
of
thyroid
prior
to
radioisotope
treatment of benign thyroid diseases, for determination of individual
patient dose. Radioiodine treatment is indicated for the treatment of
hyperthyreoidism
(Graves
Basedow
disease,
and
single
or
multiple
autonomously functioning nodules or diffuse autonomy) in order to
final
elimination of hyperfunction or size reduction of significantly
enlarged
but normally functioning nodules, often recidive goiter.
Method: known quantity of
131
I sodium iodide is swallowed by the
patient. Radioiodine uptake is measured as a function of the
radioactivity
intake
once
or
several
time after
administration.
There are various
methods for radioiodine uptake measurement. According to the simplest
method
one
measurement
is
performed:
usually
24
hours
after
administration, but measurement after 7th day is also a known method.
By performing multiple measurements (usually 4-6 hours, 24 hours and
5-8 days after administration) not only the radioiodine uptake, but
its
maximum and effective half-life of radioiodine (radioiodine kinetics)
can also be determined. I-131 amount needed for the eff