Sodium Iodide [¹³¹] Diagnostic Capsules

Ország: Málta

Nyelv: angol

Forrás: Medicines Authority

Aktív összetevők:

SODIUM IODIDE (131 I)

Beszerezhető a:

GE Healthcare Limited

ATC-kód:

V09FX03

INN (nemzetközi neve):

SODIUM IODIDE (131 I)

Gyógyszerészeti forma:

CAPSULE

Összetétel:

SODIUM IODIDE (131 I) 3.7 MBq

Recept típusa:

POM

Terápiás terület:

DIAGNOSTIC RADIOPHARMACEUTICALS

Engedélyezési státusz:

Authorised

Engedély dátuma:

2007-04-05

Betegtájékoztató

 PACKAGE LEAFLET:  
INFORMATION FOR THE USER 

SODIUM IODIDE (
131
I) 
DIAGNOSTIC CAPSULES  

SODIUM IODIDE (
131
I) DIAGNOSTIC 
CAPSULES 333 KBQ TO 3.7 MBQ 
CAPSULE 
SODIUM IODIDE (
131
I) 

READ ALL OF THIS LEAFLET CAREFULLY 
BEFORE YOU RECEIVE THIS MEDICINE. 
-  Keep this leaflet. You may need to 
  read it again. 
-  If you have any further questions, 
ask  
your doctor. 
- If any of the side effects gets serious, 
  or if you notice any side effects not 
  listed in this leaflet, please tell your 
 doctor.  

IN THIS LEAFLET: 
1.  What Sodium Iodide (
131
I) 
Diagnostic Capsules are and what 
they are used for 
2.  Before you receive Sodium 
Iodide (
131
I) Diagnostic Capsules 
3.  How Sodium Iodide (
131
I) Diagnostic 
Capsules are used 
4.  Possible side effects 
5.  How Sodium Iodide (
131
I) Diagnostic 
Capsules are stored  
6.  Further information 

1.  WHAT SODIUM IODIDE (
131
I) 
DIAGNOSTIC CAPSULES ARE 
AND WHAT THEY ARE USED 
FOR 
This medicine is for diagnostic use 
only. It is used only to help identify 
illness. 

Sodium Iodide (
131
I) Diagnostic 
Capsules contain the active substance 
called sodium iodide (
131
I). It is a 
radiopharmaceutical product. 
•  It is injected into a vein by a 
specially trained and qualified 
person. 
•  It collects in a specific organ or 
part of your body. 
•  It is seen, from outside your body, 
by taking a scan (a picture) using 
special cameras. 
•  Your doctor will explain for which 
particular part of your body the 
scan is required. 
•  The scan can help your doctor find 
out more about your condition and 
decide on possible treatment. 

The scan can be used: 
•  to help decide the treatment 
required for a tumour of the 
thyroid gland 
•  to investigate if the treatment has 
successfully removed a tumour of 
the thyroid gland 
•  to investigate

Termékjellemzők

 
Page1 of 12 
SUMMARY OF PRODUCT CHARACTERISTICS 
1 
TRADE NAME OF THE MEDICINAL PRODUCT 
Sodium Iodide 
[
131
I
] Diagnostic Capsules 
2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Sodium 
[
131
I
] Iodide Diagnostic Capsules are presented as a white capsule. Each
capsule contains 
3.7MBq (100
µCi) at the first reference date. At subsequent reference dates, at
weekly intervals, the 
nominal activity per capsule is shown in the table below. 
REFERENCE DATE 
DAYS AFTER FIRST REFERENCE  ACTIVITY –MBQ (
µCI) 
1  
0 
3.7 
(100) 
2  
7 
2.03 
(54.9) 
3 14 
1.11 
(30.0) 
4 21 
0.592 
(16.0) 
5 28 
0.333 
(9.0) 

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 8.04 days.   It
decays by emission of gamma 
radiations of 365KeV (81.2%), 637 KeV (7.3%) and 284 KeV (6.1%) and
beta radiations of 
maximal energy of 606 KeV to stable Xenon 131. 
3 
PHARMACEUTICAL FORM 
Capsule. 
4 
CLINICAL PARTICULARS 
4.1 
DIAGNOSTIC INDICATIONS 
(1) 
Sodium iodide may be given as a “tracer” dose to study
radioiodine kinetics.  An estimation 
of the thyroid uptake and effective half life obtained with a tracer
dose can be used to 
calculate the activity required for radioiodine therapy. 
(2) 
In the management of thyroid carcinoma, sodium iodide is used to
identify thyroid remnants 
and metastases (after ablation). 
(3) 
Thyroid scanning for benign conditions with iodine-131 can be
performed but only when 
radiopharmaceuticals with more favourable dosimetry, eg iodine-123
or technetium-99m are 
not available. 

Page2 of 12 
4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 
The recommended activities for an adult patient (70 kg) are as
follows: 
(1) 
For thyroid uptake studies: 0.2 - 3.7 MBq 
(2) 
For post-thyroid ablation (for metastases and thyroid remnants): a
maximum activity of 400 
MBq 
(3) 
For thyroid imaging: 7.4 - 11 MBq 
Scans are usually