Sodium Iodide [¹³¹|] Diagnostic Capsules 0.333-3.7 MBq caps, Hard

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

SODIUM IODIDE

Available from:

GE Healthcare Buchler GmbH & Co. Gieselweg 1, 38110 Braunschweig, Germany

ATC code:

V09FX03

INN (International Name):

SODIUM IODIDE (131 I) 3.7 MBq

Pharmaceutical form:

HARD CAPSULE

Composition:

SODIUM IODIDE (131 I) 3.7 MBq

Prescription type:

POM

Therapeutic area:

DIAGNOSTIC RADIOPHARMACEUTICALS

Authorization status:

Authorised

Authorization date:

2007-04-05

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
SODIUM IODIDE (131I) DIAGNOSTIC CAPSULES
Sodium Iodide (131I) Diagnostic Capsules 0.333 to 3.7 MBq Capsules,
hard
Sodium [131I] Iodide (called Sodium Iodide Diagnostic Capsules in this
leaflet)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU RECEIVE 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 doctor who will supervise
the procedure.
-
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 Sodium Iodide Diagnostic Capsules are and what they are used for
2.
What you need to know before Sodium Iodide Diagnostic Capsules are
used
3.
How Sodium Iodide Diagnostic Capsules are given
4.
Possible side effects
5.
How Sodium Iodide Diagnostic Capsules are stored
6.
Contents of the pack and other information
1.
WHAT SODIUM IODIDE DIAGNOSTIC CAPSULES ARE AND WHAT THEY ARE USED FOR
This medicine is used for diagnostic use only. It is used only to help
identify illness.
Sodium Iodide Diagnostic Capsules are a ‘radiopharmaceutical’
medicine.
• They contain an active ingredient called ‘sodium iodide’.
• Once taken they can be seen from outside your body by a special
camera used in the scan.
• The scan can help your doctor see tumours in the thyroid glands,
and to see how well a tumour is
responding to treatment or if the tumour has spread to other parts of
the body.
The use of Sodium Iodide Diagnostic Capsules does involve exposure to
amounts of radioactivity.
Your doctor has considered that the clinical benefit that you will
obtain from the procedure with the
radiopharmaceutical outweighs the risk due to radiation.
2.
WHAT YOU NEED TO KNOW BEFORE SODIUM IODIDE DIAGNOSTIC CAPSULES ARE
USED
SODIUM IODIDE DIAGNOSTIC CAPSULES MUST NOT BE USED:
• If you are allergic (hypersensitive) to Sodium Iodide Diagnostic
Capsules or any of the other
ingredients o

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Sodium Iodide (
131
I) Diagnostic Capsules 0.333-3.7 MBq capsules, hard
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium Iodide (
131
I) Diagnostic Capsules are presented as a white capsule. Each capsule
contains 3.7 MBq (100 µ Ci) 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 8.02
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 Xenon131.
Excipients with known effect:
This medicinal product contains: 85.28mg of sodium per capsule. This
needs to be taken
into consideration by patients on a sodium controlled diet.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsule, hard.
White, opaque gelatin capsule.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
1.
Sodium
[
131
I
]
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 [
131
I]iodide is used to identify
thyroid remnants and metastases (after ablation).
3.
Thyroid scanning for benign conditions with sodium [
131
I]iodide can be performed
but only where circumstances do not allow for radiopharmaceuticals
with more
favourable dosimetry to be used.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
The recommended activities for an adult patient (70 kg) are as
follows:
1.
For thyroid uptak