Theracap ¹³¹

Pajjiż: Malta

Lingwa: Ingliż

Sors: Medicines Authority

Ingredjent attiv:

SODIUM IODIDE (131 I)

Disponibbli minn:

GE Healthcare Limited

Kodiċi ATC:

V10XA01

INN (Isem Internazzjonali):

SODIUM IODIDE (131 I)

Għamla farmaċewtika:

CAPSULE

Kompożizzjoni:

SODIUM IODIDE (131 I)

Tip ta 'preskrizzjoni:

POM

Żona terapewtika:

THERAPEUTIC RADIOPHARMACEUTICALS

L-istatus ta 'awtorizzazzjoni:

Authorised

Data ta 'l-awtorizzazzjoni:

2007-04-05

Fuljett ta 'informazzjoni

PACKAGE LEAFLET:
INFORMATION FOR THE USER
THERACAP
131TM
THERACAP
131
37 MBQ‐5.55 GBQ
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 Theracap is and what it is
used for
2.
Before you receive Theracap
3.
How Theracap is used
4.
Possible side effects
5.
How Theracap is stored
6.
Further information
1.
WHAT THERACAP IS AND WHAT IT IS
USED FOR
Theracap contains the active
substance called sodium iodide (
131
I).
It is a radiopharmaceutical product.

It collects in a specific organ or
part of our body.

Your doctor will explain for which
particular organ or part of your
body the treatment is required.

The radioactivity can be used to
treat that particular area.
It can be used:

to investigate if a tumour has
spread from the thyroid to other
parts of the body

to treat an overactive thyroid
gland (Graves disease)

to treat goitre (swelling in the
neck due to an enlarged thyroid
gland).
The use of Theracap is often
combined with surgical treatment and
with medicines that inhibit the
thyroid (antithyroidal agents).
2.
BEFORE YOU RECEIVE THERACAP
DO NOT USE THERACAP:

If you are allergic (hypersensitive)
to iodine (
131
I) or any of the other
ingredients of Theracap (see
section 6 for a list of the other
ingredients)

If you are pregnant

If you are unable to swallow
normally

If you have digestive or stomach
problems

If you suspect you have problems
with digesting food or suspect you
have other problems with your
stomach or gut.
Theracap is not for diagnostic use:

in children under 10 years of age

in children over 10 years of age,
adolescents (12 to 17 years of age)
and adults except to follow up on
a tumour that may be able to
spread to other tissues or when
oth

Karatteristiċi tal-prodott

Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF MEDICINAL PRODUCT
THERACAP
131TM
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
THERACAP
131
is presented as a single yellow capsule containing sodium iodide [
131
I] in the
following dosage range; 37-2035 MBq in 37 MBq steps and 2.22 - 5.55
GBq in 185 MBq steps
at the activity reference date. Each capsule contains a maximum of 20
µg of sodium iodide. The
specific activity of the sodium iodide [
131
I] is not less than 222 GBq/mg.
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
364 KeV (81.6%), 637 KeV (7.1%) and 284 KeV (6.2%) and beta radiations
of maximal energy of
606 KeV to stable Xenon 131.
3
PHARMACEUTICAL FORM
Capsule.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Radioiodine thyroid therapy is indicated for:

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
medications.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The activity administered is a matter for clinical judgement. The
therapeutic effect is only achieved
after several months.

For the treatment of hyperthyroidism
Page 2 of 13
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 radioiodine uptake.
In subsequent