Sodium Iodide (I131) Capsule T 37-7400 MBq hard capsule

দেশ: আয়ার্লণ্ড

ভাষা: ইংরেজি

সূত্র: HPRA (Health Products Regulatory Authority)

সক্রিয় উপাদান:

Sodium iodide (131 i)

থেকে পাওয়া:

Curium Netherlands B.V.

এটিসি কোড:

V10XA; V10XA01

INN (আন্তর্জাতিক নাম):

Sodium iodide (131 i)

ডোজ:

37-7400 megabecquerel(s)

ফার্মাসিউটিকাল ফর্ম:

Capsule, hard

প্রেসক্রিপশন টাইপ:

Product subject to prescription which may not be renewed (A)

থেরাপিউটিক এলাকা:

Iodine (131I) compounds; sodium iodide (131I)

অনুমোদন অবস্থা:

Marketed

অনুমোদন তারিখ:

2001-06-29

তথ্য লিফলেট

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SODIUM IODIDE (I131) CAPSULE T 37-7400 MBQ, HARD CAPSULE
sodium iodide (
131
I)
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. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Sodium Iodide (I131) Capsule T is and what it is used for
2.
What you need to know before Sodium Iodide (I131) Capsule T is used
3.
How Sodium Iodide (I131) Capsule T is used
4.
Possible side effects
5.
How Sodium Iodide (I131) Capsule T is stored
6.
Contents of the pack and other information
1. WHAT SODIUM IODIDE (I131) CAPSULE T IS AND WHAT IT IS USED FOR
Sodium Iodide (I131) Capsule T is a medicine used in adults, children
and adolescents to treat:
•
thyroid gland tumours and
•
overactive thyroid gland
This medicine contains sodium iodide (
131
I), a radioactive substance which accumulates in certain
organs such as, the thyroid gland.
This medicine is radioactive but your doctors consider that the
medicine’s beneficial effect on your
condition outweigh the possible harm from the radiation.
2. WHAT YOU NEED TO KNOW BEFORE SODIUM IODIDE (I131) CAPSULE T IS USED
SODIUM IODIDE (I131) CAPSULE T
MUST NOT BE USED,
if you are
−
allergic to sodium iodide or any of the other ingredients of this
medicine (listed in section 6)
−
pregnant
−
breast-feeding
if you have
−
swallowing problems
−
obstructed gullet
−
stomach problems like inflammation of the stomach (gastritis) and
gastro-duodenal ulcer
−
reduced stomach or bowel movement
If any of these apply to you,
TELL YOUR NUCLEAR MEDICINE DOCTOR.
2
WARNINGS AND PRECAUTIONS
Tell the nuclear medicine doctor
−
if you have reduced kidney function.
−
if you have problems

পণ্য বৈশিষ্ট্য

Health Products Regulatory Authority
15 November 2023
CRN00D3D2
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sodium Iodide (I131) Capsule T 37-7400 MBq hard capsule
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One hard capsule contains 37-7400 MBq sodium iodide (
131
I) at the time of calibration.
Iodine-131 is produced by fission of uranium-235 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 Xenon-131.
Excipients with known effect
One hard capsule contains 63.5 mg sodium and 23 mg of sucrose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsule.
Transparent hard gelatine capsule containing a white to light brown
powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Radioiodine thyroid therapy is indicated in adults and children for:

Hyperthyroidism 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 medicinal products.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
This medicinal product should be administered only by authorised
healthcare professionals in designated clinical settings (see
section 6.6).
Posology
The activity to be administered is a matter of clinical judgement. The
therapeutic effect is only achieved after several weeks.
The activity of the capsule should be determined before use.
_Adults_
_Treatment of hyperthyroidism_
In case of failure or impossibility to pursue the medical treatment,
radioactive iodide may be administered to treat the
hyperthyroidism.
Patients should be rendered euthyroid medically whenever possible
before giving radioiodine treatment for hyperthyroidism.
The activity to be administered depends on the diagnosis, the size of
the