[¹³¹I] Meta-Iodobenzylguanidine for Diagnostic Use
Country: Malta
Language: English
Source: Medicines Authority
Patient Information leaflet
(PIL)
11-05-2024
Summary of Product characteristics
(SPC)
11-05-2024
Active ingredient:
IOBENGUANE
Available from:
GE Healthcare Limited
ATC code:
V09IX02
INN (International Name):
IOBENGUANE
Pharmaceutical form:
SOLUTION FOR INJECTION
Composition:
IOBENGUANE
Prescription type:
POM
Therapeutic area:
DIAGNOSTIC RADIOPHARMACEUTICALS
Authorization status:
Authorised
Authorization date:
2007-09-03
Patient Information leaflet
GE Healthcare
PACKAGE LEAFLET:
INFORMATION FOR THE USER
Meta-lodobenzylguanidine (
131
I)
for Diagnostic Use
Meta-lodobenzylguanidine (
131
I) for
Diagnostic Use
9.25-18.5 MBq/ml, solution for
injection
[
131
I] Iobenguane
Meta-lodobenzylguanidine (
131
I) for
Diagnostic Use 9.25-18.5 MBq/ml
solution for injection is referred to as
MIBG Diagnostic in this leaflet.
Read all of this leaflet carefully
before you are given MIBG
Diagnostic.
- 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 or nurse.
In this leaflet:
1. What MIBG Diagnostic is and
what it is used for
2. Before you are given MIBG
Diagnostic
3. How MIBG Diagnostic is given
4. Possible side effects
5. How to store MIBG Diagnostic
6. Further information
1. What MIBG Diagnostic is and
what it is used for
This medicine is used for diagnostic
use only. It is used only to help
identify illness.
MIBG Diagnostic is a
‘radiopharmaceutical’ medicine. It is
given before a scan and helps a
special camera see inside a part of
your body.
•
It contains an active ingredient
called ‘iobenguane’.
•
Once injected it can be seen from
outside your body by a special
camera used in the scan.
•
The scan can help your doctor
see if a tumour of the adrenal or
thyroid glands is suitable for
treatment and help decide on the
treatment required.
Your doctor or nurse will explain
which part of your body will be
scanned.
2.
Before you are given MIBG
Read the complete document
Summary of Product characteristics
_ _
_ _
_SPC14900101 _
_Page 1 of 8 _
SUMMARY OF PRODUCT CHARACTERISTICS
FOR
(
131
I) META-IODOBENZYLGUANIDINE FOR DIAGNOSTIC USE,
9.25-18.5 MBQ/ML, SOLUTION FOR INTRAVENOUS INJECTION
1.
NAME OF MEDICINAL PRODUCT
(
131
I) Meta-Iodobenzylguanidine for Diagnostic Use
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
[
131
I] Iobenguane: 9.25-18.5MBq/ml (0.05-0.5mg/ml).
Summary of the physical characteristics of the radioactive isotope in the active substance:
[
131
I] Iodine: physical half-life 8.02 days.
The most important radiation emissions are as below:
Energy level
Abundance %)
ß-247 keV
1.8
ß-334 keV
7.2
ß-606 keV
89.7
ß-806 keV
0.7
ϒ
-364 keV
82.0
Excipients:
•
Benzyl alcohol: 10 mg/ml
•
Sodium: 3.54 mg/ml
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for intravenous injection
Clear colourless solution
4.
CLINICAL PARTICULARS
4.1
INDICATION
This medicinal product is for diagnostic use only.
_ _
Calculation of a therapeutic [
131
I] iobenguane dose from a prior tracer-dose.
The sensitivity to diagnostic visualisation, and therefore also to therapeutic efficacy, is
different for the listed pathologic entities.
_ _
_ _
_ _
_Page 2 of 8 _
Pheochromocytomas and neuroblastomas are sensitive in approximately 90 % of patients,
carcinoids in 70 % and medullary carcinomas of the thyroid glands (MCT) in only 35 %.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
"Tracer"-dose to acquire dosimetric information (20-40 MBq).
Distribution measurement prior to administration of a therapeutic dose is recommended in
order to establish the retention time of the radiopharmaceutical in organ
Read the complete document
