[¹³¹I] Meta-Iodobenzylguanidine for Diagnostic Use solution for intravenous injection

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

IOBENGUANE

Available from:

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

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

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 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 MIBG Diagnostic is and what it is used for
2.
What you need to know before you are given MIBG Diagnostic
3.
How MIBG Diagnostic is given
4.
Possible side effects
5.
How to store MIBG Diagnostic
6.
Contents of the pack and other 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 nuclear medicine doctor will explain which part of your body will
be scanned.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN MIBG DIAGNOSTIC
MIBG DIAGNOSTIC MUST NOT BE USED:
•
If you are allergic (hypersensitive) to the active ingredient or any
other ingredient. (listed in
Section 6).
•
If you are pregnant or think you might be pregnant.
Do not have MIBG Diagnostic if any of the above

Summary of Product characteristics

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 THE MEDICINAL PRODUCT
(
131
I) Meta-Iodobenzylguanidine for Diagnostic Use
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
[
131
I] iobenguane: 9.25-18.5 MBq/ml (0.05-0.5 mg/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 with known effect:
•
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
THERAPEUTIC INDICATIONS
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. Pheochromocytomas and
neuroblastomas are
sensitive in approximately 90% of patients, carcinoids in 70% and
medullary carcinomas of
the thyroid gland (MCT) in only 35%.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
“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
organs, tumour tissue and
normal structures.
Renal impairment
Careful consideration of the activity to be administered is required
since an increased
radiation exposure is possible in these patients.
Paediatric population
The recommended dosages are identical for children and adults.
Meta-iodobenzylguanidine
(131I) for Diagnostic Use is contraindicated in premature babies and
neonates.
Method of Administration
The dose is administere