MIBG (123I) 74 MBq/mL solution for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Iobenguane

Available from:

Curium Netherlands B.V.

ATC code:

V09IX; V09IX01

INN (International Name):

Iobenguane

Dosage:

74 megabecquerel(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

Product subject to Restricted Prescription (C)

Therapeutic area:

Other diagnostic radiopharmaceuticals for tumour detection; iobenguane (123I)

Authorization status:

Marketed

Authorization date:

2000-02-18

Patient Information leaflet

22 CON 4342 Ireland PIL final
1/2
DRN 5379
Package leaflet: Information for the patient
MIBG (
123
I) 74 MBQ/ML
SOLUTION FOR INJECTION
iobenguane (
123
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 MIBG (
123
I) is and what it is used for
2. What you need to know before MIBG (
123
I) is used
3. How MIBG (
123
I) is used
4. Possible side effects
5.
How MIBG (
123
I) is stored
6. Contents of the pack and other information
1.
WHAT MIBG (
123
I) IS AND WHAT IT IS USED
FOR
This medicine is a radiopharmaceutical product for DIAGNOSTIC USE
only.
This medicine contains iobenguane (
123
I), a radioactive substance which
when injected, collects in certain organs such as the heart, the
adrenal glands
(glands which are located on the top of each kidney) and particular
tumours.
The radioactive substance can be photographed from outside the body,
using
special cameras which take a scan. This scan shows where the
radioactivity
is inside the organ and the body. This gives the doctor valuable
information
about how that organ is working or where a tumour is located.
MIBG (
123
I) is used in adults and children:

TO FIND PARTICULAR TUMOURS such as tumours of the ADRENAL GLANDS AND
OTHER
HORMONE-PRODUCING
TUMOURS
(so
called
neuroendocrine
tumours),

TO FIND, PLAN AND FOLLOW-UP TREATMENT OF NEUROBLASTOMAS (tumours
in the nervous system, mostly affecting children),

TO ESTIMATE HOW MUCH IOBENGUANE (
123
I) IS ABSORBED by your body
before starting a treatment with iobenguane,

TO EXAMINE HOW THE ADRENAL GLANDS OR HEART IS WORKING.
The use of MIBG (
123
I) does involve exposure to small amounts of
radioactivity. Yo

Summary of Product characteristics

Health Products Regulatory Authority
10 December 2021
CRN00C4TF
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
MIBG (
123
I) 74 MBq/mL solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Composition per mL, at activity reference date and time.
123
I as Iobenguane 74 MBq
iobenguane sulfate 0.5 mg
The radiochemical purity of the product at expiry date and time:
123
I-Iobenguane : ≥ 95 %
Meta-iodo(
123
I)benzylamine : ≤ 0.5 %
Free iodide(
123
I) : ≤ 5 %
The radionuclidic purity of the product at expiry date and time:
123
I: ≥ 99.7 %
121
Te: ≤ 0.9 kBq/MBq
125
I: ≤ 1.5 kBq/MBq
123
I is obtained by proton irradiation of enriched Xenon.
Summary of the physical characteristics of the radioactive isotope in
the active substance:
123
I.
Physical half-life 13.2 hours.
Most important radiation emitted
Energy level Abundance (%)
159 keV-g-rays 83.6
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection (injection).
Clear and colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.

Detection of neuroendocrine tumours such as pheochromocytomas,
paragangliomas, chemodectomas and
ganglioneuromas.

Detection, staging and follow-up on therapy of neuroblastomas.

Evaluation of the uptake of iobenguane (
123
I) for therapy planning.

Functional studies of the adrenal medulla (hyperplasia) and the
myocardium (sympathetic innervation).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_Adults _
The recommended activity range is 110-400 MBq based on a patient of
average weight (70 kg).
_Elderly population_
No special dosage-scheme is required for the elderly patient.
Health Products Regulatory Authority
10 December 2021
CRN00C4TF
Page 2 of 9
_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 use in children and adolescents has