Metaiodobenziloguanidina- 123 I (mibg-123 I)

Leaflet included in the packaging: information for the user

Metaiodobenzylguanidine-I (MIBG-I), 18.5-370 MBq/ml, solution for injection

Jobenguan (I)
You should carefully read the contents of the leaflet before using the medicine, as it contains
important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a specialist in nuclear medicine.
• If the patient experiences any adverse reactions, including any possible adverse reactions not listed in the leaflet, they should inform the specialist in nuclear medicine. See section 4.

Table of contents of the leaflet:

• 1. What is Metaiodobenzylguanidine-I (MIBG-I) and what is it used for?
• 2. Important information before using Metaiodobenzylguanidine-I (MIBG-I).
• 3. How to use Metaiodobenzylguanidine-I (MIBG-I).
• 4. Possible adverse reactions.
• 5. How to store Metaiodobenzylguanidine-I (MIBG-I).
• 6. Contents of the packaging and other information.

1. WHAT IS METAJODOBENZYLOGUANIDYNA-I (MIBG-I) AND WHAT IS IT USED FOR

WHAT IS IT USED FOR

Metaiodobenzylguanidine-I (MIBG-I) is a medicinal product (radiopharmaceutical) intended exclusively
for diagnostic purposes.
Metaiodobenzylguanidine-I (MIBG-I) is a radiopharmaceutical used in scintigraphic localization of tumors derived
from the neural crest. These are chromaffin tumors, pheochromocytomas, paragangliomas of the sympathetic
parasympathetic system, neuroblastomas.
Metaiodobenzylguanidine-I (MIBG-I) is also used for the detection, assessment of the degree of advancement and
control of neuroblastoma treatment.
With the help of Metaiodobenzylguanidine-I (MIBG-I), functional studies of the adrenal gland (suspected hyperplasia)
and heart muscle (evaluation of sympathetic innervation) are also performed.

2. IMPORTANT INFORMATION BEFORE USING THE MEDICINE

METAJODOBENZYLOGUANIDYNA-I (MIBG-I)

WHEN NOT TO USE METAJODOBENZYLOGUANIDYNA-I (MIBG-I)

If the patient is allergic to jobenguan (I) or any of the other ingredients of this medicinal product (listed in section 6).

WARNINGS AND PRECAUTIONS

It is necessary to block the thyroid gland before the examination with MIBG-I. This can be achieved by administering
iodine products, such as Lugol's solution, potassium iodide, potassium iodate in an amount equivalent to 130 mg
of iodine per day. Thyroid blockade should be started at least 30 minutes before administering I-jobenguan and
continued for 1-2 days.
The uptake of metaiodobenzylguanidine in chromaffin granules may theoretically cause sudden release of noradrenaline,
which may cause a significant increase in blood pressure.
This requires constant monitoring of the patient during administration of the medicinal product. I-jobenguan should
be administered slowly (in a time not shorter than one minute per patient).
Administering medicinal products containing radioactive isotopes creates a risk of exposure to external ionizing radiation
or contamination caused by urine stains, vomiting, etc. for other people. For this reason, basic hygiene rules should
be followed.
In order to reduce the absorbed dose of radiation by the urinary bladder, it is recommended to drink a slightly larger
than usual amount of fluids (about 1-1.5 liters per day more) and to urinate more frequently after administration of the
medicinal product.

METAJODOBENZYLOGUANIDYNA-I (MIBG-I) AND OTHER MEDICINAL PRODUCTS

You should tell your doctor about all medicinal products that the patient is currently taking or has recently taken, as
well as about the medicinal products that the patient plans to take. You should consider discontinuing, under medical
supervision, medicinal products that may affect the uptake of jobenguan, in accordance with the table below:

METAJODOBENZYLOGUANIDYNA-I (MIBG-I) WITH FOOD AND DRINK

No special precautions are recommended.

PREGNANCY AND BREASTFEEDING

If the patient is pregnant or breastfeeding, suspects that she may be pregnant or plans to have a child, she should
consult a doctor before using this medicinal product.
Before taking the medicinal product, the patient should inform the specialist doctor in nuclear medicine if:

• there is a suspicion of pregnancy in a woman,
• menstruation has not occurred at the expected time,
• the woman is breastfeeding. In case of doubt, consultation with a specialist doctor in nuclear medicine supervising
  the examination is necessary.

In the event of the need to administer the medicinal product to a woman of childbearing age, it should be ensured that
the woman is not pregnant. The absorbed dose to the uterus after administration of 370 MBq I-MIBG is 3.7 mGy.
Doses above 0.5 mGy should be considered as potentially hazardous to the fetus.
Breastfeeding should be discontinued after administration of the radiopharmaceutical due to the potential risk to the
child's health.

DRIVING AND USING MACHINES

The effect on the ability to drive and use machines has not been described.
Metaiodobenzylguanidine-I (MIBG-I) contains sodium.
The medicinal product contains less than 1 mmol of sodium (23 mg) per vial, so the product can be considered
“sodium-free”.

3. HOW TO USE METAJODOBENZYLOGUANIDYNA-I (MIBG-I)

There are strict regulations regarding the use, transfer, and disposal of radiopharmaceuticals. Metaiodobenzylguanidine-I
(MIBG-I) is used exclusively in appropriate clinical conditions and only by qualified personnel. These persons take
special precautions to ensure safe use of the medicinal product and will inform about their actions.
The medicinal product is intended for intravenous administration.
The specialist doctor in nuclear medicine supervising the procedure decides on the dose of the medicinal product to be
used in a given case. This will be the minimum dose necessary to obtain the expected diagnostic information. The recommended
dose for an adult ranges from 80 to 370 MBq (MBq = megabecquerel, a unit of measurement of radioactivity).
Adults:the recommended dose is 80-200 MBq.
In the case of examination of sympathetic innervation of the heart muscle, the proposed dosing is 111-370 MBq for adults
and not less than 80 MBq for children.

USE IN CHILDREN AND ADOLESCENTS:

In children and adolescents, the amount of medicinal product to be administered is determined based on the patient's body
weight.
The recommended dose:

• I-jobenguan is administered according to the following dosing scheme:
• children under 6 months: 4 MBq per kilogram of body weight (max. 40 MBq)
• children between 6 months and 2 years: 4 MBq per kilogram of body weight (min. 40 MBq)
• children over 2 years: the appropriate fraction of the adult dose calculated based on the child's body weight according
  to the table below:

The above recommended dosing scheme should also take into account the rules determined by local regulations regarding
the dosing of radiopharmaceuticals.
There is no special dosing for the elderly.
I-Iobenguane is administered by infusion or slow intravenous injection. If necessary, the administered volume can be
increased by diluting the solution.

ADMINISTRATION OF THE MEDICINAL PRODUCT AND PERFORMANCE OF THE EXAMINATION

Metaiodobenzylguanidine-I (MIBG-I) is a medicinal product for intravenous administration under the control of qualified
personnel.
During administration of the medicinal product, the rules of safety at work in conditions of exposure to ionizing radiation
should be strictly followed.
The radiopharmaceutical is injected slowly into a vein (in a time not shorter than 1 minute).

DURATION OF THE PROCEDURE

The doctor will inform about the standard duration of the procedure.

AFTER ADMINISTRATION OF METAJODOBENZYLOGUANIDYNA-I (MIBG-I), YOU SHOULD:

• avoid close contact with small children and pregnant women for up to 24 hours after injection,
• urinate frequently to remove the medicinal product from the body.

The doctor will inform about the need to take special precautions after administration of the medicinal product. In case of
doubt, you should consult the attending doctor or a specialist in nuclear medicine.

USE OF A HIGHER DOSE OF THE MEDICINAL PRODUCT THAN RECOMMENDED

Overdose is almost impossible, because the dose of the medicinal product administered to the patient is strictly controlled
by the specialist doctor in nuclear medicine.
The medicinal product is supplied in vials with a known activity, which makes it easier for the doctor to control the dose to be
administered to the patient. In the event of an overdose, the doctor may take appropriate treatment.
Due to the renal elimination route of the radiopharmaceutical, it is necessary to maintain proper diuresis in order to reduce the
irradiation of the patient.
In case of any further doubts related to the use of this medicinal product, you should consult a specialist doctor in nuclear
medicine.

4. POSSIBLE ADVERSE REACTIONS

Like all medicinal products, this medicinal product can cause adverse reactions, although not everybody gets them.
Administration of MIBG-I occasionally causes nausea, urticaria, skin redness, chills, or other mild symptoms of allergic
reactions.
In the event of too rapid injection, during or immediately after it, palpitations, shortness of breath, feeling of warmth, transient
increase in blood pressure, or abdominal cramps may occur.
These adverse reactions usually disappear within one hour.
Exposure to ionizing radiation may lead to an increased risk of cancer or genetic disorders.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in the leaflet, you should inform your
doctor or pharmacist, or nurse. Adverse reactions can be reported directly to the Department for Monitoring of Adverse
Reactions of Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, e-mail: ndl@urpl.gov.pl.
Adverse reactions can also be reported to the marketing authorization holder.
Reporting of adverse reactions helps to gather more information on the safety of the medicinal product.

5. HOW TO STORE METAJODOBENZYLOGUANIDYNA-I (MIBG-I)

The patient will not need to store this medicinal product.
Radiopharmaceuticals are stored exclusively by authorized persons in appropriate clinical conditions. Storage of radiopharmaceuticals
is carried out in accordance with local regulations regarding radioactive substances.
The following information is intended exclusively for medical personnel.
Do not use this medicinal product after the expiry date stated on the label after: Expiry date and time: {DD.MM.RRRR} {HH:MM}

6. CONTENTS OF THE PACKAGING AND OTHER INFORMATION

WHAT METAJODOBENZYLOGUANIDYNA-I (MIBG-I) CONTAINS

• The active substance of the medicinal product is jobenguan-I in the amount of 18.5-370 MBq/ml.
• The other ingredients of the medicinal product are: sodium metabisulfite, copper (II) sulfate pentahydrate, sodium acetate trihydrate, acetic acid, benzyl alcohol, sodium chloride, water for injections

WHAT METAJODOBENZYLOGUANIDYNA-I (MIBG-I) LOOKS LIKE AND WHAT THE PACKAGING CONTAINS

The MIBG-I solution is supplied in 10 ml glass vials with the possibility of multiple sterile sampling.
The vial is closed with a rubber stopper and an aluminum cap and placed in a lead shielding container.
The outer transport packaging is a metal box with filling.
A certificate of activity is attached to each source.

MARKETING AUTHORIZATION HOLDER AND MANUFACTURER

National Center for Nuclear Research
ul. Andrzeja Sołtana 7
05-400 Otwock
Tel: 22 7180700
Fax: 22 7180350
e-mail: polatom@polatom.pl

DATE OF LAST UPDATE OF THE LEAFLET:

The Full Characterization of the Medicinal Product (ChPL) is attached as a separate document to the packaging of the product,
in order to provide healthcare professionals with additional, scientific and practical information regarding the administration
and use of this radiopharmaceutical.