Mibeg

Package leaflet: Information for the patient

MIBEG 74 MBq/ml, injectable solution

iobenguane (I)
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult the nuclear medicine specialist supervising the procedure.
• If you experience any side effects, including those not listed in this leaflet, contact the nuclear medicine specialist. See section 4.

Contents of this leaflet:

1. What MIBEG is and what it is used for
2. What you need to know before MIBEG is used
3. How MIBEG is used
4. Possible side effects
5. How MIBEG is stored
6. Contents of the pack and other information

1. What MIBEG is and what it is used for

This medicinal product is a radiopharmaceutical intended for diagnostic use only.
This medicinal product contains iobenguane ( I), a radioactive substance which, when injected,
accumulates in certain organs such as the heart, adrenal glands (glands located above each kidney), and in certain tumours.
The radioactive substance can be detected from outside the body using special scanning machines. This scan shows the distribution of radioactivity within the organ and the body. This provides the doctor with valuable information about the function of the organ or the location of a tumour.
MIBEG is used in adults and children to:

• locate specific tumours, such as tumours of the adrenal glands and other hormone-producing tumours (so-called neuroendocrine tumours),
• locate neuroblastomas (tumours of the nervous system, which mainly affect children), plan treatment, and perform follow-up,
• estimate how much iobenguane ( I) is absorbed by your body before starting treatment with iobenguane,
• assess the function of the adrenal gland or the heart.

The use of MIBEG involves exposure to small amounts of radioactivity. Your doctor and the nuclear medicine physician have determined that the clinical benefit you will receive from the diagnostic procedure with this radiopharmaceutical outweighs the risk associated with radiation exposure.

2. What you should know before MIBEG is used

Do not use MIBEG

• if you are allergic to iobenguane (I) or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Please consult the nuclear medicine specialist before MIBEG is administered to you:

• if you are pregnant or suspect you may be pregnant,
• if you are breastfeeding,
• if you have reduced kidney function,
• if you have a disease affecting the nervous system, such as Parkinson's disease or Parkinson-like disorders.

Before administration of MIBEG:

• your doctor will instruct you to take another medicine containing non-radioactive iodine before MIBEG is administered. This medicine prevents the accumulation of radioactivity in your thyroid gland.
• you must drink plenty of water before the examination begins, to ensure frequent urination during the first hours after the examination.
• your doctor may ask you to stop taking certain medicines that could interfere with the examination (see section "Other medicines and MIBEG").

Children and adolescents
Please consult your nuclear medicine specialist if you are under 18 years of age.

Other medicines and MIBEG
Inform the nuclear medicine specialist supervising the procedure if you are taking, have recently taken, or might take any other medicines, as they could interfere with the interpretation of the images.
The following medicines may particularly affect the examination:

• calcium channel blockers (such as diltiazem, nifedipine, verapamil) used to treat hypertension and heart diseases,
• tricyclic antidepressants (such as amitriptyline, imipramine) used to treat depression,
• medicines often used to treat nasal congestion or cough (such as phenylephrine, ephedrine, phenylpropanolamine),
• reserpine and labetalol: medicines used to treat hypertension,
• medicines used to treat mental disorders whose active ingredient names generally end in “azina”, such as promethazine, levomepromazine, perphenazine,
• cocaine (a drug of abuse).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, please seek advice from the nuclear medicine specialist before this medicine is administered.
You must inform the nuclear medicine specialist before administration of MIBEG if there is any possibility you may be pregnant, if you have missed a menstrual period, or if you are breastfeeding.
If you have any doubts, it is important to consult the nuclear medicine specialist supervising the procedure.

If you are pregnant
The nuclear medicine specialist will administer MIBEG during pregnancy only if the expected benefits outweigh the potential risks.

If you are breastfeeding
The doctor may decide to postpone the examination until after breastfeeding has ended. If this is not possible, the doctor will ask you to interrupt breastfeeding for 3 days and discard the milk expressed during this period, until radioactivity has been completely eliminated from your body.

Driving and using machines
MIBEG is considered unlikely to affect your ability to drive vehicles or operate machinery.

MIBEG contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per vial, i.e. essentially ‘sodium-free’.

3. How MIBEG is used

There are very strict regulations governing the use, handling, and disposal of radiopharmaceuticals.
MIBEG will only be used in special, controlled areas. This medicine will be handled and
administered exclusively by trained and qualified personnel who are authorized to use it safely. These individuals
will pay particular attention to the safe use of this product and will keep you informed about their
actions.
The nuclear medicine specialist supervising the procedure will determine the amount of MIBEG to
be used in your case. This will be the minimum quantity necessary to obtain the required information.
The recommended administered dose in adults usually ranges from 110 to 400 MBq (megabecquerels are the units used to express radioactivity).
Use in children and adolescents
In children and adolescents, the administered dose will be adjusted according to the child's body weight.
Administration of MIBEG and performance of the procedure
MIBEG is administered by slow intravenous injection (injected into the vein over several minutes). You will be continuously monitored during administration because if the injection is too rapid, a sudden and severe increase in blood pressure may occur (see section 4).
Only one injection is required to perform the test requested by the doctor.
After the MIBEG injection, you may receive a sodium chloride flush to reduce the risk of pain at the injection site (see section 4).
Scans are performed between 15 minutes and 24 hours after injection. Scans may be repeated the following day.
Duration of the procedure
The nuclear medicine specialist will inform you about the expected duration of the procedure.
After administration of MIBEG:

• You should drink plenty of fluids and urinate frequently to eliminate the medicine from your body.
• Children and adolescents must continue taking the medication to prevent accumulation of radioactivity in the thyroid gland, according to the instructions provided by the nuclear medicine specialist.

The nuclear medicine specialist will inform you if you need to take any special precautions after
receiving the medicine. Please consult the nuclear medicine specialist if you have any questions.
If you are given more MIBEG than you should
An overdose is unlikely because you will receive a single, precisely controlled dose administered by the nuclear medicine specialist supervising the procedure. However, in the event of an overdose, you will receive appropriate treatment.
In addition, the nuclear medicine specialist performing the procedure may advise you to drink large amounts of water and to urinate frequently to help eliminate residual radioactivity from the body.
If you have any doubts about the use of MIBEG, please consult the nuclear medicine specialist supervising the procedure.

4. Possible side effects

Like all medicines, this medicinal product may cause side effects, although not everyone experiences them.
If the medicine is administered too quickly, the following side effects may occur during or immediately after
the injection with an unknown frequency:

• Fast or irregular heartbeat
• Breathing difficulties
• Feeling of excessive warmth
• Transient increase in blood pressure. Signs of this may include headache and vision changes (visual disturbances).
• Cramps and abdominal pain

These symptoms usually disappear within one hour.
Other side effects with unknown frequency:

• Allergic reactions with symptoms such as:
• difficulty breathing or dizziness,
• flushing,
• itching, hives,
• nausea, vomiting,
• chills
• headache
• tingling or numbness in hands and feet
• local swelling, pain and other reactions at the injection site, skin and tissue damage in case of accidental leakage of the medicine into the surrounding tissue. If you experience any of these symptoms, contact the nuclear medicine specialist immediately. In case of an allergic reaction, you will receive appropriate treatment.

This radiopharmaceutical will deliver low amounts of ionizing radiation, associated with a minimal risk of
cancer and hereditary abnormalities.
Reporting of side effects
If you experience any side effect, contact the nuclear medicine specialist. This
includes any possible side effects not listed in this leaflet. You may also report side effects directly via the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of
this medicine.

5. How MIBEG is stored

It is not your responsibility to store this medicine. This medicine is stored under the responsibility of a specialist in appropriate conditions. Storage of radiopharmaceuticals must comply with national regulations for radioactive materials.
The following information is intended exclusively for the specialist.
MIBEG must not be used after the expiry date stated on the label following "Exp".
MIBEG must not be used if there are any visible signs of deterioration.

6. Package contents and other information

What MIBEG contains

• The active substance is iobenguane (I) as iobenguane sulfate. 1 millilitre contains 74 MBq of iobenguane (I) and 0.5 mg of iobenguane sulfate.
• The other components are: citric acid monohydrate, sodium citrate dihydrate, gentisic acid, copper sulfate pentahydrate, tin(II) sulfate, iobenguane sulfate, and sterile water for injections.

Description of the appearance of MIBEG and contents of the pack
MIBEG is a clear, colourless solution. It is supplied in a 10 ml type I glass vial closed with a rubber stopper and sealed with an aluminium cap.
MIBEG is available in vials containing 1 ml (74 MBq), 2 ml (148 MBq), 3 ml (222 MBq), 4 ml (296 MBq) or 5 ml (370 MBq).
Marketing Authorisation Holder and Manufacturer
Curium Netherlands B.V.
Westerduinweg 3
1755 LE Petten
The Netherlands
This leaflet was last approved on

The following information is intended exclusively for medical or healthcare personnel:

The complete Summary of Product Characteristics (SmPC) for MIBEG is provided as a separate document in the product packaging, aimed at providing healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical. Refer to the MIBEG SmPC.