MIBEG 74 MBQ/ML Injectable solution

Зміст інструкції

1. MIBEG 74 MBq/ml, injectable solution
   1. What is MIBEG and what is it used for?
   2. What you need to know before you are given MIBEG
   3. How MIBEG is used
   4. Possible side effects
   5. How MIBEG is stored
   6. Contents of the pack and other information

MIBEG 74 MBq/ml, injectable solution

iobenguane ( I)

Read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask the nuclear medicine specialist supervising the procedure.
• If any side effects occur, including those not listed in this leaflet, ask 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 to store MIBEG
• 6. Contents of the pack and other information

1. What is MIBEG and what is it used for?

This medicine is a radiopharmaceutical used only for diagnostic purposes.
This medicine contains iobenguane ( I), a radioactive substance which, when injected, accumulates in certain organs such as the heart, the adrenal glands (glands located in the upper part of each kidney) and in certain tumors.
The radioactive substance can be detected from outside the body, using special machines that perform a scan. This scan shows the distribution of radioactivity within the organ and the body. This provides the doctor with valuable information about the functioning of that organ or about the location of a tumor.
MIBEG is used in adults and children for:

• localizing particular tumors, such as tumors of the adrenal glands and other tumors that produce hormones (so-called neuroendocrine tumors),
• localizing neuroblastomas (tumors in the nervous system, which primarily affect children), planning treatment and performing follow-up,
• estimating how much iobenguane ( I) is absorbed by your body before starting treatment with iobenguane,
• examining 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 assessed that the clinical benefit you will obtain from the diagnostic procedure with the radiopharmaceutical outweighs the risk due to radiation.

2. What you need to know before you are given MIBEG

Do not be given 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
Talk to your nuclear medicine specialist before you are given MIBEG:

• 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 that affects the nervous system such as, for example, Parkinson's disease and diseases similar to Parkinson's disease Before MIBEG is administered:
• your doctor will tell you to take another medicine containing non-radioactive iodine before you are given MIBEG. This medicine helps to stop the accumulation of radioactivity in your thyroid gland.
• you should drink plenty of water before the start of the examination to urinate as often as possible in the first few hours after the examination.
• - your doctor may ask you to stop taking some medicines that may affect the examination (see section "Other medicines and MIBEG")

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

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

• calcium antagonists (such as, for example, diltiazem, nifedipine, verapamil) used to treat high blood pressure and heart disease
• tricyclic antidepressants (such as, for example, amitriptyline, imipramine) used to treat depression
• medicines often used to treat a stuffy nose or cough (such as, phenylephrine, ephedrine, phenylpropanolamine)
• reserpine and labetalol: medicines to treat high blood pressure
• medicines to treat mental disorders whose active ingredient name generally ends in “azine”, such as, for example, promethazine, levomepromazine, perphenazine
• cocaine (an illicit drug)

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your nuclear medicine specialist for advice before you are given
this medicine.
You must inform your nuclear medicine specialist before being given MIBEG if there is
a possibility that you may be pregnant, if you have missed a menstrual period or if you are breastfeeding with
breast milk.
If you have any doubts, it is important that you talk to the nuclear medicine specialist who
supervises the procedure.

If you are pregnant
The nuclear medicine specialist will only administer the product during pregnancy onlywhen the
benefits are expected to outweigh the risks.

If you are breastfeeding
The doctor may decide to postpone the examinationuntil the end of breastfeeding. If this is not
possible, the doctor will ask you to stop breastfeeding for 3 daysand discard the milk
expressed, until your body is completely free of radioactivity.

Driving and using machines
It is unlikely that MIBEG will affect your ability to drive vehicles or use
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 rules regarding the use, handling and disposal of radiopharmaceuticals.
MIBEG will only be used in special and controlled areas. This medicine will be handled and
administered exclusively by people trained and qualified to use it safely. These people
will take particular care to ensure the safe use of this product and will keep you informed about their
actions.
The nuclear medicine specialist supervising the procedure will decide the amount of MIBEG to
use in your case. This will be the minimum amount necessary to obtain the desired information.
The amount to be administered, usually recommended in adults, ranges from 110 to 400 MBq (megabecquerels are the units used to express radioactivity).

Use in children and adolescents
In children and adolescents, the amount to be administered will be adjusted to the child's 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 constantly monitored during administration because if it is too
rapid, a sudden and serious increase in blood pressure may occur (see section 4).
A single injection is sufficient to perform the test requested by the doctor.
After the injection of MIBEG, you may receive a flush with sodium chloride to reduce the risk of
pain at the injection site (see section 4).
Scans are performed between 15 minutes and 24 hours after the injection. Scans may be
repeated one day later.

Duration of the procedure
The nuclear medicine specialist will inform you about the usual duration of the procedure.

After the administration of MIBEG:

• You should drink and urinate frequently to eliminate the medicine from the body,
• Children and adolescents should continue to take the medicine to prevent the accumulation of radioactivity in the thyroid gland, as instructed by the nuclear medicine specialist.

The nuclear medicine specialist will inform you if you need to take any special precautions after
receiving the medicine. Contact the nuclear medicine specialist if you have any questions.

If you are given too much MIBEG
An overdose is unlikely to occur because you will receive a single dose controlled with
precision by the nuclear medicine specialist supervising the procedure. However, in case of
overdose, you will receive appropriate treatment.
In addition, the nuclear medicine specialist performing the procedure may recommend that you drink
large amounts of water and urinate frequently to remove traces of radioactivity from the body.
If you have any doubts about the use of MIBEG, contact the nuclear medicine specialist
supervising the procedure.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If the medicine is administered too quickly, during or immediately after
the injection, the following side effects may occur withan unknown frequency:

• Fast or irregular heartbeat
• Difficulty breathing
• Feeling of heat above normal
• Transient increase in blood pressure. The signs of this may include headache and changes in vision (visual disturbances).
• Cramps and abdominal pain

These symptoms generally disappear within one hour.

Other side effects with unknown frequency:

• Allergic reactions with symptoms such as:
• difficulty breathing or dizziness,
• redness,
• itching, hives,
• nausea, vomiting,
• chills
• headache
• tingling or numbness in the 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, consult a nuclear medicine specialist immediately. In case of an allergic reaction, you will receive appropriate treatment.

This radiopharmaceutical will deliver low doses of ionizing radiation associated with a minimal risk of
cancer and hereditary abnormalities.

Reporting of side effects
If you experience any side effect, consult a nuclear medicine specialist. This
includes all possible side effects not listed in this leaflet. You can also report side effects
directly through 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 the specialist in appropriate environments. The storage of radiopharmaceuticals must be
in accordance with national regulations for radioactive materials.
The following information is reserved exclusively for the specialist.
MIBEG must not be used after the expiry date which is reported on the label after "Exp".
MIBEG must not be used if there are visible signs of deterioration.

6. Contents of the pack 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, disodium citrate dihydrate, gentisic acid, copper (II) 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 packaged in a type I glass vial of 10 ml
closed with a rubber stopper and sealed with an aluminium crimp.
MIBEG is supplied in a vial 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
Netherlands
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The following information is intended exclusively for medical or healthcare professionals:
The complete Summary of Product Characteristics (SPC) for MIBEG is provided as a separate
document in the product packaging, with the aim of providing healthcare professionals with further
scientific and practical information on the administration and use of this radiopharmaceutical
Refer to the SPC of MIBEG.