Poltechmibi

PoltechMIBI, 1 mg, kit for the preparation of a radiopharmaceutical preparation
Tetra[2-methoxy-2-methylpropyl-1-isocyanido]boron tetrafluoride copper (I)
Please read the package leaflet before using the medicinal product.

• Keep this leaflet for future reference.
• If you have any further questions, consult your physician or the nuclear medicine physician supervising your examination.
• If you experience any side effects, including those not listed in this leaflet, inform your attending physician or the nuclear medicine physician supervising the examination.

Table of contents of the leaflet

1. What PoltechMIBI is and what it is used for
2. Important information before using PoltechMIBI
3. How to use PoltechMIBI
4. Possible side effects
5. How to store PoltechMIBI
6. Contents of the pack and other information

1. WHAT PoltechMIBI IS AND WHAT IT IS USED FOR

PoltechMIBI is a radiopharmaceutical product intended solely for diagnostic use.
PoltechMIBI contains a substance called tetra[2-methoxy-2-methylpropyl-1-isocyanido]boron tetrafluoride copper (I) and is used to evaluate heart function and blood flow through the heart muscle (myocardial perfusion) by imaging the heart (scintigraphy), for example, in detecting heart attack or when a disease causes reduced blood flow to part of the heart muscle (ischaemia).
PoltechMIBI is also used for breast imaging/diagnosis in patients with equivocal mammography findings, and to locate parathyroid glands (glands that secrete a hormone regulating blood calcium levels) in cases of their hyperactivity.
After injection, PoltechMIBI temporarily accumulates in specific parts of the body. This radiopharmaceutical contains a small amount of radiation that can be detected externally using special cameras. The nuclear medicine physician will obtain an image (scintigraphy) of the organ, which may provide important information about the structure and function of that organ or the location of, for example, a tumour.
Use of PoltechMIBI results in exposure to a small dose of radiation. Your referring physician and the nuclear medicine physician have determined that the benefits of the diagnostic procedure outweigh the potential risks associated with ionizing radiation.

2. IMPORTANT INFORMATION BEFORE USING PoltechMIBI

When not to use PoltechMIBI
PoltechMIBI must not be administered if the patient is allergic to the active substance tetra(2-methoxy-2-
methylpropyl-1-isocyanido)]-tetrafluoroborate copper (I) or to any of the other components of the
medicinal product (listed in section 6).

Warnings and precautions
Special precautions should be taken in the following cases:

• if the woman is pregnant or pregnancy is suspected,
• if the woman is breastfeeding,
• if the patient has impaired kidney or liver function.

The patient should inform the nuclear medicine physician if any of the above conditions apply. The nuclear medicine physician will advise whether special precautions are necessary after administration of this medicinal product. For questions, please contact the nuclear medicine specialist.

Before administration of PoltechMIBI:

• Drink plenty of water and ensure adequate hydration prior to the examination to promote frequent urination during the first hours after the examination.
• Remain fasting for at least four hours if a cardiac examination is to be performed.

Children and adolescents
Inform the nuclear medicine physician if the patient is under 18 years of age.

Other medicines and PoltechMIBI
Many medications, foods, and beverages may adversely affect the results of the planned examination.
Therefore, it is recommended to discuss with the treating physician which medications should be discontinued before the examination and when they can be resumed. Inform the nuclear medicine physician supervising the examination about all medications currently being taken or recently taken, as well as any medications the patient intends to take, as they may influence image interpretation.
Especially inform the nuclear medicine physician about medications affecting heart function and/or blood flow.
Before taking any medication, consult the nuclear medicine physician.

Pregnancy and breastfeeding
Before administration of the product, inform the nuclear medicine physician if:

• pregnancy is suspected,
• menstruation has not occurred at the expected time,
• the woman is breastfeeding.

In case of doubt, consultation with the nuclear medicine physician supervising the examination is required.

If the patient is pregnant, it is important to inform the physician. The physician will only refer for an examination using radiopharmaceuticals during pregnancy if the benefits of the examination outweigh the potential risks to the fetus.

If the patient is breastfeeding, it is important to inform the physician. The physician will request interruption of breastfeeding until the radioactive substance has been eliminated from the body.
Breastfeeding should be discontinued for approximately 24 hours after injection, and milk expressed during this period should be discarded. Resumption of breastfeeding should be discussed with the nuclear medicine specialist supervising the examination.

If a patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should inform the nuclear medicine physician before administration of this medicinal product.

Driving and operating machinery
It is considered unlikely that this medicinal product affects the ability to drive or operate machinery.

PoltechMIBI contains sodium
This medicinal product contains less than 1 mmol of sodium (23 mg) per vial; therefore, it is considered "sodium-free".

3. HOW TO USE PoltechMIBI

There are strict regulations regarding the handling, administration, and disposal of
radiopharmaceuticals. PoltechMIBI is used exclusively under appropriate clinical conditions and only by appropriately qualified personnel. These individuals take special precautions to ensure the safe use of the product and will keep the patient informed about their actions.

The nuclear medicine specialist supervising the procedure determines the dose of the product to be administered in each individual case. This will be the minimum dose necessary to obtain the required diagnostic information.
Depending on the type of examination, the recommended dose for an adult ranges from 200 to 2000 MBq (MBq = megabecquerel, a unit of radioactivity measurement).

Use in children and adolescents
In the paediatric population, the dose of the product will be adjusted according to the child's body weight.

Administration of the product and performance of the examination
Once prepared, PoltechMIBI will be administered intravenously into a vein in the arm or foot (intravenous injection). One or two injections may be sufficient to perform the examination. After injection, the patient will be given a drink and asked to empty their bladder immediately before the scan. The nuclear medicine physician will inform the patient whether special precautions are necessary after administration of this medicinal product. For any questions, please consult the nuclear medicine specialist.

The ready-to-use solution will be injected intravenously prior to performing the scintigraphy.
Depending on the type of examination, imaging may begin 5–10 minutes or up to 6 hours after injection.

For cardiac imaging, two injections may be required: one at rest and another following a stress test (e.g. physical exercise or pharmacologically induced stress). These two injections are administered at least two hours apart, and the total activity will not exceed 2000 MBq (single-day examination). Alternatively, the examination may be performed over two days.

For breast scintigraphy, a dose of 750–1100 MBq is administered intravenously into the arm or foot on the side opposite to the breast being examined.

For the evaluation of parathyroid hyperactivity, an activity between 185 MBq and 1100 MBq is administered, depending on the method used.

If the medicinal product is to be used for cardiac imaging, the patient should remain fasting for at least four hours before the examination. The physician may instruct the patient to consume a fatty meal or drink one or two glasses of milk after injection and before the start of imaging, to reduce hepatic uptake and thus improve image quality.

Duration of the procedure
The physician will inform the patient about the standard duration of the procedure.

After administration of PoltechMIBI, the patient should:

• avoid close contact with young children and pregnant women for 24 hours after injection,
• urinate frequently to help eliminate the product from the body.

The nuclear medicine physician will inform the patient whether special precautions are necessary after administration of this medicinal product. For any questions, please consult the nuclear medicine specialist.

Administration of a higher than recommended dose of PoltechMIBI
Overdose is unlikely, as the dose administered to the patient is strictly controlled by the supervising nuclear medicine specialist. However, in the event of an overdose, appropriate treatment will be provided. In particular, the physician may recommend increased fluid intake to accelerate the elimination of the radiopharmaceutical from the body.

If there are any further doubts regarding the use of this medicinal product, please consult the nuclear medicine physician supervising the examination.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, PoltechMIBI may cause adverse reactions, although not everyone experiences
them.
In rare cases, allergic reactions have been observed, presenting with dyspnea, extreme fatigue,
nausea (usually occurring within 2 hours after administration of the medicine), subcutaneous
tissue swelling of the face and limbs (angioedema), bronchoconstriction, or dangerous drop in
blood pressure (hypotension) and slow heart rate (bradycardia). Physicians are aware of the
possibility of such reactions and have appropriate emergency measures available. In rare cases,
local skin reactions such as itching, urticaria, rash, swelling, and redness have also been observed.
If any of these symptoms occur, contact the nuclear medicine physician immediately.
Other possible adverse reactions are listed below according to their frequency of occurrence:

Administration of a radiopharmaceutical results in exposure to a small dose of ionizing radiation, which is associated with the risk of developing neoplastic diseases and congenital abnormalities.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, they should be reported to the nuclear medicine physician. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: 22 49-21-301
Fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions may also be reported to the marketing authorization holder.
Reporting of adverse reactions enables the collection of additional information on the safety of the medicinal product.

5. HOW TO STORE PoltechMIBI

The patient will not be required to store this medicinal product.
Radiopharmaceuticals are stored exclusively by authorized personnel under appropriate clinical conditions. Storage of radiopharmaceuticals is carried out in compliance with local regulations regarding radioactive substances.
The following information is intended solely for medical personnel.
Do not use the product after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.

6. PACK CONTENTS AND OTHER INFORMATION

What PoltechMIBI contains
The active substance is:
[tetra(2-methoxy-2-methylpropyl-1-isocyanido)]-tetrafluoroborate copper (I) (1.0 mg/vial)
Other components are:
Tin (II) chloride dihydrate
L-cysteine hydrochloride monohydrate
Sodium citrate dihydrate
D-mannitol
Sodium hydroxide (for pH adjustment)
Hydrochloric acid (for pH adjustment)

What PoltechMIBI looks like and contents of the pack
This is a kit for the preparation of a radiopharmaceutical.
White powder.
PoltechMIBI consists of a powder for solution for injection, which is dissolved in a solution of radioactive technetium prior to administration as an injection. After adding the radioactive substance – sodium pertechnetate (Tc) to the vial, the (Tc) sestamibi complex is formed. The solution is then ready for injection.
The kit is supplied in glass vials with a capacity of 10 ml, closed with a rubber stopper and an aluminum crimp cap, packed in a cardboard box.
Pack sizes contain either 3 or 6 vials.
Each vial contains powder for the preparation of a solution for injection.

Marketing Authorisation Holder and Manufacturer
National Centre for Nuclear Research
Andrzeja Sołtana 7
05-400 Otwock
Tel.: +48 22 718 07 00
Fax: +48 22 718 03 50
e-mail: [email protected]

For further information, please contact your doctor or a representative of the Marketing Authorisation Holder.

The following information is intended exclusively for medical personnel.
The full Summary of Product Characteristics (SmPC) for PoltechMIBI is included as a separate document within the product packaging, providing healthcare professionals with additional scientific and practical information regarding the administration and use of this radiopharmaceutical.