MEDI-MIBI

Package leaflet: Information for the patient

Medi-MIBI, 0.5 mg (500 micrograms), kit for the preparation of a radiopharmaceutical preparation
Copper tetramibu tetrafluoroborate
Please read all of this leaflet carefully before the medicine is administered, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult the nuclear medicine physician supervising the procedure.
• If you experience any side effects, including any not listed in this leaflet, tell your nuclear medicine physician. See section 4.

Leaflet contents:

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

1. What Medi-MIBI is and what it is used for

This medicine is a radiopharmaceutical intended solely for diagnostic use.
Medi-MIBI contains copper tetramibu tetrafluoroborate, a substance used to examine heart function and blood flow (myocardial perfusion) by imaging the heart (scintigraphy), for example, to detect heart attack (myocardial infarction) or when a disease causes reduced blood flow to (parts of) the heart muscle (ischemia). Medi-MIBI is also used in the diagnosis of breast abnormalities, as an additional diagnostic method when results from other tests are inconclusive.
Medi-MIBI may also be used to locate overactive parathyroid glands (glands that secrete a hormone regulating calcium levels in the blood).
After injection, Medi-MIBI temporarily accumulates in certain parts of the body. This radiopharmaceutical contains a small amount of radioactivity, which can be detected externally using special cameras. The nuclear medicine physician will then take images (scintigraphy) of the organ under investigation, allowing valuable information to be gathered about the structure and function of the organ or the location of, for example, a tumour.
Use of Medi-MIBI involves exposure to small amounts of radiation. Your supervising physician and the nuclear medicine physician have determined that the clinical benefit obtained from the radiopharmaceutical procedure outweighs the risks associated with radiation exposure.

2. Important information before using Medi-MIBI

When not to use Medi-MIBI

• if the patient is allergic to copper tetramibu tetrafluoroborate or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Special caution should be exercised when using Medi-MIBI:

• if the patient is pregnant or suspects she may be pregnant,
• if the patient is breastfeeding,
• if the patient has kidney or liver disease.

If any of the above situations apply to the patient, they should inform the nuclear medicine physician. The nuclear medicine physician will inform the patient whether special precautions are necessary after administration of this medicine. If in doubt, consult the nuclear medicine physician.

Before administration of Medi-MIBI, the patient should:

• fast for at least 4 hours if the product is to be used for cardiac imaging,
• drink plenty of water before the examination to ensure frequent urination during the first hours after the procedure.

Children and adolescents
If the patient is under 18 years of age, consult the nuclear medicine physician.

Medi-MIBI and other medicines
Many medicines, foods and drinks may adversely affect the outcome of the planned examination. Therefore, it is recommended to discuss with the referring physician which medicines should be discontinued before the examination and when their use can be resumed. The nuclear medicine physician should also be informed about all medicines currently or recently taken by the patient, as well as any medicines the patient intends to use, because they may interfere with image interpretation. Special attention should be given to informing the nuclear medicine physician if the patient is taking medicines affecting heart function and/or blood flow. Any medication intake should be discussed with the nuclear medicine physician beforehand.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult the nuclear medicine physician before using this medicine. In case of any doubts, it is important to contact the nuclear medicine physician supervising the procedure.

If the patient is pregnant, the nuclear medicine physician will administer this medicine during pregnancy only if the expected benefits outweigh the risks.

If the patient is breastfeeding, she should inform the nuclear medicine physician, who will advise temporary discontinuation of breastfeeding until the radiopharmaceutical has been eliminated from the body. This takes approximately 24 hours. Expressed milk should be discarded. The patient should ask the nuclear medicine physician when she can resume breastfeeding.

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a physician before using this medicine.

Driving and operating machinery
It is considered unlikely that Medi-MIBI will affect the ability to drive or operate machinery.

Medi-MIBI contains sodium
Administration of this medicine may deliver more than 23 mg of sodium. This should be taken into account if the patient is on a low-sodium diet. Consult the nuclear medicine physician.

3. How to use Medi-MIBI

Strict regulations apply to the handling, preparation and disposal of radiopharmaceuticals. Medi-MIBI will be administered only in specially controlled areas. This product will be prepared and administered exclusively by trained and qualified personnel experienced in its safe use. Such personnel will take all necessary precautions to ensure the safe use of this product and will inform the patient about their actions.

The nuclear medicine physician supervising the procedure will decide on the dose of Medi-MIBI to be administered to the patient. This will be the smallest dose required to obtain the necessary diagnostic information.

The recommended dose in adults usually varies depending on the type of examination and ranges from 200 to 2000 MBq (megabecquerel, a unit used to express radioactivity).

Use in children and adolescents
In children and adolescents, the dose should be adjusted according to body weight.

Administration of Medi-MIBI and performance of the procedure
Medi-MIBI is administered by intravenous injection into a vein in the arm or foot.
One or two injections are sufficient to perform the examination ordered by the physician.

After injection and immediately before imaging, the patient will be asked to drink a beverage and to empty the bladder.

The nuclear medicine physician will inform the patient whether special precautions are necessary after receiving this medicinal product. If you have any questions, please contact the nuclear medicine physician.

The ready-to-use solution will be injected intravenously prior to scintigraphy. Imaging may take place between 5 to 10 minutes or up to 6 hours after injection, depending on the type of examination.

In cardiac imaging, two injections may be required—one at rest and another under stress conditions (e.g. physical exercise or pharmacological stress). Both injections will be administered at least two hours apart, with a total administered activity not exceeding 2000 MBq (one-day protocol). A two-day protocol is also possible.

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

To determine the location of hyperfunctioning parathyroid glands, a dose with an activity between 185 and 1100 MBq is administered, depending on the method used.

If Medi-MIBI is used for cardiac imaging, the patient will be asked to fast for at least 4 hours before the examination. After injection, but before imaging (scintigraphy), the patient will be asked, if possible, to eat a low-fat meal or to drink one or two glasses of milk to reduce liver radioactivity and improve image quality.

Duration of the procedure
The nuclear medicine physician will inform the patient about the typical duration of the procedure.

After administration of Medi-MIBI, 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 receiving this medicinal product. If you have any questions, please contact the nuclear medicine physician.

Administration of a higher than recommended dose of Medi-MIBI
Overdose is almost impossible, as the patient will receive only the precisely controlled dose of Medi-MIBI determined by the supervising nuclear medicine physician. Nevertheless, in the event of an overdose, appropriate treatment will be administered. The nuclear medicine physician performing the procedure may recommend drinking large amounts of fluids to facilitate the elimination of Medi-MIBI from the body.

If you have any further questions regarding the use of this medicinal product, please consult the nuclear medicine physician supervising the procedure.

4. Possible adverse reactions

Like all medicines, this medicinal product can cause adverse reactions, although not everybody will experience them.
Allergic reactions, which may present with breathlessness, extreme fatigue, nausea (usually within 2 hours after administration), subcutaneous swelling that may occur in areas such as the face and limbs (angioedema), and which may block the airways or lead to dangerous lowering of blood pressure (hypotension) and slow heart rate (bradycardia), have been observed rarely. Physicians are aware of this possibility and have emergency treatments available for such cases. Local skin reactions such as itching, urticaria, rash, swelling and redness have also been observed rarely. If any of these symptoms occur, consult the nuclear medicine physician immediately.
Other possible adverse reactions listed below are categorized by frequency of occurrence:

This radiopharmaceutical will deliver small amounts of ionizing radiation, which involves a risk of cancer and congenital abnormalities.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in the leaflet, inform the nuclear medicine physician. Adverse reactions can be reported directly to:
Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting of adverse reactions enables continuous monitoring of the benefit-risk balance of the medicinal product.

5. How to store the Medi-MIBI medicine

The patient will not have to store this medicine. Storage of this medicine is the responsibility of a specialist and must be kept in appropriate premises. Radioactive medicinal products must be stored in accordance with national regulations concerning radioactive materials.
Information intended solely for healthcare professionals:
Do not use this medicine after the expiry date stated on the label (EXP).

6. Contents of the pack and other information

What Medi-MIBI contains

• The active substance is copper tetramibu tetrafluoroborate. One vial contains 0.5 mg of copper tetramibu tetrafluoroborate.
• The other ingredients are: tin(II) chloride dihydrate, tetrasodium pyrophosphate decahydrate, L-cysteine hydrochloride monohydrate, glycine and sodium chloride.

What Medi-MIBI looks like and contents of the pack
The product is a kit for the preparation of a radiopharmaceutical. Medi-MIBI consists of a white powder which, before use as an injection, must be dissolved in a solution and combined with radioactive technetium. After adding the radioactive substance, sodium pertechnetate (Tc), to the vial, technetium sestamibi (Tc) is formed. This solution is ready for injection.
Pack size: 1 pack contains 6 vials.

Hospital packs:
Collective pack containing 2 packs of 6 vials each.
Collective pack containing 4 packs of 6 vials each.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
RADIOPHARMACY Laboratory Kft.
Gyár u. 2., 2040 Budaörs, Hungary
[email protected]

Manufacturer
Medi-Radiopharma Kft.
Szamos u. 10-12., 2030 Érd, Hungary

This medicinal product is authorised in the European Economic Area under the following names:
Austria: Medi-MIBI 0.5 mg
Denmark: Medi-MIBI 0.5 mg
Italy: Medi-MIBI 0.5 mg
Spain: Mibi Radiopharmacy Laboratory 0.5 mg
Belgium: Medimibi 0.5 mg trousse pour préparation radiopharmaceutique;
Medimibi 0.5 mg kit voor radiofarmaceutisch preparaat;
Medimibi 0.5 mg Kit für ein radioaktives Arzneimittel
Cyprus: Medimibi
Estonia: Medimibi
Finland: Medimibi 0.5 mg
Greece: MIBI/RADIOPHARMACY LABORATORY
Latvia: Medimibi 0.5 mg komplekts radiofarmaceitiskā preparāta pagatavošanai
Lithuania: Medimibi 500 micrograms kit for radiopharmaceutical preparation
Luxembourg: Medi-MIBI 0.5 mg
Malta: Medi-MIBI 0.5 mg kit for radiopharmaceutical preparation
Netherlands: Medimibi 0.5 mg
Norway: Medi-MIBI
Poland: Medi-MIBI
Portugal: Medimibi 0.5 mg
Slovakia: Medi-MIBI 0.5 mg
Slovenia: Medi-MIBI 0.5 mg komplet za propravo radiofarmaka
Sweden: Medimibi

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Information intended exclusively for medical professionals:
The full SmPC (Summary of Product Characteristics) for Medi-MIBI is supplied in the product packaging as a separate document, intended to provide healthcare professionals with additional scientific and practical information regarding the administration and use of this radiopharmaceutical.