Medimibi

Package leaflet: Information for the user

Medi-MIBI 0.5 mg (500 micrograms) Kit for radiopharmaceutical preparation
Copper tetramibi tetrafluoroborate
Please read this leaflet carefully before this medicine is administered to you because
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 physician who will supervise the procedure.
• If you experience any adverse reactions, including those not listed in this leaflet, contact the nuclear medicine physician. See section 4.

Contents of this leaflet:

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

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

This medicine is a radiopharmaceutical for diagnostic use only.
Medi-MIBI contains a substance called Copper tetramibi tetrafluoroborate which is used to study heart function and blood flow (myocardial perfusion) by acquiring an image of the heart (scintigraphy), for example, in detecting heart attacks (myocardial infarctions) or when a disease reduces blood supply to the heart muscle (or part of it) (ischaemia). Medi-MIBI is also used in the diagnosis of breast abnormalities together with other diagnostic methods when results are inconclusive. Medi-MIBI may also be used to locate hyperactive parathyroid glands (glands that secrete the hormone controlling calcium levels in the blood).
After injection of Medi-MIBI, the product temporarily accumulates in certain parts of the body. This radiopharmaceutical contains a small amount of radioactivity, which can be detected externally by special equipment. The nuclear medicine physician will obtain an image (scintigraphy) of the organ of interest, which may provide important information about the organ's structure and function or the location, for example, of a tumour.
The use of Medi-MIBI involves exposure to small amounts of radiation. Your doctor and the nuclear medicine physician have determined that the clinical benefit you will receive from this radiopharmaceutical procedure outweighs the risks associated with radiation exposure.

2. What you should know before Medi-MIBI is used

Medi-MIBI must not be used

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

Warnings and precautions
Exercise particular caution with Medi-MIBI

• if you are pregnant or think you may be pregnant,
• if you are breastfeeding,
• if you have kidney or liver disease.

Inform the nuclear medicine physician if any of these situations apply to you. The nuclear medicine physician will advise you whether you need to take any special precautions after administration of the medicine. If you have any doubts, consult your nuclear medicine physician.
Before administration of Medi-MIBI you must

• fast for at least 4 hours if the product is to be used for imaging of the heart,
• drink plenty of water before the start of the examination to urinate as frequently as possible during the first hours following the procedure.

Children and adolescents
Please consult the nuclear medicine physician if you are under 18 years of age.
Other medicines and Medi-MIBI
Various medicines, foods, and beverages may negatively affect the outcome of the planned examination. Therefore, it is recommended to discuss with your referring physician which medicines you should stop taking before the examination and when you may resume taking them. Also inform the nuclear medicine physician if you are currently taking, have recently taken, or might take any other medicines, as they could interfere with the interpretation of the images.
In particular, inform the nuclear medicine physician if you are taking medicines that affect heart function and/or blood flow.
Before taking any medicine, consult your nuclear medicine physician.
Pregnancy and breastfeeding
Inform the nuclear medicine physician before administration of Medi-MIBI if there is any possibility that you are pregnant, if you have missed a menstrual period, or if you are breastfeeding. If in doubt, it is important to consult the nuclear medicine physician who will supervise the procedure.
If you are pregnant,
the nuclear medicine physician will administer this medicine only if the expected benefit outweighs the potential risk.
If you are breastfeeding,
inform the nuclear medicine physician, who may instruct you to interrupt breastfeeding until radioactivity has been eliminated from your body. This usually takes about 24 hours. Breast milk produced during this time must be discarded. Ask your nuclear medicine physician when you may resume breastfeeding.
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your nuclear medicine physician before taking this medicine.
Driving and using machines
Medi-MIBI is unlikely to affect your ability to drive or operate machinery.
Medi-MIBI contains sodium
Administration of this medicine may contain more than 23 mg of sodium. This should be taken into consideration if you are on a low-sodium diet. Please consult your nuclear medicine physician.

3. How Medi-MIBI is used

There are strict regulations governing the use, handling, and disposal of radiopharmaceuticals. Medi-MIBI will be used only in designated controlled areas. The product will be handled and administered exclusively by trained and qualified personnel experienced in its safe use. These individuals will pay particular attention to the safe use of the product and will keep you informed about their actions.

The nuclear medicine physician supervising the procedure will determine the amount of Medi-MIBI to be used in your case. This will be the smallest quantity necessary to obtain the required diagnostic information. The usual recommended dose for administration in adults depends on the type of test to be performed and ranges between 200 and 2,000 MBq (Megabecquerel, the unit of measurement used for radioactivity).

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

Administration of Medi-MIBI and performance of the procedure
Medi-MIBI is administered into a vein in the arm or foot (intravenous administration). One or two injections are sufficient to perform the investigation required by the physician. After the injection, you will be offered fluids to drink and will be asked to urinate immediately before the examination.

The nuclear medicine physician will inform you if you need to take any special precautions after receiving this medicinal product. If you have any doubts, consult your nuclear medicine physician. The ready-to-use solution will be injected intravenously before the scintigraphy. The scan may be performed between 5–10 minutes and up to 6 hours after injection, depending on the type of examination.

For cardiac imaging, two injections may be necessary—one at rest and one under stress (e.g., during physical exercise or pharmacological stress). The two injections will be administered at least two hours apart, and a total dose exceeding 2,000 MBq will not be administered (one-day protocol). A two-day protocol is also possible.

For scintigraphy of breast abnormalities, a single injection of 750–1,100 MBq will be administered into a vein in the arm opposite to the affected breast or into a vein in the foot.

To locate hyperactive parathyroid glands, the administered activity ranges between 185 and 1,100 MBq, depending on the method used.

If the medicinal product is used to obtain images of the heart, you will be asked not to eat for at least 4 hours before the examination. After the injection, but before image acquisition (scintigraphy), you will be asked to consume a mildly fatty meal, if possible, or to drink one or two glasses of milk, in order to reduce radioactivity in the liver and improve image quality.

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

After administration of Medi-MIBI, you must:

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

The nuclear medicine physician will inform you if you need to take any special precautions after receiving this medicinal product. If you have any doubts, consult your nuclear medicine physician.

If you have been administered more Medi-MIBI than you should have received
An overdose is extremely unlikely, as you will receive a precisely controlled dose of Medi-MIBI administered under the supervision of the nuclear medicine physician. However, in the event of an overdose, appropriate treatment will be provided. In particular, the nuclear medicine physician in charge of the procedure may recommend that you drink plenty of fluids to facilitate the elimination of Medi-MIBI from your body.

If you have any doubts about the use of this medicinal product, consult the nuclear medicine physician supervising the procedure.

4. Possible side effects

Like all medicinal products, this medicine can cause side effects, although not everyone experiences them.
Rarely, allergic reactions have been observed, such as shortness of breath, extreme fatigue, vomiting (usually within 2 hours after administration), swelling under the skin in areas such as the face and limbs (angioedema) obstructing the airways, or reactions causing a dangerous drop in blood pressure (hypotension) and slowing of the heart rate (bradycardia). Physicians are aware of this possibility and have emergency treatments available for such cases. Local skin reactions such as itching, hives, rash, swelling, and redness have also rarely been observed. If you experience any of these reactions, contact your nuclear medicine physician immediately.
Other possible side effects are listed below in order of frequency:

The radiopharmaceutical releases small amounts of ionizing radiation associated with a low risk of cancer and hereditary abnormalities.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your nuclear medicine physician. You may also report adverse reactions directly via the national reporting system at the following address:
Website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting adverse reactions, you can help provide more information on the safety of this medicinal product.

5. How Medi-MIBI is stored

You must not store this medicine. The medicine is stored under the responsibility of a specialist in appropriate conditions. Storage of radiopharmaceuticals must comply with national regulations concerning radioactive materials.
The following information is intended for specialists only.
This medicine must not be used after the expiry date stated on the label.

6. Package contents and other information

What Medi-MIBI contains

• The active substance is: Copper tetramibi tetrafluoroborate.
• Each vial contains 0.5 mg of Copper tetramibi tetrafluoroborate.
• The other components are: Tin(II) chloride dihydrate, Tetrasodium pyrophosphate decahydrate, L-Cysteine hydrochloride monohydrate, Glycine, Sodium chloride.

Description of the appearance of Medi-MIBI and contents of the pack
The product is a kit for the preparation of a radiopharmaceutical.
Medi-MIBI consists of a white lyophilized powder which must be dissolved and mixed with a solution of radioactive technetium before injection. After adding the sodium pertechnetate solution (^99mTc) to the vial, technetium (^99mTc) sestamibi is obtained. This solution is ready for injection.
Pack sizes:
1 pack contains 6 vials.
Hospital packs:
Box containing 2 packs of 6 vials
Box containing 4 packs of 6 vials
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
RADIOPHARMACY Laboratory Ltd.
2040 Budaörs, Gyár u. 2.
Hungary
[email protected]

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

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

The following information is intended exclusively for physicians or healthcare professionals:
The complete product characteristics summary of Medi-MIBI is provided as a separate document in the
package, in order to provide the specialist with additional practical-scientific information on the administration and use of this radiopharmaceutical.