PATIENT INFORMATION: PACKAGE INSERT

MIBI Technescan 1mg kit for radiopharmaceutical preparation.

Tetrafluoroborato de [Tetrakis (2-metoxi-2-metilpropil-1 isocianuro) cobre (I)]

Read this package insert carefully before you receive this medication, because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your nuclear medicine physician who is supervising the procedure.
• If you experienceadverse effects, consult your nuclear medicine physician,even if they are not listed in this package insert. See section4.

1.What is MIBI Technescan and how is it used

2.What you need to knowbefore starting to use MIBI Technescan

3.How to use MIBI Technescan

4.Possible adverse effects

5.Storage of MIBI Technescan

6.Contents of the package and additional information

This medication is a radiopharmaceutical for diagnostic use only.

MIBI Technescan contains a substance called tetrafluoroborate of [tetrakis(1‑isocyanato‑2methoxy‑2-methylpropyl)copper(I)] that is used to study the function and blood flow (myocardial perfusion) of the heart to generate an image of it (gammagraphy), for example, to detect heart attacks (myocardial infarctions) or when a disease causes a decrease in blood supply (ischemia) to the cardiac muscle (or part of it). MIBI Technescan is also used in the diagnosis of breast abnormalities, along with other diagnostic methods when the results are not conclusive. MIBI Technescan is also used to locate the position of overactive parathyroid glands (glands that secrete the hormone that controls blood calcium levels).

After injecting MIBI Technescan, it temporarily accumulates in certain parts of the body. This radiopharmaceutical contains a small amount of radioactivity, which can be detected from outside the body using special cameras. Your nuclear medicine doctor will then obtain an image (gammagraphy) of the affected organ, which can provide your doctor with valuable information about the structure and function of the organ or about the location, for example, of a tumor.

The administration of MIBI Technescan involves receiving a small amount of radioactivity. Your doctor and the nuclear medicine doctor have considered that the clinical benefit you will obtain from the exploration with the radiopharmaceutical outweighs the risk of radiation.

MIBI Technescan should not be used

-if you are allergic to tetrakis (1-isocianuro-2-methoxy-2-methylpropyl) tetrafluoroborate copper(I) or any of the other components of this medication (listed in section 6).

Warnings and precautions

You should exercise special care with MIBI Technescan

-if you are pregnant or think you may be pregnant

-if you are breastfeeding

-if you have kidney or liver disease

You must inform your nuclear medicine physician if you are in any of these circumstances.Your nuclear medicine physician will inform you if you need to take any special precautions after using this medication. Consult your nuclear medicine physician if you have any questions.

Before administration of MIBI Technescan you must

-be fasting for at least 4 hours if the product is to be used to obtain images of the heart

-drink plenty of water before starting the procedure to urinate very frequently during the first hours after its completion.

Children and adolescents

Inform your nuclear medicine physician if you are under 18 years old.

Use of MIBI Technescan with other medications

Several medications, foods, and beverages may negatively affect the outcome of the scheduled study. Therefore, it is recommended to discuss with your referring physician the intake of which products should be interrupted before the study and when to resume medication. Also, inform your nuclear medicine physician if you are taking, have recently taken, or may need to take any other medication, as they may interfere with the interpretation of the images.

Inform your nuclear medicine physician in particular if you are taking:

• medications that affect heart function and/or blood flow.
• medications known as proton pump inhibitors. They are used to reduce stomach acid production, such as omeprazole, esomeprazole, lansoprazole, rabeprazole, pantoprazole, dexlansoprazole.

Consult your nuclear medicine physician before taking any medication.

Pregnancy and lactation

You must inform your nuclear medicine physician before administration of MIBI Technescan if there is any possibility that you may be pregnant, if you experience a delay in your period, or if you are breastfeeding.It is essential to consult your nuclear medicine physician who will supervise the procedure.

If you are pregnant

Your nuclear medicine physician will only administer this medication during pregnancy if the expected benefit outweighs the risk.

If you are breastfeeding

Inform your nuclear medicine physician, as they may advise you to stop breastfeeding until the radioactivity has been eliminated from your body. This takes approximately 24 hours. The milk obtained should be discarded. Consult your nuclear medicine physician when you can resume breastfeeding.

If you are pregnant, breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your nuclear medicine physician before they administer this medication.

Driving and operating machinery

It is considered unlikely that MIBI Technescan will affect your ability to drive or operate machinery.

MIBI Technescan contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per vial, which is essentially "sodium-free".

There are strict rules for the use, handling, and disposal of radiopharmaceuticals. This product will only be handled and administered by trained and qualified personnel to use it safely. Those people will pay special attention to the safe use of this product and will inform you of their actions.

The nuclear medicine physician supervising the procedure will decide on the amount of MIBI Technescan to be used in your case. This will be the minimum amount necessary to obtain the desired information.

The generally recommended dose for an adult varies, depending on the test to be performed, between 200 and 2,000 MBq (Megabequerel, the unit used to express radioactivity).

Use in children and adolescents

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

Administration of MIBI Technescan and procedure

MIBI Technescan is administered through a vein in the arm or foot (intravenous administration).

One or two injections are sufficient to perform the procedure your doctor needs.

After the injection, you will be offered a drink and asked to urinate immediately before starting the procedure.

The nuclear medicine physician will inform you if you need to take any special precautions after receiving this medication. Consult with your nuclear medicine physician if you have any doubts.

The ready-to-use solution will be injected into a vein before obtaining the gammagraphy. The images will be obtained within 5 to 10 minutes or up to six hours after the injection, depending on the procedure.

In the case of a cardiac study, two injections may be necessary, one at rest and one under stress (for example, during physical exercise or pharmacological stress). The two injections will be applied with a separation interval of at least two hours and a total dose not exceeding 2,000 MBq (one-day protocol). A two-day protocol is also possible.

For mammography to detect breast abnormalities, an injection of 750 to 1,100 MBq is administered into a vein in the opposite arm to the affected breast or in a vein in the foot.

To locate the position of hyperactive parathyroid glands, the administered activity varies between 185 and 1,100 MBq, depending on the methods used.

If the medication is to be used to obtain images of the heart, you will be asked not to eat anything for at least four hours before the test. After the injection, but before obtaining the image (gammagraphy), you will be asked to ingest a low-fat meal, if possible, or to drink one or two glasses of milk, in order to reduce the radioactivity of your liver and to improve the image.

Duration of the procedure

Your nuclear medicine physician will inform you about the usual duration of the procedure.

After the administration of MIBI Technescan you must:

-avoid direct contact with small children and pregnant women during the 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 special precautions after receiving this medication. Consult with your nuclear medicine physician if you have any doubts.

If you have been administered more MIBI Technescan than you should

A overdose is unlikely because you will only receive a single, controlled dose of MIBI Technescan supervised by the nuclear medicine physician in charge of the procedure. However, in case of overdose, you will receive the appropriate treatment. In particular, the nuclear medicine physician in charge of the procedure may recommend that you drink a lot of water to facilitate the elimination of MIBI Technescan from your body.

Ifyou have any other doubts about the use of this medication, ask the nuclear medicine physicianwho supervises the procedure.

Like all medications,this medicationcan cause side effects, although not everyone will experience them.

Rarely observed allergic reactions may manifest with difficulty breathing, extreme fatigue, nausea (usually within 2hours after administration), and swelling under the skin that may appear in areas such as the face and extremities (angioedema), and obstruct the airways, or lead to a dangerous drop in blood pressure (hypotension) and a slowing of heart rate (bradycardia). Doctors are aware of this possibility and have emergency treatment available for use in these cases. Rarely observed local skin reactions with itching, hives, rash, swelling, and redness have also been observed. If you experience any of these symptoms, consult your nuclear medicine doctor immediately.

Other possible side effects are listed below by frequency:

The administration of this radiopharmaceutical involves receiving a small amount of ionizing radiation with a very low risk of developing cancer and hereditary defects.

Reporting of side effects

If you experienceside effects, consult your nuclear medicine doctor, even if they are side effects that do not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es

By reporting side effects, you can contribute to providing more information on the safety of this medication.

This medication does not need to be stored by the patient. This medication is stored under the responsibility of the specialist in appropriate facilities. Storage of radiopharmaceuticals will be carried out in accordance with national regulations on radioactive materials.

The following information is intended solely for the specialist.

Do not use MIBI Technescan after the expiration date appearing on the label.

Composition of MIBI Technescan

• The active principle is tetrafluoroborate of [Tetrakis(2-methoxy-2-methylpropyl-1 isocyanurate) copper(I)].
• One vial contains 1 mg of tetrafluoroborate of [Tetrakis(2-methoxy-2-methylpropyl-1 isocyanurate) copper(I)].

The other components are stannous chloride dihydrate, cysteine hydrochloride monohydrate, sodium citrate, mannitol, hydrochloric acid and sodium hydroxide.

Appearance of the product and contents of the packaging

The product is a kit of reagents for radiopharmaceutical preparation.

MIBI Technescan consists of white or almost white beads or powder, which must be dissolved in a solution and combined with radioactive technetium before use as an injectable. Once the radioactive substance pertecnetate (99mTc) of sodium is added to the vial, technetium (99mTc) sestamibi is formed. This solution is ready for injection.

Package size

5 multidose vials

Marketing authorization holder and manufacturer responsible

Curium Netherlands B.V.
Westerduinweg 3
1755 LE PETTEN

Netherlands

Local representative:

Curium Pharma Spain S. A.

Avenida Doctor Severo Ochoa Nº 29

28100, Alcobendas, Madrid

Spain

Last review date of this leaflet: May 2021.

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

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This information is intended solely for healthcare professionals:

[Note: The intention is to include the technical data sheet or summary of product characteristics]

The complete technical data sheet of MIBI Technescan is included as a separate document in the product packaging, in order to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.

Please, consult the technical data sheet[the technical data sheet must be included in the box].