MIBI INSTITUTE OF ATOMIC ENERGY 1 mg KIT FOR RADIOPHARMACEUTICAL PREPARATION

Introduction

PATIENT INFORMATION: SUMMARY OF PRODUCT CHARACTERISTICS

MIBI Institute of Atomic Energy 1 mgradiofarmaceutical preparation kit EFG

Active substance: Tetrafluoroborate of [Tetrakis (1-isocyanato-2-methoxy-2-methylpropyl) copper(I)]

Read the entire summary carefully before this medicine is administered to you because it contains important information for you.

• Keep this summary, as you may need to read it again.
• If you have any questions, consult your nuclear medicine doctor who supervises the procedure.
• If you experience side effects, consult your nuclear medicine doctor, even if they are not listed in this summary. See section 4.

Summary of contents:

1. What MIBI Institute of Atomic Energy is and what it is used for
2. What you need to know before using MIBI Institute of Atomic Energy
3. How to use MIBI Institute of Atomic Energy
4. Possible side effects
5. Storage of MIBI Institute of Atomic Energy
6. Package contents and additional information

1. What MIBI Institute of Atomic Energy is and what it is used for

This medicine is a radiopharmaceutical for diagnostic use only.

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

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

Administration of MIBI Institute of Atomic Energy involves receiving a small amount of radioactivity. Your doctor and nuclear medicine doctor have considered that the clinical benefit you will obtain from the examination with the radiopharmaceutical outweighs the risk of radiation.

2. Before using MIBI Institute of Atomic Energy

Do not useMIBI Institute of Atomic Energy

• If you are allergic to tetrafluoroborate of [tetrakis(1-isocyanato-2-methoxy-2-methylpropyl)copper(I)] or any of the other components of this medicine (listed in section 6).

Warnings and precautions

Be especially careful with MIBI Institute of Atomic Energy

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

Before administration of MIBI Institute of Atomic Energy, you must

• fast for at least 4 hours if the product is to be used for heart imaging
• drink plenty of water before starting the procedure to urinate frequently during the first hours after its completion.

Children and adolescents

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

Using MIBI Institute of Atomic Energy with other medicines

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

Inform your nuclear medicine doctor in particular if you are taking medicines that affect heart function and/or blood flow.

Consult your nuclear medicine doctor before taking any medicine.

Pregnancy and breastfeeding

You must inform the nuclear medicine doctor before administration of MIBI Institute of Atomic Energy if there is any possibility that you may be pregnant, if you have a delayed period, or if you are breastfeeding. In case of doubt, it is essential that you consult your nuclear medicine doctor who supervises the procedure.

If you are pregnant

The nuclear medicine doctor will only administer this medicine during pregnancy if the expected benefit outweighs the risk.

If you are breastfeeding

Inform your nuclear medicine doctor, as they may advise you to interrupt breastfeeding until the radioactivity has been eliminated from your body. This takes about 24 hours. The expressed milk must be discarded. Consult your nuclear medicine doctor when you can resume breastfeeding.

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

Driving and using machines

MIBI Institute of Atomic Energy contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per vial, i.e., it is essentially "sodium-free".

3. How to use MIBI Institute of Atomic Energy

There are strict rules for the use, handling, and disposal of radiopharmaceuticals. MIBI Institute of Atomic Energy will only be used in special controlled areas. This product will only be handled and administered by trained and qualified personnel to use it safely. These people will take special care in the safe use of this product and will inform you of their actions.

The nuclear medicine doctor who supervises the procedure will decide the amount of MIBI Institute of Atomic Energy to be used in your case. This will be the minimum amount necessary to obtain the desired information.

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

Use in children and adolescents

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

Administration of MIBI Institute of Atomic Energy and performance of the procedure

MIBI Institute of Atomic Energy is administered into a vein in the arm or foot (intravenous administration).

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

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

Your nuclear medicine doctor will inform you if you need to take any special precautions after receiving this medicine. Consult your nuclear medicine doctor if you have any questions.

The ready-to-use solution will be injected into a vein before scintigraphy. 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 another under stress (e.g., during physical exercise or pharmacological stress). The two injections will be administered with an interval of at least two hours, and a dose not exceeding 2,000 MBq in total (1-day protocol) will be administered. A 2-day protocol is also possible.

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

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

If the medicine is to be used for heart imaging, you will be asked not to eat anything for at least four hours before the test. After the injection, but before scintigraphy, 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 liver radioactivity and improve the image.

Duration of the procedure

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

After administration of MIBI Institute of Atomic Energy, you must:

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

Your nuclear medicine doctor will inform you if you need to take any special precautions after receiving this medicine. Consult your nuclear medicine doctor if you have any questions.

If you have been administered more MIBI Institute of Atomic Energy than you should

Overdose is unlikely because you will only receive a single, precisely controlled dose of MIBI Institute of Atomic Energy from your nuclear medicine doctor. However, in case of overdose, you will receive appropriate treatment. In particular, the nuclear medicine doctor in charge of the procedure may recommend that you drink plenty of water to facilitate elimination of the product from your body.

If you have any other questions about the use of this medicine, ask your nuclear medicine doctor who supervises the procedure.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Rarely, allergic reactions have been observed, which can manifest with difficulty breathing, extreme fatigue, nausea (usually within 2 hours after administration), and swelling under the skin that can appear in regions such as the face and limbs (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 these cases. Rarely, 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:

Administration of this radiopharmaceutical involves receiving a small amount of ionizing radiation with a very low risk of developing cancer and genetic defects.

Reporting of side effects

If you experience side effects, consult your nuclear medicine doctor, even if they are not listed in this summary. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of MIBI Institute of Atomic Energy

You will not need to store this medicine. This medicine is stored under the responsibility of a specialist in suitable facilities. The storage of radiopharmaceuticals will be carried out in accordance with national regulations on radioactive materials.

The following information is intended only for specialists.

Do not use MIBI Institute of Atomic Energy after the expiration date stated on the label. The expiration date refers to the last day of that month.

6. Package contents and additional information

Composition of MIBI Institute of Atomic Energy

The active substance is: tetrafluoroborate of [tetrakis(1-isocyanato-2-methoxy-2-methylpropyl)copper(I)]

One vial contains 1.0 mg of tetrafluoroborate of [tetrakis(1-isocyanato-2-methoxy-2-methylpropyl)copper(I)].

The other components are:

Dihydrate tin chloride

Monohydrate cysteine hydrochloride

Sodium citrate dihydrate

D-mannitol

Appearance of the product and package contents

The product is a radiofarmaceutical preparation kit.

MIBI Institute of Atomic Energy consists of a white, lyophilized powder that must be dissolved in a solution and combined with radioactive technetium before use in an injection. Once the radioactive substance pertecnetate (99mTc) sodium is added to the vial, technetium (99mTc) sestamibi is formed. This solution is ready for injection.

Package size:

10 ml vials sealed with a chlorobutyl rubber stopper and an aluminum cap.

The vials are packed in cardboard boxes.

Package size: 3 or 6 vials.

Marketing authorization holder and manufacturer

Marketing authorization holder:

NATIONAL CENTRE FOR NUCLEAR RESEARCH

Andrzej Soltan 7

05-400 Otwock, Poland

Tel. +48 22 718 07 00

Fax: +48 22 718 03 50

e-mail: polatom@polatom.pl

Manufacturer:

NATIONAL CENTRE FOR NUCLEAR RESEARCH

Andrzej Soltan 7

05-400 Otwock, Poland

ROTOP Pharmaka GmbH

Bautzner Landstrabe 400

01328 Dresden, Germany

This summary was approved in September 2016

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es

This information is intended only for healthcare professionals:

The complete summary of product characteristics of MIBI Institute of Atomic Energy is provided as a detachable section at the end of the printed leaflet in the product packaging, with the aim of providing healthcare professionals with additional scientific and practical information about the administration and use of this radiopharmaceutical.

Please consult the Technical Data Sheet.