PATIENT INFORMATION: PACKAGE INSERT

MIBI Institute of Atomic Energy 1 mgradioactive reagent kit for preparation of EFG pharmaceutical

Active ingredient: Tetrafluoroborato de [Tetrakis(1-isocyanato-2-methoxy-2-methylpropyl)copper(I)]

Read this package insert carefully before administration of this medication because it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your nuclear medicine physician who is supervising the procedure.
• If you experience any adverse effects, consult your nuclear medicine physician, even if they are not listed in this package insert. See section 4.

1.What is MIBI Institute of Atomic Energyand how it is used

2.What you need to know before starting to use MIBI Institute of Atomic Energy

3.How to use MIBI Institute of Atomic Energy

4.Possible adverse effects

5.Storage of MIBI Institute of Atomic Energy

6.Contents of the package and additional information

This medication is a radioisotope for diagnostic use only.

MIBI Institute of Atomic Energy contains a substance called tetrafluoroborato de [tetrakis(1-isocianuro-2-metoxi-2-metilpropil)cobre(I)] that is used to study the function and blood flow (myocardial perfusion) of the heart by generating an image of it (gammagraphy), for example, to detect heart attacks (myocardial infarcts) or when a disease causes a decrease in blood supply (ischemia) to the cardiac muscle (or part of it). MIBI Institute of Atomic Energy is also used in the diagnosis of breast abnormalities, 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 hyperactive 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 radioisotope contains a small amount of radioactivity, which can be detected from outside the body using special cameras. Your nuclear physician 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 the location, for example, of a tumor.

The administration of MIBI Institute of Atomic Energy involves receiving a small amount of radioactivity. Your doctor and the nuclear physician have considered that the clinical benefit you will obtain from the exploration with the radioisotope outweighs the risk of radiation.

No useMIBI Institute of Atomic Energy

• If you are allergic to tetrabutylammonium tetrafluoroborate or any of the other components of this medication (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 medication. Consult your nuclear medicine doctor if you have any questions.

Before administration of MIBI Institute of Atomic Energy 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 doctor if you are under 18 years old.

Use of MIBI Institute of Atomic Energy 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 doctor what products you should interrupt before the study and when you should restart taking medications. Also, inform your nuclear medicine doctor if you are taking, have taken recently, or may need to take any other medication, as they may interfere with the interpretation of the images.

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

Consult your nuclear medicine doctor before taking any medication.

Pregnancy and lactation

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

If you are pregnant

Your nuclear medicine doctor will only administer this medication 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 milk obtained should be discarded. Consult your nuclear medicine doctor when you can resume breastfeeding.

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

Driving and operating machines

It is considered unlikely that MIBI Institute of Atomic Energy will affect your ability to drive or operate machines.

MIBI Institute of Atomic Energy contains sodium

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

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

The nuclear medicine physician supervising 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 dose for an adult varies, depending on the test to be performed, between 200 and 2,000 MBq (Megabequerelios, the unit used to express radioactivity).

Use in children and adolescents

The dose to be administered will be adjusted according to your body weight in children and adolescents.

Administration of MIBI Institute of Atomic Energy and procedure performance

MIBI Institute of Atomic Energy 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 solution ready for use 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 another 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 you will be administered a dose not exceeding 2,000 MBq in total (protocol of 1 day). A two-day protocol is also possible.

For mammography to detect breast anomalies, 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 heart images, 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.

Procedure duration

Your nuclear medicine physician 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 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 any special precautions after receiving this medication. Consult with your nuclear medicine physician if you have any doubts.

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

It is unlikely to have an overdose because you will only receive a single controlled dose of MIBI Institute of Atomic Energy by the nuclear medicine physician supervising the procedure. However, in the event of an 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 the product from your body.

If you have any other doubts about the use of this medication, ask the nuclear medicine physician supervising the procedure.

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

Rarely observed allergic reactions may manifest with difficulty breathing, extreme fatigue, nausea (usually within 2 hours of administration), and swelling under the skin that may appear in areas such as the face and extremities (angioedema), and obstruct 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 experience side effects, consult your nuclear medicine doctor, even if they are side effects not listed in this prospectus. You can also report them directly throughthe Spanish System for Pharmacovigilance of Medicinal Products 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. This medication is stored under the responsibility of the specialist in appropriate facilities. Radioactive pharmaceutical storage will be carried out in accordance with national regulations on radioactive materials.

This information is intended solely for the specialist.

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

Composition ofMIBI Institute of Atomic Energy

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

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

The other components are:

Stannous chloride dihydrate

Cysteine hydrochloride monohydrate

Sodium citrate dihydrate

D-mannitol

Appearance of the product and contents of the packaging

The product is a kit of reagents for the preparation of radiopharmaceuticals.

MIBI Institute of Atomic Energy consists of a white, lyophilized powder that must be dissolved in a solution and combined with radioactive technetium before being used in an injection. 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:

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

The vials are packed in cardboard boxes.

Package size: 3 or 6 vials.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

NATIONAL CENTRE FOR NUCLEAR RESEARCH

Andrzej Soltan 7

05-400 Otwock, Poland

Phone: +48 22 718 07 00

Fax: +48 22718 03 50

Email: [email protected]

Responsible for manufacturing:

NATIONAL CENTRE FOR NUCLEAR RESEARCH

Andrzej Soltan 7

05-400 Otwock, Poland

ROTOP Pharmaka GmbH

Bautzner Landstrabe 400

01328 Dresden, Germany

This leaflet was approved in September of July 2016

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es

This information is intended solely for healthcare professionals:

The complete summary of the product characteristics of MIBI Institute of Atomic Energy is provided as a section that can be detached 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.