MIBI TECHNESCAN 1 mg KIT FOR RADIOPHARMACEUTICAL PREPARATION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

MIBI Technescan 1 mg kit for radiopharmaceutical preparation.

Tetrafluoroborate of [Tetrakis (2-methoxy-2-methylpropyl-1 isocyanide) copper (I)]

Read all of this leaflet carefully before you are given this medicine, because it contains important information for you.

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

Contents of the package leaflet:

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

1. What MIBI Technescan is and what it is used for

This medicine is a radiopharmaceutical for diagnostic use only.

MIBI Technescan contains a substance called tetrafluoroborate of [tetrakis(1-isocyanide-2-methoxy-2-methylpropyl)copper(I)] which is used to study the function and blood flow (myocardial perfusion) of the heart by generating an image of it (scintigraphy), for example to detect heart attacks (myocardial infarctions) or when a disease causes a reduction in blood supply (ischemia) to the heart muscle (or part of it). MIBI Technescan is also used in the diagnosis of breast anomalies, together with other diagnostic methods when the results are not conclusive. MIBI Technescan 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 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 (scintigraphy) of the affected organ, which can provide your doctor with valuable information about the structure and function of that 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 nuclear medicine doctor have considered that the clinical benefit you will obtain from the examination with the radiopharmaceutical outweighs the risk of radiation.

2. What you need to know before using MIBI Technescan

MIBI Technescan must not be used

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

Warnings and precautions

Be particularly careful with MIBI Technescan

• If you are pregnant or think you may be pregnant
• If you are breast-feeding
• If you have kidney or liver disease

You must inform your nuclear medicine doctor if you are in any of these situations. 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 Technescan you must

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

Children and adolescents

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

Use of MIBI Technescan with other medicines

Several medicines, foods, and drinks 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 taking medications. 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.

Particularly inform your nuclear medicine doctor if you are taking:

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

Consult your nuclear medicine doctor before taking any medicine.

Pregnancy and breast-feeding

You must inform the nuclear medicine doctor before administration of MIBI Technescan if there is any possibility that you may be pregnant, if you have a delayed period, or if you are breast-feeding. In case of doubt, it is important 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 breast-feeding

Inform your nuclear medicine doctor, as they may advise you to interrupt breast-feeding 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 breast-feeding.

If you are pregnant or breast-feeding, 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 Technescan is unlikely to affect your ability to drive or use machines.

MIBI Technescan 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 Technescan

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 take special care in the safe use of this product and will inform you of their actions.

The nuclear medicine doctor supervising the procedure will decide 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 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 Technescan and performance of the procedure

MIBI Technescan 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.

The 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 doubts.

The ready-to-use solution will be injected into a vein before obtaining the 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 will be administered (1-day protocol). 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 product 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 (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 the radioactivity of your liver and to 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 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 doctor will inform you if you need to take any special precautions after being administered this medicine. Consult your nuclear medicine doctor if you have any doubts.

If you have been given more MIBI Technescan than you should

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

If you have any further questions about the use of this medicine, ask the nuclear medicine doctor supervising 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 that 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 can obstruct the airways, or lead to a dangerous drop in blood pressure (hypotension) and a slowing of the heart rate (bradycardia). Doctors are aware of this possibility and have emergency treatment available for use in 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:

The 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 leaflet. 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 help provide more information on the safety of this medicine.

5. Storage of MIBI Technescan

You will not need to store this medicine. This medicine is stored under the responsibility of the 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 healthcare professionals.

Do not use MIBI Technescan after the expiry date stated on the label.

6. Package contents and further information

Composition of MIBI Technescan

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

The other ingredients are tin(II) chloride dihydrate, cysteine hydrochloride monohydrate, sodium citrate, mannitol, hydrochloric acid, and sodium hydroxide.

Appearance of the product and package contents

The product is a kit for radiopharmaceutical preparation.

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

Package size

5 multidose vials

Marketing authorisation holder and manufacturer

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

Date of last revision of this leaflet: May 2021.

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.gob.es/

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This information is intended only for healthcare professionals:

[Note: It is intended to include the technical sheet or summary of product characteristics]

The complete technical 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 sheet [the technical sheet must be included in the box].