Technemibi

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Technemibi 1 mg kit for radiopharmaceutical preparation

[Copper(I) tetrakis(2-methoxy-2-methylpropyl-1 isocyanide)] 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 side effects, including those not listed in this leaflet, contact the nuclear medicine physician. See section 4.

Contents of this leaflet:

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

1. WHAT TECHNEMIBI IS AND WHAT IT IS USED FOR

This medicinal product is a radiopharmaceutical for diagnostic use only.
Technemibi contains a substance called [tetrakis(2-methoxy-2-methylpropyl-1-isonitrile)copper(I)]
tetrafluoroborate, which is used to study the function and blood flow (myocardial perfusion) of the
heart 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 to part of it)
(ischaemia). Technemibi is also used in the diagnosis of breast abnormalities, together with other
diagnostic methods, when results are inconclusive.
Technemibi may also be used to locate hyperactive parathyroid glands (glands that secrete the
hormone controlling calcium levels in the blood).
After injection of Technemibi, the product 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 equipment. The nuclear medicine physician will acquire 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 Technemibi involves exposure to small amounts of radioactivity. Your doctor and the
nuclear medicine physician have determined that the clinical benefit you will obtain from the
radiopharmaceutical procedure outweighs the risks associated with radiation exposure.

2. WHAT YOU SHOULD KNOW BEFORE TECHNEMIBI IS USED

Technemibi must not be used

• if you are allergic to [tetrakis(2-methoxyisobutylisonitrile)copper(I)] tetrafluoroborate or to any of the other ingredients of this medicinal product (listed in section 6).

Warnings and precautions
Exercise particular caution with Technemibi

• 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 special precautionary measures are required after administration of this medicinal product. If you have any doubts, consult your nuclear medicine physician.
Before administration of Technemibi you must

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

Children and adolescents
Consult the nuclear medicine physician if you are under 18 years of age.
Other medicines and Technemibi
Various medicines, foods, and beverages may negatively affect the outcome of the planned examination. Therefore, it is recommended that you discuss with your referring physician which medications 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 medicine, 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;
• medicines called proton pump inhibitors. These are used to reduce gastric acid production, such as omeprazole, esomeprazole, lansoprazole, rabeprazole, pantoprazole, dexlansoprazole. Before taking any medicine, consult your nuclear medicine physician.

Pregnancy and breastfeeding
Inform the nuclear medicine physician before administration of Technemibi if there is any possibility you may be 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 supervising the procedure.
If you are pregnant,
the nuclear medicine physician will administer this medicinal product 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 expressed during this period must be discarded. Ask your nuclear medicine physician when you may resume breastfeeding.
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your nuclear medicine physician before taking this medicinal product.
Driving and using machines
Technemibi is unlikely to affect your ability to drive or operate machinery.
Technemibi contains sodium
This medicinal product contains less than 1 mmol (23 mg) of sodium per vial, i.e., essentially 'sodium-free'.

3. HOW TECHNEMIBI IS USED

There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. Technemibi will only be used in specially controlled areas. The product will be handled and administered exclusively by trained and qualified personnel who are experienced in its safe use. These individuals will pay particular attention to ensuring 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 Technemibi 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 being performed and ranges between 200 and 2,000 MBq (Megabecquerel, the unit of measurement used to express radioactivity).

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

Administration of Technemibi and performance of the procedure
Technemibi is administered into a vein in the arm or foot (intravenous administration). One or two injections are sufficient to perform the required investigation.

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 medicine. If you have any doubts, please consult your nuclear medicine physician.

The ready-to-use solution will be injected into a vein before the scintigraphy is performed. Scanning may be carried out anywhere from 5–10 minutes up to 6 hours after injection, depending on the type of examination.

For cardiac imaging, two injections may be required—one at rest and one under stress (e.g., during physical exercise or pharmacological stress). The two injections will be given 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 medicine is used to obtain images of the heart, you will be asked not to eat any food 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 body and improve image quality.

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

After receiving Technemibi, you must:

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

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

If you have been given more Technemibi than you should have received
An overdose is extremely unlikely, as you will receive a precisely controlled dose administered by the nuclear medicine physician supervising the procedure. However, in the event of an overdose, appropriate treatment will be provided. In particular, the nuclear medicine physician in charge of the procedure may advise you to drink plenty of fluids to help eliminate Technemibi from your body.

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

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicinal product can cause adverse reactions, although not all people
experience them.
Allergic reactions have rarely been observed, such as shortness of breath, extreme fatigue,
vomiting (usually within 2 hours after administration), swelling under the skin of areas such as the face and
limbs (angioedema) causing airway obstruction, or reactions leading to a dangerous reduction in
blood pressure (hypotension) and slowing of the heart rate (bradycardia). Physicians are
aware of this possibility and have emergency treatments available for use in such cases. Rarely, local skin reactions have also been observed, including itching, urticaria, skin rash, swelling, and redness. If you experience any of these reactions, consult the nuclear medicine physician immediately.
Other possible adverse reactions 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 through the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TECHNEMIBI IS STORED

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

6. PACKAGING CONTENTS AND OTHER INFORMATION

What Technemibi contains

• The active substance is [tetrakis(2-methoxy-2-methylpropyl-1 isocyanide)copper(I)] tetrafluoroborate.
• Each vial contains 1 mg of [tetrakis(2-methoxy-2-methylpropyl-1 isocyanide)copper(I)] tetrafluoroborate.
• The other components are tin(II) chloride dihydrate, cisteamine hydrochloride monohydrate, sodium citrate, mannitol, hydrochloric acid and sodium hydroxide. Description of the appearance of Technemibi and contents of the pack

The product is a kit for the preparation of a radiopharmaceutical.
Technemibi consists of white or almost white granules or powder, to be dissolved and mixed with
a radioactive technetium solution before injection. After adding the sodium pertechnetate ( Tc) solution to the vial, technetium ( Tc) sestamibi is obtained. This solution is ready for injection.
Packaging
5 multidose vials
Marketing Authorisation Holder and Manufacturer
Curium Netherlands B.V.
Westerduinweg 3
1755 LE PETTEN
The Netherlands
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Austria Technescan Sestamibi
Belgium Technescan Sestamibi
Bulgaria Technescan Sestamibi
Cyprus Technescan Sestamibi
Czech Republic Technescan Sestamibi
Germany Technescan Sestamibi
Denmark Technescan Sestamibi
Estonia Technescan Sestamibi
Greece Technescan Sestamibi
Spain MIBI Technescan
Finland Technescan Sestamibi
France Technescan Sestamibi
Hungary Technescan Sestamibi
Ireland Technescan MIBI
Italy Technemibi
Lithuania Technescan Sestamibi
Luxembourg Technescan Sestamibi
Latvia Technescan Sestamibi
Malta Technescan MIBI
The Netherlands Technescan Sestamibi
Norway Technescan Sestamibi
Portugal Technescan Sestamibi
Romania Technescan Sestamibi
Sweden Technescan Sestamibi
Slovenia Technescan Sestamibi
Slovakia Technescan Sestamibi
United Kingdom Technescan MIBI