Cortrace

Package Leaflet: Information for the Patient

Cortrace 1.0 mg kit for radiopharmaceutical preparation

[tetrakis (2-methoxy isobutyl isonitrile) copper (I)] tetrafluoroborate
Please read 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 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 Cortrace is and what it is used for
2. What you need to know before Cortrace is used
3. How Cortrace is used
4. Possible side effects
5. How Cortrace is stored
6. Contents of the pack and other information

1. What Cortrace is and what it is used for

This medicinal product is a radiopharmaceutical for diagnostic use only.
Cortrace contains a substance called [tetrakis (2-methoxy isobutyl isonitrile) copper (I)] tetrafluoroborate,
which is used to study heart function and blood flow (myocardial perfusion) 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) (ischemia). Cortrace is also used in the diagnosis of breast abnormalities, together with other diagnostic methods, when results are inconclusive. Cortrace may also be used to locate hyperactive parathyroid glands (glands that secrete the hormone regulating calcium levels in the blood).
After injection of Cortrace, the product temporarily accumulates in certain parts of the body.
This radiopharmaceutical contains a small amount of radioactivity, which can be detected externally using special equipment. The nuclear medicine physician will acquire an image (scintigraphy) of the organ of interest, which can provide important information about the organ's structure and function or the location, for example, of a tumour.
The use of Cortrace 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 need to know before Cortrace is used

Cortrace must not be used

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

Warnings and precautions
Exercise particular caution with Cortrace

• if you are pregnant or think you may be pregnant,
• if you are breastfeeding,
• if you have kidney or liver disease,
• if you have abnormal heart rhythms, chest pain when your heart works harder during physical activity, and need to undergo a stress test.

Inform the nuclear medicine physician if any of these situations apply to you. The nuclear medicine physician
will tell you whether you need to take special precautionary measures after receiving this medicine. If you have
any doubts, consult the nuclear medicine physician.
Before administration of Cortrace you must

• fast for at least 4 hours if the product will be used to acquire images of the heart,
• drink plenty of water before the start of the examination to urinate as frequently as possible during the first hours after the study.

Children and adolescents
Consult the nuclear medicine physician if you are under 18 years of age.
Other medicines and Cortrace
Several medicines, foods, and beverages may negatively affect the outcome of the scheduled examination.
Therefore, it is recommended that you discuss with your referring physician which medicines you should
discontinue before the examination and when you can 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 the function and/or blood flow of the heart,
• 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 the nuclear medicine physician.
Pregnancy and breastfeeding
Inform the nuclear medicine physician before administration of Cortrace if there is any possibility that 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 who will supervise the procedure.
If you are pregnant,
the nuclear medicine physician will administer this medicine during pregnancy only if the expected benefit outweighs the potential risk.
If you are breastfeeding,
inform the nuclear medicine physician, who may ask you to interrupt breastfeeding until radioactivity has been eliminated from your body. This occurs within approximately 24 hours. Breast milk produced during this time should be discarded. Ask the nuclear medicine physician when you can resume breastfeeding.
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, please seek advice from the nuclear medicine physician before taking this medicine.
Driving and use of machines
Cortrace is unlikely to affect your ability to drive or operate machinery.
Cortrace contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. essentially 'sodium-free'.

3. How Cortrace is used

There are strict regulations governing the use, handling, and disposal of radiopharmaceuticals. Cortrace will be used only in specially controlled areas. The product will be handled and administered exclusively by trained and qualified personnel who are skilled in its safe use. These individuals will pay particular attention to safe handling procedures and will keep you informed about their actions.

The nuclear medicine physician supervising the procedure will determine the amount of Cortrace to be used in your case. This will be the minimum quantity necessary to obtain the required diagnostic information.

The usually recommended dose for administration in adults depends on the type of test and ranges between 150 and 1,600 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 Cortrace and performance of the procedure
Cortrace 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 intravenously before the scintigraphy is performed. The scan may be carried out anywhere between 5–10 minutes and up to 6 hours after injection, depending on the type of examination.

For heart imaging, two injections may be necessary—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 1,600 MBq will not be administered (one-day protocol). A two-day protocol is also possible.

For scintigraphy of breast abnormalities, a single injection of 700–1,000 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 400 and 900 MBq, depending on the method used.

If the medicine is used to obtain images of the heart, you will be asked not to eat for at least 4 hours before the examination. After the injection, but before image acquisition (scintigraphy), you will be asked, if possible, to consume a mildly fatty meal or to drink one or two glasses of milk, in order to reduce radioactivity in the liver and improve image quality.

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

After receiving Cortrace, 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, consult your nuclear medicine physician.

If you have been given more Cortrace than you should have
An overdose is extremely unlikely, as you will receive a precisely controlled dose of Cortrace 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 recommend that you drink plenty of fluids to help eliminate Cortrace from your body.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reactions such as breathlessness, extreme fatigue, vomiting (usually within 2 hours after administration), swelling under the skin in areas such as the face and limbs (angioedema) and which obstructs the airways, or reactions causing a dangerous drop in blood pressure (hypotension) and slowing of the heartbeat (bradycardia) have rarely been observed. Physicians are aware of this possibility and have emergency treatments available for use in such cases. Local skin reactions with itching, hives, rash, swelling, and redness have also rarely been observed. If you experience any of these reactions, contact your nuclear medicine physician immediately.
Other possible side effects are listed below by 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 medicinal product.

5. How Cortrace is stored

You should not store this medicine. The medicine is stored under the responsibility of the
specialist in appropriate environments. Storage of radiopharmaceuticals must comply with
national regulations concerning radioactive materials.
The following information is intended exclusively for the specialist.
Cortrace must be protected from light in its original packaging.
After labelling with technetium-99m, the kit must be kept within the lead shielding and must be used within 8 hours of labelling.
This medicine must not be used after the expiry date, which is stated on the label, on the vial,
and on the carton after EXP. The expiry date refers to the last day of that month.

6. Package contents and other information

What Cortrace contains
The active substance is [tetrakis(2-methoxy isobutyl isonitrile) copper(I)] tetrafluoroborate.
Each vial contains 1 mg of [tetrakis(2-methoxy isobutyl isonitrile) copper(I)] tetrafluoroborate.
The other ingredients are sodium citrate dihydrate, L-cysteine hydrochloride monohydrate, mannitol, stannous chloride (II) dihydrate, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment).

Description of the appearance of Cortrace and contents of the pack
The product is a kit for the preparation of a radiopharmaceutical.
Cortrace consists of a sterile, white, lyophilized powder, which must be dissolved and mixed with a solution of radioactive technetium prior to injection. Once the radioactive substance sodium pertechnetate (Tc) is added to the vial, technetium (Tc) sestamibi is formed. This solution is then ready for injection.

Pack size
5 vials/box

Marketing Authorization Holder
Curium Romania SRL
Str. Grădinarilor, nr.1, Pantelimon,
Ilfov county, ZIP 077145, Romania

Manufacturer
Mefar İlaç San. A.Ş.
Ramazanoğlu Mahallesi Ensar Caddesi
No: 20 TR-34906 Kurtköy
Pendik – Istanbul / TURKEY

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Austria MONMIBI 1 mg Kit für ein radioaktives Arzneimittel
Belgium MICOLDBI 1 mg kit voor radiofarmaceutisch preparaat
France MIBOLIC 1,0 mg, trousse pour préparation radiopharmaceutique
Germany MONMIBI 1,0 mg Kit für ein radioaktives Arzneimittel
Italy Cortrace 1,0 mg kit per preparazione radiofarmaceutica
Netherlands Monmibi 1 mg, kit voor radiofarmaceutisch preparaat
Portugal MONMIBI 1,0 mg conjunto para preparações radiofarmacêuticas

The following information is intended exclusively for healthcare professionals:

The full SmPC (Summary of Product Characteristics) of Cortrace is provided as a separate document within the medicinal product's packaging,
aimed at providing healthcare professionals with additional scientific and practical information on
the administration and use of this radiopharmaceutical.
Refer to the Summary of Product Characteristics.