Mibispect

PATIENT LEAFLET: INFORMATION FOR THE PATIENT

Mibispect 1 mg kit for radiopharmaceutical preparation

[tetrakis(1-isocyanido-2-methoxy-2-methylpropane) 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 patient leaflet:

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

1. What Mibispect is and what it is used for

This medicinal product is a radiopharmaceutical for diagnostic use only.
Mibispect contains a substance called [tetrakis(1-isocyanido-2-methoxy-2-methylpropyl)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). Mibispect is also used in the diagnosis of breast abnormalities, together with other diagnostic methods, when results are inconclusive.
Mibispect may also be used to locate overactive parathyroid glands (glands that secrete the hormone controlling calcium levels in the blood).
After injection, Mibispect 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 obtain an image (scintigraphy) of the organ of interest, providing important information on the organ's structure and function, or on the location, for example, of a tumour.
The use of Mibispect involves exposure to small amounts of radioactivity. Your doctor and the nuclear medicine physician have determined that the clinical benefit you will receive from this radiopharmaceutical procedure outweighs the risks associated with radiation exposure.

2. What you should know before Mibispect is used

Mibispect must not be used

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

Warnings and precautions
Exercise particular caution with Mibispect

• 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 the medicine. If you have any doubts, consult your nuclear medicine physician. Before administration of Mibispect you must
• fast for at least 4 hours if the product is to be used for cardiac imaging,
• drink plenty of water before the examination begins, to urinate as frequently as possible during the first hours following the procedure.

Children and adolescents
Please consult the nuclear medicine physician if you are under 18 years of age.

Other medicines and Mibispect
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 medicines, 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.
Before taking any medication, consult your nuclear medicine physician.

Pregnancy and breastfeeding
Inform the nuclear medicine physician before administration of Mibispect if there is any possibility you may be pregnant, if you have missed a menstrual period, or if you are breastfeeding. In case of doubt, it is important to consult the nuclear medicine physician supervising the procedure.
If you are pregnant,
the nuclear medicine physician will administer this medicine 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 produced during this time 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 medicine.

Driving and using machines
It is considered unlikely that Mibispect will impair your ability to drive vehicles or operate machinery.

Mibispect contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, which is considered 'essentially sodium-free'.

3. How Mibispect is used

There are strict regulations governing the use, handling, and disposal of radiopharmaceuticals. Mibispect will be used only in specially controlled areas. The product will be handled and administered only by trained and qualified personnel who are skilled in its safe use. These individuals will pay particular attention to the safe handling of the product and will keep you informed about their actions.
The nuclear medicine physician supervising the procedure will determine the amount of Mibispect to be used in your case. This will be the smallest quantity necessary to obtain the required information.
The amount usually recommended for administration in adults depends on the type of test to be performed and ranges between 200 and 2,000 MBq (Megabecquerel, the unit of measurement used for radioactivity).

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

Administration of Mibispect and performance of the procedure
Mibispect is administered into a vein in the arm or foot (intravenous administration). One or two injections are sufficient to perform the investigation required by the physician.
After the injection, you will be offered something to drink and will be asked to urinate immediately before the examination.
The nuclear medicine physician will inform you whether 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. The scan may be carried out anywhere between 5–10 minutes and up to 6 hours after the 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 administered 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 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 usual duration of the examination.

After receiving Mibispect, 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 whether 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 Mibispect than you should have received
An overdose is extremely unlikely, as you will receive a precisely controlled dose of Mibispect administered by the nuclear medicine physician supervising the procedure. However, in the event of an overdose, you will receive appropriate treatment. In particular, the nuclear medicine physician in charge of the procedure may recommend that you drink plenty of fluids to help eliminate the product from your body.

If you have any questions about the use of this medicine, please 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 have rarely been observed, such as breathlessness, extreme fatigue, vomiting (usually within 2 hours of administration), swelling under the skin of areas such as the face and limbs (angioedema) obstructing the airways, or reactions causing a dangerous drop 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. Local skin reactions have also rarely been observed, including itching, urticaria, rash, swelling, and redness. 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, contact your nuclear medicine physician. You may also report adverse reactions directly via the website: http://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 Mibispect is stored

You must not store this medicinal product. The medicinal product is stored under the responsibility of the specialist in appropriate conditions. Storage of radiopharmaceuticals must comply with national regulations concerning radioactive materials.
The following information is intended for specialists only.
This medicinal product must not be used after the expiry date stated on the label. The expiry date refers to the last day of that month.

6. Package contents and other information

What Mibispect contains
The active substance is: [tetrakis(1-isocyanido-2-methoxy-2-methylpropyl) copper(I)] tetrafluoroborate
Each vial contains 1.0 mg of [tetrakis(1-isocyanido-2-methoxy-2-methylpropyl) copper(I)] tetrafluoroborate
The other components are:
Tin(II) chloride dihydrate
L-cysteine hydrochloride monohydrate
Sodium citrate dihydrate
D-mannitol

Description of the appearance of Mibispect and contents of the pack
The product is a kit for radiopharmaceutical preparation.
Mibispect consists of a white lyophilized powder which must be dissolved in solution and combined with radioactive technetium prior to use as an injectable preparation. After adding sodium pertechnetate (Tc) solution to the vial, technetium (Tc) sestamibi is obtained.
This solution is ready for injection.
Packaging:
10 mL glass vials with chlorobutyl rubber stoppers and aluminium seals.
The vials are packaged in cardboard boxes.
Pack size: 3 or 6 vials.

Marketing Authorization Holder
National Centre for Nuclear Research
Andrzej Sołtan 7
05-400 Otwock
Poland
Tel.: +48 22 718 07 00
Fax: +48 22 718 03 50
E-mail: [email protected]

Manufacturers
National Centre for Nuclear Research
Andrzej Sołtan 7
05-400 Otwock
Poland
ROTOP Pharmaka GmbH
Bautzner Landstrasse 400
01328 Dresden
Germany

The following information is intended exclusively for healthcare professionals:
The complete product characteristics summary of Mibispect is provided as a separate document at the end of the printed leaflet included in the product packaging, in order to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.
Refer to the product characteristics summary.