Prospect: information for the patient

STAMICIS 1 mgekit of reagents for radio pharmaceutical preparation EFG

Tetrafluoroborato de [Tetrakis (2-metoxi -2-metilpropil-1 isocianuro) cobre(I)]

Read the prospect carefully before starting to use the medication, because it contains important information for you.

• Conserve this prospect, since you may have to read it again.
• If you have any doubts, consult your nuclear physician, who supervises the procedure.
• If you experience adverse effects, consult your nuclear physician, even if they are adverse effects that do not appear in this prospect. See section4.

1.What is STAMICIS and for what it is used

2.What you need to know before starting to use STAMICIS

3.How to use STAMICIS

4.Possible adverse effects

1. Conservation of STAMICIS
2. Contents of the package and additional information

This medication is a radiopharmaceutical for diagnostic use only.

STAMICIScontains a substance calledtetrafluoroborato de [tetrakis (2-metoxi-2-metilpropil-1 isocianuro) cobre(I)] that is used to study the function and blood flow (myocardial perfusion) of the heart to generate an image of it (gammagraphy), for example, to detect heart attacks (myocardial infarctions) or when a disease causes a decrease in blood supply (ischemia) to the cardiac muscle (or part of it). STAMICIS is also used in the diagnosis of breast abnormalities along with other diagnostic methods when the results are not conclusive. STAMICIS is also used to locate the position of overactive parathyroid glands (glands that secrete the hormone that controls blood calcium levels).

After injecting STAMICIS, 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 (gammagraphy) of the affected organ, which can provide your doctor with valuable information about the structure and function of the organ or about the location, for example, of a tumor.

The administration of STAMICIS involves receiving a small amount of radioactivity. Your doctor and the nuclear medicine doctor have considered that the clinical benefit you will obtain from the radiopharmaceutical examination outweighs the risk of radiation.

Do not use STAMICIS

• if you are allergic to Tetrafluoroborato de [tetrakis (2-metoxi-2-metilpropil-1 isocianuro) cobre(I)]or any of the other ingredients of this medicine (listed in section6).

Warnings and precautions

Consult your doctor before starting to useSTAMICIS:

• If you are pregnant or think you may be pregnant.
• If you are breastfeeding.
• If you have a kidney or liver disease.
• If you have an abnormal heart rhythm, chest pain when your heart works harder while exercising and need a stress test.

Consult your nuclear medicine specialist if you are in any of the above situations. The nuclear medicine specialist will inform you if you need to take any special precautions after using this medicine. If you have any doubts, consult your nuclear medicine specialist.

Before administration of STAMICIS, you must:

• Fast for at least 4hours, if the medicine is to be used to obtain images of the heart.
• Drink plenty of water before starting the examination so that you urinate as frequently as possible during the first hours after the examination.

Children and adolescents

If you are under 18years, consult your nuclear medicine specialist.

Use of STAMICIS with other medicines

Certain medicines, foods and drinks may negatively affect the results of the planned study. Therefore, it is recommended that you speak with your specialist to inform you of the foods and medicines that you should not take before the examination and when you can take them again after it.

Inform your nuclear medicine specialist 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.

In particular, inform your nuclear medicine specialist if you are taking

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

Before taking any medicine, speak with your nuclear medicine specialist.

Pregnancy and lactation

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your nuclear medicine specialist before using this medicine. In case of doubt, it is essential that you consult your nuclear medicine specialist, who will supervise the procedure.

If you are pregnant:

Your nuclear medicine specialist will administer this medicine during pregnancy only if the expected benefit outweighs the risks.

If you are breastfeeding:

Consult your nuclear medicine specialist, as they will inform you to stop breastfeeding until the radioactivity has disappeared from your body, which takes approximately 24hours. The milk extracted during this period should be discarded. Your doctor will inform you when you can resume breastfeeding.

Driving and operating machines

It isunlikely that STAMICIS will affect your ability to drive or operate machines.

STAMICIS contains sodium

This medicine contains less than 1mmol of sodium (23mg) per vial; this is, essentially «sodium-free»

There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. STAMICIS will only be used in specially 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 physician overseeing the procedure will decide on the amount of STAMICIS 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, and ranges from 150 to 1600 MBq (Megabequerel, 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 STAMICIS and procedure performance

STAMICIS 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 physician will inform you if you need to take any special precautions after receiving this medication. Consult with your nuclear physician if you have any doubts.

The ready-to-use solution will be injected into a vein before obtaining the gamma scan. The images will be obtained within 5 to 10 minutes or up to 6 hours after injection, depending on the procedure.

In the case of a cardiac study, two injections may be necessary, one at rest and one 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 a dose not exceeding 1600 MBq will be administered in total (1-day protocol). A 2-day protocol is also possible.

For a gamma scan to detect breast abnormalities, a dose of 700-1000 MBq will be administered through 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 400 and 900 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 (gamma scan), you will be asked to ingest a low-fat meal, if possible, or drink one or two glasses of milk to reduce the radioactivity of your liver and improve the image.

Procedure duration

Your nuclear physician will inform you about the usual duration of the procedure.

After STAMICIS administration, you should:

-avoid direct contact with small children and pregnant women for 24 hours after injection.

-urinate frequently to eliminate the product from your body.

The nuclear physician will inform you if you need to take special precautions after receiving this medication. Consult with your nuclear physician if you have any doubts.

If you have been administered more STAMICIS than you should

It is unlikely to have an overdose because you will receive a single, controlled dose of STAMICIS precisely controlled by the nuclear physician overseeing the procedure. However, in the event of an overdose, you will receive the appropriate treatment.Specifically, the nuclear physician in charge of the procedure may recommend that you drink a lot of water to facilitate the elimination of STAMICIS from your body.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

In rare cases, allergic reactions have occurred, accompanied by difficult breathing, extreme fatigue, dizziness (usually within 2 hours after administration), subcutaneous swelling that may appear in areas such as the face and limbs (angioedema) and obstruct the airways, or reactions that led to a dangerous decrease in blood pressure (hypotension) and heart rate (bradycardia). Doctors are aware of this risk and have an emergency treatment that they will use if this occurs. Rare cases of local skin reactions, accompanied by itching, urticarial hives, rash, swelling, and redness, have also been observed. If you experience any of these side effects, consult your specialist nuclear medicine doctor immediately.

The following are other possible side effects in order of frequency:

This radiopharmaceutical will administer small amounts of ionizing radiation associated with the risk of cancer and hereditary defects.

Reporting of side effects

If you experience any type of side effect, consult your specialist nuclear medicine doctor,even if it is possible side effects that do not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

This medication does not need to be stored by you. This medication will be stored under the responsibility of the specialist in appropriate facilities. Radioactive medication storage will be carried out in accordance with national regulations on radioactive materials.

The following information is intended solely for the specialist.

Do not use STAMICIS after the expiration date that appears on the box after CAD.

Composition of STAMICIS

• The active principle is Tetrafluoroborato of [tetrakis (2-methoxy-2-methylpropyl-1 isocyanate) copper(I)]. Each vial contains 1 mg of tetrafluoroborato of [Tetrakis (2-methoxy-2-methylpropyl-1 isocyanate) copper(I)].
• The other components are stannous chloride dihydrate, cysteine hydrochloride monohydrate, sodium citrate, and mannitol.

Appearance of the product and contents of the packaging

STAMICIS is a kit of reagents for the preparation of radiopharmaceuticals.

STAMICIS is a powder that must be dissolved in a solution and combined with radioactive technetium before its use as an injectable. Once the radioactive substance pertecnetato ( 99m Tc) of sodium is added to the vial, technetium ( 99m Tc) sestamibi is formed. This solution is ready for injection.

Package size: 5 vials.

Holder of the marketing authorization and responsible for manufacturing

CIS bio international

B.P. 32

91192 GIF-SUR-YVETTE CEDEX

FRANCE

For more information about this medication, please contact the local representative of the holder of the marketing authorization:

Curium Pharma Spain, S.A.

Avda. Dr. Severo Ochoa, 29

28100-Alcobendas

Phone: 91 4841989

Last review date of this prospectus: April 2024.

Other sources of information

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

This information is intended solely for healthcare professionals:

The complete technical file of STAMICIS is included in a document attached to the medication prospectus, in order to provide healthcare professionals with additional scientific and practical information about the administration and use of this radiopharmaceutical.

Please, consult the technical file [the technical file must be included in the box].