Stamicis 1 mg radiopharmaceutical preparation kit EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
STAMICIS 1 mg kit for radiopharmaceutical preparation EFG
Copper(I) [tetrakis(2-methoxy-2-methylpropylisonitrile)] tetrafluoroborate
Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, consult your nuclear medicine physician, who supervises the procedure.
- If you experience any adverse effects, consult your nuclear medicine physician, even if they are not listed in this leaflet. See section 4.
Leaflet contents:
- What STAMICIS is and what it is used for
- What you need to know before using STAMICIS
- How to use STAMICIS
- Possible side effects
- How to store STAMICIS
- Contents of the pack and other information
1. What STAMICIS is and what it is used for
This medicine is a radiopharmaceutical for diagnostic use only.
STAMICIS contains a substance called [tetrakis(2-methoxy-2-methylpropyl-1-isocyanide)copper(I)] tetrafluoroborate, which is used to study heart function and blood flow (myocardial perfusion) by generating images of the heart (scintigraphy), for example, to detect heart attacks (myocardial infarctions) or when a disease causes reduced blood supply (ischemia) to the heart muscle (or part of it). STAMICIS is also used in the diagnosis of breast abnormalities, together with other diagnostic methods, when results are inconclusive. STAMICIS may also be used to locate the position of overactive parathyroid glands (glands that secrete the hormone controlling blood calcium levels).
After STAMICIS is injected, 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 physician will then obtain an image (scintigram) of the affected organ, which can provide your doctor with valuable information about the organ's structure and function, or about the location, for example, of a tumor.
Administration of STAMICIS involves receiving a small amount of radioactivity. Your doctor and the nuclear medicine physician have determined that the clinical benefit you will receive from the radiopharmaceutical scan outweighs the risk from radiation exposure.
2. What you need to know before using STAMICIS
Do not use STAMICIS
- 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
Consult your doctor before starting to use STAMICIS:
- If you are pregnant or think you may be pregnant.
- If you are breastfeeding.
- If you have kidney or liver disease.
- If you have an abnormal heart rhythm, chest pain when your heart works harder during exercise, and require a stress test.
Please consult your nuclear medicine specialist if you are in any of the situations mentioned above. The nuclear medicine specialist will advise you whether 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 4 hours, if the medicine is to be used for imaging of the heart.
- Drink plenty of water before starting the scan so that you urinate as frequently as possible during the first few hours after the scan.
Children and adolescents
If you are under 18 years of age, 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, who will advise you which foods and medicines you should avoid before the scan and when you can resume taking them afterwards.
Inform your nuclear medicine specialist if you are taking, have recently taken, or might need to take any other medicines, as they could 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 known as proton pump inhibitors. These are used to reduce acid production in the stomach, such as omeprazole, esomeprazole, lansoprazol, rabeprazole, pantoprazole, dexlansoprazole.
Before taking any medicine, speak with your nuclear medicine specialist.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your nuclear medicine specialist before using this medicine. If in doubt, it is important to 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 potential risks.
If you are breastfeeding:
Consult your nuclear medicine specialist, who will advise you to interrupt breastfeeding until radioactivity has cleared from your body, which takes approximately 24 hours. Breast milk expressed during this period should be discarded. Your doctor will advise you when you can resume breastfeeding.
Driving and use of machines
It is unlikely that STAMICIS will affect your ability to drive or operate machinery.
STAMICIS contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per vial; i.e., essentially "sodium-free".
3. How to use STAMICIS
There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. STAMICIS will only be used in specially designated controlled areas. This product will be handled and administered solely by trained and qualified personnel who are skilled in its safe use. These individuals will take special care in ensuring the safe use of this product and will inform you of their actions.
The nuclear medicine physician supervising the procedure will determine the amount of STAMICIS to be used in your case. This will be the minimum quantity necessary to obtain the required diagnostic information.
The generally recommended dose for administration to an adult varies depending on the type of test to be performed and ranges between 150 and 1600 MBq (Megabecquerels, the unit 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 STAMICIS and performance of the procedure
STAMICIS is administered into a vein in the arm or foot (intravenous administration).
One or two injections are sufficient to perform the procedure required by your physician.
After the injection, you will be offered a drink and asked to urinate immediately before starting the procedure.
The nuclear medicine physician will inform you whether you need to take any special precautions after receiving this medicine. Please consult your nuclear medicine physician if you have any doubts.
The ready-to-use solution will be injected intravenously before the scintigraphy is performed. Images will be acquired between 5 and 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 another under stress (e.g., during physical exercise or pharmacological stress). The two injections will be given at an interval of at least two hours, and the total administered dose will not exceed 1600 MBq (one-day protocol). A two-day protocol is also possible.
For breast scintigraphy to detect abnormalities, an injection of 700–1000 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 hyperactive parathyroid glands, the administered activity ranges between 400 and 900 MBq, depending on the method used.
If the medicine is to be used for cardiac imaging, you will be instructed not to eat anything for at least four hours before the test. After the injection, but before image acquisition (scintigraphy), you will be asked to consume a low-fat meal, if possible, or to drink one or two glasses of milk, in order to reduce radioactivity in your liver and improve image quality.
Duration of the procedure
Your nuclear medicine physician will inform you about the typical duration of the procedure.
After administration of STAMICIS you should:
- avoid direct contact with young children and pregnant women during the 24 hours following 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. Please consult your nuclear medicine physician if you have any questions.
If you have been given more STAMICIS than you should
An overdose is unlikely, as you will receive a single, precisely controlled dose of STAMICIS determined by the nuclear medicine physician supervising the procedure. However, in the event of an overdose, appropriate treatment will be administered. Specifically, the nuclear medicine physician in charge of the procedure may recommend that you drink plenty of water to facilitate the elimination of STAMICIS from your body.
If you have any further questions about the use of this medicine, please ask the nuclear medicine physician supervising the procedure.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
Allergic reactions have rarely occurred, accompanied by difficulty breathing, extreme tiredness, dizziness (usually within 2 hours after administration), subcutaneous swelling that may appear in areas such as the face and extremities (angioedema) and may obstruct the airways, or reactions leading to a dangerous drop in blood pressure (hypotension) and heart rate (bradycardia). Physicians are aware of this risk and have emergency treatments available to use should this occur. Rare cases of local skin reactions have also been observed, accompanied by itching, hives, rash, swelling, and redness. If you experience any of these adverse effects, consult your nuclear medicine specialist physician immediately.
The following is a list of other possible adverse effects, listed by frequency:
Frequency | Possible adverse effects |
Common: may affect up to 1 in 10 people. | Metallic or bitter taste, altered sense of smell, and dry mouth immediately after injection. |
Uncommon: may affect up to 1 in 100 people. | Headache, chest pain, abnormal ECG, and nausea. |
Rare: may affect up to 1 in 1,000 people. | Abnormal heart rhythm, local reactions at the injection site, stomach pain, fever, fainting, seizures, dizziness, flushing, numbness or tingling of the skin, fatigue, transient joint pain. |
Frequency not known: cannot be estimated from available data. | Erythema multiforme, a widespread rash affecting the skin and mucous membranes. |
This radiopharmaceutical will administer small amounts of ionizing radiation, which is associated with the risk of cancer and hereditary defects.
Reporting of side effects
If you experience any type of adverse reaction, consult your specialist in nuclear medicine, even if they are possible adverse reactions not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products at www.notificaRAM.es.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.
5. Storage of STAMICIS
You will not be required to store this medicine. This medicine is stored under the responsibility of the specialist in appropriate facilities. Storage of radiopharmaceuticals must comply with national regulations regarding radioactive materials.
The following information is intended for the specialist only.
Do not use STAMICIS after the expiry date stated on the carton after EXP.
6. Contents of the pack and other information
Composition of STAMICIS
- The active substance is Tetrafluoroborate [tetrakis(2-methoxy-2-methylpropyl-1-isocyanide) copper(I)]. Each vial contains 1 mg of tetrafluoroborate [tetrakis(2-methoxy-2-methylpropyl-1-isocyanide) copper(I)].
- The other components are tin chloride dihydrate, cysteine hydrochloride monohydrate, sodium citrate, and mannitol.
Appearance of the product and contents of the pack
STAMICIS is a reagent kit for radiopharmaceutical preparation.
STAMICIS is a powder which must be dissolved in a solution and combined with radioactive technetium before use as an injectable. Once the radioactive substance sodium pertechnetate (99mTc) is added to the vial, technetium (99mTc) sestamibi is formed. This solution is then ready for injection.
Pack size: 5 vials.
Marketing Authorization Holder and Manufacturer
CIS bio international
B.P. 32
91192 GIF-SUR-YVETTE CEDEX
FRANCE
Further information on this medicinal product is available from the local representative of the Marketing Authorization Holder:
Curium Pharma Spain, S.A.
Avda. Dr. Severo Ochoa, 29
28100-Alcobendas
Tel.: 91 4841989
Date of the most recent review of this summary: April 2024.
Other sources of information
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicinal Products and Health Products (AEMPS) http://www.aemps.gob.es/
This information is intended for healthcare professionals only:
The complete summary of product characteristics for STAMICIS is included in an attached document to the package leaflet, providing healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.
Please refer to the summary of product characteristics [the summary of product characteristics must be included in the package].