MIBI Institute of Atomic Energy 1 mg radiopharmaceutical preparation kit EFG
SpainTable of Contents
- Package leaflet: Information for the user
- Introduction
- 1. What MIBI Institute of Atomic Energy is and what it is used for
- 2. BEFORE USING MIBI Institute of Atomic Energy
- 3. How MIBI Institute of Atomic Energy is used
- 4. Possible adverse effects
- 5. Storage of MIBI Institute of Atomic Energy
- 6. Contents of the pack and other information
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MIBI Institute of Atomic Energy 1 mg kit for radiopharmaceutical preparation EFG
Active substance: Tetrafluoroborate [Tetrakis(1-isocyanido-2-methoxy-2-methylpropyl)copper(I)]
Read the entire leaflet carefully before you are administered this medicine because it contains important information for you.
- Keep this leaflet. 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 reactions, consult your nuclear medicine physician, even if they are adverse reactions not listed in this leaflet. See section 4.
Leaflet contents:
- What MIBI Institute of Atomic Energy is and what it is used for
- What you need to know before you are given MIBI Institute of Atomic Energy
- How MIBI Institute of Atomic Energy is used
- Possible side effects
- How to store MIBI Institute of Atomic Energy
- Contents of the pack and other information
1. What MIBI Institute of Atomic Energy is and what it is used for
This medicine is a radiopharmaceutical for diagnostic use only.
MIBI Institute of Atomic Energy contains a substance called [tetrakis(1-isocyanido-2-methoxy-2-methylpropane)copper(I)] tetrafluoroborate, which is used to study the function and blood flow (myocardial perfusion) of the heart by generating an image of it (scintigraphy), for example, to detect heart attacks (myocardial infarctions) or when a disease causes a reduction in blood supply (ischemia) to the heart muscle (or part of it). MIBI Institute of Atomic Energy is also used in the diagnosis of breast abnormalities, together with other diagnostic methods when results are inconclusive. MIBI Institute of Atomic Energy may also be used to locate the position of hyperactive parathyroid glands (glands that secrete the hormone regulating blood calcium levels).
After MIBI Institute of Atomic Energy 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 (scintigraphy) of the affected organ, which can provide your doctor with valuable information about the structure and function of that organ, or about the location, for example, of a tumor.
Administration of MIBI Institute of Atomic Energy involves receiving a small amount of radioactivity. Your doctor and the nuclear medicine physician have determined that the clinical benefit you will obtain from the radiopharmaceutical scan outweighs the risk from radiation exposure.
2. BEFORE USING MIBI Institute of Atomic Energy
Do not use MIBI Institute of Atomic Energy
- If you are allergic to tetrafluoroborate [tetrakis(1-isocyanido-2-methoxy-2-methylpropyl)copper(I)] or to any of the other components of this medicine (listed in section 6).
Warnings and precautions
Take special care with MIBI Institute of Atomic Energy
- If you are pregnant or think you might be pregnant
- If you are breastfeeding
- If you suffer from kidney or liver disease
You must inform your nuclear medicine physician if you are in any of these situations. Your nuclear medicine physician will advise you whether you need to take any special precautions after using this medicine. Please consult your nuclear medicine physician if you have any questions.
Before administration of MIBI Institute of Atomic Energy you should
- Fast for at least 4 hours if the product is to be used for imaging of the heart
- Drink plenty of water before starting the procedure to ensure frequent urination during the first hours after completion.
Children and adolescents
Inform your nuclear medicine physician if you are under 18 years of age.
Use of MIBI Institute of Atomic Energy with other medicines
Various medicines, foods, and beverages may negatively affect the results of the planned study. Therefore, it is recommended to discuss with your referring physician which products should be discontinued before the study and when you should resume taking your medications. Also inform your nuclear medicine physician if you are taking, have recently taken, or might need to take any other medicine, as they may interfere with the interpretation of the images.
In particular, inform your nuclear medicine physician if you are taking medicines that affect heart function and/or blood flow.
Consult your nuclear medicine physician before taking any medication.
Pregnancy and breastfeeding
You must inform the nuclear medicine physician before administration of MIBI Institute of Atomic Energy 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 your nuclear medicine physician supervising the procedure.
If you are pregnant
The nuclear medicine physician will only administer this medicine during pregnancy if the expected benefit outweighs the potential risk.
If you are breastfeeding
Inform your nuclear medicine physician, as they may advise you to interrupt breastfeeding until radioactivity has been eliminated from your body. This takes approximately 24 hours. Breast milk expressed during this time should be discarded. Consult your nuclear medicine physician regarding when you may resume breastfeeding.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your nuclear medicine physician before being administered this medicine.
Driving and use of machines
MIBI Institute of Atomic Energy is considered unlikely to affect your ability to drive or operate machinery.
MIBI Institute of Atomic Energy contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per vial, i.e., essentially “sodium-free”.
3. How MIBI Institute of Atomic Energy is used
There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. MIBI Institute of Atomic Energy will be used only in specially controlled areas. This product will be handled and administered exclusively by trained and qualified personnel who are skilled in its safe use. These individuals will take special care in the safe handling of this product and will inform you about their actions.
The nuclear medicine physician supervising the procedure will determine the amount of MIBI Institute of Atomic Energy 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 in adults varies, depending on the type of test to be performed, between 200 and 2,000 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 MIBI Institute of Atomic Energy and performance of the procedure
MIBI Institute of Atomic Energy is administered intravenously into a vein in the arm or foot.
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 if you need to take any special precautions after receiving this medication. Please consult your nuclear medicine physician if you have any doubts.
The ready-to-use solution will be injected intravenously prior to obtaining the scintigraphy. Images will be acquired between 5 and 10 minutes and up to six 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 (e.g., during physical exercise or pharmacological stress). The two injections will be administered at an interval of at least two hours, and the total administered dose will not exceed 2,000 MBq (one-day protocol). A two-day protocol is also possible.
For breast imaging to detect abnormalities, an injection of 750 to 1,100 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 185 and 1,100 MBq, depending on the method used.
If the medication is to be used for cardiac imaging, you will be asked to fast 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 the liver and improve image quality.
Duration of the procedure
Your nuclear medicine physician will inform you about the usual duration of the procedure.
After administration of MIBI Institute of Atomic Energy, you should:
- avoid direct contact with young children and pregnant women during the 24 hours following 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 medication. Please consult your nuclear medicine physician if you have any doubts.
If you have been administered more MIBI Institute of Atomic Energy than you should have received
An overdose is unlikely, as you will receive only a single dose of MIBI Institute of Atomic Energy, precisely controlled by the supervising nuclear medicine physician. 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 facilitate the elimination of the product 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 everybody experiences them.
Allergic reactions have rarely been observed, which may manifest as difficulty breathing, extreme fatigue, nausea (usually within 2 hours after administration), and swelling under the skin that may appear in areas such as the face and limbs (angioedema), potentially obstructing the airways, leading to a dangerous drop in blood pressure (hypotension), or causing a 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, hives, rash, swelling, and redness. If you experience any of these symptoms, consult your nuclear medicine physician immediately.
Other possible adverse effects are listed below according to their 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 electrocardiogram, and nausea. |
Rare: may affect up to 1 in 1,000 people | Heart rhythm abnormality, local reactions at the injection site, stomach pain, fever, fainting, seizures, dizziness, hot flushes, numbness or tingling of the skin, fatigue, joint pain, and stomach discomfort (dyspepsia). |
Frequency not known: frequency cannot be estimated from the available data | Erythema multiforme, a widespread rash affecting the skin and mucous membranes. |
Administration of this radiopharmaceutical involves receiving a small amount of ionizing radiation, with a very low risk of developing cancer and hereditary defects.
Reporting of adverse reactions
If you experience any adverse reactions, please consult your nuclear medicine physician, even if they are adverse reactions not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.
5. Storage of MIBI Institute of Atomic Energy
You will not be required to store this medicinal product. This medicine is stored under the responsibility of the specialist in appropriate facilities. Storage of radiopharmaceuticals must comply with national regulations concerning radioactive materials.
The following information is intended for the specialist only.
Do not use MIBI Institute of Atomic Energy after the expiry date stated on the label. The expiry date refers to the last day of that month.
6. Contents of the pack and other information
Composition of MIBI Institute of Atomic Energy
The active substance is: tetrafluoroborate of [tetrakis(1-isocyanido-2-methoxy-2-methylpropyl)copper(I)]
One vial contains 1.0 mg of tetrafluoroborate of [tetrakis(1-isocyanido-2-methoxy-2-methylpropyl)copper(I)].
The other components are:
Dihydrate stannous chloride
Monohydrate cisteine hydrochloride
sodium citrate dihydrate
D-mannitol
Appearance of the product and contents of the pack
The product is a reagent kit for radiopharmaceutical preparation.
MIBI Institute of Atomic Energy consists of a white, lyophilized powder which must be dissolved in a solution and combined with radioactive technetium before being used for injection. Once the radioactive substance sodium pertechnetate (99mTc) is added to the vial, technetium (99mTc) sestamibi is formed. This solution is ready for injection.
Pack size:
10 ml vials sealed with a chlorobutyl rubber stopper and aluminium cap.
The vials are packed in cardboard boxes.
Pack size: 3 or 6 vials.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
NATIONAL CENTRE FOR NUCLEAR RESEARCH
Andrzej Soltan 7
05-400 Otwock, Poland
Tel. +48 22 718 07 00
Fax: +48 22 718 03 50
e-mail: [email protected]
Manufacturer:
NATIONAL CENTRE FOR NUCLEAR RESEARCH
Andrzej Soltan 7
05-400 Otwock, Poland
ROTOP Pharmaka GmbH
Bautzner Landstrabe 400
01328 Dresden, Germany
This summary of product characteristics was approved in July 2016
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es
This information is intended for healthcare professionals only:
The full Summary of Product Characteristics for MIBI Institute of Atomic Energy is provided as a detachable section at the end of the printed leaflet in the product packaging, in order to provide healthcare professionals with additional scientific and practical information regarding the administration and use of this radiopharmaceutical.
Please consult the Technical Data Sheet.