Adreview 74 MBq/ml solution for injection
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
AdreView 74 MBq/ml solution for injection
Iobenguane (123I)
Read the entire leaflet carefully before you are administered this medicine, because 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 reactions, consult your nuclear medicine physician, even if they are adverse reactions not listed in this leaflet. See section 4.
Leaflet contents:
- What AdreView is and what it is used for
- What you need to know before receiving AdreView
- How to use AdreView
- Possible adverse effects
- How to store AdreView
- Contents of the pack and other information
1. What AdreView is and what it is used for
This medicine is a radiopharmaceutical for diagnostic use only.
AdreView is used to detect certain tumours and to visualise specific diseases of the adrenal glands and the heart. Because the radiopharmaceutical contains a small amount of radioactivity, it can be detected from outside the body using a special medical device called a gamma camera, allowing an image known as a scintigram to be obtained. This scintigram will show exactly the location and distribution of the radiopharmaceutical in the tumour or organs where it accumulates, providing the physician with valuable information regarding the location and function of the organs and/or tumour.
Administration of AdreView involves receiving a small amount of radioactivity. Your doctor and the nuclear medicine physician have determined that the clinical benefit you will obtain from this radiopharmaceutical procedure outweighs the risk from radiation exposure.
2. What you need to know before using AdreView
AdreView must not be used
- if you are allergic to AdreView or to any of the other components of this medicine (listed in section 6).
- in premature infants or newborns
Warnings and precautions
Take special care with AdreView
- if you have kidney problems
Inform your nuclear medicine physician in the following cases:
- if you are pregnant or think you might be pregnant
- if you are breastfeeding
Before administration of AdreView, you must:
- drink plenty of water before starting the procedure to ensure frequent urination during the first hours after completion.
- take another medication to prevent accumulation of radioactivity in your thyroid gland, starting 24–48 hours before and continuing for at least 3 days. The thyroid-blocking agent will be administered at least one hour before the iobenguane (123I) dose.
Children and adolescents
Inform your nuclear medicine physician if you are under 18 years of age.
Use of AdreView with other medicines
Inform your nuclear medicine physician if you are taking, have recently taken, or might need to take any other medicines, as some medicines may interfere with image interpretation:
- medicines used to lower blood pressure
- nasal decongestants
- cocaine
- antidepressants
- phenothiazines
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your nuclear medicine physician before receiving this medicine.
You must inform the nuclear medicine physician before administration of AdreView if there is any possibility you could 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
Your nuclear medicine physician will only administer this medicine during pregnancy if the expected benefit outweighs the potential risk.
If you are breastfeeding
You must stop breastfeeding for 72 hours after the injection and discard any milk expressed during this period.
Please consult your nuclear medicine physician regarding when you may resume breastfeeding.
Driving and using machines
No effects of AdreView on the ability to drive or operate machinery have been reported.
AdreView contains
- This medicine contains 10.4 mg/ml of benzyl alcohol.
Benzyl alcohol may cause allergic reactions. Consult your physician or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).
Consult your physician or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).
Benzyl alcohol has been associated with the risk of serious adverse effects, including respiratory problems (“gasping syndrome”), in children.
Do not administer this medicine to your newborn (up to 4 weeks of age) unless specifically instructed by your physician.
It may cause toxic and allergic reactions in children under 3 years of age.
- This medicine contains less than 23 mg of sodium (1 mmol of sodium per dose) and is therefore considered essentially “sodium-free”.
3. How to use AdreView
There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. AdreView will only be used in specially controlled areas. This product will only be handled and administered by trained and qualified personnel competent to use it safely. These individuals will take particular care in 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 AdreView to be used in your case. This will be the minimum quantity necessary to obtain the required information. The generally recommended administered activity for an adult is 80 to 370 MBq (Megabecquerels, the unit used to express radioactivity).
Use in children and adolescents
In children and adolescents, the administered amount will be adjusted according to body weight. AdreView must not be used in premature infants and newborns.
Administration of AdreView and performance of the procedure
AdreView is always administered intravenously by slow injection.
A single injection is sufficient to perform the procedure required by your physician.
You will be continuously monitored during administration of the radiopharmaceutical because a hypertensive crisis may occur.
Duration of the procedure
Your nuclear medicine physician will inform you about the usual duration of the procedure.
After administration of AdreView, you should:
Be continuously monitored during administration of the radiopharmaceutical because a hypertensive crisis may occur.
The nuclear medicine physician will inform you if you need to take special precautions after receiving this medicine. Consult your nuclear medicine physician if you have any doubts.
If you have been given more AdreView than you should have received
An overdose is unlikely, as you will receive a precisely controlled dose of AdreView determined by the nuclear medicine physician supervising the procedure. However, in the event of an overdose, appropriate treatment will be given.
If you have any further questions about the use of AdreView, ask the nuclear medicine physician supervising the procedure.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
The following adverse effects have been reported with unknown frequency (frequency cannot be estimated from the available data): redness, itching, nausea, chills, allergic reactions, hypersensitivity. When the drug is administered too rapidly, the following may occur during or immediately after administration: palpitations, difficulty breathing, sensations of warmth, transient increase in blood pressure, and abdominal cramps.
Administration of this radiopharmaceutical involves exposure to a small amount of ionizing radiation, with a very low risk of developing cancer and hereditary defects.
Reporting of adverse effects:
If you experience any adverse effect, consult your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of AdreView
You will not be required to store this medicinal product. This medicine is stored under the responsibility of a specialist in appropriate facilities. Storage of radiopharmaceuticals must comply with national regulations regarding radioactive materials.
The following information is intended for specialists only.
Before first opening of the container, the product should be stored at a temperature between 15°C and 25°C.
After first opening of the container, it must be stored at 2–8°C.
Storage must be carried out in the original lead container or in another equivalent shielding device.
Do not use AdreView after the expiry date stated on the container label and on the vial after EXP.
Before first opening of the container, the shelf life is 36 hours from the date and time of calibration.
After first opening of the container, the shelf life is 8 hours when stored at 2–8°C.
6. Contents of the pack and other information
Composition of AdreView
- The active substance is iobenguane (123I). Each ml of injectable solution contains 74 MBq of iobenguane (123I) at the date and time of calibration.
- The other components are benzyl alcohol, 3-iodobenzylguanidine, sodium dihydrogen phosphate, disodium hydrogen phosphate, and water for injections. 1 ml of solution contains 10.4 mg of benzyl alcohol.
Appearance of the medicinal product and contents of the container
This medicine is presented as a clear, colourless injectable solution. It is supplied in multi-dose vials of neutral glass type I according to Ph.Eur. with a capacity of 10 ml, sealed with a bromobutyl rubber stopper and an aluminium cap.
One vial contains between 0.5 ml and 10 ml of injectable solution, corresponding to an activity range between 37 MBq and 740 MBq at the date and time of calibration.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
GE Healthcare Bio-Sciences, S.A.U.
Calle Gobelas, 35-37, La Florida
28023 (Madrid), Spain
Manufacturer:
GE Healthcare BV
De Rondom 8
5612 AP
Eindhoven, The Netherlands
Date of the most recent revision of this leaflet: November 2020
Other sources of information
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/
This information is intended for healthcare professionals only:
The complete Summary of Product Characteristics for AdreView is included as a separate document in the product packaging, providing additional scientific and practical information for healthcare professionals on the administration and use of this radiopharmaceutical.
Please consult the Summary of Product Characteristics.