Patient Information Leaflet

AdreView 74 MBq/ml injectable solution

Iobenguane (123I)

Read this leaflet carefully before you receive 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 is supervising the procedure.
• If you experience any side effects, consult your nuclear medicine physician, even if they are not listed in this leaflet. See section 4.

1. What AdreView is and how it is used

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

3. How to use AdreView

4. Possible side effects

5. Storage of AdreView

6. Contents of the pack and additional information

This medication is a radiopharmaceutical for diagnostic use only.

AdreView is used for the detection of certain tumors and visualization of certain diseases of the adrenal glands and the heart. Due to the fact that the radiopharmaceutical contains a small amount of radioactivity, it can be detected from the outside of the body using a special medical device called a gamma camera, and an image known as a gamma scan can be obtained. This gamma scan will show exactly the location and distribution of the radiopharmaceutical in the tumor or in the organs where it accumulates, providing the doctor with valuable information regarding the location and function of the organs and/or the tumor.

The administration of AdreView 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 procedure with the radiopharmaceutical outweighs the risk of radiation.

AdreView should not be used

- if you are allergic to AdreView or any of the other components of this medication (listed in section 6).

- in premature babies or newborns

Warnings and precautions

Be especially careful with AdreView

- if you have kidney problems

Inform your nuclear medicine doctor in the following cases:

- if you are pregnant or think you may be pregnant

- if you are breastfeeding

Before AdreView administration, you must:

- drink a lot of water before starting the procedure to urinate very frequently during the first hours after its completion.

- take another medication to prevent the accumulation of radioactivity in your thyroid gland in the 24-48 hours prior and continue for at least 3 days.The thyroid-blocking agent will be administered at least one hour before the 123I dose.

Children and adolescents

Inform your nuclear medicine doctor if you are under 18 years old.

Use of AdreView with other medications:

Inform your nuclear medicine doctor if you are taking, have taken recently, or may need to take any other medication, as some medications may interfere with image interpretation:

- blood pressure-lowering medications

- nasal decongestants

- cocaine

- antidepressants

- phenothiazine

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your nuclear medicine doctor before this medication is administered.

You must inform the nuclear medicine doctor before AdreView administration if there is any possibility of pregnancy, if you experience a delay in your period, or if you are breastfeeding.

In case of doubt, it is essential to consult your nuclear medicine doctor who will supervise the procedure.

If you are pregnant

Your nuclear medicine doctor will only administer this medication during pregnancy if the expected benefit outweighs the risk.

If you are breastfeeding

You must stop breastfeeding your child for 72 hours after the injection and discard the milk expressed during that period.

Please consult your nuclear medicine doctor when you can resume breastfeeding.

Driving and operating machinery

No adverse effects of AdreView on the ability to drive and operate machinery have been described.

AdreView contains

- This medication contains 10.4 mg/ml of benzyl alcohol.

Benzyl alcohol may cause allergic reactions. Consult your doctor 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 doctor 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 a risk of severe adverse effects, including respiratory problems (“breathing difficulty”) in children.

Do not administer this medication to your newborn (up to 4 weeks old) unless your doctor recommends it.

It may cause toxic reactions and allergic reactions in children under 3 years old.

- This medication contains less than 23 mg of sodium (1 mmol of sodium per dose), making it essentially “sodium-free”.

There are strict guidelines for 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 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 medicine physician overseeing the procedure will decide the amount of AdreView 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 is80to 370 MBq. (Megabecquerel, the unit used to express radioactivity).

Use in children and adolescents

In children and adolescents, the dose to be administered will be adjusted according to their body weight. In premature infants and newborns, AdreView should not be used.

Administration of AdreView and procedure performance

AdreView is always administered intravenously in a slow manner.

One injection is sufficient to perform the procedure your physician needs.

You will be constantly monitored during the administration of the radiopharmaceutical because hypertension crisis may occur.

Procedure duration

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

After AdreView administration, you must:

Be constantly monitored during the administration of the radiopharmaceutical because hypertension crisis may occur.

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

If you have been administered more AdreView than you should

A overdose is unlikely because you will receive a controlled and precise dose of AdreView from the nuclear medicine physician overseeing the procedure. However, in case of overdose, you will receive the appropriate treatment.

If you have any other questions about the use of AdreView, ask the nuclear medicine physician overseeing the procedure.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

The following adverse effects have been found with an unknown frequency (the frequency cannot be estimated from the available data): redness, itching, nausea, chills, allergic reactions, hypersensitivity. When the medication is administered too quickly, the following may occur during or immediately after administration: palpitations, difficulty breathing, feelings of heat, temporary blood pressure increase, and abdominal cramps.

The administration of this radiopharmaceutical involves receiving a small amount of ionizing radiation with a very low risk of developing cancer and hereditary defects.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance for Human Use Medications:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

The following information is intended solely for the specialist.

Before opening the packaging for the first time, the product must be stored at a temperature between 15°C and 25°C.

After opening the packaging for the first time, it must be stored between 2-8°C.

Storage must be carried out in the original lead-lined container or an equivalent shield.

Do not use AdreView after the expiration date that appears on the packaging label and the vial after CAD.

Before opening the packaging for the first time, the validity period is 36 hours from the date and time of calibration.

After opening the packaging for the first time, the validity period is 8 hours when stored between 2-8°C..

Composition of AdreView

- The active principle is iobenguane (123I). Each ml of injectable solution contains 74 MBq of iobenguane (123I) at the time and date of calibration.

- The other components are benzyl alcohol, 3-iodobenzylguanidine, sodium dihydrogen phosphate, disodium hydrogen phosphate, and water for injection. 1 ml of solution contains 10.4 mg of benzyl alcohol.

Appearance of the product and contents of the packaging

This medicine is presented in the form of a clear and colorless injectable solution. It is supplied in multi-dose glass vials of type I of the Ph.Eur. of 10 ml, sealed with a bromobutyl stopper and with an aluminum overcap.

A vial contains between 0.5 ml and 10 ml of injectable solution, corresponding to a range of activity between 37 MBq and 740 MBq at the time and date of calibration.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

GE Healthcare Bio-Sciences, S.A.U.

Calle Gobelas, 35-37, La Florida

28023 (Madrid) Spain

Responsible for manufacturing:

GE Healthcare BV

De Rondom 8

5612 AP

Eindhoven - Netherlands

Last review date of this leaflet:November 2020

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Other sources of information

The detailed information on this medicine 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 doctors or healthcare professionals:

The complete technical file of AdreView is included as a separate document in the product packaging, in order to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.

Please, consult the technical file.