ADREVIEW 74 MBq/ml INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the Patient

AdreView 74 MBq/ml Solution for Injection

Iobenguane (123I)

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your nuclear medicine doctor who is supervising the procedure.
• If you experience any side effects, talk to your nuclear medicine doctor, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet:

1. What is AdreView and what is it used for
2. What you need to know before you start using AdreView
3. How to use AdreView
4. Possible side effects
5. Storage of AdreView
6. Contents of the pack and further information

1. What is AdreView and what is it used for

This medicine is a radiopharmaceutical for diagnostic use only.

AdreView is used to detect certain tumors and to visualize certain diseases of the adrenal glands and heart. Because the radiopharmaceutical contains a small amount of radioactivity, it can be detected from outside the body using special medical equipment called a gamma camera, and an image known as a scintigram can be obtained. This scintigram 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 about the location and function of the organs and/or tumor.

Administration of AdreView involves receiving a small amount of radioactivity. Your doctor and nuclear medicine doctor have considered that the clinical benefit you will gain from the procedure with the radiopharmaceutical outweighs the risk of radiation.

2. What you need to know before you start using AdreView

AdreView must not be used

• if you are allergic to AdreView or any of the other components of this medicine (listed in section 6).
• in premature infants or newborns

Warnings and precautions

Be careful with AdreView

• if you have kidney problems

Tell your nuclear medicine doctor in the following cases:

• if you are pregnant or think you may be pregnant
• if you are breast-feeding

Before administration of AdreView, you should:

• drink plenty of water before starting the procedure to urinate frequently during the first hours after its completion.
• take another medicine to prevent the accumulation of radioactivity in your thyroid gland 24-48 hours prior and continue for at least 3 days. The thyroid blocking agent will be administered to you at least one hour before the dose of iobenguane (123I).

Children and adolescents

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

Using AdreView with other medicines:

Tell your nuclear medicine doctor if you are taking, have recently taken, or might take any other medicines, as some medicines may interfere with the interpretation of the images:

• medicines used to reduce blood pressure
• nasal decongestants
• cocaine
• antidepressants
• phenothiazine

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or plan to become pregnant, consult your nuclear medicine doctor before you are given this medicine.

You must inform the nuclear medicine doctor before administration of AdreView if there is any possibility that you may be pregnant, if you have a delayed period, or if you are breast-feeding.

In case of doubt, it is important that you consult your nuclear medicine doctor who supervises the procedure.

If you are pregnant

The nuclear medicine doctor will only give you this medicine during pregnancy if the expected benefit outweighs the risk.

If you are breast-feeding

You must stop breast-feeding your child for 72 hours after the injection and discard the milk expressed during this period.

Please consult your nuclear medicine doctor when you can resume breast-feeding.

Driving and using machines

No effects of AdreView on the ability to drive and use machines have been described.

AdreView contains

• This medicine contains 10.4 mg/ml of benzyl alcohol.

Benzyl alcohol may cause allergic reactions. Consult your doctor or pharmacist if you are pregnant or breast-feeding. This is because large amounts of benzyl alcohol can accumulate in your body and cause side effects (metabolic acidosis).

Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol can accumulate in your body and cause side effects (metabolic acidosis).

Benzyl alcohol has been associated with the risk of serious side effects, including respiratory problems ("gasping syndrome") in children.

Do not give this medicine to your newborn (up to 4 weeks old) unless your doctor has recommended it.

It may cause toxic reactions 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), so it is considered essentially "sodium-free".

3. How to use AdreView

There are strict rules on 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 people will take special care in the safe use of this product and will inform you of their actions.

The nuclear medicine doctor who supervises 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 recommended amount for administration to an adult is usually 80 to 370 MBq (Megabecquerels, the unit used to express radioactivity).

Use in children and adolescents

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

Administration of AdreView and performance of the procedure

AdreView is always administered intravenously and slowly.

A single injection is sufficient to perform the procedure that your doctor needs.

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

Duration of the procedure

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

After administration of AdreView, you should:

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

The nuclear medicine doctor will inform you if you need to take special precautions after you are given this medicine. Consult your nuclear medicine doctor if you have any doubts.

If you have been given more AdreView than you should

Overdose is unlikely because you will receive a precisely controlled dose of AdreView from the nuclear medicine doctor who supervises the procedure. However, in case of overdose, you will receive the appropriate treatment.

If you have any further questions about the use of AdreView, ask the nuclear medicine doctor who supervises the procedure.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

Administration of this radiopharmaceutical involves receiving a small amount of ionizing radiation with a very low risk of developing cancer and genetic disorders.

Reporting of side effects:

If you experience any side effects, talk to your doctor or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of AdreView

You will not need to store this medicine. This medicine is stored under the responsibility of the specialist in suitable facilities. The storage of radiopharmaceuticals will be carried out in accordance with national regulations on radioactive materials.

The following information is intended only for the specialist.

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

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

Storage must be carried out in the original lead container or equivalent shielding.

Do not use AdreView after the expiry date stated on the label of the pack and vial after EXP.

Before opening the pack for the first time, the shelf-life is 36 hours from the date and time of calibration.

After opening the pack for the first time, the shelf-life is 8 hours when stored between 2-8°C.

6. Contents of the pack and further information

Composition of AdreView

• The active substance is iobenguane (123I). Each ml of solution for injection 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 and pack contents

This medicine is presented as a clear and colorless solution for injection. It is supplied in multidose glass vials type I Ph.Eur. of 10 ml, sealed with a bromobutyl stopper and aluminum overseal.

A vial contains between 0.5 ml and 10 ml of solution for injection, corresponding to an activity range of 37 MBq to 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 - Netherlands

Date of last revision of this leaflet: November 2020

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Other sources of information

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

This information is intended only for healthcare professionals:

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

Please consult the technical data sheet.