MAG3 TECHNESCAN 1 mg KIT FOR RADIOPHARMACEUTICAL PREPARATION

Warnings and precautions

Before MAG3 Technescan is administered to you, consult your nuclear medicine doctor:

Before administration of MAG3 Technescan, you must:

• Drink plenty of water before starting the procedure so that you can urinate frequently during the first few hours after it is finished.

Children and adolescents

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

Other medicines and MAG3 Technescan

Tell your doctor if you are using, have recently used, or might use any other medicines, as they may interfere with the interpretation of the images.

It is known that MAG3 Technescan is influenced by or affects other medicines, such as acetylsalicylic acid, contrast media, probenecid, hydrochlorothiazide, NSAIDs like diclofenac, sulfonamides, and calcium antagonists.

Pregnancy and breast-feeding

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

You must inform your nuclear medicine doctor before administration of MAG3 Technescan 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 will supervise the procedure.

If you are pregnant

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

If you are breast-feeding

The doctor may delay treatment until breast-feeding is finished. If this is not possible, your doctor may ask you to interrupt breast-feeding for 4 hours and discard the expressed milk during this period.

You do not need to avoid close contact with your baby after the procedure.

Driving and using machines

MAG3 Technescan is unlikely to affect your ability to drive or use machines.

MAG3 Technescan contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per vial; it is essentially "sodium-free".

3. How to use MAG3 Technescan

There are strict rules on the use, handling, and disposal of radiopharmaceuticals. MAG3 Technescan will only be handled in special controlled areas. This product will only be handled and administered by persons with the training and qualifications for its safe use. These persons will take special care to use this product safely and will keep you informed of their actions.

The nuclear medicine doctor supervising the procedure will decide the amount of MAG3 Technescan to be used in your case. This will be the minimum amount necessary to obtain the desired information.

The generally recommended amount for administration to an adult varies between 40 and 200 MBq (Megabecquerel, the unit used to express radioactivity).

Use in children

In children and adolescents, the amount to be administered will be adjusted according to their body weight.

Administration of MAG3 Technescan and performance of the procedure

MAG3 Technescan is administered by intravenous injection.

A single injection of MAG3 Technescan is sufficient to perform the procedure your doctor needs.

Duration of the procedure

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

After administration of MAG3 Technescan, you must:

• Drink plenty of water to urinate frequently and eliminate the product from your body.

Your nuclear medicine doctor will inform you if you need to take special precautions after this medicine is administered to you. If you have any questions, ask your nuclear medicine doctor.

If you have been administered more MAG3 Technescan than you should

Overdose is unlikely because you will receive a precisely controlled single dose of MAG3 Technescan by the nuclear medicine doctor supervising the procedure. However, in case of overdose, you will receive appropriate treatment. In particular, the nuclear medicine doctor in charge of the procedure may recommend that you drink plenty of water and urinate frequently to eliminate the remains of radioactivity from your body.

If you have any further questions about the use of MAG3 Technescan, ask your nuclear medicine doctor who is supervising the procedure.

4. Possible side effects

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

Side effects of unknown frequency (cannot be estimated from the available data):

• Allergic reactions, including severe and sudden allergic reaction with symptoms such as itching rash, swelling of the eyelids, cough, nausea, vomiting.
• Vasovagal reactionswith symptoms such as convulsions, difficulty breathing, flushing of the skin, headache, facial swelling, pain, abnormal sensation, feeling of instability, low blood pressure, rapid heartbeat.
• Reactions at the injection sitewith symptoms such as skin rash, pain, swelling.

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, consult your nuclear medicine doctor, 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 MAG3 Technescan

You will not need to store this medicine. This medicine is stored under the responsibility of the specialist in suitable facilities.

Storage of radiopharmaceuticals will be carried out in accordance with national regulations on radioactive materials.

The following information is intended only for the specialist.

Do not use MAG3 Technescan after the expiry date stated on the label after EXP.

Do not use MAG3 Technescan if there are visible signs of deterioration.

6. Contents of the pack and further information

Composition ofMAG3 Technescan

• The active substance is betiatide. Each vial contains 1 mg of betiatide.
• The other components are disodium tartrate dihydrate, tin(II) chloride dihydrate, hydrochloric acid.

Appearance and pack contents

MAG3 Technescan contains a powder, packaged in a 10 ml type I glass vial with a rubber stopper and closed with an aluminum cap. Pack size: 5 vials.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Curium Pharma Spain S.A.

Avenida Doctor Severo Ochoa, nº 29, 3º-2

28100, Alcobendas, Madrid, Spain

Manufacturer:

Curium Netherlands B.V.

Westerduinweg 3

1755 LE Petten

(Netherlands)

Date of last revision of this leaflet:12/2023

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 complete technical data sheet for MAG3 Technescan 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.