Label: information for the user

MAG3 Technescan 1 mg kit for radiopharmaceutical preparation

Betiatida

1.What is MAG3 Technescan and how is it used

2.What you need to know before starting to use MAG3 Technescan

3.How to use MAG3 Technescan

4.Possible adverse effects

5Storage of MAG3 Technescan

6.Contents of the package and additional information

This medication is for diagnostic use only.

MAG3 Technescan is used through a gamma camera to examine:

• the kidneys
• urine production
• the bladder

This medication is a powder. When qualified individuals mix it with a solution of a radioactive substance, sodium pertechnetate (99mTc), it forms technetium (99mTc) mag3. When injected into the body, it accumulates in certain organs, such as the kidneys.

The radioactive substance can be photographed from the outside of the body using special cameras that perform a gamma scan. This gamma scan shows the distribution of radioactivity within the organ and the body. It also provides the doctor with valuable information about the structure and function of the organ.

The administration of MAG3 Technescan in combination with sodium pertechnetate (99mTc) involves receiving a small amount of radioactivity. Your nuclear doctor has considered that the clinical benefit you will obtain from the procedure with the radiopharmaceutical outweighs the risk of radiation.

No useMAG3 Technescan

If you are allergic to the active ingredient or any of the other components of this medication (listed in section 6).

Warnings and precautions

Before MAG3 Technescan is administered, consult your nuclear medicine specialist:

• If you are pregnant or think you may be pregnant
• If you are breastfeeding.

Before MAG3 Technescan administration, you must:

• Drink a lot of water before starting the procedure to be able to urinate very frequently during the first hours after its completion.

Children and adolescents

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

Other medications and MAG3 Technescan

Inform your doctor if you are using, have used recently, or may need to use any other medication, as they may interfere with the interpretation of the images..

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

Pregnancy and breastfeeding

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

You must inform your nuclear medicine specialist before MAG3 Technescan 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 specialist who will supervise the procedure.

If you are pregnant

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

If you are breastfeeding

Your doctor may delay treatment until you finish breastfeeding. If this is not possible, your doctor may ask you to interrupt breastfeeding for 4 hours and discard the expressed milk during that period.

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

Driving and operating machinery

It is considered unlikely that MAG3 Technescan will affect your ability to drive or operate machinery.

MAG3 Technescan contains sodium

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

There are strict guidelines for 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 individuals with the necessary training and qualifications for its safe use. Those individuals will take special care to use this product safely and will keep you informed of their actions.

The nuclear medicine physician overseeing the procedure will decide on 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 dose for an adult typically ranges from 40 to 200 MBq (MegaBecquerel, the unit used to express radioactivity).

Use in children

The dose to be administered will be adjusted according to the child's or adolescent's body weight.

Administration of MAG3 Technescan and procedure performance

MAG3 Technescan is administered via intravenous injection.

One injection of MAG3 Technescan is sufficient to perform the procedure your physician needs.

Procedure duration

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

After MAG3 Technescan administration, you should:

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

Your nuclear medicine physician will inform you if you need to take any special precautions after receiving this medication. If you have any questions, consult with your nuclear medicine physician.

If you have been administered more MAG3 Technescan than you should

It is unlikely to experience an overdose, as you will receive a single, precisely controlled dose of MAG3 Technescan administered by the nuclear medicine physician overseeing the procedure. However, in the event of an overdose, you will receive the appropriate treatment. In particular, the nuclear medicine physician in charge of the procedure may recommend that you drink plenty of water and urinate frequently to eliminate any remaining radioactivity from your body.

If you have any other questions about the use of MAG3 Technescan, ask the nuclear medicine physician overseeing the procedure.

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

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

• Allergic Reactions, including severe and sudden allergic reaction with symptoms such as hives with itching, swelling of the eyelids, cough, nausea, vomiting.
• Vasovagal Reactionswith symptoms such as convulsions, difficulty breathing, skin redness, headache, facial swelling, pain, abnormal sensation, feeling of instability, low blood pressure, rapid heartbeats.
• Reactions at the Injection Sitewith symptoms such as skin rash, pain, swelling.

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 nuclear physician, even if it is about possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on 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 appropriate facilities.

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

The following information is intended solely for the specialist.

Do not use MAG3 Technescan after the expiration date that appears on the label after CAD.

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

Composition ofMAG3 Technescan

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

Appearance of the product and contents of the packaging

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

Holder of the marketing authorization and manufacturer

Holder of the marketing authorization:

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)

Last review date of this leaflet:12/2023

The detailed information of 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 healthcare professionals:

The complete technical file ofMAG3 Technescanis includedas a separate document in the packaging of the product, in order to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.