Label: Information for the User

MAG3 Radiopharmacy 1 mg Reactant Kit for Radiochemical Preparation EFG

Betiatida

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your nuclear medicine physician who is overseeing the procedure.
• If you experience any adverse effects, consult your nuclear medicine physician, even if they are not listed in this label. See section 4.

1.What MAG3 Radiopharmacy is and how it is used

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

3.How to use MAG3 Radiopharmacy

4.Possible adverse effects

1. Storage of MAG3 Radiopharmacy
2. Contents of the package and additional information

This medication is a radiopharmaceutical for diagnostic use only.

MAG3 Radiopharmacy 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 radioactive solution, sodium pertechnetate (99mTc), it forms technetium-99m (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 Radiopharmacy involves receiving a small amount of radioactivity. Your nuclear medicine doctor has considered that the clinical benefit you will obtain from the procedure with the radiopharmaceutical outweighs the risk of radiation.

No use MAG3 Radiopharmacy

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

Warnings and precautions

Be especially careful with MAG3 Radiopharmacy

- If you are pregnant or think you may be

- If you are breastfeeding

This medication involves exposure to radiation. Your doctor will only administer this medication if the benefit outweighs the risk.

MAG3 Radiopharmacy is administered by specialists, who will assume responsibility for any necessary precautions.

Your doctor will inform you if you need to take special precautions after using this medication. Contact your doctor if you have any questions.

Before administration of MAG3 Radiopharmacy, 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

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

Other medications and MAG3 Radiopharmacy

Inform your nuclear doctor if you are using or may need to use any other medication, as some medications may interfere with the interpretation of images.

The following medications may influence or be influenced by MAG3 Radiopharmacy:

• contrast agents,
• medications for high blood pressure,
• medications for heart disease,
• diuretics

Pregnancy, breastfeeding, and fertility

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

You must inform your nuclear doctor before administration of MAG3 Radiopharmacy 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 doctor, who will supervise the procedure.

Pregnancy

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

Breastfeeding

If you are breastfeeding, consult your doctor, as they may delay treatment until breastfeeding is completed. You can also ask them to stop breastfeeding for 4 hours and discard this milk until you no longer present radiation in your body.

Driving and using machines

It is considered unlikely that MAG3 Radiopharmacy will affect the ability to drive or use machines.

MAG3 Radiopharmacy contains sodium

This medication contains less than 1 mmol (23 mg) of sodium per dose; that is, it is essentially 'sodium-free'.

Depending on when this medication is administered, the sodium content may be higher than 1 mmol. This should be taken into account in the treatment of patients with low-sodium diets.

There are strict guidelines for the use, handling, and disposal of radiopharmaceuticals. MAG3 Radiopharmacy will only be handled in specially controlled areas. Only trained and qualified individuals will handle and administer this product to you. Those individuals will take special care in the safe use of this product and keep you informed of their actions.

The nuclear medicine physician overseeing the procedure will decide on the amount of MAG3 Radiopharmacy 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 varies between 37 and 185 MBq (megabecquerel, the unit used to express radioactivity).

Use in children

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

Administration of MAG3 Radiopharmacy and procedure performance

MAG3 Radiopharmacy is administered via a vein.

One injection is sufficient to perform the procedure needed by your physician.

Procedure duration

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

After MAG3 Radiopharmacy administration, you should:

Drink and urinate as much as possible before and after treatment.

This will prevent the active principle from accumulating in the bladder.

If you have been administered more MAG3 Radiopharmacy than you should have

It is unlikely to experience an overdose since you will receive a single, precisely controlled dose of MAG3 Radiopharmacy from the nuclear medicine physician overseeing the procedure. However, in the event of an overdose, you will receive the appropriate treatment.

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

Like all medications, MAG3 Radiopharmacy may produce adverse effects, although not everyone will experience them.

Adverse effects may occur with the following frequencies:

Rare: may affect up to 1 in 1000 people

• Mild allergic reactions, such as urticaria, eyelid swelling, and cough.

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 specialist nuclear medicine doctor, 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 you. This medication is stored under the responsibility of the specialist in appropriate facilities. 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 MAG3Radiopharmacyafter the expiration date that appears on the label after CAD.

The hospital staff will ensure that the product is stored and disposed of correctly and that it is not used after the expiration date.

Composition of MAG3 Radiopharmacy

• The active ingredient is betiatida.
• The other excipients are dihydrate sodium tartrate, dihydrate stannous chloride and hydrochloric acid for pH adjustment.

Aspect of MAG3 Radiopharmacy and contents of the package

10 ml glass vial Type 1 Ph. Eur. with a bromobutyl rubber stopper Ph. Eur. and sealed with an aluminum cap.

MAG3 Radiopharmacy is supplied in a cardboard box with six or two vials.

Holder of the marketing authorization and responsible for manufacturing

Medi-Radiopharma Ltd

2030, Érd, Szamos st. 10-12

Hungary

This medicinal product is authorized in the member states of the European Economic Area (EEA) under the following names:

Last review date of this leaflet: September 2017

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This information is intended solely for medical doctors or healthcare professionals:

The full technical datasheet of MAG3 Radiopharmacy 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 refer to the datasheet.