MAG3 Radiopharmacy 1 mg radiopharmaceutical preparation kit EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

MAG3 Radiopharmacy 1 mg radiopharmaceutical preparation kit for radiopharmaceutical preparation EFG

Betiatide

Read the entire leaflet carefully before you start using 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 supervises the procedure.
• If you experience any adverse reactions, consult your nuclear medicine physician, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What MAG3 Radiopharmacy is and what it is used for
2. What you need to know before using MAG3 Radiopharmacy
3. How to use MAG3 Radiopharmacy
4. Possible side effects
   1. Storage of MAG3 Radiopharmacy
   2. Contents of the pack and other information

1. What MAG3 Radiopharmacy is and what it is used for

This medicine is a radiopharmaceutical for diagnostic use only.

MAG3 Radiopharmacy is used with a gamma camera to examine:

• the kidneys
• urine production
• the bladder

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

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

Administration of MAG3 Radiopharmacy involves receiving a small amount of radiation. Your nuclear medicine physician has determined that the clinical benefit you will receive from this radiopharmaceutical procedure outweighs the radiation risk.

2. What you need to know before using MAG3 Radiopharmacy

Do not use MAG3 Radiopharmacy

• if you are allergic to betiatide or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Take special care with MAG3 Radiopharmacy

• If you are pregnant or think you might be pregnant
• If you are breastfeeding

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

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

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

Before administration of MAG3 Radiopharmacy, you should:

Drink plenty of water before starting the procedure so that you can urinate frequently during the first hours after completion.

Children

Inform your nuclear medicine physician if you are under 18 years of age.

Other medicines and MAG3 Radiopharmacy

Inform your nuclear medicine physician if you are taking or may need to take any other medicines, as some medicines may interfere with the interpretation of images.

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

• contrast media,
• medicines for high blood pressure,
• medicines for heart disease,
• diuretics

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your nuclear medicine physician before receiving this medicine.

You must inform the nuclear medicine physician before administration of MAG3 Radiopharmacy if there is any possibility you might be pregnant, if you have missed a menstrual period, or if you are breastfeeding.

If in doubt, it is important to consult your nuclear medicine physician, who will supervise the procedure.

Pregnancy

The nuclear medicine physician will only administer this medicine during pregnancy if the expected benefit outweighs the potential risk.

Breastfeeding

If you are breastfeeding, consult your doctor, as he or she may delay treatment until after breastfeeding has ended. Alternatively, you may be instructed to stop breastfeeding for 4 hours and discard the milk produced during this time, until radioactivity is no longer present in your body.

Driving and use of machines

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

MAG3 Radiopharmacy contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per vial; i.e., essentially 'sodium-free'.

Depending on when this medicine is administered, the sodium content may exceed 1 mmol. This should be taken into account in the treatment of patients on sodium-restricted diets.

3. How to USE MAG3 Radiopharmacy

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

The nuclear medicine physician supervising the procedure will determine the amount of MAG3 Radiopharmacy to be used in your case. This will be the minimum quantity necessary to obtain the required information.

The amount generally recommended for administration in adults ranges between 37 and 185 MBq (megabecquerel, the unit used to express radioactivity).

Use in children

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

Administration of MAG3 Radiopharmacy and performance of the procedure

MAG3 Radiopharmacy is administered intravenously.

A single injection is sufficient to perform the procedure required by your physician.

Duration of the procedure

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

After administration of MAG3 Radiopharmacy, you should:

Drink plenty of fluids and urinate as frequently as possible before and after the procedure.

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

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

An overdose is unlikely, as you will receive a single, precisely controlled dose of MAG3 Radiopharmacy determined by the supervising nuclear medicine physician. However, in the event of an overdose, appropriate treatment will be administered.

If you have any further questions about the use of MAG3 Radiopharmacy, consult the nuclear medicine physician supervising the procedure.

4. Possible adverse effects

Like all medicines, MAG3 Radiopharmacy may cause adverse effects, although not everyone experiences them.

Adverse effects may occur with the following frequencies:

Rare: may affect up to 1 in 1,000 people

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

Administration of this radiopharmaceutical involves exposure to a small amount of ionizing radiation, with a very low risk of developing cancer and hereditary defects.

Reporting of adverse effects

If you experience any type of adverse effect, consult your nuclear medicine specialist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Conservation of MAG3 RADIOPHARMACY

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

The following information is intended for healthcare professionals only.

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

Hospital staff will ensure that the product is properly stored and disposed of, and that it is not used beyond the expiry date.

6. Contents of the pack and other information

Composition of MAG3 Radiopharmacy

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

Appearance of MAG3 Radiopharmacy and contents of the pack

10 ml Type I glass vial Ph. Eur., with a bromobutyl rubber stopper Ph. Eur. and sealed with an aluminum cap. The vial contains a white, sterile lyophilized powder.

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

Marketing Authorization Holder and Manufacturer

Medi-Radiopharma Ltd
2030 Érd, Szamos st. 10-12
Hungary

This medicinal product is authorized in the European Economic Area (EEA) Member States under the following names:

Date of the most recent review of this leaflet: November 2023

<-----------------------------------------------------------------------------------------------------------------

This information is intended for healthcare professionals only:

The Summary of Product Characteristics for MAG3 Radiopharmacy is included as a separate document in the product package, to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.

Please consult the Summary of Product Characteristics.