MAG3 RADIOPHARMACY 1 mg KIT FOR RADIOPHARMACEUTICAL PREPARATION

Introduction

Package Leaflet: Information for the User

MAG3 Radiopharmacy 1 mg kit for radiopharmaceutical preparation EFG

Betiatide

Read all of this leaflet carefully before you start using 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 MAG3 Radiopharmacy is and what it is used for
2. What you need to know before you use 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
• diuresis
• the bladder

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

The radioactive substance can be photographed from outside the body using special cameras that make a scintigram. This scintigram 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.

Administration of MAG3 Radiopharmacy involves receiving a small amount of radioactivity. Your nuclear medicine doctor has considered that the clinical benefit you will get from the procedure with the radiopharmaceutical outweighs the risk of radiation.

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

Do not use MAG3 Radiopharmacy

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

Warnings and precautions

Be careful with MAG3 Radiopharmacy

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

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

MAG3 Radiopharmacy is administered by specialists who will take responsibility for any precautions that need to be taken.

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

Before administration of MAG3 Radiopharmacy, 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

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

Other medicines and MAG3 Radiopharmacy

Tell your nuclear medicine doctor if you are using or may need to use any other medicine, as some medicines may interfere with the interpretation of the 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, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your nuclear medicine doctor before you are given this medicine.

You must tell your nuclear medicine doctor before administration of MAG3 Radiopharmacy 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.

Pregnancy

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

Breast-feeding

If you are breast-feeding, talk to your doctor, as he may delay treatment until breast-feeding is finished. He may also ask you to stop breast-feeding for 4 hours and discard this milk until it no longer shows radioactivity in your body.

Driving and using machines

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

MAG3 Radiopharmacy contains sodium

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

Depending on when this medicine 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.

3. How to use MAG3 Radiopharmacy

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

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

The recommended dose for an adult is usually between 37 and 185 MBq (megabecquerel, the unit used to express radioactivity).

Use in children

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

Administration of MAG3 Radiopharmacy and performance of the procedure

MAG3 Radiopharmacy is administered into a vein.

A single injection is sufficient to perform the procedure that 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 Radiopharmacy, you must:

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

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

If you have been given more MAG3 Radiopharmacy than you should

Overdose is unlikely because you will receive a single, precisely controlled dose of MAG3 Radiopharmacy from your nuclear medicine doctor. However, in case of overdose, you will receive appropriate treatment.

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

4. Possible side effects

Like all medicines, MAG3 Radiopharmacy can cause side effects, although not everybody gets them.

Side effects may occur with the following frequencies:

Rare: may affect up to 1 in 1000 people

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

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 nuclear medicine doctor, even if they are not listed in this leaflet. You can also report side effects 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 Radiopharmacy

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 specialists.

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

Hospital staff will ensure that the product is stored and disposed of correctly and not used after 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, tin (II) chloride dihydrate, and hydrochloric acid for pH adjustment.

Appearance of MAG3 Radiopharmacy and contents of the pack

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.

Marketing authorisation holder and manufacturer

Medi-Radiopharma Ltd

2030, Érd, Szamos st. 10-12

Hungary

This medicine is authorised in the Member States of the European Economic Area (EEA) under the following names:

Date of last revision of this leaflet: September 2017

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This information is intended only for doctors or healthcare professionals:

The full summary of product characteristics 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 consult the summary of product characteristics.