Renoscint Mag3

LEAFLET INCLUDED IN THE PACKAGING

Leaflet included in the packaging: information for the user

Renoscint MAG3, 1 mg, kit for the preparation of a radiopharmaceutical

Betiatide

You should carefully read the contents of this leaflet before taking this product, as it contains important information for the patient.

• You should keep this leaflet. If necessary, you can read it again.
• If you have any further questions, you should contact the nuclear medicine doctor who will be supervising the procedure.
• If you experience any side effects, you should talk to the nuclear medicine doctor. This includes any possible side effects not listed in this leaflet. See section 4.

Table of contents of the leaflet

• 1. What is Renoscint MAG3 and what is it used for
• 2. Important information before using Renoscint MAG3
• 3. How to use Renoscint MAG3
• 4. Possible side effects
• 5. How to store Renoscint MAG3
• 6. Package contents and other information

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

This is a radiopharmaceutical preparation intended exclusively for diagnostic purposes.
Renoscint MAG3 is used during imaging examinations to examine:

• kidneys,
• urine excretion and
• urinary bladder.

The product is in the form of a powder. After mixing it with a solution of a radioactive substance
(Tc) sodium pertechnetate by a qualified person, technetium-99m-mertiatide (Tc) is formed. After injection into the body, it accumulates in certain organs, such as the kidneys.
This radioactive substance can be photographed using a special camera located outside the patient's body. The image obtained in this way is used to assess the distribution of the radioactive substance in individual organs and throughout the body. This image provides the doctor with valuable information about the structure and function of individual organs.
Using Renoscint MAG3 involves exposure to small amounts of radiation. However, the nuclear medicine doctor has previously determined that the clinical benefits obtained during the procedure using the radiopharmaceutical preparation outweigh the risk associated with radiation.

2. Important information before using Renoscint MAG3

When not to use Renoscint MAG3

• if the patient is allergic to betiatide or any of the other ingredients of the medicinal product (listed in section 6).

Warnings and precautions

When to exercise special caution when using Renoscint MAG3

• if the patient is or may be pregnant;
• if the patient is breastfeeding. The use of this medicinal product involves contact with radioactive material used in the diagnostic procedure. The doctor will decide to administer it to the patient only if the expected benefits outweigh the risk.

Renoscint MAG3 is administered by specialists who will take responsibility for all necessary precautions.
The doctor will inform the patient if it is necessary to take any special precautions after using this medicinal product. If you have any questions about the medicinal product, you should contact the doctor.

Before using Renoscint MAG3, you should:

Drink plenty of water before the examination to urinate as frequently as possible in the first hours after the examination.
Children and adolescentsYou should talk to the nuclear medicine doctor if the patient is under 18 years old.

Renoscint MAG3 and other medicinal products

You should tell the nuclear medicine doctor about all medicinal products that the patient is currently taking or has recently taken, as well as any medicinal products that the patient plans to take, as they may interfere with the interpretation of the images.
The following medicinal products may affect or influence the result of the examination performed with Renoscint MAG3:

• contrast agents,
• antihypertensive medicinal products,
• medicinal products used in heart diseases,
• diuretics.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects that she may be pregnant, or plans to have a child, she should consult the nuclear medicine doctor before using this medicinal product.
Before administering Renoscint MAG3, the patient should inform the nuclear medicine doctor about the possibility of pregnancy, delayed menstruation, or breastfeeding.
In case of doubts, you should contact the nuclear medicine doctor who will be supervising the procedure.
Pregnancy
The nuclear medicine doctor will recommend the use of this medicinal product during pregnancy only if the expected benefit to the woman outweighs the risk to the fetus.
Breastfeeding
Patient should inform the doctor about breastfeeding. The doctor may decide to postpone therapy until breastfeeding is stopped. The doctor may also recommend that the patient interrupt breastfeeding for 4 hours and discard the expressed milk until the time when the radioactive substance is no longer present in the body.

Driving and using machines

It is unlikely that Renoscint MAG3 will adversely affect the ability to drive and use machines.
Renoscint MAG3 contains sodiumThis medicinal product contains less than 1 mmol of sodium (23 mg) per vial, which means that the medicinal product is considered "sodium-free".
Depending on the time of injection, the sodium content administered to the patient may in some cases be higher than 1 mmol. This should be taken into account in patients on a low-sodium diet.

3. HOW TO USE RENOSCINT MAG3

There are strict regulations regarding the use of radiopharmaceutical preparations, their handling, and disposal. Renoscint MAG3 will be used only in controlled areas. Only qualified medical personnel trained in the safe handling of radioactive materials are authorized to administer and handle it. These persons will pay special attention to the safe use of this product, and patients will be informed about their actions.
The decision on the amount of Renoscint MAG3 to be used in a specific patient is made by the nuclear medicine doctor supervising the procedure. The smallest possible dose will be used to obtain the necessary information.
For adults, the recommended dose is usually 37-185 MBq (megabecquerel is a unit used to measure radioactivity).

Use in children and adolescents

In children and adolescents, the amount of radioactive material administered will be adjusted according to body weight.
Administration of Renoscint MAG3 and performance of the procedureRenoscint
is injected into a vein.
It is sufficient to perform a single injection to perform the examination required by the doctor.

Duration of the procedure

The nuclear medicine doctor will inform the patient about the standard duration of the procedure.

After administration of Renoscint MAG3, you should:

Drink and urinate as frequently as possible before and after the procedure. This will prevent the accumulation of the active substance in the urinary bladder.
Use of a higher than recommended dose of Renoscint MAG3Overdose is unlikely.
This is because the patient receives a single dose of Renoscint MAG3 under the strict control of the nuclear medicine doctor supervising the procedure. However, if a higher dose is taken, the doctor will ensure appropriate therapy.
In case of any further doubts about the use of Renoscint MAG3, you should contact the nuclear medicine doctor who will be supervising the procedure.

4. POSSIBLE SIDE EFFECTS

Like all medicinal products, Renoscint MAG3 can cause side effects, although not everybody gets them.

Side effects may occur with the following frequencies:

Rare side effects: may occur in less than 1 in 1000 patients

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

This radiopharmaceutical preparation emits small amounts of ionizing radiation, which is associated with a very small risk of cancer and congenital anomalies.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products
Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Aleje Jerozolimskie 181C
PL-02 222 Warsaw
Phone: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicinal product.

5. HOW TO STORE RENOSCINT MAG3

This medicinal product will not be stored by the patient. This medicinal product is stored under the responsibility of a specialist in a suitable location. The storage of radiopharmaceuticals should be in accordance with local regulations regarding radioactive materials.
Hospital personnel will ensure the proper storage and disposal of the medicinal product and will not administer it after the expiry date.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What Renoscint MAG3 contains

• The active substance of the medicinal product is betiatide.
• The other ingredients are: disodium edetate dihydrate, tin(II) chloride dihydrate, and hydrochloric acid used to adjust the pH.

What Renoscint MAG3 looks like and what the package contains

Renoscint MAG3 is packaged in 10 ml glass vials (Type I Ph. Eur.) closed with a chlorobutyl rubber stopper and an aluminum cap. One vial contains a sterile, white lyophilized powder.
Renoscint MAG3 is supplied in a carton containing 6 vials.

Marketing authorization holder and manufacturer

Medi-Radiopharma Kft
Szamos u 10-12
2030 Érd
Hungary
Phone number: + 36-23-521-261
Fax number:
+36-23-521-260
e-mail: [email protected]

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

Date of last revision of the leaflet:

---------------------------------------------------------------------------------------------------------------------------
-------
Information intended for healthcare professionals only:
The full Summary of Product Characteristics (SmPC) of Renoscint MAG3 is presented in a separate document included in the product packaging. Its purpose is to provide healthcare professionals with additional medical and practical information on the administration and use of this radiopharmaceutical.
See SmPC.