Renoscint mag3

PACKAGE LEAFLET

Package leaflet: Information for the user

Renoscint MAG3, 1 mg, kit for the preparation of a radiopharmaceutical preparation
Betiatide
Please read all of this leaflet carefully before this product is administered, as it contains important information for the patient.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask the nuclear medicine physician who will supervise the procedure.
• If any adverse reactions occur, please talk to the nuclear medicine physician. This includes any possible adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Renoscint MAG3 is and what it is used for
2. Important information before use of Renoscint MAG3
3. How to use Renoscint MAG3
4. Possible side effects
5. How to store Renoscint MAG3
6. Contents of the pack and other information

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

This is a radiopharmaceutical preparation intended solely for diagnostic use.
Renoscint MAG3 is used during imaging procedures to examine:

• kidneys,
• urinary excretion, and
• urinary bladder.

The product is in the form of a powder. After being mixed by a qualified person with a radioactive solution, sodium [^99mTc]pertechnetate, technetium (99mTc) tiatide is formed. After injection into the body, this compound accumulates in certain organs, such as the kidneys.
This radioactive substance can be imaged using a special camera located outside the patient's body. The resulting images allow assessment of the distribution of the radioactive substance in specific organs and throughout the body. These images provide the physician with valuable information about the structure and function of individual organs.
Use of Renoscint MAG3 involves exposure to small amounts of radiation. However, the nuclear medicine physician has determined that the clinical benefits obtained from the procedure using the radiopharmaceutical outweigh the associated radiation risk.

2. Important information before using Renoscint MAG3

When not to use Renoscint MAG3

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

Warnings and precautions
When to exercise special caution when using Renoscint MAG3

• if the patient is pregnant or suspects she may be pregnant;
• if the patient is breastfeeding. The use of this medicine involves exposure to radioactive material used in the diagnostic procedure. The physician will decide whether to administer the medicine only if the expected benefits outweigh the risks.

Renoscint MAG3 is administered by specialists who will take all necessary precautionary measures.
The physician will inform the patient if any special precautions are required after administration of this medicine. If you have any questions about the medicine, please contact your physician.

Before using Renoscint MAG3:

Drink plenty of water before starting the examination to ensure frequent urination during the first hours after the procedure.

Children and adolescents
Please consult the nuclear medicine physician if the patient is under 18 years of age.

Renoscint MAG3 and other medicines
Please inform the nuclear medicine physician about any medicines currently taken or recently taken, as well as any medicines planned for future use, because they may interfere with image interpretation.

The following medicines may affect or influence the results of the examination performed with Renoscint MAG3:

• contrast agents,
• antihypertensive drugs,
• drugs used in heart diseases,
• diuretics.

Pregnancy, breastfeeding and effects on fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult the nuclear medicine physician before using this medicine.
Before administration of Renoscint MAG3, inform the nuclear medicine physician about possible pregnancy, delayed menstruation, or breastfeeding.
In case of doubt, please consult the nuclear medicine physician supervising the procedure.

Pregnancy
The nuclear medicine physician will recommend using this medicine during pregnancy only if the expected benefit to the woman outweighs the potential risk to the fetus.

Breastfeeding
Patients should inform the physician about breastfeeding. The physician may decide to delay therapy until breastfeeding has ended. Alternatively, the physician may advise the patient to interrupt breastfeeding for 4 hours and discard the milk expressed during this period, until the radioactive substance is no longer present in the body.

Driving and operating machinery
It is unlikely that Renoscint MAG3 will adversely affect the ability to drive or operate machinery.

Renoscint MAG3 contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per vial, meaning the medicine is considered "sodium-free".
However, depending on the time of injection, the amount of sodium administered to the patient may in some cases exceed 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 governing the use, handling, and disposal of radiopharmaceuticals. Renoscint MAG3 will be administered only in controlled areas. Only qualified medical personnel trained in the safe handling of radioactive materials are authorized to administer and handle this product. These individuals pay special attention to the safe use of this product, and patients will be informed about their procedures.
The decision on the amount of Renoscint MAG3 to be administered to a specific patient is made by the supervising nuclear medicine physician. The lowest possible dose ensuring acquisition of the necessary diagnostic information will be used.
For adults, the recommended dose is usually 37–185 MBq (megabecquerel is the unit used to measure radioactivity).

Use in children and adolescents
In children and adolescents, the administered amount of radioactive material will be adjusted according to body weight.

Administration of Renoscint MAG3 and performance of the procedure
Renoscint is injected intravenously.
A single injection is sufficient to perform the examination required by the physician.

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

After administration of Renoscint MAG3, the patient should:
Drink fluids and urinate as frequently as possible before and after the procedure. This will prevent accumulation of the active substance in the urinary bladder.

Administration of a higher than recommended dose of Renoscint MAG3
Overdose is unlikely.
This is because the patient receives a single dose of Renoscint MAG3 under strict supervision of the nuclear medicine physician overseeing the procedure. However, if a higher dose is administered, the physician will provide appropriate therapy.

If you have any further questions regarding the use of Renoscint MAG3, please consult the nuclear medicine physician who will supervise the procedure.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Renoscint MAG3 may cause adverse reactions, although not everyone experiences them.
Adverse reactions may occur with the following frequencies:
Rare adverse reactions: may occur in no more than 1 in 1,000 patients

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

This radiopharmaceutical preparation emits small amounts of ionizing radiation, which entails a very low risk of developing malignant tumors and congenital abnormalities.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions
of the Office for Registration of Medicinal Products,
Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the responsible entity.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. HOW TO STORE RENOSCINT MAG3

This medicinal product will not be stored by the patient. This product is stored under the responsibility of a specialist in an appropriate facility. Storage of radiopharmaceuticals should comply with local regulations concerning radioactive materials.
Hospital staff will ensure proper storage and disposal of the medicinal product and will not administer it after the expiry date.

6. Contents of the pack and other information

What Renoscint MAG3 contains

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

What Renoscint MAG3 looks like and contents of the pack
Renoscint MAG3 is supplied in glass vials (Type I Ph. Eur.) with a capacity of 10 ml, closed with a chlorobutyl rubber stopper and an aluminium cap. Each vial contains a sterile, white lyophilized powder.
Renoscint MAG3 is supplied in packs containing 6 vials in a cardboard box.
Marketing Authorisation Holder and Manufacturer
Medi-Radiopharma Kft
Szamos u 10-12
2030 Érd
Hungary
Tel. No.: +36-23-521-261
Fax No.: +36-23-521-260
e-mail: [email protected]
This medicinal product is authorised in the member states of the European Economic Area under the following names:

Information intended exclusively for medical professionals:

The complete Product Information (SmPC) for Renoscint MAG3 is provided as a separate document included in the product packaging. Its purpose is to present medical professionals with additional medical and practical information regarding the administration and use of this radiopharmaceutical.
See SmPC.