Medirenosscint

PACKAGE LEAFLET

Package leaflet: Information for the user

Medirenoscint 1mg kit for radiopharmaceutical preparation

Betiatide
Generic Medicine
Please read this leaflet carefully before receiving this medicine as it contains
important information for you

• Keep this leaflet. You may need to read it again.
• For further information, contact the Nuclear Medicine physician who will supervise the procedure.
• If you notice any side effect, inform your Nuclear Medicine physician. This includes any possible side effect, even if not listed in this leaflet. See section 4.

Contents of this leaflet:

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

1. What Medirenoscint is and what it is used for

This medicinal product is a radiopharmaceutical for diagnostic use.
Medirenoscint is used in an imaging diagnostic procedure to examine:

• kidneys
• urinary flow and
• bladder

This medicine is a powder. Once mixed by qualified personnel with a solution containing the radioactive substance sodium pertechnetate (Tc), it forms Technetium (Tc) tiatide. 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 machines that provide a scan. This scan shows the distribution of radioactivity within the organ and the body. It also provides the physician with useful information about the structure and function of the organ.
The use of Medirenoscint involves exposure to a small amount of radioactivity.
The nuclear medicine specialist has determined that the clinical benefit obtained from the procedure outweighs the risk associated with radiation exposure.

2. What you need to know before using Medirenoscint

Medirenoscint must not be used
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 Medirenoscint

• If you are pregnant or suspect you may be pregnant
• If you are breastfeeding

This medicine involves exposure to radiation. Your doctor will prescribe it only if the benefits outweigh the risks.
Medirenoscint is prescribed by specialists, who will take all necessary precautions.
Your doctor will inform you if special precautions need to be taken after administration of the medicine. For any questions, please contact your doctor.

Before administration of Medirenoscint, it is necessary to:
Drink large amounts of water before the examination begins, so as to urinate as frequently as possible during the first hours following the procedure.

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

Other medicines and Medirenoscint
Inform your nuclear medicine physician if you are taking or might take other medicines, as they could interfere with the interpretation of images.
The following medicines may interact with Medirenoscint:

• contrast agents,
• antihypertensive drugs,
• heart medications,
• diuretics

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, suspect you may be pregnant, or are trying to have a baby, consult your nuclear medicine physician before taking this medicine.
You must inform the nuclear medicine physician before administration of Medirenoscint if there is any possibility you may be pregnant, if you have missed a menstrual period, or if you are breastfeeding.
If in doubt, it is important to consult the nuclear medicine physician who will supervise the procedure.

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

Breastfeeding
Inform your physician if you are breastfeeding, as treatment may be postponed until after breastfeeding has ended.
Your physician may also ask you to interrupt breastfeeding for 4 hours and to discard breast milk until radioactivity is no longer present in your body.

Driving and using machines
Medirenoscint is considered unlikely to affect your ability to drive vehicles or operate machinery.

Medirenoscint contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. essentially 'sodium-free'.
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 if you are on a low-sodium diet.

3. HOW TO USE MEDIRENOSCINT

The use, handling, and disposal of radiopharmaceuticals are governed by strict regulations. Medirenoscint will be used only in designated controlled areas. This product will be handled and administered exclusively by trained and qualified personnel experienced in its safe use.
The staff will pay attention to the use of this product and will keep you informed about the procedure.
The nuclear medicine physician responsible for the procedure will determine the amount of Medirenoscint to be used in your case. This will be the smallest possible amount necessary to obtain the required information.
The recommended administered activity for adults normally ranges between 37–185 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 Medirenoscint and information on the procedure
Renoscint is injected intravenously.
A single injection is sufficient to perform the test required by the physician.

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

After administration of Medirenoscint, it is necessary to
Drink fluids and urinate as frequently as possible before and after the procedure.
This will prevent the accumulation of radioactive substance in the bladder.

If you have received more Medirenoscint than you should have
Overdose is unlikely,
since you will be given a single, carefully controlled dose of Medirenoscint by the nuclear medicine physician supervising the procedure. However, in the event of an overdose, appropriate treatment will be administered.

If you have any further questions regarding the use of Medirenoscint, please contact the nuclear medicine physician supervising the procedure.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Medirenoscint can cause side effects, although not everyone experiences them.
Side effects may occur with the following frequencies:
Rare: may occur in 1 in 1,000 people

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

This radiopharmaceutical will result in a low dose of ionizing radiation associated with minimal risks of cancer and hereditary abnormalities.
Reporting of adverse reactions
If you experience any adverse effect, including those not listed in this leaflet, please consult the nuclear medicine specialist physician or pharmacist. You may also report adverse effects directly via the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE MEDIRENOSCINT

This medicinal product must not be stored by the user. The medicinal product is stored under the responsibility of a specialist in appropriate locations. Storage of radiopharmaceuticals must comply with national regulations concerning radioactive materials.
Hospital staff will ensure that the product is properly stored and disposed of, and that it is not used beyond the expiry date.

6. PACK CONTENTS AND OTHER INFORMATION

What Medirenoscint contains

• The active substance is betiatide.
• The other excipients are: disodium tartrate dihydrate, stannous chloride (II) dihydrate, and hydrochloric acid for pH adjustment.

Description of the appearance of Medirenoscint and pack contents
10 ml glass vial, type 1 Ph. Eur., closed with a chlorobutyl rubber stopper Ph. Eur. and sealed with an aluminium crimp cap. The vial contains a sterile, white, lyophilized powder.
Medirenoscint is supplied in packs of 6 or 2 vials.

Marketing Authorisation Holder and Manufacturer
Medi-Radiopharma Ltd.
2030 Érd, Szamos st. 10-12
Hungary

This medicinal product is authorised in the European Economic Area (EEA) Member States and in the United Kingdom (Northern Ireland) under the following names:

This patient leaflet was last approved on
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The following information is intended for medical professionals or healthcare personnel:
The complete Summary of Product Characteristics for Medirenoscint is included as a separate document in the product packaging, with the aim of providing healthcare professionals with the scientific and practical information relating to the administration and use of this radiopharmaceutical. Please refer to the Summary of Product Characteristics.