PATIENT INFORMATION LEAFLET

DMSATechnescan1 mg kit for radiopharmaceutical preparation

Succimer

1. What isDMSATechnescanand what is it used for

2. What you need to know before usingDMSATechnescan

3. How to useDMSATechnescan

4. Possible side effects

5. Storage ofDMSATechnescan

6. Contents of the pack and additional information

This medication is a radiopharmaceutical for diagnostic use only.

DMSA Technescan contains the active ingredient succimer. It is used for the preparation of an injectable radioactive solution of technetium (99mTc) succimer.

DMSA Technescan is used in adults and children to examine the kidneys. When injected, this medication temporarily accumulates in the kidneys. Due to its radioactivity, it can be detected outside the body using a special camera and images, known as scans, can be taken. These scans provide valuable information about thestructure and/or function of your kidneys.The administration of DMSA Technescan involves receiving a small amount of radioactivity. Your doctor and the nuclear medicine physician have considered that the clinical benefit you will obtain from the procedure with the radiopharmaceutical outweighs the risk due to radiation.

No use DMSA Technescan:

• If you are allergic to succimer or any of the other components of this medication (listed in section 6), or to any of the components of the radiolabeled product (technetium 99m Tc succimer).

Warnings and precautions

Be especially careful with DMSA Technescan:

• If you are pregnant or think you may be.
• If you are breastfeeding.
• If you have kidney disease.

Consult your nuclear medicine doctor if any of the above applies to you. It may not be suitable for you. Your nuclear medicine doctor will advise you.

Before administering DMSA Technescan, you must

• Drink plenty of water before starting the procedure to urinate frequently during the first few hours after its completion.

Children and adolescents

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

Other medications and DMSA Technescan

Inform your nuclear medicine doctor if you are using, have used recently, or may need to use any other medication, including over-the-counter medications, as they may interfere with image interpretation.

Your nuclear medicine doctor/doctor may recommend that you stop taking the following medications before the DMSA Technescan procedure:

• ammonium chloride, (a substance present in some cough medications and licorice root juice)
• sodium bicarbonate, (a medication administered to reduce blood and urine acidity)
• mannitol, (a diuretic medication that helps produce more urine and eliminate excess salt and water from the body)
• someanti-hypertensive medicationsfor treating high blood pressure (the so-called ACE inhibitors, such as captopril)

Some cancer medications (methotrexate, cyclophosphamide, vincristine) may also influence or be influenced by DMSA Technescan.

Pregnancy and lactation

If you are pregnant or breastfeeding, or think you may be, consult your nuclear medicine doctor before using this medication.

You must inform your nuclear medicine doctorbeforeadministering DMSA Technescan if there is any possibility of pregnancy, if you have a delayed period, or if you are breastfeeding.

In case of doubt, it is essential to consult your nuclear medicine doctor who supervises the procedure.

If you are pregnant

Your nuclear medicine doctorwill onlyadminister DMSA Technescan during pregnancy if the expected benefit outweighs the risk.

If you are breastfeeding

Consult your nuclear medicine doctor if you are breastfeeding as they maydelaythe treatment until breastfeeding has ended. They may also ask you tointerruptbreastfeeding for a short period and discard this milk during that period until the radioactivity is no longer in your body. Please consult your nuclear medicine doctor when you can resume breastfeeding.

You do not need to avoid close contact with your baby after the procedure.

Driving and using machines

It is considered unlikely that DMSA Technescan will affect your ability to drive or use machines.

DMSATechnescan contains sodium

This medication contains less than 1 mmol (23 mg) of sodium per dose; it is “sodium-free”.

There are strict guidelines for the use, handling, and disposal of radiopharmaceuticals. DMSA Technescan will only be used in specially controlled areas. This product will only be handled and administered by trained and qualified personnel to use it safely. Those individuals will take special care in the safe use of this product and will inform you of their actions.

The nuclear medicine physician overseeing the procedure will decide on the amount of technetium (99mTc) succimer that should be used in your case. This will be the minimum amount necessary to obtain the desired information.

The generally recommended dose for an adult is30 to 120 MBq(MegaBecquerel, the unit used to express radioactivity).

Use in Children and Adolescents

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

Administration of DMSA Technescan and Procedure Performance

DMSA Technescan is administered by injection, usually in a vein of the arm.

One injection is sufficient to perform the procedure your doctor needs.

After the injection, you will be offered a drink and asked to urinate immediately before starting the procedure.

Procedure Duration

The examinations are usually performed 2 to 3 hours after the injection. In some cases, they may be delayed up to 24 hours after the injection. Your nuclear medicine doctor will inform you about the duration of the procedure.

After DMSA Technescan Administration, You Must:

• Urinate frequently to eliminate the product from your body

Your nuclear medicine doctor will inform you if you need to take any special precautions after receiving this medication. Consult with your nuclear medicine doctor if you have any doubts.

If You Have Been Administered More DMSA Technescan Than Necessary

It is unlikely to have an overdose because you will receive a controlled and precise dose of DMSA Technescan from the nuclear medicine doctor overseeing the procedure. However, in the event of an overdose, you will receive the appropriate treatment. In particular, the nuclear medicine doctor may recommend that you drink plenty of water and urinate frequently to eliminate radioactive residues from your body.

If you have any other questions about the use of DMSA Technescan, ask your nuclear medicine doctor who is overseeing the procedure.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Adverse effects of unknown frequency (cannot be estimated from available data):

• Allergic Reactionswith symptoms such as skin rash, redness, or itching, increased sweating, swelling of the eyes, tongue, or throat, eye inflammation, cough, difficulty breathing, nausea, vomiting, increased salivation, abdominal pain, redness, or low blood pressure.
• Circulatory Reactionswith symptoms such as fainting, low blood pressure, headache, dizziness, paleness, feeling of weakness or fatigue
• Reactions at the injection site,with symptoms such as skin rash, swelling, or inflammation.

The hospital staff will treat these reactions if they occur.

This radiopharmaceutical provides low levels of ionizing radiation associated with a very low risk of cancer and hereditary anomalies.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

This medication does not need to be stored by the patient. This medication will be stored under the responsibility of the specialist in appropriate facilities. Storage of radiopharmaceuticals will be carried out in accordance with national regulations on radioactive materials.

The following information is only for the specialist.

Do not use DMSA Technescan after the expiration date that appears on the label after CAD.

Composition of DMSA Technescan

• The active principle is succimer (or dimercaptosuccinic acid).

One vial contains 1.2 milligrams of succimer

• The other components are: inositol, stannous chloride dihydrate (E512), sodium hydroxide (E524) and hydrochloric acid (E507).

Appearance of the product and contents of the packaging

DMSA Technescan is a kit of reagents for radiopharmaceutical preparation intended to be used only by healthcare professionals. Before using it, the powder from the vial is mixed with a radioactive solution called technetium (99mTc) to form a technetium (99mTc) succimer solution.

DMSA Technescan is packaged in a colorless type I glass vial of 10 ml closed with a bromobutyl rubber stopper and sealed with an aluminum capsule.

One package contains 5 vials.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization:

Curium Pharma Spain S.A.

Avenida Doctor Severo Ochoa, N.º 29

28100, Alcobendas, Madrid

Responsible for manufacturing:

Curium Netherlands B.V.

Westerduinweg 3.

1755 LE Petten

Netherlands

Last review date of this leaflet: November 2023

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

This information is intended solely for healthcare professionals:

The complete technical file of DMSA Technescan is included as a separate document in the product packaging, in order to facilitate healthcare professionals with other scientific and practical information on the administration and use of this radiopharmaceutical. Please consult the technical file of DMSA Technescan.