Label: information for the user

DTPA Technescan 20.8 mg kit for radiopharmaceutical preparation

Pentetic acid

1. What is DTPA Technescan and how is it used

2. What you need to know before starting to use DTPA Technescan

3. How to use DTPA Technescan

4. Possible adverse effects

5. Storage of DTPA Technescan

6. Contents of the package and additional information

This medication is a radiopharmaceutical for diagnostic use only.

DTPA Technescan is used in explorations to examine:

• Kidneys.
• Brain.
• Lungs.
• Gastroesophageal reflux and gastric emptying.

This medication is a non-radioactive powder. When mixed by qualified personnel with the radioactive substance pertecnetate (99mTc) of sodium, it forms pentetate of technetium (99mTc). When administered in the body, it accumulates in certain organs, such as the kidneys or brain.

The radioactive substance can be photographed from outside the body with special cameras that take a scan. This examination shows where the radioactivity is inside the organ and the body. It also provides the doctor with valuable information about the structure and function of the said organ.

The use of DTPA Technescan involves exposure to small amounts of radioactivity. Your doctor and the nuclear medicine doctor have considered that the clinical benefit you will obtain from the procedure with the radiopharmaceutical outweighs the risk due to radiation.

No use DTPA Technescan

• If you are allergic to the active ingredient or to any of the other components of this medication (listed in section 6).

Warnings and precautions

• This medication should not be administered in the spinal canal or in the cerebral space, known as the subarachnoid space.

Be especially careful with DTPA Technescan:

• If you are pregnant or think you may be pregnant.
• If you are breastfeeding.

Before DTPA Technescan administration, you should:

• Drink plenty of water before starting the procedure to urinate as frequently as possible during the first hours after its completion. This will prevent the active ingredient from accumulating in the bladder.
• Inform your doctor if you have symptoms of decreased renal function.

Children and adolescents

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

Other medications and DTPA Technescan

Inform your nuclear medicine doctor if you are taking, have taken recently, or may need to take any other medication.

The following medications may specifically interfere with the results of the Technescan DTPA procedure:

• Medications that interfere with renal imaging:

• blood pressure medications, for example, medications with active ingredients with names ending in"pril", such as captopril,
• medications for treating inflammatory diseasessuch as diclofenac,
• medications that stimulate the elimination of body fluids, such as furosemide or hydrochlorothiazide,
• medications that may affect your renal function, such as:
• • medications for treating infections (antibiotics),such as aminoglycosides
  • medications for treating tumors, such as cisplatin
  • contrast agents for radiography

• Medications that interfere with gastric emptying:
• • acute analgesicssuch as morphine
  • medications for treating Parkinson's diseasesuch as levodopa
  • medications for preventing or alleviating nausea and vomitingsuch as metoclopramide
  • medications that neutralize stomach acidsuch as aluminum antacids
  • medications for treating ulcerssuch as propantelina

• Medications that interfere with brain imaging:

• medications that affect mood, emotional state, and disposition.

Pregnancy and lactation

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

You must inform your nuclear medicine specialist before administering DTPA Technescan if there is any possibility of pregnancy, if you have a delayed menstrual period, or if you are breastfeeding. In case of doubt, it is essential to consult your nuclear medicine specialist who will supervise the procedure.

• If you are pregnant

Your nuclear medicine specialist will only administer this product during pregnancy if they predict that you will obtain a benefit that outweighs the risks.

• If you are breastfeeding

Inform your doctor that you are breastfeeding, as it may be possible todelay the studyuntil you have finished breastfeeding. It may also be possible for your doctor to ask you tointerrupt breastfeeding for 12 hoursand discard that milk until your body is no longer radioactive. Consult your nuclear medicine specialist when you can resume breastfeeding.

Driving and operating machinery

It is unlikely that DTPA Technescan will affect your ability to drive and operate machinery.

There are strict guidelines for the use, handling, and disposal of radiopharmaceuticals. DTPA Technescan will only be used in specially controlled areas. This product will only be handled and administered by trained and qualified personnel who will 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 DTPA Technescan to be used in your case. The administered dose will depend on the procedure being performed and other factors such as the method of administration. This will be the minimum amount necessary to obtain the desired information. The generally recommended dose for an adult typically ranges from 7 to 1000 MBq (MegaBecquerel, the unit used to express radioactivity).

Use in Children and Adolescents

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

Administration of DTPA Technescan and Procedure Performance

DTPA Technescan is administered via a vein to obtain images of the kidneys or brain, orally to explore the stomach or esophagus, and inhaled to examine the lungs. A single administration is usually sufficient.

Procedure Duration

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

After DTPA Technescan Administration, You Must:

• Urinate frequently to eliminate the product from your body,

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

If You Receive More DTPA Technescan Than You Should

A overdose is unlikely because you will receive a single, precisely controlled dose of DTPA Technescan administered by the nuclear medicine physician overseeing the procedure. However, in the event of an overdose, you will receive the appropriate treatment.

If you have any other questions about the use of DTPA Technescan, ask the nuclear medicine physician overseeing the procedure.

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

The following adverse effects may occur (frequency cannot be estimated from available data):

• vasodilation that causes sudden redness of the skin,
• dizziness,
• difficulty breathing (dyspnea),
• itching,
• hives (urticaria),
• low blood pressure (hypotension).

The administration of this radiopharmaceutical involves receiving a small amount of ionizing radiation with a very low risk of developing cancer and hereditary defects.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your nuclear physician, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

The following information is intended solely for the specialist.

Keep this medication out of sight and reach of children.

Do not use DTPA Technescan after the expiration date that appears in the vial after "CAD.". The expiration date is the last day of the month indicated.

DTPA Technescan should not be used if there are visible signs of deterioration.

Composition of DTPA Technescan

• The active principle is pentetic acid.

Each vial contains 20.8 mg of pentetic acid.

• The other components are: gentisic acid, stannous chloride dihydrate, calcium chloride dihydrate, sodium hydroxide, and hydrochloric acid.

Appearance of the product and contents of the packaging

DTPA Technescan is a white to slightly yellowish lyophilized powder for injectable solution. It is supplied in 10 ml glass vials sealed with bromobutyl rubber stoppers and aluminum overseals.

DTPA Technescan is supplied in a package containing 5 vials.

Marketing authorization holder and responsible manufacturer:

Marketing authorization holder:

Curium Pharma Spain S. A.

Avenida Doctor Severo Ochoa, nº 29, 3º-2

28100, Alcobendas, Madrid, Spain

Responsible manufacturer:

Curium Netherlands B.V.

Westerduinweg 3.

1755 LE Petten

Holland

Last review date of this leaflet:December 2022.

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 data sheet of DTPA Technescan is included as a separate document in the packaging of the product, in order to facilitate doctors or healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.

Please refer to the technical data sheet included in the packaging.