DTPA TECHNESCAN 20.8 mg KIT FOR RADIOPHARMACEUTICAL PREPARATION

Introduction

Package Leaflet: Information for the User

DTPA Technescan 20.8 mg kit for radiopharmaceutical preparation

Pentetic acid

Contents of the package leaflet:

1. What DTPA Technescan is and what it is used for
2. What you need to know before you start using DTPA Technescan
3. How to use DTPA Technescan
4. Possible side effects
5. Storage of DTPA Technescan
6. Package contents and further information

1. What DTPA Technescan is and what it is used for

This medicine is a radiopharmaceutical for diagnostic use only.

DTPA Technescan is used in examinations to examine:

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

This medicine is a non-radioactive powder. When mixed by qualified personnel with the radioactive substance pertechnetate (99mTc) sodium, it forms technetium (99mTc) pentetate. When administered to 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 body. It also provides the doctor with valuable information about the structure and function of the organ.

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

2. What you need to know before you start using DTPA Technescan

Do not use DTPA Technescan

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

Warnings and precautions

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

Be particularly careful with DTPA Technescan:

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

Before administration of DTPA Technescan, you should:

• Drink plenty of water before starting the procedure to urinate as frequently as possible during the first few hours after its completion. This will prevent the active substance from accumulating in the bladder.
• Tell 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 medicines and DTPA Technescan

Tell your nuclear medicine doctor if you are taking, have recently taken, or might take any other medicines.

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

• Medicines that interfere with renal imaging:

• medicines for treating hypertension, such as those with active ingredients ending in "pril", like captopril,
• medicines for treating inflammatory diseasessuch as diclofenac,
• medicines that stimulate the elimination of fluids from the body, such as furosemide or hydrochlorothiazide,
• medicines that may affect your renal function, such as:
• • antibiotics for treating infections, such as aminoglycosides
  • medicines for treating tumors, such as cisplatin
  • contrast media for radiographs

• Medicines that interfere with gastric emptying:
• • acute pain relieverssuch as morphine
  • medicines for treating Parkinson's diseasesuch as levodopa
  • medicines for preventing or alleviating nausea and vomitingsuch as metoclopramide
  • medicines that neutralize stomach aciditysuch as aluminum antacids
  • medicines for treating ulcerssuch as propanteline

• Medicines that interfere with brain images:

• medicines that influence mood, emotional state, and disposition.

Pregnancy and breastfeeding

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

You must inform your nuclear medicine specialist before administering DTPA Technescan if there is any possibility that you may be pregnant, if you have a delayed menstrual period, or if you are breastfeeding. In case of doubt, it is essential that you 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 foresee that you will obtain a benefit that outweighs the risks.

• If you are breastfeeding

Tell your doctor that you are breastfeeding, as it may be possible to delay the studyuntil you have finished breastfeeding. Your doctor may also ask you to interrupt breastfeeding for 12 hoursand discard that milk, until your body no longer shows radioactivity. Consult your nuclear medicine specialist about when you can resume breastfeeding.

Driving and using machines

It is unlikely that DTPA Technescan will affect your ability to drive and use machines.

3. How to use DTPA Technescan

There are strict rules about 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 to use it safely. These individuals will take special care in the safe use of this product and will inform you of their actions.

The nuclear medicine doctor supervising the procedure will decide the amount of DTPA Technescan to be used in your case. The administered dose will depend on the procedure you will undergo and other factors such as the route of administration. This will be the minimum amount necessary to obtain the desired information. The generally recommended amount for administration to an adult varies between 7 and 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 performance of the procedure

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

Duration of the procedure

Your nuclear medicine doctor will inform you about the usual duration of the procedure.

After administration of DTPA Technescan, you should:

• Urinate frequently to eliminate the product from your body,

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

If you are given more DTPA Technescan than you should

Overdose is unlikely because you will receive a single, precisely controlled dose of DTPA Technescan by the nuclear medicine doctor supervising the procedure. However, in case of overdose, you will receive the appropriate treatment.

If you have any further questions about the use of DTPA Technescan, ask the nuclear medicine doctor supervising the procedure.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

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

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

Reporting of side effects

If you experience any side effects, talk to your nuclear medicine doctor, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of DTPA Technescan

You will not need to store this medicine. This medicine is stored under the responsibility of the specialist in suitable facilities. The storage of radiopharmaceuticals will be carried out in accordance with national regulations on radioactive materials.

The following information is intended only for specialists.

Keep this medicine out of the sight and reach of children.

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

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

6. Package contents and further information

Composition of DTPA Technescan

• The active substance is pentetic acid.

Each vial contains 20.8 mg of pentetic acid.

• The other components are: gentisic acid, tin(II) chloride dihydrate, calcium chloride dihydrate, sodium hydroxide, and hydrochloric acid.

Appearance of the product and package contents

DTPA Technescan is a white to slightly yellow lyophilized powder for injectable solution. It is supplied in 10 ml glass vials sealed with a bromobutyl rubber stopper and an aluminum overseal.

DTPA Technescan is supplied in a package containing 5 vials.

Marketing authorization holder and manufacturer:

Marketing authorization holder:

Curium Pharma Spain S.A.

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

28100, Alcobendas, Madrid, Spain

Manufacturer:

Curium Netherlands B.V.

Westerduinweg 3

1755 LE Petten

Netherlands

Date of last revision of this leaflet:December 2022.

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).

This information is intended only for healthcare professionals:

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

Please consult the technical data sheet included in the package.