INDIO (111In) DTPA Curium Pharma Spain 37 MBq/ml Injectable Solution

1. What Indium (111In) DTPA Curium Pharma Spain is and what it is used for

This medicinal product is for diagnostic use only.

Indium (111In) DTPA is used to examine:

• the brainand spinal cord
• • obstructions of cerebrospinal fluid flow, which is the fluid surrounding the brain and spinal cord
  • to distinguish between normal pressure associated with hydrocephalus and other forms of hydrocephalus
• loss of cerebrospinal fluid through the nose or ears.

This medicinal product contains a radioactive substance that, when injected, accumulates in certain organs such as the brain.

The radioactive substance can be detected from outside the body using a special medical device called a gamma camera. This examination will show the distribution of the radiopharmaceutical in a particular organ and in the body. This can provide the doctor with valuable information about the structure and function of that organ.

The use of Indium (111In) DTPA involves exposure to small amounts of radioactivity. Your doctor and the nuclear medicine doctor have considered that the clinical benefit you will gain from the procedure with the radiopharmaceutical outweighs the risk of radiation.

2. Before using Indium (111In) DTPA Curium Pharma Spain

Do not useIndium (111In) DTPA Curium Pharma Spain:

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

If you have:

• Bleeding tendency.
• Increased intracranial pressure not associated with hydrocephalus.

Warnings and precautions

Be careful with Indium (111In) DTPA Curium Pharma Spain:

If you have any kidney problems.

Children and adolescents

Tell your nuclear medicine doctor if you are under 18 years old, because the effects of radiation exposure are proportionally greater than in adults.

Use of other medicinal products and Indium (111In) DTPA:

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

No medicinal products are known to affect or be affected by Indium (111In) DTPA.

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or plan to become pregnant, consult your nuclear medicine doctor before this medicinal product is administered to you. You must inform the nuclear medicine doctor before administration of Indium (111In) DTPA if there is any possibility that you may be pregnant, if you have a delayed period, or if you are breast-feeding.

In case of doubt, it is important that you consult your nuclear medicine doctor who is supervising the procedure.

• If you are pregnant

The nuclear medicine doctor will onlyadminister this medicinal product during pregnancy if the expected benefit outweighs the risk, as it may harm the fetus.

• If you are breast-feeding

Tell your doctor if you are breast-feeding, as it may delay treatmentuntil breast-feeding has stopped. Consideration should be given to expressing milk before administration of Indium (111In) DTPA and storing it for later use. Breast-feeding can be resumed when the level of radioactivity in breast milk no longer poses a radiation dose to the child greater than 1 mSv.

Driving and using machines

No effects on the ability to drive and use machines have been described.

Indium (111In) DTPA Curium Pharma Spain contains sodium

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

3. How to use Indium (111In) DTPA Curium Pharma Spain

There are strict rules for the use, handling, and disposal of radiopharmaceuticals. Indium (111In) DTPA will only be used in special controlled areas. This product will only be handled and administered by trained and qualified personnel to use it safely. These people 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 Indium (111In) DTPA to be used in your case, which will be the minimum amount necessary to obtain the desired information.

The generally recommended amount to administer to an adult is:

• 9 – 20 MBq injected into the skull or spinal column

(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 Indium (111In) DTPA and performance of the procedure

Indium (111In) DTPA is administered by intrathecal route (into the skull or spinal column).

One injection is usually sufficient to perform the procedure.

Duration of the procedure

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

After administration of Indium (111In) DTPA, you should:

The nuclear medicine doctor will inform you if you need to take special precautions after this medicinal product is administered to you. Consult your nuclear medicine doctor if you have any doubts.

If you have been administered more Indium (111In) DTPA than you should

Overdose is unlikely because you will receive a single, precisely controlled dose of Indium (111In) DTPA by the nuclear medicine doctor supervising the procedure. However, in case of overdose, you will receive the appropriate treatment.

Drinking as much as possible will help to eliminate the radioactive substance more quickly.

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If you have any further questions about the use of Indium (111In) DTPA, ask your nuclear medicine doctor who is supervising the procedure.

4. Possible side effects

Like all medicinal products, Indium (111In) DTPA Curium Pharma Spain can cause side effects, although not everybody gets them.

Information has been received about some cases of headache and signs of meningeal irritation that improve within 48 hours. Cases of meningitis and fever have been described.

Information has also been received, under certain circumstances of administration, of ptosis or drooping eyelids, ringing in the ears, or deviation of the mouth.

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

Reporting of side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, 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 medicinal product.

5. Storage of Indium (111In) DTPA Curium Pharma Spain

You will not need to store this medicinal product. This medicinal product 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 the specialist:

• Keep this medicinal product out of the sight and reach of children.
• Do not use this medicinal product after the expiry date stated on the label.
• Store below 25 °C. If more than one dose is to be used, the vial should be stored between 2 and 8 °C after the first aliquot is taken.

6. Contents of the pack and further information

Composition of Indium (111In) DTPA Curium Pharma Spain

• The active substance is indium pentetate (111In). Each ml of solution contains 37 MBq of indium (111In) at the date and time of calibration.
• The other components are: sodium chloride, disodium hydrogen phosphate dodecahydrate, sodium hydroxide, and hydrochloric acid (pH adjustment), calcium chloride dihydrate, and water for injections.

Appearance of the product and contents of the pack

Indium (111In) DTPA Curium Pharma Spain is supplied in multidose glass vials type I Ph. Eur. of 10 ml, sealed with a bromobutyl rubber stopper, with an aluminum overseal. One vial is supplied containing 0.5 or 1 ml.

Marketing authorisation holder and manufacturer:

Marketing authorisation holder:

Curium Pharma Spain S.A.

Avenida Doctor Severo Ochoa Nº 29

28100, Alcobendas, Madrid.

Manufacturer:

Curium Netherlands B.V.

Westerduinweg 3.

1755 Le Petten

Netherlands

Date of last revision of this leaflet: August 2020

This information is intended only for healthcare professionals:

The full summary of product characteristics of Indium (111In) DTPA Curium Pharma Spain is included as a section at the end of this leaflet, in order to provide doctors or healthcare professionals with scientific information and practical information on the administration and use of this radiopharmaceutical.

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