PATIENT INFORMATION LEAFLET

Indium (111In) DTPA Curium Pharma Spain 37 MBq/ml injectable solution

Pentetic acidindium (111In)

1. What isIndium (111In) DTPA Curium Pharma Spainand what is it used for

2. What you need to know before starting to useIndium (111In) DTPA Curium Pharma Spain

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

4. Possible side effects

5. Storage ofIndium (111In) DTPA Curium Pharma Spain

6. Contents of the pack and additional information

This medication is for diagnostic use only.

Indio (111In) DTPA is used to examine:

• the brain and spinal cord
• • obstructions of cerebrospinal fluid flow, which is the fluid that surrounds 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 medication contains a radioactive substance that accumulates in certain organs such as the brain when injected.

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 radioactive compound in a specific organ and in the body. This may provide valuable information to the doctor about the structure and function of that organ.

The use of Indio (111In) DTPA 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 radioactive compound outweighs the risk of radiation.

No useIndium (111In) DTPA Curium Pharma Spain:

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

If you have:

• Tendency to bleed.
• Head hypertension, not associated with hydrocephalus.

Warnings and precautions

Be especially careful withIndium (111In) DTPA Curium Pharma Spain:

If you have any kidney problems.

Children and adolescents

Inform your nuclear doctor if you are under 18 years of age because the effects derived from radiation exposure are proportionally greater than in adults.

Use of other medications and Indium (111In) DTPA:

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

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, believe you may be pregnant, or intend to become pregnant, consult your nuclear doctor before this medication is administered.You must inform the nuclear doctor before administration ofIndium (111In) DTPAif there is any possibility of pregnancy, if you experience a delay in your period, or if you are breastfeeding.

It is essential to consult your nuclear doctor who will supervise the procedure in case of doubt.

• If you are pregnant

Your nuclear doctor will only administer this medicationduring pregnancy if the expected benefit outweighs the risk,as it could harm the fetus.

• If you are breastfeeding

Inform your doctor if you are breastfeeding as it maydelay treatmentuntil breastfeeding has ended. Consider the possibility of expressing milk before administration of Indium (111In) DTPA and storing it for later use. Breastfeeding can be resumed when the level of radioactivity in breast milk does not represent a radiation dose to the child exceeding 1 mSv.

Driving and operating machines

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

Indium (111In) DTPA Curium Pharma Spain contains sodium

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

There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. Indium ( 111 In) DTPA 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 physician supervising the procedure will decide on the amount of Indium ( 111 In) DTPA to be used in your case, which will be the minimum amount necessary to obtain the desired information.

The generally recommended dose for an adult is:

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

(MBq, Megabequerel, 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 Indium ( 111 In) DTPA and procedure performance

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

One injection is usually sufficient to perform the procedure.

Procedure duration

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

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

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

It is unlikely to experience an overdose since you will receive a controlled and precise dose of Indium (111In) DTPA from the nuclear medicine physician supervising the procedure. However, in the event of an overdose, you will receive the appropriate treatment.

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

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

Like all medications,Indio (111In) DTPA Curium Pharma Spainmay have adverse effects, although not everyone experiences 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, in certain circumstances of administration, of ptosis or eyelid drooping, ringing in the ears, or deviation of the mouth's commissure.

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 doctor, pharmacist, or nurse, even if it is about possible adverse effects that do 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 about the safety of this medication.

This medication does not need to be stored by the patient. This medication is 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 intended solely for the specialist:

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the label of the container.
• Store below 25 ° C. If more than one dose is to be used, the vial must be stored between 2 and 8°C after taking the first aliquot.

Composition of Indium ( 111 DTPA Curium Pharma Spain

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

Aspect of the product and contents of the packaging

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

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization:

Curium Pharma Spain S.A.

Avenida Doctor Severo Ochoa Nº 29

28100, Alcobendas, Madrid.

Responsible for manufacturing:

Curium Netherlands B.V.

Westerduinweg 3.

1755 Le Petten

Holland

Last review date of this leaflet: August 2020

This information is intended solely for healthcare professionals:

The complete technical data sheet of Indium ( 111 In) DTPA Curium Pharma Spain is included as a section at the end of this leaflet, in order to facilitate information for doctors or healthcare professionals on the scientific and practical information on the administration and use of this radiopharmaceutical.

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