Label: Information for the User

Cerium Chloride (111In) Curium Pharma Spain 370 MBq/ml Radiopharmaceutical Precursor in Solution

Cerium Chloride (111In)

1. What it isCerium Chloride (111In) Curium Pharma Spainand how it is used

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

3. How to useCerium Chloride (111In) Curium Pharma Spain

4. Possible adverse effects

5. Storage ofCerium Chloride (111In) Curium Pharma Spain

6. Contents of the package and additional information

This medication is a radiopharmaceutical for diagnostic use only.

Indium Chloride (111In) Curium Pharma Spain belongs to a group of medications known as indium (111In) radiopharmaceuticals. This radiopharmaceutical binds to certain substances and is then injected into the patient. Due to the radiopharmaceutical containing a small amount of radioactivity, it can be detected from the outside of the body using a specialized medical device called a gamma camera and an image, known as a gamma scan, can be obtained. This gamma scan will show exactly the distribution of the radiopharmaceutical in a specific organ and in the body. This can provide the doctor with valuable information regarding the structure and function of that organ.

Before administering this medication, read the warnings of the medication to which this radiopharmaceutical will be added.

Indium Chloride (111In) Curium Pharma Spainshould not be used:

If you are allergic (hypersensitive) to the active ingredient or to any of the other components ofIndium Chloride (111In) Curium Pharma Spain (including those listed in section 6).

Warnings and precautions

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

• When you are administered this medication, as it involves exposure to small amounts of radiation. Although your doctor will always consider the possible risks and benefits.
• If you are pregnant or think you may be.
• If you are breastfeeding.

Before theadministration of indium chloride, you should:

• Drink a lot of water before starting the procedure to urinate very frequently during the first hours after its completion.

If you have reduced kidney function, as it may increase your exposure to radiation.

Children and adolescents

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

Use of Indium Chloride (111In) Curium Pharma Spain with other medications:

Inform your nuclear doctor if you are taking, have taken recently, or may need to take any other medication, as some medications may interfere with the interpretation of images by your doctor.

Pregnancy, breastfeeding, and fertility

You must inform the nuclear doctor before the administration ofIndium Chloride (111In)Curium Pharma Spain if there is any possibility that you may be pregnant, if you experience a delay in menstruation, or if you are breastfeeding.

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

If you are pregnant:

Your nuclear doctor will only administer this medication during pregnancy if the expected benefit outweighs the risk.

If you are breastfeeding:

Please consult your nuclear doctor when you can resume breastfeeding.

Ask your nuclear doctor before taking any medication.

Driving and operating machines

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

Indium Chloride (111In) Curium Pharma Spain contains sodium.

This medication contains less than 1 mmol of sodium (23 mg) per dose, so it is considered essentially "sodium-free".

There are strict guidelines for the use, handling, and disposal of radiopharmaceuticals. Chloride Indium (111In) Curium Pharma Spain 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 physician overseeing the procedure will decide on the amount of Chloride Indium (111In) Curium Pharma Spain to be used in your case. This will be the minimum amount necessary to obtain the desired information.

The recommended dose for administration will depend on the medication to be labeled.

Use in children and adolescents

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

Administration of Chloride Indium (111In) Curium Pharma Spain and procedure performance

Chloride Indium (111In) Curium Pharma Spain is administered intravenously, after labeling another medication.

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

Procedure duration

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

After administration of Chloride Indium (111In) Curium Pharma Spain, you must

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

If you have been administered moreChloride Indium (111In) Curium Pharma Spainthan you should

Since this product is administered by a physician under strict control conditions, it is very difficult for any overdose to occur.

However, in the event of an excessive dose of this medication being administered, you should follow the instructions provided in the medication's package insert to which it has been added.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone 91 5620420.

If you have any other questions about the use ofChloride Indium (111In) Curium Pharma Spain, ask your nuclear physician who oversees the procedure.

Like all medications,Indium Chloride (111In) Curium Pharma Spainmay have adverse effects, although not everyone will experience them.

In addition, reactions that are detailed in the information about the medication with which it has been combined may also occur.

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 adverse effects, consult your nuclear physician, even if they do not appear 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 by the patient. 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.

The product must be preservedbelow25°C.

Storage must be carried out in the original lead-lined container or any other equivalent shielding.

Storage must be carried out in accordance with national regulations on radioactive materials.

Do not use Indium Chloride (111In) Curium Pharma Spainafter the expiration date that appears on the label of the packaging.

The expiration date is 24 hours from the date and time of calibration.

Composition of Indium Chloride ( 111 In) Curium Pharma Spain

• The active ingredient is indium chloride ( 111 In). Each milliliter of solution contains 370 MBq of indium chloride ( 111 In) at the time and date of calibration.
• The other components are: hydrochloric acid and water for injection preparations.

Appearance of the product and contents of the packaging

This medication is presented in the form of a colorless solution. It is supplied in type I glass ampoules of 10 ml, sealed with a bromobutyl rubber stopper and an aluminum overcap.

A package contains 1 ampoule with 0.3; 0.5; 1; 1.5 or 2 ml corresponding to the following activities: 111, 185, 370, 555 or 740 MBq respectively, at the time and date of calibration.

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

Netherlands

Last review date of this leaflet: March 2016

Other sources of information

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/

This information is intended solely for doctors or healthcare professionals:

The complete technical data sheet for Indium Chloride ( 111 In) Curium Pharma Spain is included as a separate document in the packaging of the product, in order to provide doctors or healthcare professionals with scientific and practical information on the administration and use of this radiopharmaceutical.

Please consult the technical data sheet.