INDIUM(111) CHLORIDE CURIUM PHARMA SPAIN 370 MBq/ml RADIO-PHARMACEUTICAL PRECURSOR IN SOLUTION

Introduction

Package Leaflet: Information for the User

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

Indium Chloride (111In)

Contents of the Package Leaflet:

1. What is Indium Chloride (111In) Curium Pharma Spain and what is it used for
2. What you need to know before using Indium Chloride (111In) Curium Pharma Spain
3. How to use Indium Chloride (111In) Curium Pharma Spain
4. Possible side effects
5. Storage of Indium Chloride (111In) Curium Pharma Spain
6. Package Contents and Additional Information

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

This medicine is a radiopharmaceutical for diagnostic use only.

Indium Chloride (111In) Curium Pharma Spain belongs to the group of medicines called indium (111In) radiopharmaceutical compounds. This radiopharmaceutical binds to certain substances and is then injected into the patient. Because the radiopharmaceutical contains a small amount of radioactivity, it can be detected from outside the body using special medical equipment called a gamma camera, and an image, known as a scintigram, can be obtained. This scintigram will show exactly 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.

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

Before administering this medicine, read the warnings for the medicine to which this radiopharmaceutical will be attached.

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

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

Warnings and Precautions

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

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

Before administration of indium chloride, you should:

• drink plenty of water before starting the procedure to urinate frequently during the first hours after its completion.

If you have reduced kidney function, as you may be more exposed to radiation.

Children and Adolescents

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

Using Indium Chloride (111In) Curium Pharma Spain with other medicines:

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

Pregnancy, Breastfeeding, and Fertility

You must inform your nuclear medicine doctor before administration of Indium Chloride (111In) Curium Pharma Spain 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 important that you consult your nuclear medicine doctor who is supervising the procedure.

If you are pregnant:

Your nuclear medicine doctor will only administer this medicine during pregnancy if the benefit is expected to outweigh the risk.

If you are breastfeeding:

Please consult your nuclear medicine doctor about when you can resume breastfeeding.

Ask your nuclear medicine doctor before taking any medicine.

Driving and Using Machines

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

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

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

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

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

The recommended amount to administer will depend on the medicine to be labeled.

Use in Children and Adolescents

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

Administration of Indium Chloride (111In) Curium Pharma Spain and Performance of the Procedure

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

A single injection is sufficient to perform the procedure that your doctor needs.

Duration of the Procedure

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

After Administration of Indium Chloride (111In) Curium Pharma Spain, you should

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

If you have been administered moreIndium Chloride (111In) Curium Pharma Spainthan you should

Since this product is administered by a doctor under strict control conditions, any overdose is very unlikely.

However, in the event that you are administered an excessive dose of this medicine, you should follow the instructions indicated in the package leaflet of the medicine to which it has been attached.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Telephone 91 5620420.

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

4. Possible Side Effects

Like all medicines, Indium Chloride (111In) Curium Pharma Spain can have side effects, although not everyone gets them.

In addition, there may be reactions that are detailed in the information about the medicine to which it has been attached.

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

Reporting Side Effects

If you experience side effects, consult 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 Indium Chloride (111In) Curium Pharma Spain

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.

The product must be stored below 25°C.

Storage must be carried out in the original lead container or equivalent shielding.

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

Do not use Indium Chloride (111In) Curium Pharma Spain after the expiration date stated on the package label.

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

6. Package Contents and Additional Information

Composition of Indium Chloride (111In) Curium Pharma Spain

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

Appearance of the Product and Package Contents

This medicine is presented as a colorless solution. It is supplied in 10 ml type I glass vials, sealed with a bromobutyl rubber stopper and an aluminum overseal.

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

Marketing Authorization Holder and Manufacturer:

Marketing Authorization 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 the Last Revision of this Leaflet: March 2016

Other Sources of Information

Detailed and up-to-date 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 doctors or healthcare professionals:

The complete technical data sheet of Indium Chloride (111In) Curium Pharma Spain is included as a separate document in the product package, 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.