INDIO (111In) OXINA CURIUM PHARMA SPAIN 37 MBq/ml RADIOPHARMACEUTICAL PRECURSOR IN SOLUTION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Indium (111In) oxine Curium Pharma Spain 37 MBq/ml radiopharmaceutical precursor solution

Indium oxinate (111In)

Contents of the package leaflet:

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

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

This medicine is for diagnostic use only.

Indium (111In) oxine Curium Pharma Spain belongs to a group of medicines called indium (111In) radiopharmaceuticals. This radiopharmaceutical binds to blood cells 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 the body. This can provide the doctor with valuable information about certain organs, possible infections, and hemorrhages.

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

Indium (111In) oxine Curium Pharma Spain must not be used:

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

Warnings and precautions

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

• When this medicine is administered to you because 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.

Children and adolescents

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

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

Tell your nuclear medicine doctor if you are using, have recently used, or might use any other medicines, as some medicines may interfere with the interpretation of the images.

Corticosteroids and antibiotics used to treat abscesses may interfere with the results of the examination performed with this medicine.

Pregnancy and breastfeeding

You must inform your nuclear medicine doctor before administration of Indium (111In) oxine 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 expected benefit outweighs the risk.

If you are breastfeeding:

• The possibility of delaying the test with this medicine until you have stopped breastfeeding should be considered, and it should be considered whether the most suitable radiopharmaceutical has been selected, taking into account the secretion of activity in breast milk.
• If the administration of blood cells labeled with indium (111In) is considered necessary, it is not recommended to interrupt breastfeeding.
• Please consult your nuclear medicine doctor 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 (111In) oxine 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 (111In) oxine Curium Pharma Spain

There are strict rules for the use, handling, and disposal of radiopharmaceuticals. Indium (111In) oxine Curium Pharma Spain will only be used in special controlled areas. This product will only be handled and administered by qualified personnel to use it safely. Those 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 (111In) oxine 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 adults is normally in the range of 1.85-30 MBq (MBq is the unit used to measure radioactivity).

Use in children and adolescents

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

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

Indium (111In) oxine Curium Pharma Spain is administered intravenously, after labeling of blood cells.

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

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.

Duration of the procedure

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

After administration of Indium (111In) oxine Curium Pharma Spain, you should

Avoid direct contact with small children and pregnant women during the first hours after the injection.

If you have been administered more Indium (111In) oxine Curium Pharma Spain than you should

Overdose is unlikely because you will receive a single dose of Indium (111In) oxine Curium Pharma Spain, precisely controlled by the nuclear medicine doctor who supervises the procedure.

However, in case of overdose, you will receive the appropriate treatment.

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 (111In) oxine Curium Pharma Spain, ask your nuclear medicine doctor who is supervising the procedure.

4. Possible side effects

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

Information has been received about some cases of hypersensitivity, skin reactions, and generalized reactions, probably of an anaphylactic nature, after administration of blood cells labeled with indium (111In). It should also be taken into account that the materials used in cell separation can cause hypersensitivity reactions. It is essential that the cells are washed of any sedimentation agent before re-injecting them into the patient.

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

If you experience side effects, consult your nuclear medicine doctor, even if they are not listed in this leaflet.

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 medicine.

5. Storage of Indium (111In) oxine 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.

Do not use Indium (111In) oxine Curium Pharma Spain after the expiration date stated on the label of the container. The validity period of this product is 24 hours from the date and time of calibration.

The product must be stored at a temperature below 25°C.

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

6. Package contents and further information

Composition of Indium (111In) oxine Curium Pharma Spain

Vial of Indium (111In) oxinate:

• The active substance is Indium (111In) oxinate. Each ml of solution contains 37 MBq of Indium (111In) oxinate at the date and time of calibration.
• The other components are: sodium acetate trihydrate and glacial acetic acid (for pH adjustment), sodium chloride, iron (III) chloride hexahydrate, hydrochloric acid, and water for injections.

Vial of buffer:

• Contains trometamol, hydrochloric acid, and water for injections

Appearance of the product and package contents

Indium (111In) oxine Curium Pharma Spain is supplied in 10 ml glass vials, type I, Ph. Eur., sealed with a bromobutyl rubber stopper and aluminum overseal, containing an activity of 37 MBq at the date and time of calibration. It includes 1 glass vial, type I, Ph. Eur., 10 ml, sealed with a bromobutyl rubber stopper and aluminum overseal, yellow, containing 3 ml of buffer solution.

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 last revision of this leaflet: July 2015

Other sources of information

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