Indio (111 In) Oxina Curium Pharma Spain 37 MBq/ml radiopharmaceutical precursor solution

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Indio (111In) oxina Curium Pharma Spain 37 MBq/ml radiopharmaceutical precursor in solution

Indium (111In) oxinate

Package leaflet:

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

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

This medicine is for diagnostic use only.

Indio (111In) oxina Curium Pharma Spain belongs to a group of medicines called radiopharmaceuticals composed of indium (111In). 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 a special medical device called a gamma camera, allowing an image, known as a scintigraphy, to be obtained. This scintigraphy will show precisely the distribution of the radiopharmaceutical in the body. This can provide the physician with valuable information regarding certain organs, possible infections, and bleeding.

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

Indio (111In) oxina Curium Pharma Spain must not be used:

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

Warnings and precautions

Take special care with Indio (111In) oxina Curium Pharma Spain:

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

Children and adolescents

Inform your nuclear medicine physician if you are under 18 years of age.

Use of Indio (111In) oxina Curium Pharma Spain with other medicines

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

Corticosteroids and antibiotics used in the treatment of abscesses may interfere with the results of the scan performed with this medicine.

Pregnancy and breastfeeding

You must inform the nuclear medicine physician before administration of Indio (111In) oxina Curium Pharma Spain if there is any possibility you may be pregnant, if you have missed a menstrual period, or if you are breastfeeding.

In case of doubt, it is important that you consult your supervising nuclear medicine physician.

If you are pregnant:

• The nuclear medicine physician will only administer this medicine during pregnancy if the expected benefit outweighs the potential risk.

If you are breastfeeding:

• Consideration should be given to reasonably delaying the test with this medicine until you have stopped breastfeeding, and it should be evaluated whether the most appropriate radiopharmaceutical has been selected, taking into account the excretion of radioactivity into breast milk.
• If administration of indium (111In)-labelled blood cells is considered necessary, interruption of breastfeeding is not recommended.
• Please consult your nuclear medicine physician regarding when you may resume breastfeeding.

Ask your nuclear medicine physician before taking any medicine.

Driving and using machines

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

Indio (111In) oxina Curium Pharma Spain contains sodium.

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

3. How to use Indio (111In) oxina Curium Pharma Spain

There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. Indio (111In) oxina Curium Pharma Spain will only be used in specially controlled areas. This product will only be handled and administered by qualified personnel trained 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 determine the amount of Indio (111In) oxina Curium Pharma Spain to be used in your case. This will be the minimum quantity necessary to obtain the required information.

The normally administered and recommended dose for adults is 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 administered dose will be adjusted according to body weight.

Administration of Indio (111In) oxina Curium Pharma Spain and performance of the procedure

Indio (111In) oxina Curium Pharma Spain is administered intravenously, following the labelling of blood cells.

A single injection is sufficient to perform the procedure required by your physician.

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

Duration of the procedure

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

After administration of Indio (111In) oxina Curium Pharma Spain, you should

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

If you have been given more Indio (111In) oxina Curium Pharma Spain than you should have

An overdose is unlikely, as you will receive a single dose of Indio (111In) oxina Curium Pharma Spain precisely controlled by the supervising nuclear medicine physician.

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

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

If you have any further questions about the use of Indio (111In) oxina Curium Pharma Spain, ask the nuclear medicine physician supervising the procedure.

4. Possible adverse effects

Like all medicines, Indio (111In) oxina Curium Pharma Spain may have adverse effects, although not everyone will experience them.

Cases of hypersensitivity, including cutaneous reactions and generalized reactions, probably of anaphylactic nature, have been reported following administration of blood cells labelled with indium (111In). It should also be noted that materials used in cell separation may cause hypersensitivity reactions. It is essential that cells are thoroughly washed to remove any sedimentation agent before re-injecting them into the patient.

Administration of this radiopharmaceutical involves exposure to a small amount of ionizing radiation, carrying a very low risk of developing cancer and hereditary defects.

If you experience any adverse effects, consult your nuclear medicine physician, including effects not listed in this leaflet.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Indio (111In) oxina Curium Pharma Spain

You will not have to store this medicine. This medicine is stored under the responsibility of the specialist in appropriate facilities. Storage of radiopharmaceuticals must comply with national regulations concerning radioactive materials.

The following information is intended exclusively for the specialist.

Do not use Indio (111In) oxina Curium Pharma Spain after the expiry date stated on the container label. The shelf life 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 in another equivalent shielding.

6. Contents of the pack and other information

Composition of Indium (111In) oxine Curium Pharma Spain

Vial of Indium (111In) oxine:

• The active substance is indium (111In) oxine. Each ml of solution contains 37 MBq of indium (111In) oxine at the date and time of calibration.
• 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.

Buffer vial:

• Contains trometamol, hydrochloric acid and water for injections.

Presentation of the product and contents of the pack

Indium (111In) oxine Curium Pharma Spain is supplied in single-dose vials made of neutral glass type I according to Ph. Eur., 10 ml in size, sealed with a bromobutyl rubber stopper coated with Teflon® and an aluminum seal. Each contains an activity of 37 MBq at the date and time of calibration. One vial of neutral glass type I according to Ph. Eur., 10 ml in size, sealed with a bromobutyl rubber stopper and a yellow aluminum seal, containing 3 ml of buffer solution, is included.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Curium Pharma Spain S. A.

Avenida Doctor Severo Ochoa, Nº 29

28100, Alcobendas, Madrid, Spain

Manufacturer:

Curium Netherlands B.V.

Westerduinweg 3

1755 LE Petten

The Netherlands

Date of the most recent revision of this summary: July 2015

Other sources of information

Detailed and up-to-date 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/

This information is intended exclusively for healthcare professionals:

The full summary of product characteristics for Indium (111In) oxine Curium Pharma Spain is included as a separate document within the product packaging, providing healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.