Indium (111In) chloride CuriPharma Spain 370 MBq/ml radiopharmaceutical precursor solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Indium (111In) Chloride Curium Pharma Spain 370 MBq/ml radiopharmaceutical precursor in solution

Indium (111In) Chloride

Package leaflet contents:

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

1. What Cloruro de indio (111In) Curium Pharma Spain is and what it is used for

This medicine is a radiopharmaceutical intended solely for diagnostic use.

Cloruro de indio (111In) Curium Pharma Spain belongs to a group of medicines known as radiopharmaceuticals composed of indium (111In). 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 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 a specific organ and in the body. This can provide the physician with valuable information regarding the structure and function of that organ.

2. What you need to know before using Cloruro de indio (111In) Curium Pharma Spain

Before administering this medicine, read the warnings of the drug to which this radiopharmaceutical will be linked.

Cloruro de indio (111In) Curium Pharma Spain must not be used:

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

Warnings and precautions

Take special care with Cloruro de indio (111In) Curium Pharma Spain:

• When this medicine is administered to you, 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.

Before administration of indium chloride, you should:

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

If you have reduced kidney function, your exposure to radiation may be increased.

Children and adolescents

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

Use of Cloruro de indio (111In) 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 by your physician.

Pregnancy, breastfeeding, and fertility

You must inform the nuclear medicine physician before administration of Cloruro de indio (111In) Curium Pharma Spain if there is any possibility you might be pregnant, if you have missed your period, or if you are breastfeeding.

If in doubt, it is important that you consult your nuclear medicine physician supervising the procedure.

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:

Please consult your nuclear medicine physician regarding when you can resume breastfeeding.

Ask your nuclear medicine physician before taking any medicine.

Driving and use of machines

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

Cloruro de indio (111In) 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 Indium Chloride (111In) Curium Pharma Spain

There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. Indium Chloride (111In) Curium Pharma Spain will be used only in specially controlled areas. This product will be handled and administered exclusively by trained and qualified personnel experienced in the safe use of radiopharmaceuticals. These individuals will take special care in the safe use of this product and will inform you about their actions.

The nuclear medicine physician supervising the procedure will determine the amount of Indium Chloride (111In) Curium Pharma Spain to be used in your case. This will be the minimum quantity necessary to obtain the required information.

The recommended administered activity depends on the medicinal product to be labeled.

Use in children and adolescents

In children and adolescents, the administered amount will be adjusted according to 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 medicinal product.

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

Duration of the procedure

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

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

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

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

Since this product is administered by a physician under conditions of strict control, overdose is highly unlikely.

However, in the event that an excessive dose of this medicinal product is administered, you should follow the instructions provided in the package leaflet of the medicinal product to which it has been bound.

In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone number 91 562 0420.

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

4. Possible adverse effects

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

In addition, reactions described in the information of the medicinal product with which it has been combined may also occur.

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

Reporting of adverse effects

If you experience any adverse effects, consult your nuclear medicine physician, even if they are adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse 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 have to store this medicinal product. This medicine is stored under the responsibility of a specialist in appropriate facilities. The storage of radiopharmaceuticals must comply with national regulations concerning radioactive materials.

The following information is intended exclusively for the specialist.

The product must be stored below 25°C.

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

Storage must comply with national regulations concerning radioactive materials.

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

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

6. Contents of the pack and other information

Composition of Indium Chloride (111In) Curium Pharma Spain

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

Nature of the product and pack contents

This medicinal product is presented as a colourless solution. It is supplied in 10 ml vials made of colourless drawn glass type I according to Ph. Eur., sealed with a bromobutyl rubber stopper and an aluminium overseal.

One pack contains 1 vial 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 date and time of calibration.

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation 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 of product characteristics: March 2016

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 for healthcare professionals only:

The complete package leaflet of Indium Chloride (111In) Curium Pharma Spain is included as a separate document within the product packaging, to provide healthcare professionals with scientific information and practical guidance on the administration and use of this radiopharmaceutical.

Please consult the package leaflet.