PATIENT INFORMATION LEAFLET

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

Indium oxinate(111In)

This medication is solely for diagnostic use.

Indio (111In) oxina Curium Pharma Spain belongs to a group of medications known as indium (111In) radio-pharmaceutical compounds. This radio-pharmaceutical binds to blood cells and is subsequently injected into the patient. Due to the radio-pharmaceutical containing a small amount of radioactivity, it can be detected from outside 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 radio-pharmaceutical in the body. This can provide the doctor with valuable information related to certain organs, possible infections, and hemorrhages.

Indium (111In) oxina Curium Pharma Spain should not be used:

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

Warnings and precautions

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

• When you are administered this medicine because 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.

Children and adolescents

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

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

Inform your nuclear doctor if you are using, have used recently, or may need to use any other medicine, 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 examination performed with this medicine.

Pregnancy and breastfeeding

You must inform your nuclear doctor before the administration of Indium (111In) oxina 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 essential that you consult your nuclear doctor who supervises the procedure.

If you are pregnant:

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

If you are breastfeeding:

• Consideration should be given to delaying the test with this medicine reasonably until you have stopped breastfeeding, and consideration should be given to whether the selected radiopharmaceutical has taken into account the secretion of activity in breast milk.
• If it is considered necessary to administer cells marked with indium (111In), it is not recommended to interrupt breastfeeding.
• Please consult your nuclear doctor when you can resume breastfeeding.

Ask your nuclear doctor before taking any medicine.

Driving and operating machines

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

Indium (111In) oxina 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".

There are strict guidelines for the use, handling, and disposal of radiopharmaceuticals. Indium (111In) oxina Curium Pharma Spain will only be used in specially controlled areas. This product will only be handled and administered by qualified personnel who will 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 medicine physician who supervises the procedure will decide on the amount of Indium (111In) oxina 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 typically 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) oxina Curium Pharma Spain and procedure performance

Indium (111In) oxina Curium Pharma Spain is administered intravenously after blood cell labeling.

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

The 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.

Procedure duration

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

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

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

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

It is unlikely to experience an overdose because you will receive a controlled and precise dose of Indium (111In) oxina Curium Pharma Spain from the nuclear medicine physician who supervises the procedure.

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

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

If you have any other questions about the use of Indium (111In) oxina Curium Pharma Spain, ask the nuclear medicine physician who supervises the procedure.

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

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

The administration of this radiopharmaceutical involves receiving a small amount of ionizing radiation with a very low risk of developing cancer and hereditary defects.

If you experience adverse effects, consult your nuclear physician, even if they are adverse effects that do not appear in this prospectus.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on 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.

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

The product must be stored at a temperature below25ºC.

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

Composition of Indium ( 111 Oxinate Curium Pharma Spain

Vial of Oxinato of indium ( 111 In):

• The active ingredient is Oxinato of indium ( 111 In). Each ml of solution contains 37 MBq of Oxinato of indium ( 111 In) at the time and date 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 injection.

Vial of buffer:

• Contains trometamol, hydrochloric acid, and water for injection.

Appearance of the product and contents of the packaging

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

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

Holland

Last review date of this leaflet: July 2015

Other sources of information

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

This information is intended solely for doctors or healthcare professionals:

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