Patient Information Leaflet

Curium 2 mg Human Albumin Macroaggregates Diagnostic Kit

Human Albumin Macroaggregates

Read this leaflet carefully before you receive this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your nuclear medicine doctor, who will oversee the procedure.
• If you experience any side effects, consult your nuclear medicine doctor, even if they are not listed in this leaflet. See section 4.

The active principle of Human Albumin Macroaggregates Curium is human albumin macroaggregates, which is a natural protein found in human blood.

This medication is a radiopharmaceutical for diagnostic use only.

Human Albumin Macroaggregates Curium must be radiolabeled with «technetium-99m», and the resulting product is used to perform gamma scans in adults and children.

When injected, certain organs temporarily capture this medication. Since it contains a small amount of radioactivity, it can be detected from the outside of the body with special cameras and images, known asgamma scanscan be obtained. These explorations show the distribution of radioactivity in the organ and the body and can provide your doctor with very valuable information about the structure and function of this organ.

Human Albumin Macroaggregates Curiumis used mainly for lung explorations. These explorations provide information about the structure of the lungs and the blood flow through the lung tissue.

This medication is also used to show how blood circulates through the veins.

The use of Human Albumin Macroaggregates Curium involves exposure to small amounts of radioactivity. Your doctor and the nuclear medicine physician have considered that the clinical benefit you will obtain from this procedure with the radiopharmaceutical outweighs the risk due to radiation.

No use Macroagregados de albúmina humana Curium

• if you are allergic to human albumin or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your nuclear medicine physician:

• If you have severely high blood pressure in the arteries of the lungs (severe pulmonary hypertension), pulmonary insufficiency,
• If you know you have a known heart defect calledright-to-left cardiac shuntor,
• If you have had a lung transplant.
• If you are pregnant or think you may be.
• If you are breastfeeding.
• If you have a kidney or liver disease.

Your nuclear medicine physician will inform you if you need to take any special precautions in these cases.

If you have any doubts, consult your nuclear medicine physician.

Before administration of Macroagregados de albúmina humana Curium, you mustdrink plenty of water before starting the examination so that you urinate as frequently as possible during the first hours after the study.

Children and adolescents

Inform your nuclear medicine physician if you are under 18years or if your child is under 18years.

Medicaments prepared from human blood or plasma

When medications are prepared from human blood or plasma, certain measures must be taken to prevent the transmission of infectious organisms, which include:

• Careful selection of blood and plasma donors to ensure that donors who may be carriers of an infection are excluded.
• Analysis of each donation and plasma samples grouped to rule out the presence of viruses or infections.
• Incorporation into the manufacturing process of stages that allow viruses to be inactivated or eliminated.

Despite these measures, when administering medications derived from human blood or plasma, the possibility of transmission of infectious diseases cannot be completely ruled out. The same applies to unknown or new viruses and other types of infectious organisms.

No viral infections have been reported with albumin manufactured in accordance with the specifications and procedures established by the European Pharmacopoeia.

Other medications and Macroagregados de albúmina humana Curium

Informyour nuclear medicine physician if you are taking, have taken recently, or may need to take any other medication, even those purchased without a prescription, as they may interfere with the interpretation of images.

Some specific examples are:

• a medication to prevent blood clotting(heparin).
• chemotherapy medications(busulfan, cyclophosphamide, bleomycin, methotrexate).
• medications to breathe better(bronchodilators).
• some antibiotics used in the treatment of urinary tract infections(e.g., nitrofurantoin).
• some medications used in the prevention of headaches(e.g., methysergide).
• a medication for the treatment of magnesium deficiency(magnesium sulfate).
• opioids(heroin)

Pregnancy and lactation

If you are pregnant or breastfeeding, or think you may be, consult your nuclear medicine physician before this medication is administered.

You must inform your nuclear medicine physician before the administration of Macroagregados de albúmina humana Curium if there is a possibility that you are pregnant,if you experience a delay in your period or if you are breastfeeding.

It is essential to consult your nuclear medicine physician, who will oversee the procedure.

If you are pregnant:

Your nuclear medicine physician will only administer Macroagregados de albúmina humana Curium during pregnancy if the expected benefit outweighs the risk.

If you are breastfeeding:

If you are breastfeeding, inform your nuclear medicine physician, as you may need to delay the study until you have finished breastfeeding or ask them to interrupt breastfeeding for a short period until the radioactivity in your body has decreased, which may take around 12hours. The milk extracted during this period should be discarded.

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

Driving and operating machinery

It is considered unlikely that Macroagregados de albúmina humana Curium will affect your ability to drive or operate machinery.

Macroagregados de albúmina humana Curium contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per administration; this is, essentially "sodium-free".

There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. Macroagregados de albúmina humana Curium will only be used in specially controlled areas.

This product will only be handled and administered by trained and qualified personnel to 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 overseeing the procedure will decide on the amount of Macroagregados de albúmina humana Curium to be used in your case. This will be the minimum amount necessary to obtain the desired information. The generally recommended dose for an adult ranges from 40 to 200 MBq (MBq: megabequerel, the unit of measurement for radioactivity).

Use in children and adolescents

In the case of children and adolescents under 18 years old, the dose to be administered will be adjusted according to the child's weight.

Administration of Macroagregados de albúmina humana Curium and procedure performance

Macroagregados de albúmina humana Curium is administered via an injection into a vein.

To perform the procedure indicated by your physician, a single injection is sufficient. The test can be performed at any time after the injection has been administered. The exact time will depend on the type of examination.

After the injection, you will be offered a drink and asked to urinate just before the examination.

Procedure duration

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

After administration of Macroagregados de albúmina humana Curium, you must:

• avoid direct contact with young children and pregnant women for the first 12 hours after administration.
• drink as much as possible throughout the day after treatment.This will help the radioactive residue to leave your body more quickly.
• urinate frequently to eliminate the product from your body.

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

If you have been administered more Macroagregados de albúmina humana Curium than you should

A overdose is unlikely because you will receive a single, precisely controlled dose of Macroagregados de albúmina humana Curium from the nuclear medicine physician overseeing the procedure. A high number of particles may cause vascular blockage. If you notice any noticeable changes in breathing (respiratory rate), pulse, or blood pressure, inform your nuclear medicine physician, who will take the necessary measures.

However, in the event of an overdose, you will receive the appropriate treatment. Specifically, the nuclear medicine physician responsible for the procedure may recommend that you drink abundantly to facilitate the elimination of Macroagregados de albúmina humana Curium from your body.

If you have any doubts about the use of this medication, ask the nuclear medicine physician overseeing the procedure.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Unknown Frequency:(cannot be estimated from available data).

Allergic Reactions:urticaria (hives), chills, fever, nausea, facial flushing, and sweating, as well as heart and circulation disorders, such as changes in breathing, pulse, blood pressure, and collapse (syncope). Local allergic reactions, such as redness, swelling, and itching at the injection site, have been observed. In this case, contact your nuclear medicine doctor.

Very Rare:(may affect up to 1 in 10,000 people)

Severe Allergic Reactions: severe allergic reactions, includingshock, which can be fatal, have been reported. It is also possible that the onset of these reactions may not be immediate.

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or nuclear medicine specialist,even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

This medication will not be stored by you. This medication is stored under the responsibility of the specialist in appropriate facilities. The storage of radiopharmaceuticals will be carried out in accordance with national regulations on radioactive materials.

Composition of Macroaggregates of Human Serum Albumin Curium

• The active principle is macroaggregates of human serum albumin (or macrosalb).
• Each vial contains 2 mg of macroaggregates of human serum albumin.
• The other components are human albumin, tin chloride dihydrate (E-512), sodium chloride, in a nitrogen atmosphere (E-941).

Appearance of the product and content of the packaging

Macroaggregates of human serum albumin Curium is a set of reagents for radio pharmaceutical preparation.

Packaging sizes: set of 5 multidose vials.

Holder of the marketing authorization and responsible for manufacturing

CIS bio international

RN 306 - Saclay

B.P. 32

91192 Gif-sur-Yvette Cedex

France

This medicine is authorized in the following member statesof the European Economic Area with the name:

Austria, Belgium, Croatia, Denmark, Slovakia, Slovenia, Malta, Norway, Netherlands, Portugal, Czech Republic:Pulmocis

Spain: Macroaggregates of human serum albumin Curium

Last review date of this leaflet: April2020

Other sources of information

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

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This informationis intended solely for healthcare professionals:

The complete technical data sheet of Macroaggregates of human serum albumin Curium is included in a separate document in this leaflet, in order to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.

Please, consult the technical data sheet of the medicine included in the box.