Human albumin curium 2 mg aggregates reagent kit for radiopharmaceutical preparation

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Macroaggregates of Human Albumin Curium 2 mg reagent kit for radiopharmaceutical preparation

macroaggregates of human albumin

Read the entire leaflet carefully before you are administered 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 physician, who will supervise the procedure.
• If you experience any adverse reactions, consult your nuclear medicine physician, even if they are not listed in this leaflet. See section 4.

Leaflet contents

1. What Macroaggregates of Human Albumin Curium are and what they are used for
2. What you need to know before using Macroaggregates of Human Albumin Curium
3. How to use Macroaggregates of Human Albumin Curium
4. Possible adverse effects
5. How to store Macroaggregates of Human Albumin Curium
6. Contents of the pack and other information

1. What Macroagregados de albúmina humana Curium is and what it is used for

The active substance in Macroagregados de albúmina humana Curium is human albumin aggregates, which is a natural protein derived from human blood.

This medicine is a radiopharmaceutical intended solely for diagnostic use.

Macroagregados de albúmina humana Curium must be radiolabelled with «technetium-99m». The resulting product is used to perform scintigraphies in adults and children.

When injected, certain organs temporarily take up this medicine. Because it contains a small amount of radioactivity, it can be detected from outside the body using special cameras, allowing images known as scintigraphies to be obtained. These scans show the distribution of radioactivity in the organ and body, providing your doctor with valuable information about the structure and function of the organ.

Macroagregados de albúmina humana Curium is mainly used for lung scans. These scans provide information about the structure of the lungs and blood flow through lung tissue.

This medicine is also used to visualize blood circulation in the veins.

The use of Macroagregados de albúmina humana Curium involves exposure to small amounts of radioactivity. Your doctor and the nuclear medicine physician have determined that the clinical benefit you will obtain from this radiopharmaceutical procedure outweighs the radiation risk.

2. What you need to know before using Human Albumin Aggregates Curium

Do not use Human Albumin Aggregates Curium

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

Warnings and precautions

Consult your nuclear medicine physician:

• If you have abnormally high blood pressure in the lung arteries (severe pulmonary hypertension), or lung failure,
• If you know you have a heart defect known as right-to-left cardiac shunt,
• If you have had a lung transplant,
• If you are pregnant or think you might be pregnant,
• If you are breastfeeding,
• If you have kidney or liver disease.

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

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

Before administration of Human Albumin Aggregates Curium, you should drink plenty of water before starting the procedure to ensure 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 18 years of age or if your child is under 18 years of age.

Medicines derived from human blood or plasma

When medicines are prepared from human blood or plasma, certain measures are taken to prevent the transmission of infectious agents, including:

• Careful selection of blood and plasma donors to ensure exclusion of donors who might carry an infection,
• Testing of each donation and pooled plasma samples to rule out the presence of viruses or infections,
• Incorporation into the manufacturing process of steps that inactivate or eliminate viruses.

Despite these measures, when medicines derived from human blood or plasma are administered, the possibility of transmitting infectious diseases cannot be completely ruled out. This also applies to unknown or new viruses and other types of infectious agents.

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

Other medicines and Human Albumin Aggregates Curium

Inform your nuclear medicine physician if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription, as they could interfere with the interpretation of the images.

Some specific examples are:

• a medicine to prevent blood clotting (heparin),
• cancer medicines (busulfan, cyclophosphamide, bleomycin, methotrexate),
• medicines to help breathing (bronchodilators),
• some antibiotics used to treat urinary tract infections (e.g., nitrofurantoin),
• some medicines used to prevent headaches (e.g., methysergide),
• a medicine to treat magnesium deficiency (magnesium sulfate),
• opioids (heroin).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your nuclear medicine physician before receiving this medicine.

You must inform the nuclear medicine physician before administration of Human Albumin Aggregates Curium if there is any possibility you are pregnant, if you have missed a menstrual period, or if you are breastfeeding.

In case of doubt, it is important to consult your nuclear medicine physician, who will supervise the procedure.

If you are pregnant:

The nuclear medicine physician will only administer Human Albumin Aggregates Curium during pregnancy if the expected benefit outweighs the potential risk.

If you are breastfeeding:

If you are breastfeeding, inform your nuclear medicine physician, as they may delay the study until after you have finished breastfeeding or may ask you to interrupt breastfeeding for a short period until radioactivity is no longer present in your body, which may take about 12 hours. Breast milk expressed during this period should be discarded.

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

Driving and using machines

Human Albumin Aggregates Curium is considered unlikely to affect your ability to drive or operate machinery.

Human Albumin Aggregates Curium contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per dose; hence, it is essentially "sodium-free".

3. How to use Macroaggregates of human albumin Curium

There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. Macroaggregates of human albumin Curium will only be used in specially controlled areas.

This product will only be handled and administered by trained and qualified personnel who are skilled in its safe use. These individuals will take special care in the safe handling of this product and will inform you about their actions.

The nuclear medicine physician supervising the procedure will determine the amount of Macroaggregates of human albumin Curium to be used in your case. This will be the minimum quantity necessary to obtain the required information. The amount generally recommended for administration in adults ranges between 40 and 200 MBq (MBq: megabecquerel, the unit of measurement of radioactivity).

Use in children and adolescents

In children and adolescents under 18 years of age, the administered amount will be adjusted according to the child's body weight.

Administration of Macroaggregates of human albumin Curium and performance of the procedure

Macroaggregates of human albumin Curium are administered by intravenous injection.

For the procedure indicated by your physician, a single injection is sufficient. The test can be performed at any time after the injection. The exact timing of the test depends on the type of examination.

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

Duration of the procedure

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

After administration of Macroaggregates of human albumin Curium, you should:

• avoid all direct contact with young children and pregnant women during the first 12 hours after administration.
• drink as much as possible during the day following treatment. This will help eliminate residual radioactivity from your body more quickly.
• urinate frequently to remove the product from your system.

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

If you have been administered more Macroaggregates of human albumin Curium than you should have received

An overdose is unlikely, as you will receive a single, precisely controlled dose of Macroaggregates of human albumin Curium, determined by the nuclear medicine physician supervising the procedure. However, administration of a very high number of particles may cause vascular blockage. If you notice significant changes in breathing (respiratory rate), pulse, or blood pressure, inform your nuclear medicine physician, who will take appropriate measures.

Nevertheless, in the event of an overdose, you will receive appropriate treatment. Specifically, the nuclear medicine physician in charge of the procedure may recommend that you drink plenty of fluids to facilitate the elimination of Macroaggregates of human albumin Curium from the body.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Frequency not known: (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 (fainting). Local allergic reactions have been observed, such as redness, swelling and itching at the injection site. In such cases, you should contact your nuclear medicine physician.

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

Severe allergic reactions: cases of severe allergic reactions have been reported, including shock, which may be fatal. These reactions may not occur immediately.

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 type of adverse effect, consult your doctor or nuclear medicine specialist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Curium Human Serum Albumin Aggregates

You will not be required to store this medicine. This medicine is stored under the responsibility of a specialist in appropriate facilities. Storage of radiopharmaceuticals will comply with national regulations regarding radioactive materials.

6. Contents of the pack and other information

Composition of Human Serum Albumin Macroaggregates Curium

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

Appearance of the product and contents of the pack

Human Serum Albumin Macroaggregates Curium is a reagent kit for radiopharmaceutical preparation.

Pack sizes: kit of 5 multidose vials.

Marketing Authorization Holder and Manufacturer

CIS bio international
RN 306 - Saclay
B.P. 32
91192 Gif-sur-Yvette Cedex
France

This medicinal product is authorized in the following European Economic Area countries under the following names:

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

Spain: Human Serum Albumin Macroaggregates Curium

Date of the most recent revision of this leaflet: April 2020

Other sources of information

Detailed 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 technical data sheet for Human Serum Albumin Macroaggregates Curium is included separately within this package leaflet, in order to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.

Please consult the medicinal product's technical data sheet included in the package.