Macroaggregates of human albumin Medi-Radiopharma 2.5 mg radiopharmaceutical preparation kit

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Human Serum Albumin Macroaggregates Medi-Radiopharma 2.5 mg radiopharmaceutical preparation kit

human serum albumin macroaggregates

Read all of this leaflet carefully before you are given this medicine, because it contains important information for you.

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

Leaflet contents:

1. What Human Serum Albumin Macroaggregates Medi-Radiopharma is and what it is used for

2. What you need to know before being administered Human Serum Albumin Macroaggregates Medi-Radiopharma

3. How Human Serum Albumin Macroaggregates Medi-Radiopharma is used

4. Possible side effects

5. How to store Human Serum Albumin Macroaggregates Medi-Radiopharma

6. Contents of the pack and other information

1. What Macroaggregates of Human Albumin Medi-Radiopharma is and what it is used for

This medicinal product contains the active substance human albumin macroaggregates, which is a natural protein derived from human blood.

This medicine is a radiopharmaceutical intended solely for diagnostic use.

This medicinal product must be radiolabelled with 'technetium-99m', and the resulting product is used to perform scintigraphy scans in adults and children.

When injected, certain organs temporarily take up this medicinal product. Because it contains a small amount of radioactivity, it can be detected from outside the body using special cameras, allowing images known as scintigrams to be obtained. These scans show the distribution of radioactivity and provide information on how the organ is functioning.

This medicinal product is primarily used for lung imaging. These scans provide information on lung structure and blood flow through the lung tissue.

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

The use of this medicinal product involves exposure to small amounts of radiation. Your doctor and the nuclear medicine physician have determined that the clinical benefit you will obtain from the radiopharmaceutical procedure outweighs the radiation risk.

2. What you need to know before using Macroagregados de albúmina humana Medi-Radiopharma

Do not use Macroagregados de albúmina humana Medi-Radiopharma:

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

Warnings and precautions:

Consult your nuclear medicine physician:

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

Your nuclear medicine physician will inform you whether special precautions are necessary in these cases.

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

Before administration of Macroagregados de albúmina humana Medi-Radiopharma, you must

• drink plenty of water before the examination begins, 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 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 infections to patients. These include:

• Careful selection of blood and plasma donors to ensure that donors who may carry infections are excluded.
• Testing of each donation and pooled plasma samples to rule out the presence of viruses or infections.
• Incorporation, during processing of blood or plasma, 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 agents cannot be completely ruled out. This also applies to unknown or new viruses or other types of infections.

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

It is strongly recommended that each time you receive a dose of this medicine, the name and batch number of the product be recorded, in order to maintain a record of the batches used.

Other medicines and Macroagregados de albúmina humana Medi-Radiopharma

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 images.

Specific examples include:

• a medicine used to prevent blood clotting (heparin);
• anticancer medicines (busulfan, cyclophosphamide, bleomycin, methotrexate);
• medicines that help breathing (bronchodilators);
• certain antibiotics used to treat urinary tract infections (e.g., nitrofurantoin);
• certain medicines used to prevent headaches (e.g., methysergide);
• a medicine used 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 using this medicine.

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

When in 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 this medicine during pregnancy if the expected benefit outweighs the potential risks.

If you are breastfeeding:

If you are breastfeeding, inform your nuclear medicine physician, as they may delay the study until after breastfeeding has ended or may ask you to interrupt breastfeeding for a short period of time until radioactivity is no longer present in your body.

This may take approximately 12 hours. Breast milk expressed during this time should be discarded.

Consult your nuclear medicine physician about when you can resume breastfeeding.

Driving and using machines

It is considered unlikely that this medicine will affect your ability to drive or operate machinery.

Macroagregados de albúmina humana Medi-Radiopharma contains sodium

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

3. How Macroaggregated Human Albumin Medi-Radiopharma is used

There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. This medicine 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 ensuring 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 this medicine to be used in your case. This will be the minimum quantity necessary to obtain the required information. The generally recommended dose for administration in adults ranges between 40 and 200 MBq (MBq: megabecquerel, the unit of measurement for 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 weight.

Administration of Macroaggregated Human Albumin Medi-Radiopharma and performance of the procedure

This medicine is administered by intravenous injection. This product is not intended for periodic or continuous administration.

For the test prescribed by your doctor, a single injection is sufficient. The tests 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 Macroaggregated Human Albumin Medi-Radiopharma, you should:

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

Your nuclear medicine physician will inform you if special precautions are necessary after administration of this medicine. If you have any doubts, consult your nuclear medicine physician.

If you have been administered more Macroaggregated Human Albumin Medi-Radiopharma than you should have received

An overdose is unlikely, as you will receive only a single dose precisely controlled by the nuclear medicine physician supervising the procedure. 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.

However, in the event of an overdose, you will receive appropriate treatment. Specifically, the nuclear medicine physician responsible for the procedure may advise you to drink plenty of fluids to facilitate the elimination of this medicine from your body.

If you have any further questions regarding the use of this medicine, consult the nuclear medicine physician supervising the procedure.

4. Possible adverse effects

Like all medicines, this medicinal product may produce adverse effects, although not everyone will experience them.

Frequency not known: (cannot be estimated from available data)

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

Very rare: (may affect less than 1 in 10,000 patients)

Severe allergic reactions: cases of severe allergic reactions, including shock, which may potentially be fatal, have been reported. It is also possible that 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 physician, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es

By reporting adverse effects, you can help provide more information on the safety of this medicinal product.

5. Storage of Human Serum Albumin Macroaggregates Medi-Radiopharm

This medicine does not require storage by the patient. This medicine is stored under the responsibility of a specialist in appropriate facilities. Storage of radiopharmaceuticals must comply with national regulations regarding radioactive materials.

6. Contents of the container and other information

Composition of Macroaggregates of human serum albumin Medi-Radiopharma

• The active substance is human serum albumin macroaggregates (or macrosalb).

One vial contains 2.5 mg of human serum albumin macroaggregates.

• The other components are human serum albumin, stannous chloride dihydrate (E-512), sodium chloride.

Appearance of the product and contents of the container

The product is a reagent kit for radiopharmaceutical preparation.

Pack sizes:

6 multidose vials.

2 multidose vials.

Some pack sizes may not be marketed.

Marketing Authorization Holder and Manufacturer

Medi-Radiopharma Ltd.

2030 Érd, Szamost st. 10-12.

Hungary

This medicinal product is authorized in the European Economic Area (EEA) member states under the following names:

Date of the last revision of this leaflet: 11/2022

Other sources of information

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

This information is intended for healthcare professionals only:

The complete summary of product characteristics for Macroaggregates of human albumin Medi-Radiopharma 2.5 mg, radiopharmaceutical preparation kit, is included as a separate document from the product packaging, in order to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.