HUMAN ALBUMIN MACROAGGREGATES MEDI-RADIOPHARMA 2.5 mg KIT FOR RADIOPHARMACEUTICAL PREPARATION

2. What you need to know before you are given Human Albumin Macroaggregates Medi-Radiopharma

You should not be given Human Albumin Macroaggregates Medi-Radiopharma:

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

Warnings and precautions:

Talk to your nuclear medicine doctor:

• if you have unusually high blood pressure in the arteries of the lungs (severe pulmonary hypertension), lung failure, or if you know you have a heart defect known as right-to-left shunt.
• if you are pregnant or think you may be pregnant.
• if you are breast-feeding.
• if you have kidney or liver disease.
• if you have had a lung transplant.

Your nuclear medicine doctor will inform you if it is necessary to take special precautions in these cases.

If you have any doubts, talk to your nuclear medicine doctor.

Before you are given Human Albumin Macroaggregates Medi-Radiopharma, you must

• drink plenty of water before starting the examination so that you urinate as frequently as possible during the first few hours after the study.

Children and adolescents

Tell your nuclear medicine doctor if you are under 18 years old or your child is under 18 years old.

Medicines made 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 be carriers of infections are excluded.
• testing of each donation and of plasma pools for the presence of viruses or infections.
• incorporation of steps in the processing of blood or plasma that allow viruses to be inactivated or removed.

Despite these measures, when medicines derived from human blood or plasma are administered, the possibility of transmitting infectious diseases cannot be completely ruled out. The same 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 medicine be recorded to keep a record of the batches used.

Other medicines and Human Albumin Macroaggregates Medi-Radiopharma

Tell your nuclear medicine doctor if you are taking, have recently taken, or might take any other medicines, including those bought without a prescription, as they may interfere with the interpretation of the images.

Specific examples include:

• a medicine to prevent blood clotting (heparin);
• cancer medicines (busulfan, cyclophosphamide, bleomycin, methotrexate);
• medicines that help you breathe (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 breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your nuclear medicine doctor before using this medicine.

You must inform your nuclear medicine doctor before administration of this medicine if you are pregnant, have missed a period, or are breast-feeding.

When in doubt, it is important to talk to your nuclear medicine doctor who will be supervising the procedure.

If you are pregnant:

Your nuclear medicine doctor will only give you this medicine during pregnancy if the expected benefit outweighs the risks.

If you are breast-feeding:

If you are breast-feeding, tell your nuclear medicine doctor, as you may need to delay the study until you finish breast-feeding or be asked to interrupt breast-feeding for a short period of time until no radioactivity is left in your body.

This may take approximately 12 hours. You should discard the expressed milk.

Ask your nuclear medicine doctor when you can restart breast-feeding.

Driving and using machines

It is unlikely that this medicine will affect your ability to drive or use machines.

Human Albumin Macroaggregates Medi-Radiopharma contains sodium

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

3. How Human Albumin Macroaggregates Medi-Radiopharma is given

There are strict rules about the use, handling, and disposal of radiopharmaceuticals. This medicine will only be used in special controlled areas.

This product will only be handled and administered by trained and qualified personnel who are authorized to use it safely. These people will take special care in the safe use of this product and will inform you of their actions.

The nuclear medicine doctor supervising the procedure will decide the amount of this medicine to be used in your case. This will be the minimum amount necessary to obtain the desired information. The recommended amount to be administered to an adult is usually between 40 and 200 MBq (MBq: megabecquerel, the unit of measurement of radioactivity).

Use in children and adolescents

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

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

This medicine is administered by injection into a vein. This product is not intended for periodic or continuous administration.

A single injection is sufficient to perform the test indicated by your doctor. The tests can be performed at any time after you have been given the injection. The exact time when the test will be performed depends on the type of examination.

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

Duration of the procedure

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

After you have been given Human Albumin Macroaggregates Medi-Radiopharma, you must:

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

Your nuclear medicine doctor will inform you if it is necessary to take special precautions after you have been given this medicine. If you have any doubts, talk to your nuclear medicine doctor.

If you have been given more Human Albumin Macroaggregates Medi-Radiopharma than you should

Overdose is unlikely because you will only receive a single, precisely controlled dose of this medicine from your nuclear medicine doctor. Administration of a very high number of particles may cause vascular blockage. If you notice changes in breathing (breathing rate), pulse, or blood pressure, tell your nuclear medicine doctor, who will take the necessary measures.

However, in case of overdose, you will receive appropriate treatment. In particular, your nuclear medicine doctor may recommend that you drink plenty of fluids to facilitate the elimination of this medicine from your body.

If you have any further questions about the use of this medicine, ask your nuclear medicine doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

Allergic reactions: urticaria (hives), chills, fever, nausea, flushing of the face, and sweating, as well as heart and circulation disorders, 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 this case, you should contact your nuclear medicine doctor.

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

Severe allergic reactions: cases of severe allergic reactions, including shock, which can be potentially life-threatening, 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 cancer and genetic defects.

Reporting of side effects

If you experience any side effects, talk to your doctor or nuclear medicine doctor, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaRAM.es

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Human Albumin Macroaggregates Medi-Radiopharma

You will not need to store this medicine. This medicine is stored under the responsibility of the specialist in suitable facilities. The storage of radiopharmaceuticals will be carried out in accordance with national regulations on radioactive materials.

6. Contents of the pack and other information

Composition of Human Albumin Macroaggregates Medi-Radiopharma

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

One vial contains 2.5 mg of human albumin macroaggregates.

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

Appearance of the product and contents of the pack

The product is a kit for radiopharmaceutical preparation.

Package sizes:

6 multidose vials.

2 multidose vials.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Medi-Radiopharma Ltd.

2030 Érd, Szamost st. 10-12.

Hungary

This medicine is authorised in the Member States of the European Economic Area (EEA) under the following names:

Date of last revision of this leaflet: 11/2022

Other sources of information

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/.

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This information is intended only for healthcare professionals:

The full summary of product characteristics of Human Albumin Macroaggregates Medi-Radiopharma 2.5 mg Kit for Radiopharmaceutical Preparation 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.