Macrosalb Medi-radiopharma

Package Leaflet: Patient Leaflet

Macrosalb Medi-Radiopharma, 2.5 mg, Kit for the Preparation of a Radiopharmaceutical

Radiopharmaceutical
Human albumin, macroaggregates

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

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your nuclear medicine specialist who will be supervising your treatment.
If you experience any side effects, talk to your nuclear medicine specialist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

What Macrosalb Medi-Radiopharma 2.5 mg is and what it is used for
Important information before using Macrosalb Medi-Radiopharma 2.5 mg
How to use Macrosalb Medi-Radiopharma 2.5 mg
Possible side effects
How to store Macrosalb Medi-Radiopharma 2.5 mg
Contents of the pack and other information

1. What it is and what it is used for

Macrosalb Medi-Radiopharma 2.5 mg contains the active substance human albumin macroaggregates, which is a natural human blood protein.
This medicine is a radiopharmaceutical product intended solely for diagnostic purposes.
Macrosalb Medi-Radiopharma 2.5 mg is to be radiolabeled with "technetium-99m", and the resulting product is used for scintigraphic imaging in adults and children.
After injection, the medicine is temporarily taken up by some organs. Because the medicine contains a small amount of radioactivity, its presence can be detected by special detection devices (cameras) outside the body, which can also take pictures, called scans. This scan shows the distribution of radioactivity in the organ and how it functions.
Macrosalb Medi-Radiopharma 2.5 mg is mainly used for lung scanning. These scans provide information about the structure of the lungs and blood flow through lung tissue.
Macrosalb Medi-Radiopharma 2.5 mg is also used to show how blood flows through the veins.
The use of Macrosalb Medi-Radiopharma 2.5 mg involves exposure to small amounts of radiation.
Your doctor and nuclear medicine specialist have decided that the clinical benefit of the procedure using the radiopharmaceutical product outweighs the risk from radiation exposure.

2. Important information before using Macrosalb Medi-Radiopharma 2.5 mg

Macrosalb Medi-Radiopharma 2.5 mg must not be used:

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

Warnings and precautions:

You should inform your nuclear medicine specialist:
if you have extremely high blood pressure in the pulmonary arteries (severe pulmonary hypertension), respiratory failure, or if you have been diagnosed with a heart defect called right-to-left shunt;
if you are pregnant or think you may be pregnant;
if you are breastfeeding;
if you have kidney or liver disease;
if you have had a lung transplant.
Your nuclear medicine specialist will inform you about any precautions to be taken in such cases.
If you have any questions, you should ask your nuclear medicine specialist.

Before administration of Macrosalb Medi-Radiopharma 2.5 mg, you should

before the examination, you should drink plenty of water so that you can urinate as often as possible in the first few hours after the examination.

Children and adolescents

You should consult your nuclear medicine specialist if your child is under 18 years old.

Medicines made from human blood or plasma

When medicines are made 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 individuals at risk of transmitting infections are excluded;
testing each donation and plasma pool for signs of viruses/infectious agents;
including steps in the manufacturing process that can inactivate or remove viruses.
Despite these precautions, when medicines are prepared from human blood or plasma, the possibility of transmitting infectious agents cannot be completely excluded.
This also applies to any unknown or newly emerging viruses and other infectious agents.
There have been no reports of viral infections with the use of albumin produced in accordance with the requirements of the European Pharmacopoeia using established processes.
It is strongly recommended that for each administration of Macrosalb Medi-Radiopharma 2.5 mg to a patient, the name and batch number of the medicine should be recorded to keep a record of the batches used.

Macrosalb Medi-Radiopharma 2.5 mg and other medicines

You should inform your nuclear medicine specialist about all medicines you are taking or have recently taken, including those that are available without a prescription, as they may interfere with the interpretation of the examination.
Specific examples include:
medicines that prevent blood clotting (heparin);
anticancer medicines (busulfan, cyclophosphamide, bleomycin, methotrexate);
medicines that make breathing easier (bronchodilators);
certain antibiotics used to treat urinary tract infections (e.g. nitrofurantoin);
certain medicines used to prevent headaches (e.g. methysergide);
medicines used to treat magnesium deficiency (magnesium sulfate);
opium-like medicines (heroin).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your nuclear medicine specialist before using this medicine.
If you are pregnant, your nuclear medicine specialist will only give you Macrosalb Medi-Radiopharma 2.5 mg if the expected benefits outweigh the potential risks.
If you are breastfeeding, you should inform your nuclear medicine specialist, as they may delay the examination until you have finished breastfeeding or ask you to temporarily stop breastfeeding until the radioactivity has been eliminated from your body. This takes about 12 hours. You should discard the expressed milk.
The possibility of resuming breastfeeding should be discussed with your nuclear medicine specialist.

Driving and using machines

It is unlikely that Macrosalb Medi-Radiopharma 2.5 mg will affect your ability to drive or use machines.

Macrosalb Medi-Radiopharma 2.5 mg contains sodium

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

3. How to use Macrosalb Medi-Radiopharma 2.5 mg

There are strict regulations regarding the use, preparation, and disposal of radiopharmaceutical products. Macrosalb Medi-Radiopharma 2.5 mg will only be used in specially controlled facilities.
This medicine can only be prepared and administered by persons with the appropriate training in safety and qualifications in the safe use of this product. These persons will take special precautions to ensure the safe use of this product and will inform you of their actions.
Your nuclear medicine specialist will choose the appropriate dose of Macrosalb Medi-Radiopharma 2.5 mg to be used in your case. This will be the minimum dose necessary to obtain the expected diagnostic information. The recommended dose for adults is usually between 40 and 200 MBq (megabecquerel, the unit in which radioactivity is expressed).

Use in children and adolescents

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

Administration of Macrosalb Medi-Radiopharma 2.5 mg and procedure

Macrosalb Medi-Radiopharma 2.5 mg is administered by intravenous injection. This medicine is not intended for regular or continuous administration.
A single injection is sufficient for the examination. The examination can be performed at any time after injection. The exact time of the examination depends on its type.
After injection, you will be given a drink and asked to urinate immediately before the examination.

Duration of the examination

Your nuclear medicine specialist will inform you about the expected duration of the procedure.

After administration of Macrosalb Medi-Radiopharma 2.5 mg, you should:

avoid close contact with small children and pregnant women for the first 12 hours after administration;
drink plenty of fluids the next day after the procedure to help eliminate any remaining radioactivity from your body;
urinate frequently to eliminate the product from your body.
Your nuclear medicine specialist will inform you about any precautions to be taken after receiving this medicine. If you have any questions, you should ask your nuclear medicine specialist.

Overdose of Macrosalb Medi-Radiopharma 2.5 mg

There is a very small chance of overdose, as Macrosalb Medi-Radiopharma 2.5 mg is administered in a single dose under strictly controlled conditions by a nuclear medicine specialist performing the procedure. Administration of a very large number of particles may lead to blockage of blood vessels. If you notice any changes in breathing (breathing rate), pulse, or blood pressure, you should tell your nuclear medicine specialist, who will take appropriate action.
If overdose occurs, appropriate treatment will be given. In particular, your nuclear medicine specialist may recommend drinking plenty of fluids to help eliminate the medicine from your body.
If you have any further questions about the use of Macrosalb Medi-Radiopharma 2.5 mg, you should ask your nuclear medicine specialist.

4. Possible side effects

Like all medicines, this product can cause side effects, although not everybody gets them.
Frequency not known (frequency cannot be estimated from the available data).
Allergic reactions: Hives, chills, fever, nausea, flushing, and sweating, as well as impaired heart function and circulation in the form of changes in breathing, pulse, blood pressure, and shock. Local allergic reactions have been observed in the form of redness, swelling, and itching at the injection site. If this occurs, you should contact your nuclear medicine specialist.
Very rare: (less than 1 in 10,000)
Severe allergic reactions: Severe allergic reactions, including anaphylactic shock, which can be life-threatening, have been reported. The onset of these reactions may not be immediate.
This radiopharmaceutical product is a source of very small amounts of ionizing radiation and poses a very small risk of cancer or genetic disorders.

Reporting of side effects

If you experience any side effects, you should talk to your doctor or nuclear medicine specialist. This includes any possible side effects not listed in this leaflet. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181 C, 02-222 Warsaw
Phone: +48 22 49 21 301, Fax: + 48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Macrosalb Medi-Radiopharma 2.5 mg

You do not need to store this medicine yourself. This medicine is stored under the supervision of a specialist in appropriate facilities. The storage of radiopharmaceuticals will be in accordance with national regulations regarding radioactive materials.

6. Contents of the pack and other information

What Macrosalb Medi-Radiopharma 2.5 mg contains

The active substance is human albumin macroaggregates (macrosalb).
One vial contains 2.5 mg of human albumin macroaggregates.
The other ingredients are: human albumin, serum, tin (II) chloride dihydrate, sodium chloride.

What Macrosalb Medi-Radiopharma 2.5 mg looks like and contents of the pack

The product is a component of a kit for the preparation of a radiopharmaceutical product.
Pack sizes: 6 multidose vials
2 multidose vials
Not all pack sizes may be marketed

Marketing Authorization Holder and Manufacturer

Medi-Radiopharma Ltd.
Szamos Utca 10-12
2030 Érd
Hungary
phone
+36-23-521-261
fax
+36-23-521-260
email: mediradiopharma-ltd@mediradiopharma.hu

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Proposed Name Country

Medi-MAA
Denmark
Medi-MAA 2,5 mg Kit für ein radioaktives Arzneimittel
Austria
Medi-Macro 2,5 mg trousse pour préparation radiopharmaceutique
Medi-Macro 2,5 mg kit voor radiofarmaceutisch preparaat
Belgium
Medi-Macro 2,5 mg Kit für ein radioaktives Arzneimittel
Medi-MAA 2.5 mg
Bulgaria
MAA Medi-Radiopharma
Czech Republic
Macrosalb Medi-Radiopharma 2.5 mg
Finland
MediMAA 2,5 mg kit pour préparation radio-pharmaceutique
France
Medi-MAA 2,5 mg
Germany
Macrosalb Medi-Radiopharma
Hungary
Macrosalb Medi-Radiopharma 2.5 mg
Italy
Medi-MAA 2.5 mg
Luxembourg
Macrosalb 2.5 mg kit for radiopharmaceutical preparation
Malta
Medimaa 2.5 mg
Norway
Macrosalb Medi-Radiopharma 2,5 mg
Poland
Medi-MAA 2.5 mg equipo de reactivos para preparación radiofarmacéutica
Spain
Macrosalb Medi-Radiopharma
Sweden
Macrosalb Medi-Radiopharma 2.5 mg
Netherlands

Date of last revision of the leaflet:

Other sources of information

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The following information is intended for healthcare professionals only:
The full SmPC for Macrosalb Medi-Radiopharma 2.5 mg is included in the package as a separate document, which is intended to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical product.