Macrosalb medi-radiopharma

Macrosalb Medi-Radiopharma, 2.5 mg, kit for the preparation of a radiopharmaceutical preparation
human serum albumin, macroaggregates

Please read this entire leaflet carefully before receiving this medicine, as 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 supervise the procedure.
If you experience any adverse reactions, discuss them with your nuclear medicine specialist. This includes any possible adverse reactions not listed in this leaflet. See section 4.

What this leaflet contains:
What Macrosalb Medi-Radiopharma 2.5 mg is and what it is used for
Important information before use of Macrosalb Medi-Radiopharma 2.5 mg
How to use Macrosalb Medi-Radiopharma 2.5 mg
Possible adverse reactions
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 in the form of human serum albumin macroaggregates, which is a natural protein found in human blood.
This medicine is a radiopharmaceutical product intended solely for diagnostic purposes.
Macrosalb Medi-Radiopharma 2.5 mg must be radiolabelled 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 certain organs. Because the medicine contains a small amount of radioactivity, its presence can be detected by special external detection devices (cameras), which can also produce images known as scans. This scan shows the distribution of radioactivity within the organ and how it functions.
Macrosalb Medi-Radiopharma 2.5 mg is primarily used for lung scanning. These scans provide information about lung structure and blood flow through lung tissue.
Macrosalb Medi-Radiopharma 2.5 mg is also used to show how blood flows through veins.
Use of Macrosalb Medi-Radiopharma 2.5 mg involves exposure to low doses of radiation.
Your physician and nuclear medicine specialist have determined that the clinical benefit derived from the procedure using this radiopharmaceutical product outweighs the risk associated with radiation exposure.

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

Macrosalb Medi-Radiopharma 2.5 mg must not be used:
if the patient is allergic to human albumin or to any of the other
components of this medicine (listed in section 6),
in case of severe pulmonary hypertension.

Warnings and precautions:
Please inform the nuclear medicine specialist:
if the patient has extremely high blood pressure in the lung arteries
(severe pulmonary hypertension), respiratory failure, or if the patient has a heart defect known as a right-to-left shunt;
if the patient is pregnant or there is suspicion of pregnancy;
if the patient is breastfeeding;
if the patient has kidney or liver disease;
if the patient has a transplanted lung.
The nuclear medicine specialist will advise the patient on any necessary precautions to take in such cases.
If you have any questions, please ask your nuclear medicine specialist.

Before administration of Macrosalb Medi-Radiopharma 2.5 mg
the patient should
drink plenty of fluids before starting the examination, to ensure frequent urination during the first hours after the examination.

Children and adolescents
Please consult your nuclear medicine specialist if the child is under 18 years of age.

Medicines made from human blood or plasma
When medicines are manufactured from human blood or plasma, specific measures are taken to prevent transmission of infections to patients. These include:
careful selection of blood and plasma donors to ensure that individuals at risk of carrying infections are excluded;
testing of each donation and plasma pool for signs of viral/infectious agents;
inclusion of steps in the blood or plasma processing that can inactivate or remove viruses.
Despite these precautions, when administering medicines prepared from human blood or plasma, it cannot be completely ruled out that transmission of infectious agents may occur.
This also applies to unknown or newly emerging viruses and other infectious agents.
There have been no reports of viral infections associated with the use of albumin manufactured according to the requirements of the European Pharmacopoeia using established processes.
It is strongly recommended that, for every administration of Macrosalb Medi-Radiopharma 2.5 mg to a patient, the name and batch number of the medicine be recorded, in order to maintain traceability of the batches used.

Macrosalb Medi-Radiopharma 2.5 mg and other medicines
Please inform the nuclear medicine specialist about all medicines currently taken by the patient, those taken recently, and any medicines the patient may have taken, including those available without a prescription, as they may interfere with the interpretation of the examination.
Specific examples include:
a medicine preventing blood clotting (heparin);
anticancer medicines (busulfan, cyclophosphamide, bleomycin, methotrexate);
medicines facilitating breathing (bronchodilators);
some antibiotics used to treat urinary tract infections (e.g. nitrofurantoin);
some medicines used to prevent headaches (e.g. methysergide);
a medicine used in the treatment of magnesium deficiency (magnesium sulfate);
an opium-like narcotic (heroin).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult the nuclear medicine specialist before using this medicine.
If there is any possibility that the patient is pregnant, if menstrual bleeding is delayed, or if the patient is breastfeeding, this should be reported to the nuclear medicine specialist before administering Macrosalb Medi-Radiopharma 2.5 mg.
If there is any uncertainty, it is important to consult the nuclear medicine specialist who will supervise the procedure.
If the patient is pregnant:
The nuclear medicine specialist will administer Macrosalb Medi-Radiopharma 2.5 mg to a pregnant patient only if the expected benefits outweigh the potential risks.
If the patient is breastfeeding:
Please inform the nuclear medicine specialist if the patient is breastfeeding, as the examination may be postponed until the end of the breastfeeding period, or temporary interruption of breastfeeding may be requested until the body is free of radioactivity. This takes approximately 12 hours. Expressed milk should be discarded.
The possibility of resuming breastfeeding should be discussed with the nuclear medicine specialist.

Driving and operating machinery
It is considered unlikely that Macrosalb Medi-Radiopharma 2.5 mg will affect the ability to drive or operate machinery.

Macrosalb Medi-Radiopharma 2.5 mg contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, meaning this medicine is considered "sodium-free".

3. How to use Macrosalb Medi-Radiopharma 2.5 mg

There are strict regulations regarding the handling, preparation and disposal of radiopharmaceuticals.
Macrosalb Medi-Radiopharma 2.5 mg will be administered only in specially controlled facilities.
This medicine may be prepared and administered solely by personnel with appropriate training in safety and with adequate qualifications for its safe use. Such personnel will exercise special caution to ensure safe handling of this product and will inform the patient about their actions.

The nuclear medicine specialist responsible for performing the procedure will determine the appropriate dose of Macrosalb Medi-Radiopharma 2.5 mg to be administered in each individual case. This will be the minimum dose necessary to obtain the required diagnostic information. The usual recommended dose for adults is 40 to 200 MBq (MBq: megabecquerel, a unit used to express 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 Macrosalb Medi-Radiopharma 2.5 mg and procedure details
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 to perform the examination required by the physician. The examination may be performed at any time after the injection. The exact timing of the examination depends on the type of imaging study being performed.

After the injection, the patient will be given a drink and will be asked to urinate immediately before the examination.

Duration of the examination
The nuclear medicine specialist will inform the patient about the expected duration of the procedure.

After receiving Macrosalb Medi-Radiopharma 2.5 mg, the patient should:

• avoid close contact with young children and pregnant women during the first 12 hours after administration;
• drink plenty of fluids the day after the procedure; this will help eliminate trace amounts of radioactivity from the body more quickly;
• urinate frequently to assist in eliminating the product from the body.

The nuclear medicine specialist will inform the patient of any additional precautions to be taken after receiving this medicine. If there are any questions, the patient should contact the nuclear medicine specialist.

Overdose of Macrosalb Medi-Radiopharma 2.5 mg
The risk of overdose is extremely low, as Macrosalb Medi-Radiopharma 2.5 mg is administered as a single dose under strictly controlled conditions by a nuclear medicine specialist performing the procedure. However, administration of a very high number of particles may lead to capillary blockage in the lungs. If noticeable changes in breathing (respiratory rate), pulse or blood pressure occur, the patient should inform the nuclear medicine specialist immediately, who will take appropriate measures.

In the event of an overdose, appropriate treatment will be initiated. In particular, the nuclear medicine specialist in charge of the procedure may recommend drinking large amounts of fluids to facilitate elimination of Macrosalb Medi-Radiopharma 2.5 mg from the body.

If there are further doubts regarding the use of Macrosalb Medi-Radiopharma 2.5 mg, please consult the nuclear medicine specialist supervising the procedure.

4. Possible adverse reactions

Like any medicine, this product may cause adverse reactions, although they do not occur in everyone.
Frequency unknown (frequency cannot be estimated from the available data).
Allergic reactions: Urticaria, chills, fever, nausea, facial flushing and sweating, as well as impaired heart and circulatory function manifested by changes in respiration, pulse, blood pressure and collapse. Local allergic reactions have been observed at the injection site, including redness, swelling and itching. In such cases, contact should be made with a nuclear medicine specialist.
Very rare: (less than 1 patient in 10,000)
Severe allergic reactions: Severe allergic reactions, including life-threatening anaphylactic shock, have been reported. The onset of these reactions may not be immediate.
This radiopharmaceutical product is a source of a very small amount of ionizing radiation and carries a very low risk of cancer or hereditary diseases.
Reporting of adverse reactions
If any adverse reactions occur, they should be discussed with the treating physician or a nuclear medicine specialist. This includes any possible adverse reactions not listed in this leaflet. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181 C, 02-222 Warsaw
Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions enables continuous monitoring of the medicine's safety and helps to provide more information on its safe use.

5. How to store Macrosalb Medi-Radiopharma 2.5 mg

The patient does not need to store this medicinal product personally. This medicine is stored under the supervision of a specialist in appropriate facilities. Storage of radiopharmaceuticals will comply with national regulations concerning 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).
Each vial contains 2.5 mg of human albumin macroaggregates.
Other components 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 Authorisation Holder and Manufacturer
Medi-Radiopharma Ltd.
Szamos Utca 10-12
2030 Érd
Hungary
Tel +36-23-521-261
Fax +36-23-521-260
E-mail: [email protected]

This medicinal product is authorised 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 | Belgium |
| Medi-Macro 2,5 mg kit voor radiofarmaceutisch preparaat | Belgium |
| Medi-Macro 2,5 mg Kit für ein radioaktives Arzneimittel | 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 |

Other sources of information

The following information is intended exclusively for medical professionals:

The complete SmPC for Macrosalb Medi-Radiopharma 2.5 mg is included in the product packaging as a
separate document, intended to provide medical professionals with additional scientific and practical
information regarding the administration and use of this radiopharmaceutical product.