Macrosalb Medi-Radiopharma

Package leaflet: Information for the patient

Macrosalb Medi-Radiopharma 2.5 mg kit for radiopharmaceutical preparation

human albumin microaggregates
Read 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 questions, consult the nuclear medicine specialist supervising
the procedure.
If you experience any side effects, including those not listed in this
leaflet, consult the nuclear medicine specialist. See section 4.
Contents of this leaflet
What Macrosalb Medi-Radiopharma is and what it is used for
What you need to know before you are given Macrosalb Medi-Radiopharma
How Macrosalb Medi-Radiopharma is used
Possible side effects
How to store Macrosalb Medi-Radiopharma
Contents of the pack and other information

1. What Macrosalb Medi-Radiopharma is and what it is used for

Macrosalb Medi-Radiopharma contains the active substance human albumin aggregates,
which is a natural protein derived from human blood.
This medicinal product is a radiopharmaceutical used solely for diagnostic purposes.
Macrosalb Medi-Radiopharma must be radiolabelled with "technetium-99m", and the resulting
product is used for scintigraphy in adults and children.
When injected, the product is temporarily taken up by certain organs.
Because the product contains a small amount of radioactivity, it can be detected from outside
the body using special cameras, and an image, called a scan, can be taken. This scan shows
the distribution of radioactivity in the organ and provides information on how the organ is
functioning.
Macrosalb Medi-Radiopharma is primarily used for lung scans. These scans provide information
on the structure of the lungs and on blood flow through lung tissue.
Macrosalb Medi-Radiopharma is also used to study blood flow in veins.
The use of Macrosalb Medi-Radiopharma involves exposure to small amounts of radioactivity.
Your doctor and the nuclear medicine specialist have determined that the clinical benefit you
will receive from the radiopharmaceutical examination outweighs the risk associated with radiation exposure.

2. What you need to know before receiving Macrosalb Medi-Radiopharma

Macrosalb Medi-Radiopharma must not be used:
if you are allergic to human albumin or to any of the other ingredients of
this medicine (listed in section 6).
in case of severe pulmonary hypertension.

Warnings and precautions
You must inform the nuclear medicine specialist:
if you have abnormally high pressure in the pulmonary arteries (severe pulmonary
hypertension), respiratory failure, or if you are aware of having a heart abnormality
known as a right-to-left cardiac shunt.
if you are pregnant or think you might be pregnant.
if you are breastfeeding.
if you have liver or kidney disease.
if you have undergone a lung transplant.

The nuclear medicine specialist will inform you whether, in these cases, you need to take
any special precautions.
Talk to the nuclear medicine specialist if you have any questions.

Before administration of Macrosalb Medi-Radiopharma you should:
drink plenty of water before starting the examination, so as to urinate as frequently as
possible during the first few hours after the examination, thereby reducing radiation
exposure.

Children and adolescents
Inform the nuclear medicine specialist if you or your child is under 18 years of age.

Medicinal products derived from human blood or plasma
When medicines are prepared from human blood or plasma, specific precautions 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 carrying
infections are excluded,
testing of each individual donation and plasma pools for signs of viruses/infections,
incorporation of steps in the processing of blood or plasma capable of inactivating or
removing viruses.

Despite these measures, when medicines prepared from human blood or plasma are administered,
the possibility of transmitting an infection cannot be completely ruled out.
This also applies to unknown or emerging viruses or other types of infections.
There have been no reports of virus transmission with albumin manufactured according to
European Pharmacopoeia specifications using established procedures.
It is strongly recommended to record the name and batch number of Macrosalb Medi-
Radiopharma each time it is administered, in order to maintain documentation of the batches
used.

Other medicines and Macrosalb Medi-Radiopharma
Inform the nuclear medicine specialist if you are taking, have recently taken, or might take
any other medicines, including medicines obtained without a prescription, as they could
interfere with the interpretation of the images.
Specific examples include:
a medicine used to prevent blood clotting (heparin)
anticancer medicines (busulfan, cyclophosphamide, bleomycin, methotrexate)
medicines used to assist 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 to treat magnesium deficiency (magnesium sulfate)
opioids (heroin)

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding,
consult the nuclear medicine specialist before receiving this medicine.
Inform the nuclear medicine specialist before administration of Macrosalb
Medi-Radiopharma if there is any possibility that you are pregnant, if you have missed
your period, or if you are breastfeeding.

In case of doubt, it is important to consult the nuclear medicine specialist supervising
the examination.

If you are pregnant:
the nuclear medicine specialist will administer Macrosalb
Medi-Radiopharma only if the expected benefit outweighs the potential risks.

If you are breastfeeding:
Inform the nuclear medicine specialist, as they may choose to postpone the examination
until after breastfeeding is completed, or may ask you to stop breastfeeding for a short
period until radioactivity has been eliminated from your body. This takes approximately
12 hours. Breast milk produced during this time must be discarded.
Ask the nuclear medicine specialist when you can resume breastfeeding.

Driving and using machines
Macrosalb Medi-Radiopharma is considered unlikely to affect your ability to drive
vehicles or operate machinery.

Macrosalb Medi-Radiopharma contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose and is therefore essentially sodium-free.

3. How Macrosalb Medi-Radiopharma is used

There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals.
Macrosalb Medi-Radiopharma will be used exclusively in controlled, specialized areas.
This product will be handled and administered only by trained and qualified personnel who are experienced in its safe use. Staff will take particular care in the safe handling of this product and will keep you informed about their actions.
The nuclear medicine specialist supervising your examination will determine the exact amount of Macrosalb Medi-Radiopharma to be administered in your case. This will be the smallest quantity necessary to obtain the required diagnostic information. The normally recommended administered activity for an adult ranges between 40 and 200 MBq (megabecquerel, the unit used to express radioactivity).

Use in children and adolescents
The administered activity for children and adolescents under 18 years of age must be adjusted according to body weight.

Administration of Macrosalb Medi-Radiopharma and performance of the examination
Macrosalb Medi-Radiopharma is administered by intravenous injection. This product is not suitable for regular or continuous administration.
A single injection is sufficient to provide the physician with the necessary information.
Imaging may be performed at any time after the injection. Specifically, the timing of the examination depends on the type of investigation being performed.
After the injection, you will be offered fluids to drink and will be asked to urinate immediately before the examination.

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

After receiving Macrosalb Medi-Radiopharma, you should:

• avoid close contact with children and pregnant women for the first 12 hours following administration.
• drink as much water as possible on the day of treatment. This will help eliminate residual radioactivity from your body more quickly.
• urinate frequently to help clear the product from your system.

The nuclear medicine specialist will inform you if you need to take any special precautions after receiving this medicinal product. Please consult the nuclear medicine specialist if you have any questions.

If you are given more Macrosalb Medi-Radiopharma than you should
Overdose is unlikely, as you will receive only a single dose of Macrosalb Medi-Radiopharma, precisely determined by the nuclear medicine specialist supervising the examination. However, administration of a very high number of particles may cause vascular blockage. If you notice any significant changes in your breathing (respiratory rate), pulse, or blood pressure, inform the nuclear medicine specialist immediately, who will take appropriate measures.
In the event of an overdose, you will receive appropriate treatment. In particular, the nuclear medicine specialist in charge of the procedure may recommend that you drink plenty of fluids to facilitate the elimination of Macrosalb Medi-Radiopharma from your body.

If you have any further questions about the use of Macrosalb Medi-Radiopharma, please consult the nuclear medicine specialist supervising the examination.

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, chills, fever, nausea, facial flushing and sweating, as well as alterations in cardiac and circulatory functions in the form of changes in breathing, pulse, blood pressure and collapse. Local allergic reactions have been observed at the injection site, manifesting as redness, swelling and itching. In such cases, contact the nuclear medicine specialist.
Very rare (less than 1 patient in 10,000)
Severe allergic reactions: serious reactions including shock with potentially fatal outcome have been reported. The onset of these reactions may not be immediate.
This radiopharmaceutical will deliver small amounts of ionizing radiation, which is associated with a very low risk of cancer and congenital abnormalities.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or to the nuclear medicine specialist. You can also report side effects directly through the national reporting system at: www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How Macrosalb Medi-Radiopharma is stored

It is not your responsibility to store this medicinal product. This medicine is stored under the responsibility of a specialist in appropriate premises. Storage of radiopharmaceuticals must comply with national regulations regarding radioactive materials.

6. Package contents and other information

What Macrosalb Medi-Radiopharma contains
The active substance is human albumin microaggregates (or macrosalb).
Each vial contains 2.5 mg of human serum albumin microaggregates.
The other components are human serum albumin, stannous chloride dihydrate (E512), sodium chloride.

Description of the appearance of Macrosalb Medi-Radiopharma and package contents
The product is a kit for the preparation of a radiopharmaceutical.
Pack size: 6 multidose vials.
2 multidose vials.
It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer
Medi-Radiopharma Ltd.
2030 Érd, Szamost st. 10-12.
Hungary

This medicinal product is authorised in the EU Member States under the following names:

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

Other sources of information

The following information is intended for healthcare professionals only:

The complete Summary of Product Characteristics (SmPC) for Macrosalb
Medi-Radiopharma is provided as a separate document within the product packaging,
intended to provide healthcare professionals with additional scientific and practical
information regarding the administration and use of this radiopharmaceutical.