MACROAGGREGATES OF HUMAN ALBUMIN CURIUM 2 MG KIT FOR RADIOPHARMACEUTICAL PREPARATION

Introduction

Package Leaflet: Information for the Patient

Human Albumin Macroaggregates Curium 2 mg Reagent Kit for Radiopharmaceutical Preparation

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 doctor, who will be supervising the procedure.
• If you experience any side effects, talk to your nuclear medicine doctor, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Human Albumin Macroaggregates Curium and what is it used for
2. What you need to know before you start using Human Albumin Macroaggregates Curium
3. How to use Human Albumin Macroaggregates Curium
4. Possible side effects
5. Storage of Human Albumin Macroaggregates Curium
6. Contents of the pack and further information

1. What is Human Albumin Macroaggregates Curium and what is it used for

The active substance of Human Albumin Macroaggregates Curium is human albumin macroaggregates, which is a natural protein from human blood.

This medicine is a radiopharmaceutical for diagnostic use only.

Human Albumin Macroaggregates Curium must be radiolabelled with «technetium-99m», and the resulting product is used to perform scintigraphies in adults and children.

When injected, certain organs temporarily capture this medicine. Since it contains a small amount of radioactivity, it can be detected from outside the body with special cameras and images can be obtained, known as scintigraphies. These examinations show the distribution of radioactivity in the organ and body and can provide your doctor with very valuable information about the structure and function of this organ.

Human Albumin Macroaggregates Curiumis mainly used for lung examinations. These examinations provide information about the structure of the lungs and blood flow through lung tissue.

This medicine is also used to show how blood circulates through the veins.

The use of Human Albumin Macroaggregates Curium involves exposure to small amounts of radioactivity. Your doctor and nuclear medicine doctor have considered that the clinical benefit you will gain from this procedure with the radiopharmaceutical outweighs the risk due to radiation.

2. What you need to know before you start using Human Albumin Macroaggregates Curium

Do not use Human Albumin Macroaggregates Curium

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

Warnings and precautions

Talk to your nuclear medicine doctor:

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

Your nuclear medicine doctor will tell you if you need to take any special precautions in these cases.

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

Before administration of Human Albumin Macroaggregates Curium, you shoulddrink 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 infectious agents, including:

• Careful selection of blood and plasma donors to ensure that donors who may be carriers of an infection are excluded.
• Testing of each donation and plasma pools for the presence of viruses or infections.
• Inclusion in the manufacturing process of steps that allow inactivation or elimination of viruses.

Despite these measures, when human blood or plasma-derived medicines are administered, the possibility of transmitting infectious diseases cannot be completely ruled out. The same applies to unknown or new viruses and other types of infectious agents.

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

Other medicines and Human Albumin Macroaggregates Curium

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.

Some specific examples are:

• a medicine to prevent blood clotting(heparin).
• cancer medicines(busulfan, cyclophosphamide, bleomycin, methotrexate).
• medicines to breathe better(bronchodilators).
• some antibiotics used to treat urinary tract infections(e.g. nitrofurantoin).
• some medicines used to prevent headaches(e.g. methysergide).
• a medicine for the treatment of magnesium deficiency(magnesium sulfate).
• opioids(heroin)

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, talk to your nuclear medicine doctor before you are given this medicine.

You must inform your nuclear medicine doctor before administration of Human Albumin Macroaggregates Curium if you might be pregnant, if you have a delayed period, or if you are breastfeeding.

In case of doubt, it is important that you talk to your nuclear medicine doctor, who will be supervising the procedure.

If you are pregnant:

Your nuclear medicine doctor will only give you Human Albumin Macroaggregates Curium during pregnancy if the expected benefit outweighs the risk.

If you are breastfeeding:

If you are breastfeeding, tell your nuclear medicine doctor, as they may delay the study until you finish breastfeeding or ask you to interrupt breastfeeding for a short period of time until there is no longer radioactivity in your body, which may take around 12 hours. The expressed milk during this period should be discarded.

Please ask your nuclear medicine doctor when you can restart breastfeeding.

Driving and using machines

It is considered unlikely that Human Albumin Macroaggregates Curium will affect your ability to drive or use machines.

Human Albumin Macroaggregates Curium contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per administration; i.e., it is essentially «sodium-free».

3. How to use Human Albumin Macroaggregates Curium

There are strict rules for the use, handling, and disposal of radiopharmaceuticals. Human Albumin Macroaggregates Curium will only be used in special controlled areas.

This product will only be handled and administered by trained and qualified personnel 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 Human Albumin Macroaggregates Curium to be used in your case. This will be the minimum amount necessary to obtain the desired information. The generally recommended amount for administration to an adult is 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 old, the amount to be administered will be adjusted according to the child's weight.

Administration of Human Albumin Macroaggregates Curium and performance of the procedure

Human Albumin Macroaggregates Curium is administered by injection into a vein.

To perform the procedure indicated by your doctor, a single injection is sufficient. The test can be carried out at any time after the injection has been administered. The exact time when it 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 administration of Human Albumin Macroaggregates Curium, you should:

• 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 radioactivity leave your body more quickly.
• urinate frequently to eliminate the product from your body.

Your nuclear medicine doctor will inform you if you need to take any special precautions after receiving this medicine. If you have any doubts, talk to your nuclear medicine doctor.

If you have been given more Human Albumin Macroaggregates Curium than you should

Overdose is unlikely because you will receive a single, precisely controlled dose of Human Albumin Macroaggregates Curium, supervised by the nuclear medicine doctor. Administration of a very high number of particles may cause vascular blockage. If you notice obvious changes in breathing (respiratory rate), pulse, or blood pressure, inform your nuclear medicine doctor, who will take the necessary measures.

However, in case of overdose, you will receive the appropriate treatment. In particular, the nuclear medicine doctor responsible for the procedure may recommend that you drink plenty of water to facilitate the elimination of Human Albumin Macroaggregates Curium from the body.

In case of doubt about the use of this medicine, ask the nuclear medicine doctor supervising the procedure.

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 (fainting). 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 people)

Severe allergic reactions: cases of severe allergic reactions, including anaphylactic shock, which can be fatal, have been reported. It is also possible that the onset of these reactions may not be immediate.

Administration of this radiopharmaceutical involves receiving a small amount of ionizing radiation with a very low risk of developing cancer and genetic defects.

Reporting of side effects

If you experience any side effects, talk to your doctor or nuclear medicine specialist, even if it is a possible side effect not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Health 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 Curium

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 further information

Composition of Human Albumin Macroaggregates Curium

• The active substance is human serum albumin macroaggregates (or macrosalb).
• Each vial contains 2 mg of human serum albumin macroaggregates.
• The other components are human albumin, tin(II) chloride dihydrate (E-512), sodium chloride, in a nitrogen atmosphere (E-941).

Appearance of the product and pack contents

Human Albumin Macroaggregates Curium is a reagent kit for radiopharmaceutical preparation.

Pack sizes: 5-vial multidose kit.

Marketing authorisation holder and manufacturer

CIS bio international

RN 306 - Saclay

B.P. 32

91192 Gif-sur-Yvette Cedex

France

This medicine is authorised in the following European Economic Area Member States with the name

Austria, Belgium, Croatia, Denmark, Slovakia, Slovenia, Malta, Norway, Netherlands, Portugal, Czech Republic: Pulmocis

Spain: Human Albumin Macroaggregates Curium

Date of last revision of this leaflet: April 2020

Other sources of information

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health 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 Curium is included in a separate document in this leaflet, in order to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.

Please consult the summary of product characteristics of the medicine included in the package.