NANOCOLLOIDS OF ALBUMIN RADIOPHARMACY 500 MICROGRAMS RADIOPHARMACEUTICAL PREPARATION KIT

Introduction

Package Leaflet: Information for the User

Nanocolloids of human albumin Radiopharmacy 500 micrograms kit for radiopharmaceutical preparation

Colloidal human albumin labeled with technetium (99mTc)

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 is 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 Nanocolloids of human albumin Radiopharmacy 500 micrograms and what is it used for
2. What you need to know before you are given Nanocolloids of human albumin Radiopharmacy 500 micrograms
3. How to use Nanocolloids of human albumin Radiopharmacy 500 micrograms
4. Possible side effects
5. Storage of Nanocolloids of human albumin Radiopharmacy 500 micrograms
6. Package contents and further information

1. What is Nanocolloids of human albumin Radiopharmacy 500 micrograms and what is it used for

This medicine is a radiopharmaceutical for diagnostic use only.

Nanocolloids of human albumin Radiopharmacy 500 micrograms must be radiolabeled with technetium (99mTc) and the resulting product is used for the acquisition of scintigraphic images and evaluation of:

• bone marrow,

• inflammation in the body
• lymphatic system integrity and differentiation between venous and lymphatic obstruction
• sentinel lymph nodes in tumor diseases (sentinel node mapping in melanoma, breast cancer, penile cancer, epidermoid carcinoma of the oral cavity, and vulvar cancer).

The use of Nanocolloids of human albumin Radiopharmacy 500 micrograms labeled with technetium (99mTc) implies exposure to small amounts of radioactivity. Your doctor and nuclear medicine doctor consider that the clinical benefit you will gain from this intervention with the radiopharmaceutical is greater than the risk involved in radiation exposure.

2. What you need to know before you are given Nanocolloids of human albumin Radiopharmacy 500 micrograms

Nanocolloids of human albumin Radiopharmacy 500 micrograms must not be used

• if you are allergic to human colloidal albumin or to any of the other components of this medicine (see section 6).
• during pregnancy if you are to undergo a lymphoscintigraphy of the pelvis. In patients with complete lymphatic obstruction, lymphoscintigraphy is not recommended due to the risk of radiation necrosis at the injection site.

Warnings and precautions

Be particularly careful with Nanocolloids of human albumin Radiopharmacy 500 micrograms

• if you are pregnant or think you may be pregnant,
• if you are breastfeeding,
• if you have kidney or liver problems.

You should inform your nuclear medicine doctor if any of these apply to you. Your nuclear medicine doctor will inform you if you need to take special precautions after using this medicine. Talk to your nuclear medicine doctor if you have any questions.

Before administration of Nanocolloids of human albumin Radiopharmacy 500 micrograms, you should:

• drink plenty of water and be well-hydrated before starting the procedure to urinate frequently during the first hours after the procedure.

Children and adolescents

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

Medicines made from human blood or plasma

When medicines are made from human blood or plasma, certain measures are put in place to prevent the transmission of infections to patients. These include:

• careful selection of blood and plasma donors to ensure that those at risk of carrying infections are excluded,
• testing of each donation and plasma pools for signs of virus/infection,
• inclusion of steps to inactivate or remove viruses during the processing of blood or plasma.

Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of transmitting infections cannot be completely excluded. This also applies to unknown or emerging viruses or other types of infections.

There have been no reports of virus infections related to albumin manufactured according to the specifications of the European Pharmacopoeia and in accordance with established processes.

It is strongly recommended that each time you receive a dose of Nanocolloids of human albumin Radiopharmacy 500 micrograms, the name and batch number of the medicine should be recorded to keep a record of the batches used.

Use of Nanocolloids of human albumin Radiopharmacy 500 micrograms with other medicines

Tell your nuclear medicine doctor if you are taking, have recently taken, or might take other medicines, as they may interfere with the interpretation of the images. Talk to your doctor before undergoing a lymphatic system examination and if you have previously been investigated with X-rays or contrast agent examinations. This may affect the outcome. Ask your nuclear medicine doctor before taking any medicine.

Pregnancy and breastfeeding

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

You should inform your nuclear medicine doctor before administration of Nanocolloids of human albumin Radiopharmacy 500 micrograms if there is a possibility that you are pregnant, if you have a delayed period, or if you are breastfeeding. In case of doubt, it is important to consult your nuclear medicine doctor who will supervise the procedure.

Do not use Nanocolloids of human albumin Radiopharmacy 500 micrograms during pregnancy.

If you are breastfeeding, inform your nuclear medicine doctor, as they will advise you to stop breastfeeding until the radioactivity has left your body. This may take 24 hours. You should discard the expressed milk. Consult your nuclear medicine doctor when you can resume breastfeeding.

Driving and using machines

Nanocolloids of human albumin Radiopharmacy 500 micrograms is unlikely to affect your ability to drive or use machines.

Nanocolloids of human albumin Radiopharmacy 500 micrograms contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per vial; this is essentially "sodium-free".

3. How to use Nanocolloids of human albumin Radiopharmacy 500 micrograms

There are strict rules for the use, handling, and disposal of radiopharmaceuticals. Nanocolloids of human albumin Radiopharmacy 500 micrograms 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 Nanocolloids of human albumin Radiopharmacy 500 micrograms to be used in your case. This will be the minimum amount necessary to obtain the desired information.

The generally recommended amount to administer to an adult is 5 to 500 MBq (Megabecquerels, the unit used to express radioactivity).

No dose reduction is necessary in renal or hepatic insufficiency.

Use in children and adolescents

In children and adolescents, the amount to be administered will be adjusted according to their body weight.

Administration of Nanocolloids of human albumin Radiopharmacy 500 micrograms and performance of the procedure

Nanocolloids of human albumin Radiopharmacy 500 micrograms is administered after radiolabeling by intravenous or subcutaneous route (one or more injection sites).

This medicine is not intended for regular or continuous administration.

After injection, you will be offered something to drink and asked to urinate immediately before starting the procedure.

Duration of the procedure

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

After administration of Nanocolloids of human albumin Radiopharmacy 500 micrograms, you should:

• avoid direct contact with small children and pregnant women during the first 24 hours after administration
• urinate frequently to eliminate the product from your body

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

If you have been given more Nanocolloids of human albumin Radiopharmacy 500 micrograms than you should

Overdose is unlikely, as you will receive a dose of Nanocolloids of human albumin Radiopharmacy 500 micrograms under the precise control of the nuclear medicine doctor supervising the procedure. However, in the event of an overdose, you will receive appropriate treatment.

In particular, the nuclear medicine doctor in charge of the procedure may recommend that you take plenty of fluids to facilitate the elimination of Nanocolloids of human albumin Radiopharmacy 500 micrograms from your body.

If you have any further questions about the use of Nanocolloids of human albumin Radiopharmacy 500 micrograms, ask your nuclear medicine doctor.

4. Possible side effects

Like all medicines, Nanocolloids of human albumin Radiopharmacy 500 micrograms can cause side effects, although not everybody gets them.

During evaluation, the following frequency data are taken as a basis:

Very rare:

Mild and temporary hypersensitivity reactions, which may present with symptoms such as injection site reactions/local skin reactions, rash, pruritus, immune system disorders, dizziness, decreased blood pressure.

When a radiopharmaceutical containing proteins, such as Nanocolloids of human albumin Radiopharmacy 500 micrograms, is administered to a patient, hypersensitivity reactions may occur, including, rarely, life-threatening anaphylaxis with a frequency not known.

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

If you experience side effects, tell your nuclear medicine doctor. This includes possible side effects not listed in this leaflet.

Reporting of side effects

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

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

5. Storage of Nanocolloids of human albumin Radiopharmacy 500 micrograms

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.

The following information is intended only for the specialist.

Do not use Nanocolloids of human albumin Radiopharmacy 500 micrograms after the expiry date stated on the carton and label.

Do not use Nanocolloids of human albumin Radiopharmacy 500 micrograms if the integrity of this vial is compromised.

6. Package contents and further information

Composition of Nanocolloids of human albumin Radiopharmacy 500 micrograms

The active substance is human colloidal albumin. Each vial contains 500 micrograms of human colloidal albumin

The other ingredients are:

Tin(II) chloride dihydrate (E512), sodium dihydrogen phosphate dihydrate (E339), disodium phosphate dihydrate (E339), glucose monohydrate, hydrochloric acid (E507), sodium hydroxide (E524), nitrogen (E941)

Appearance and package contents

This product is a kit for radiopharmaceutical preparation.

Each vial contains a white or almost white powder for the preparation of an injectable solution.

Nanocolloids of human albumin Radiopharmacy 500 micrograms consists of six vials. The contents of the vial must be dissolved in a solution and combined with radioactive technetium before use as an injectable solution. Once the radioactive substance sodium pertechnetate (99mTc) is added to the vial, the technetium-labeled human albumin nanocolloids are formed. This solution is ready for injection.

Package sizes:

1 package of 6 vials

Package of 2 vials

Not all package sizes may be marketed

Marketing authorization holder:

RADIOPHARMACY Laboratory Ltd

2040, Budaörs, Gyár st. 2. Hungary

Tel: +36-23-886-950, +36-23-886-951

Fax: +36-23-886-955

e-mail: [email protected]

Manufacturer:

Medi-Radiopharma Ltd

2030 Érd, Szamos u. 10-12.

Hungary

You can request more information about this medicine from the local representative of the marketing authorization holder:

Date of last revision of this leaflet:September 2020

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

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This information is intended only for healthcare professionals

The complete Summary of Product Characteristics of Nanocolloids of human albumin Radiopharmacy 500 micrograms is included in a separate document in the product package, 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 [the Summary of Product Characteristics must be included in the package]