Prospect: information for the user

Albumin nanocolloidsRadiopharmacy 500 micrograms kit of reagents for

radioactive pharmaceutical preparation

Albuminnanocolloidallabeled with technetium (99mTc)

Read this prospect thoroughly before the medication is administered to you, because it contains important information for you.

- Keep this prospect, as you may need to read it again.

- If you have any doubts, consult your nuclear medicine physician who supervises the procedure.

- If you experience adverse effects, consult your nuclear medicine physician, even if they are not listed in this prospect (see section 4).

1. What is Albumin nanocolloids Radiopharmacy 500 micrograms and for what it is used

2. What you need to know before starting to use Albumin nanocolloids Radiopharmacy 500 micrograms

3. How to use Albumin nanocolloids Radiopharmacy 500 micrograms

4. Possible adverse effects

5. Storage of Albumin nanocolloids Radiopharmacy 500 micrograms

6. Contents of the package and additional information

This medication is a radiopharmaceutical for diagnostic use only.

Nanocoloides de albúmina Radiopharmacy 500 microgramosmust be radiolabeled with technetium (99mTc) and the resulting product is usedforacquiringgamma images and evaluating:

• the bone marrow,

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

The use of Nanocoloides de albúmina Radiopharmacy 500 microgramos labeled with technetium (99mTc), involves exposure to small amounts of radioactivity. Your doctor and the nuclear medicine physician consider that the clinical benefit you will obtain from this intervention with the radiopharmaceutical is greater than the risk involved with radiation.

Nanocolloids of Albumin Radiopharmacy 500 micrograms should not be used

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

Warnings and precautions

Be especially careful with Nanocolloids of 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 must inform your nuclear medicine specialist if this applies to you. Your nuclear medicine specialist will inform you if you need to take special precautions after using this medication. Talk to your nuclear medicine specialist if you have any questions.

Before administration of Nanocolloids of Albumin Radiopharmacy 500 micrograms you should:

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

Children and adolescents

Inform your nuclear medicine specialist if you or your child areunder 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 those at risk of being carriers of infections are excluded,
• analysis of each donation and plasma volumes for signs of virus/infection,
• inclusion of steps to inactivate or eliminate viruses in the processing of blood or plasma.

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

There are no reports of virus-related infections associated with albumin manufactured in accordance with the European Pharmacopoeia specifications and in compliance with established processes.

It is strongly recommended that each time you receive a dose of Nanocolloids of Albumin Radiopharmacy 500 micrograms, you record the name and batch number of the medication to keep a record of the batches used.

Use of Nanocolloids of Albumin Radiopharmacy 500 micrograms with other medications

Inform your nuclear medicine specialist if you are takinghave recently taken, or may need to take other medications as they may interfere with image interpretation. Talk to your nuclear medicine specialist before undergoing a lymphatic system examination and if you have previously been investigated with radiographs or contrast medium examinations. This may affect the outcome. Ask your nuclear medicine specialist before taking any medication.

Pregnancy and lactation

If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your nuclear medicine specialist before this medication is administered.

You must inform your nuclear medicine specialist before administration of Nanocolloids of 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 essential to consult your nuclear medicine specialist who will oversee the procedure.

Do not use Nanocolloids of Albumin Radiopharmacy 500 micrograms during pregnancy.

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

Driving and operating machinery

Nanocolloids of Albumin Radiopharmacy 500 micrograms is unlikely to affect your ability to drive or operate machinery.

Nanocolloids of Albumin Radiopharmacy 500 micrograms contains Sodium

This medication contains less than 1 mmol (23 mg) of sodium per vial; it is essentially “sodium-free”.

There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. Nanocoloides de albúmina Radiopharmacy 500 micrograms will be used exclusively in special controlled areas. This product will only be handled and administered by trained and qualified personnel to use it safely. These individuals will take special care in the safe use of this product and will inform you of their actions.

The nuclear physician overseeing the procedure will decide the amount of Nanocoloides de albúmina Radiopharmacy 500 micrograms to be used in your case. This will be the minimum amount necessary to obtain the desired information.

The generally recommended dose for an adult is 5 to 500 MBq (MegaBecquerelios, 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 dose to be administered will be adjusted according to their body weight.

Administration of Nanocoloides de albúmina Radiopharmacy 500 micrograms and procedure performance

Nanocoloides de albúmina Radiopharmacy 500 micrograms is administeredafter radioactive markingvia intravenous or subcutaneous route(one or more injection sites).

This medication 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.

Procedure duration

Your nuclear physician will inform you of the usual duration of the procedure.

After administration of Nanocoloides de albúmina Radiopharmacy 500 micrograms, you must:

- 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 physician will inform you if you need to take any special precautions after receiving this medication. Consult your nuclear physician if you have any doubts.

If you have been administered more Nanocoloides de albúmina Radiopharmacy 500 micrograms than you should have

It is unlikely to have an overdose, as you will receive a dose of Nanocoloides de albúmina Radiopharmacy 500 micrograms under the precise control of the nuclear physician overseeing the procedure. However, in the event of an overdose, you will receive the appropriate treatment.

Specifically, the nuclear physician in charge of the procedure may recommend that you take abundant liquids to facilitate the elimination of Nanocoloides de albúmina Radiopharmacy 500 micrograms from your body.

If you have any other doubts about the use of Nanocoloides de albúmina Radiopharmacy 500 micrograms, ask the nuclear physician overseeing the procedure.

Like all medications, Nanocoloides de albúmina Radiopharmacy 500 micrograms may cause adverse effects, although not everyone experiences them.

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

Very rare:

Mild and temporary hypersensitivity reactions, which may present symptoms such as reactions at the injection site/local skin reactions, skin rash, pruritus, immune system disease, vertigo, decreased blood pressure.

When administering a radiopharmaceutical that contains proteins, such as Nanocoloides de albúmina Radiopharmacy 500 micrograms, hypersensitivity reactions may occur, including rarely life-threatening anaphylaxis with an unknown frequency.

The administration of this radiopharmaceutical involves receivingsmallamounts of ionizing radiation with a very low risk of developing cancer and hereditary defects.

If you experience adverse effects, report them to the nuclear medicine specialist doctor.This includes possibleadverse effects that do not appear in this prospectus.

Adverse Effect Reporting

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use: www.notificaRAM.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

This medication does not need to be stored by the patient. This medication is stored under the responsibility of the specialist in appropriate facilities. Storage of radiopharmaceuticals will be carried out in accordance with national standards for radioactive materials.

The following information is intended solely for the specialist.

Nanocolloids of Albumin Radiopharmacy 500 micrograms should not be used after the expiration date appearing on the box and the label.

Nanocolloids of Albumin Radiopharmacy 500 micrograms should not be used if the integrity of this vial is compromised.

Composition of Nanocolloid Albumin Radiopharmacy 500 micrograms

The active principle is human albumin nanocolloid.Each vial contains 500 micrograms of human albumin nanocolloid.

The other components are:

Stannous chloride dihydrate (E512), sodium dihydrogen phosphate dihydrate (E339), sodium hydrogen phosphate dihydrate (E339), Monohydrate of glucose, hydrochloric acid (E507), sodium hydroxide (E524),Nitrogen (E941)

Appearance of the product and contents of the package

This product is a kit for radiofarmaceutical preparation.

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

Nanocolloid 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 its use as an injectable solution. Once the radioactive substance sodium pertechnetate (99mTc) is added to the vial, human albumin nanocolloids labeled with technetium (99mTc) are formed. This solution is ready for injection.

Package sizes:

1 package of 6 vials

Package of 2 vials

Only some 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

Further information about this medicinal product can be obtained by contacting the local representative of the marketing authorization holder:

Last review date of this leaflet:September 2020

Further detailed information about this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices http://aemps.gob.es

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This information is intended solely for doctors or healthcare professionals

The complete Technical Dossier of Nanocoloides de albúmina Radiopharmacy 500 micrograms is included in a separate document in the product packaging, in order to provide healthcare professionals with additional scientific and practical information about the administration and use of this radiopharmaceutical.

Please, consult the technical dossier [the technical dossier must be included in the box]