Label: Information for the User

ROTOP NanoHSA 500 microgramsradioactive pharmaceutical preparation kit

Human nanocolloidal albumin

Read the entire label carefully before the medication is administeredbecause it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult the nuclear physician overseeing the procedure.
• If you experience adverse effects, consult your nuclear physician, even if they are side effects not listed in this label. See section 4.

1. What is ROTOP NanoHSA 500 micrograms and how it is used

2. What you need to know before starting to use ROTOP NanoHSA 500 micrograms

3. How to use ROTOP NanoHSA 500 micrograms

4. Possible adverse effects

5. Storage of ROTOP NanoHSA 500 micrograms

6. Contents of the package and additional information

This medication is a radiopharmaceutical for diagnostic use only.

ROTOP NanoHSA 500 micrograms must be radiolabeled with technetium (99mTc) and the resulting product is used for gamma imaging and the evaluation of

• the integrity of the lymphatic system and to differentiate between venous and lymphatic obstruction
• sentinel lymph nodes in malignant diseases (sentinel lymph node mapping in melanoma, breast carcinoma, penile carcinoma, squamous cell carcinoma of the oral cavity, and vulvar carcinoma)

The administration of ROTOP NanoHSA 500 micrograms involves receiving a small amount of radioactivity. Your doctor and the nuclear medicine physician have considered that the clinical benefit you will obtain from the procedure with the radiopharmaceutical outweighs the risk of radiation.

ROTOP NanoHSA 500 microgramos should not be used:

• if you are allergic to human nanocolloidal albumin or any of the other components of this medication (listed in section 6).
• during pregnancy if a lymphangiography procedure involving the pelvis is to be performed.

Lymph node imaging is not recommended in patients with total lymphatic obstruction due to the risk of radiation necrosis at the injection site.

Warnings and precautions

Be particularly careful with ROTOP NanoHSA 500 microgramos

• if you are pregnant or think you may be pregnant
• if you are breastfeeding
• if you have kidney or liver disease

You should inform your nuclear medicine physician if you are in any of these circumstances. The nuclear medicine physician will inform you if you need to take any special precautions after using this medication. Consult your nuclear medicine physician if you have any questions.

Before administration of ROTOP NanoHSA 500 microgramos, you should:

• drink plenty of water before starting the procedure to urinate as frequently as possible during the first hours after the study.

Children and adolescents

Inform your nuclear medicine physician if you or your child are under 18 years old.

Medicines made from blood or human plasma

When medicines are made from blood or human 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,
• testing each donation and plasma mixtures for signs of viruses or infections,
• including steps in the preparation of blood or plasma that can inactivate or remove viruses.

Despite these measures, when medicines prepared from blood or plasma are administered, it is not possible to completely rule out the possibility of transmitting an infection. This also applies to any unknown or newly emerging viruses, or other types of infections.

There are no reports of viral infections with albumin prepared according to the European Pharmacopoeia requirements using established processes.

It is strongly recommended that each time you receive a dose of ROTOP NanoHSA 500 microgramos, the name and batch number of the medication be recorded in order to maintain a record of the lots used.

Use of ROTOP NanoHSA 500 microgramos with other medications

Iodinated contrast media used for lymphangiographies may interfere with lymphatic imaging studies that use nanocolloidal albumin labeled with 99mTc.

Inform your nuclear medicine physician if you are taking or using, have recently taken or used, or may take or use other medications, as some medications may interfere with image interpretation.

If you are to undergo a lymphatic system study, speak with your nuclear medicine physician before the procedure if you have previously had radiographs or imaging studies with contrast media. This may influence the results.

Consult your nuclear medicine physician before using 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 physician before using this medication.

You should inform your nuclear medicine physician before administration of ROTOP NanoHSA 500 microgramos if there is any possibility of pregnancy, if you experience a delay in your period, or if you are breastfeeding.

It is essential to consult the nuclear medicine physician who will supervise the procedure in case of doubt.

If you are pregnant:

Do not use ROTOP NanoHSA 500 microgramos during pregnancy.

If you are breastfeeding:

If you are breastfeeding, inform your doctor, as it may be recommended that you stop breastfeeding until the radioactivity has been eliminated from your body, which may take up to 24 hours. Discard any expressed milk.

Please consult your nuclear medicine physician when you can resume breastfeeding.

Driving and operating machinery

It is considered unlikely that ROTOP NanoHSA 500 microgramos will affect your ability to drive or operate machinery.

ROTOP NanoHSA 500 microgramos contains sodium

This medication contains less than 1 mmol (23 mg) of sodium per vial, making it essentially "sodium-free".

There are strict guidelines for the use, handling, and disposal of radiopharmaceuticals. ROTOP NanoHSA 500 micrograms will only be used in specially controlled areas. This product will only be handled and administered by trained and qualified personnel to ensure safe use. Those individuals will take special care in the safe use of this product and will inform you of their actions.

The nuclear medicine physician overseeing the procedure will decide the amount of ROTOP NanoHSA 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 varies between 5 and 200 MBq (megabecquerel, the unit used to express radioactivity).

No dose reduction is necessary for patients with renal or hepatic insufficiency.

Use in children and adolescents

The dose to be administered will be adjusted according to the child's or adolescent's body weight.

Administration of ROTOP NanoHSA 500 micrograms and procedure performance

ROTOP NanoHSA 500 micrograms is administered subcutaneously after radiolabeling (at one or more injection sites). This product is not indicated for regular or continuous administration.

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

Procedure duration

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

After administration of ROTOP NanoHSA 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 medicine physician will inform you if you need to take any special precautions after this medication is administered. Consult your nuclear medicine physician if you have any doubts.

If you have been administered more ROTOP NanoHSA 500 micrograms than you should

An overdose is unlikely because you will receive a single, precisely controlled dose of ROTOP NanoHSA 500 micrograms from the nuclear medicine physician overseeing the procedure. However, in the event of an overdose, you will receive the necessary treatment.

In particular, the nuclear medicine physician in charge of the procedure may recommend that you drink plenty of water to facilitate the elimination of ROTOP NanoHSA 500 micrograms from your body.

If you have any other questions about the use of ROTOP NanoHSA 500 micrograms, ask the nuclear medicine physician overseeing the procedure.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

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

Very rare:

Mild and temporary hypersensitivity reactions, which may present symptoms such as:

Local reactions at the site of administration / skin
local reactions, skin rash, itching

Autoimmune disease
dizziness, decreased blood pressure

When a patient is administered a radiopharmaceutical containing proteins such as ROTOP NanoHSA 500 micrograms, hypersensitivity reactions may develop, including very rarely potentially fatal anaphylaxis, with an unknown frequency.

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

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your nuclear physician, even if it is possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://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. This medication is stored under the responsibility of the specialist in suitable facilities. Radioactive medication storage will be carried out in accordance with national regulations on radioactive materials.

The following information is intended solely for the specialist.

Do not use ROTOP NanoHSA 500 micrograms after the expiration date appearing on the label. The expiration date is the last day of the month indicated.

Storage Conditions:

Do not store at temperatures above 25 °C.

Validity Period After Opening and Radioactive Marking

After radioactive marking: 12 hours. Do not store at temperatures above 25 °C after radioactive marking.

After radioactive marking: chemical and physical stability has been demonstrated in use for 12 hours at 25°C.

From a microbiological point of view, unless the opening/marking radioactive/dilution method prevents microbiological contamination risk, the product must be used immediately.

If not used immediately, storage times and conditions in use are the responsibility of the user.

The ready-to-use injectable suspension must be stored in accordance with national regulations on radioactive materials.

Composition of ROTOP NanoHSA 500 micrograms

The active ingredient is

Human albumin nanocolloid. A vial contains 0.5 mg of human albumin nanocolloids

The excipients are

Stannous chloride dihydrate

Glucose

Poloxamer 238

Dihydrogen phosphate disodium

Sodium phosphate

Appearance of the product and contents of the package

The product is a kit for radio pharmaceutical preparation.

Each vial contains a white or almost white lyophilisate for preparation of an injectable suspension.

Once the radioactive substance sodium pertechnetate (99m Tc) is added to the vial, albumin nanocolloids labeled with technetium (99m Tc) are formed. This suspension is ready for injection.

The package contains 5 glass vials of 10 ml in a cardboard box.

Holder of the marketing authorization and manufacturer

ROTOP Pharmaka GmbH

Bautzner Landstrasse 400

01328 Dresden

Germany

Tel.: +49 (0) 351 – 26 310 100

Fax: +49 (0) 351 – 26 310 303

Email: [email protected]

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Curium Pharma Spain S.A.

Avda. Doctor Severo Ochoa, 29

28100 Alcobendas. Madrid

Spain

This medication is authorized in the member states of the European Economic Area (EEA) under the following names:

SpainROTOP NanoHSA 500 micrograms
kit for radio pharmaceutical preparation

GermanyNANOTOP

AustriaNANOTOP 0.5 mg
Kit for a radioactive drug

FinlandROTOP NanoHSA

FranceROTOP NanoHSA 0.5 mg
Kit for radiopharmaceutical preparation

ItalyNANOTOP

NorwayNanotop

PortugalNANOTOP

United KingdomNanotop

SwedenNanoHSA

Last review date of this leaflet: April 2022

Other sources of information

The detailed information about this medication is available on the website of the Spanish Agency of Medicineshttp://www.aemps.es

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This information is intended solely for doctors or healthcare professionals:

The complete Technical Dossier of ROTOP NanoHSA 500 micrograms is included as a separate document in the product packaging, in order to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.

Please consult the Technical Dossier included in the box.