Rotop NanoHSA 500 micrograms radiopharmaceutical preparation kit

Patient Information Leaflet

Introduction

Patient Information Leaflet

ROTOP NanoHSA 500 micrograms reagent kit for radiopharmaceutical preparation

Human nanocolloidal albumin

Read this entire leaflet carefully before you are administered this medicine, because it contains important information for you.

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

Leaflet Contents

1. What ROTOP NanoHSA 500 micrograms is and what it is used for
2. What you need to know before using ROTOP NanoHSA 500 micrograms
3. How to use ROTOP NanoHSA 500 micrograms
4. Possible side effects
5. How to store ROTOP NanoHSA 500 micrograms
6. Contents of the pack and other information

1. What ROTOP NanoHSA 500 micrograms is and what it is used for

This medicine is a radiopharmaceutical for diagnostic use only.

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

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

Administration of ROTOP NanoHSA 500 micrograms involves exposure to a small amount of radioactivity. Your doctor and the nuclear medicine physician have determined that the clinical benefit you will derive from the radiopharmaceutical procedure outweighs the radiation risk.

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

ROTOP NanoHSA 500 micrograms must not be used:

• if you are allergic to nanocolloidal human albumin or any of the other ingredients of this medicine (listed in section 6).
• during pregnancy if a lymphoscintigraphy involving the pelvis is required.

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

Warnings and precautions

Take special care with ROTOP NanoHSA 500 micrograms

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

You must inform the nuclear medicine physician if you are in any of these situations. The nuclear medicine physician will advise you whether you need to take any special precautions after receiving this medicine. Please consult your nuclear medicine physician if you have any questions.

Before administration of ROTOP NanoHSA 500 micrograms 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 of age.

Medicines derived from human blood or plasma

When medicines are prepared from human blood or plasma, certain measures are taken to prevent transmission of infections to patients. These include:

• careful selection of blood and plasma donors to exclude those at risk of carrying infections,
• testing each donation and pooled plasma for signs of viruses or infections,
• inclusion of manufacturing steps that can inactivate or remove viruses.

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

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

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

Use of ROTOP NanoHSA 500 micrograms with other medicines

Iodinated contrast media used for lymphangiography may interfere with lymphatic scintigraphy using 99mTc-labeled albumin nanocolloids.

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

If you are scheduled for a lymphatic system study, discuss with your physician prior to the procedure if you have previously undergone radiographic or imaging studies with contrast agents. This may influence the results.

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

You must inform the nuclear medicine physician before administration of ROTOP NanoHSA 500 micrograms if there is any possibility you may be pregnant, if you have missed a menstrual period, or if you are breastfeeding.

In case of doubt, it is important to consult the nuclear medicine physician supervising the procedure.

If you are pregnant:

Do not use ROTOP NanoHSA 500 micrograms during pregnancy.

If you are breastfeeding:

If you are breastfeeding, inform your physician, as they may advise you to stop breastfeeding until radioactivity has been eliminated from your body, which may take approximately 24 hours. Breast milk expressed during this period should be discarded.

Please consult your nuclear medicine physician regarding when you may resume breastfeeding.

Driving and using machines

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

ROTOP NanoHSA 500 micrograms contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per vial and is therefore considered essentially “sodium-free”.

3. How to use ROTOP NanoHSA 500 micrograms

There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. ROTOP NanoHSA 500 micrograms will only be used in special controlled areas. This product will only be handled and administered by trained and qualified personnel who are skilled in its safe use. These individuals will take special care in the safe use of this product and will inform you of their actions.

The nuclear medicine physician supervising the procedure will determine 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 amount generally recommended for administration to an adult ranges between 5 and 200 MBq (megabecquerel, the unit used to express radioactivity).

There is no need to reduce the dose in patients with renal or hepatic impairment.

Use in children and adolescents

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

Administration of ROTOP NanoHSA 500 micrograms and performance of the procedure

ROTOP NanoHSA 500 micrograms is administered by subcutaneous route after radiolabelling (at one or more injection sites). This product is not intended for regular or continuous administration.

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

Duration of the procedure

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

After administration of ROTOP NanoHSA 500 micrograms, you should

• avoid direct contact with young children and pregnant women during the first 24 hours after administration.

• urinate frequently to help eliminate the product from your body.

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

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

An overdose is unlikely, as you will receive a single, precisely controlled dose of ROTOP NanoHSA 500 micrograms, administered under the supervision of the nuclear medicine physician. However, in the event of an overdose, appropriate treatment will be given.

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

When assessing side effects, the following frequency data are used as a basis:

Very rare:

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

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

Autoimmune disease: dizziness, decreased blood pressure

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

Administration of this radiopharmaceutical involves exposure to a small amount of ionizing radiation, entailing a very low risk of developing cancer and hereditary defects.

Reporting of adverse reactions:

If you experience any type of adverse reaction, consult your nuclear medicine physician, even if they are possible adverse reactions not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es.

By reporting adverse reactions, you can help provide more information on the safety of this medicinal product.

5. Storage of ROTOP NanoHSA 500 micrograms

You will not be required to store this medicine. This medicine is stored under the responsibility of the specialist in appropriate facilities. Storage of radiopharmaceuticals must comply with national regulations concerning radioactive materials.

The following information is intended for specialists only.

Do not use ROTOP NanoHSA 500 micrograms after the expiry date stated on the label. The expiry date refers to the last day of the month indicated.

Storage conditions:

Do not store above 25 °C.

Shelf-life after reconstitution and radioactive labelling

After radioactive labelling: 12 hours. Do not store above 25 °C after radioactive labelling.

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

From a microbiological standpoint, unless the method of opening/radioactive labelling/dilution precludes the risk of microbiological contamination, the product should be used immediately.

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

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

6. Contents of the pack and other information

Composition of ROTOP NanoHSA 500 micrograms

The active substance is

Human nanocolloidal albumin. One vial contains 0.5 mg of human albumin nanocolloids.

The excipients are

Tin(II) chloride dihydrate

Glucose

Poloxamer 238

Disodium dihydrogen phosphate

Sodium phytate

Appearance of the product and contents of the pack

The product is a kit for radiopharmaceutical preparation.

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

Once the radioactive substance sodium pertechnetate (99mTc) is added to the vial, technetium (99mTc)-labelled albumin nanocolloids are formed. This suspension is ready for injection.

The pack contains 5 glass vials of 10 ml in a cardboard carton.

Marketing Authorisation Holder 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]

Further information on this medicinal product is available by contacting the local representative of the Marketing Authorisation Holder:

Curium Pharma Spain S.A.

Avda. Doctor Severo Ochoa, 29

28100 Alcobendas, Madrid

Spain

This medicinal product is authorised in European Economic Area (EEA) Member States under the following names:

Spain ROTOP NanoHSA 500 micrograms kit for radiopharmaceutical preparation

Germany NANOTOP

Austria NANOTOP 0.5 mg Kit for a radioactive medicinal product

Finland ROTOP NanoHSA

France ROTOP NanoHSA 0.5 mg Trousse pour préparation radiopharmaceutique

Italy NANOTOP

Norway Nanotop

Portugal NANOTOP

United Kingdom Nanotop

Sweden NanoHSA

Date of the most recent review of this leaflet: April 2022

Other sources of information

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines: http://www.aemps.es

This information is intended for healthcare professionals only:

The complete Summary of Product Characteristics for ROTOP NanoHSA 500 micrograms is included as a separate document in the product packaging, providing healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.

Please consult the Summary of Product Characteristics included in the package.