ROTOP NANOHSA 500 MICROGRAMS RADIOPHARMACEUTICAL PREPARATION KIT

Introduction

Package Leaflet: Information for the User

ROTOP NanoHSA 500 micrograms radiopharmaceutical preparation kit

Human albumin nanocolloid

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 pack

1. What ROTOP NanoHSA 500 micrograms is and what it is used for
2. What you need to know before you are given ROTOP NanoHSA 500 micrograms
3. How to use ROTOP NanoHSA 500 micrograms
4. Possible side effects
5. Storage of ROTOP NanoHSA 500 micrograms
6. Contents of the pack and further 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 obtaining gamma camera images and evaluating

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

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

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

ROTOP NanoHSA 500 micrograms must not be used:

• if you are allergic to human albumin nanocolloid or to any of the other components of this medicine (listed in section 6).
• during pregnancy if a lymphoscintigraphy that involves the pelvis is to be performed.

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

Be particularly careful with ROTOP NanoHSA 500 micrograms

• if you are pregnant or think you may be pregnant
• if you are breast-feeding
• if you have kidney or liver disease

You should inform your nuclear medicine doctor if you are in any of these situations. The nuclear medicine doctor will inform you if you need to take any special precautions after using this medicine. Ask your nuclear medicine doctor 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 few hours after the study.

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 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 carrying infections are excluded,
• testing of each donation and plasma pools for signs of viruses or infections,
• inclusion of steps in the preparation process that can inactivate or remove viruses.

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

There are no reports of viral infections with albumin prepared according to the requirements of the European Pharmacopoeia 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 should 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-labelled albumin nanocolloids.

Tell your nuclear medicine doctor if you are taking or using, have recently taken or used, or might take or use any other medicines, as some medicines may interfere with the interpretation of the images.

If you are to undergo a lymphatic system study, talk to your doctor before the procedure if you have previously undergone radiographs or imaging studies with contrast media. This may affect the results.

Consult your nuclear medicine doctor before using any medicine.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your nuclear medicine doctor for advice before taking this medicine.

You should inform your nuclear medicine doctor before administration of ROTOP NanoHSA 500 micrograms if there is any possibility that you may be pregnant, if you have missed a period or if you are breast-feeding.

In case of doubt, it is important that you consult your nuclear medicine doctor who is supervising the procedure.

If you are pregnant:

Do not use ROTOP NanoHSA 500 micrograms during pregnancy.

If you are breast-feeding:

If you are breast-feeding, inform your doctor, as it is possible that they may recommend that you stop breast-feeding until the radioactivity has been eliminated from your body, which may take about 24 hours. Discard the expressed milk.

Please consult your nuclear medicine doctor when you can restart breast-feeding.

Driving and using machines

ROTOP NanoHSA 500 micrograms is unlikely to affect your ability to drive or use machines.

ROTOP NanoHSA 500 micrograms contains sodium

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

3. How to use ROTOP NanoHSA 500 micrograms

There are strict rules for 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 authorised to use it safely. These persons will take special care in the safe use of this product and will inform you of their actions.

The nuclear medicine doctor who is supervising 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 recommended amount to be administered to an adult is usually between 5 and 200 MBq (megabecquerel, the unit used to express radioactivity).

No dose reduction is necessary in patients with renal or hepatic impairment.

Use in children and adolescents

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

Administration of ROTOP NanoHSA 500 micrograms and performance of the procedure

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

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

Duration of the procedure

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

After administration of ROTOP NanoHSA 500 micrograms, you should

• avoid close 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 any special precautions after this medicine has been administered. Consult your nuclear medicine doctor if you have any questions.

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

Overdose is unlikely because you will receive a precisely controlled single dose of ROTOP NanoHSA 500 micrograms, administered by the nuclear medicine doctor who is supervising the procedure. However, in case of overdose, you will receive appropriate treatment.

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

If you have any further questions on the use of ROTOP NanoHSA 500 micrograms, ask your nuclear medicine doctor who is supervising the procedure.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

During evaluation of side effects, the following frequency categories are used:

Very rare:

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

Local reactions at the injection site/skin reactions, rash, itching

Autoimmune disease/vertigo, decreased blood pressure

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

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

Reporting of side effects:

If you experience any side effects, talk to your nuclear medicine doctor, even if they are not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency at https://www.notificaram.es.

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

5. Storage of ROTOP NanoHSA 500 micrograms

You will not need to store this medicine. This medicine is stored under the responsibility of the specialist in suitable premises. Storage of radiopharmaceuticals will be carried out in accordance with national regulations on radioactive materials.

The following information is intended for the specialist only.

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

Storage conditions:

Do not store above 25°C.

Shelf-life after opening and radiolabelling

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

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

From a microbiological point of view, unless the opening/radiolabelling/dilution method precludes the risk of microbial contamination, the product should be used immediately.

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

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

6. Contents of the pack and further information

Composition of ROTOP NanoHSA 500 micrograms

The active substance is

Human albumin nanocolloid. One vial contains 0.5 mg of human albumin nanocolloid

The excipients are

Tin(II) chloride dihydrate

Glucose

Poloxamer 238

Sodium dihydrogen phosphate

Sodium phosphate

Appearance and pack contents

The product is a radiopharmaceutical preparation kit.

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

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

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

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]

For further information about this medicine, contact the local representative of the marketing authorisation holder:

Curium Pharma Spain S.A.

Avda. Doctor Severo Ochoa, 29

28100 Alcobendas, Madrid

Spain

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

Spain ROTOP NanoHSA 500 micrograms radiopharmaceutical preparation kit

Germany NANOTOP

Austria NANOTOP 0.5 mg Kit für ein radioaktives Arzneimittel

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 last revision of this leaflet: April 2022

Other sources of information

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

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This information is intended only for healthcare professionals:

The full Summary of Product Characteristics of ROTOP NanoHSA 500 micrograms is included as a separate document in the product pack, 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 included in the pack.