NANOTOP

Package leaflet: Information for the patient

NANOTOP 0.5 mg

Kit for radiopharmaceutical preparation
Active substance: human albumin, colloidal particles
Please read 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 questions, ask the nuclear medicine physician who will supervise the procedure.
• If you experience any side effects, inform your nuclear medicine physician. This includes any possible adverse reactions, even those not listed in this leaflet.

Contents of this leaflet

1. What NANOTOP is and what it is used for
2. What you need to know before NANOTOP is used
3. How NANOTOP is used
4. Possible side effects
5. How NANOTOP is stored
6. Contents of the pack and other information

1. What NANOTOP is and what it is used for

This medicinal product is a radiopharmaceutical for diagnostic use only.
It is used for scintigraphy and detection of:
sentinel lymph nodes in tumour diseases (sentinel lymph node mapping)
lymphatic system integrity and differentiation between venous and lymphatic obstruction
The use of NANOTOP involves exposure to low levels of radioactivity. Your doctor and the nuclear medicine physician have determined that the benefits you will derive from the procedure using this radiopharmaceutical outweigh the risks associated with radiation exposure.

2. What you need to know before NANOTOP is used

NANOTOP must not be used:

• if you are allergic to NANOTOP or to any of the ingredients of this medicine (listed in section 6)
• during pregnancy. In patients with complete lymphatic obstruction, lymph node scintigraphy is not recommended due to the risk of radiation-induced necrosis at the injection site.

Warnings and precautions
Exercise particular caution with NANOTOP

• if you are breastfeeding

Before administration of NANOTOP you must:

• drink plenty of water before the examination begins, so that you urinate as frequently as possible during the first hours after the examination.

Children and adolescents
Talk to the nuclear medicine physician if you are under 18 years of age.
Medicinal products derived from human blood or plasma
When medicinal products are derived from human blood or plasma, certain precautionary measures are taken to prevent transmission of infections to patients. These include:

• careful selection of blood and plasma donors to ensure exclusion of those at risk of transmitting infections,
• testing of each donation and plasma for possible viruses/infections,
• inclusion of steps in the manufacturing process that can inactivate or remove viruses. Nevertheless, the risk of transmission of infectious agents cannot be completely eliminated when medicinal products prepared from human blood or plasma are administered. This also applies to new viruses and other pathogens of unknown or emerging nature. Transmission of viruses through albumin produced according to European Pharmacopoeia specifications using well-established processes has not been reported. It is strongly recommended that, each time you receive a dose of NANOTOP, the name and batch number of the medicine be recorded, in order to maintain a record of the batches used.

Other medicines and NANOTOP
Iodinated contrast media used in lymphangiography may interfere with visualization of the lymphatic system performed with Tc-nanocolloidal albumin.
Inform your nuclear medicine physician if you are taking/using, have recently taken/used, or might take/use any other medicines, as they could interfere with image interpretation.
If you are scheduled for lymphatic system scintigraphy, consult your physician beforehand if you have previously undergone X-ray examinations or procedures with contrast agents, as these could influence the outcome of the examination.

Pregnancy and breastfeeding
You must inform the nuclear medicine physician before administration of NANOTOP if there is any possibility that you are pregnant, if you have missed a menstrual period, or if you are breastfeeding.
If in doubt, it is important to consult the nuclear medicine physician who will supervise your procedure.
If you are pregnant:
Do not use NANOTOP during pregnancy.
If you are breastfeeding
If you are breastfeeding, inform your physician, as he or she may advise you to interrupt breastfeeding until radioactivity has left your body.
The expressed milk must be discarded. Ask your nuclear medicine physician when you can resume breastfeeding.

Driving and using machines
NANOTOP is considered unlikely to affect your ability to drive vehicles or operate machinery.

NANOTOP contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per vial, i.e. it is essentially "sodium-free".

3. How NANOTOP is used

There are strict regulations regarding the use, handling, and disposal of
radiopharmaceuticals. NANOTOP may only be used in specially controlled areas. The
product may only be handled and administered by trained and qualified personnel
who are skilled in its safe use. These individuals will pay particular attention to safe
handling practices and will keep you informed about their actions.
The nuclear medicine physician supervising the procedure will determine the amount of
NANOTOP to be used in your case. This will be the lowest quantity necessary to
obtain the required information.
The recommended administered activity for adults usually ranges between
5 and 200 MBq (megabecquerel, the unit used to express radioactivity).
Dose reductions are not required in cases of renal or hepatic impairment.

Use in children and adolescents
In children and adolescents, the administered amount will be adjusted according to
the child's body weight.

Administration of NANOTOP and performance of the procedure
After labelling, the medicinal product is administered subcutaneously (at one or more injection sites).
This product is not intended for regular or continuous administration.
After the injection, you will be offered fluids to drink and will be asked to urinate immediately before the examination.

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

After administration of NANOTOP you must
Urinate frequently to eliminate the product from your body.
The nuclear medicine physician will inform you whether you need to take special precautions
after receiving the medicinal product. If you have any doubts, consult your nuclear medicine physician.

If you have been given more NANOTOP than you should have
An overdose is extremely unlikely, as you will receive only a single dose of NANOTOP, precisely controlled by the nuclear medicine physician supervising the procedure. However, in the event of an overdose, you will receive appropriate treatment.
If you have any questions about the use of the medicinal product, please consult the nuclear medicine physician who will supervise the procedure.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although
not everyone experiences them.
The following frequency categories have been used to assess side effects:
very common: more than 1 in 10 patients
common: 1 to 10 in 100 patients
uncommon: 1 to 10 in 1,000 patients
rare: 1 to 10 in 10,000 patients
very rare: less than 1 in 10,000 patients
not known: frequency cannot be estimated from the available data

Very rare:
mild and temporary hypersensitivity reactions, which may present symptoms such as
at the site of administration/on the skin
local reactions, rash, pruritus
immune system disorders
dizziness, lowering of blood pressure

This radiopharmaceutical emits low amounts of ionizing radiation, associated with a minimal risk of cancer and hereditary abnormalities.

When a radiopharmaceutical containing proteins, such as Nanotop labelled with technetium-99m, is administered to a patient, hypersensitivity reactions may occur.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your nuclear medicine physician.

You may also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.

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

5. How to store NANOTOP

This medicinal product must not be stored by the user. It is stored under the responsibility of a specialist in appropriate locations. Storage of radiopharmaceuticals must comply with national regulations concerning radioactive materials.
The following information is intended for specialists only.
NANOTOP must not be used after the expiry date stated on the label.
Storage conditions:
Store at a temperature not exceeding 25°C.
Shelf life after first opening and labelling
After labelling: 6 hours. After labelling, store at a temperature not exceeding 25°C.
The ready-to-use injectable suspension must be stored in accordance with national regulations concerning radioactive materials.

6. Package contents and other information

What NANOTOP contains
The active substance is
1 vial contains 0.5 mg of human albumin, colloidal particles
The country of origin of the plasma is Belgium
The other components are
Tin chloride dihydrate
Glucose
Poloxamer 238
Disodium phosphate dihydrate, E339
Sodium phytate

Description of the appearance of NANOTOP and contents of the pack
The pack consists of 5 glass vials of 10 mL in a cardboard box.
Each vial contains a white or almost white lyophilisate for the preparation of an injectable suspension.

Marketing Authorization Holder and Manufacturer
ROTOP Pharmaka AG
Bautzner Landstraße 400
01328 Dresden
Germany
Tel.: +49 (0) 351 – 26 310 100
Fax: +49 (0) 351 – 26 310 303
E-mail: [email protected]

The medicinal product is authorized in the EEA Member States under the following names:
Italy 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
Germany NANOTOP
Norway Nanotop
Portugal NANOTOP
United Kingdom Nanotop
Spain ROTOP-NanoHSA 500 micrograms
equipo de reactivos para preparación radiofarmacéutica
Sweden NanoHSA

The following information is intended for healthcare professionals only:

The complete summary of product characteristics for NANOTOP is provided as a
separate document within the product packaging, intended to supply healthcare
professionals with additional scientific and practical information on the administration and
use of this radiopharmaceutical.
Refer to the summary of product characteristics.
Other sources of information
Detailed information on this medicinal product is available on the website