Nanoscan

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
NanoScan, 500 micrograms kit for the preparation of a radiopharmaceutical
nanocolloid albumin labelled with technetium [Tc]

Please read carefully the entire leaflet before use, as it contains important information for the patient.

• Keep this leaflet to be able to read it again if needed.
• If you have any questions, please consult the nuclear medicine physician who will supervise the procedure.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your physician. See section 4.

Table of contents:

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

1. WHAT IS NANOSCAN AND WHAT IS IT USED FOR?

This product is intended for diagnostic use only.
NanoScan must be labelled with technetium [Tc]; the resulting radiopharmaceutical is used for scintigraphic imaging and evaluation of:

• bone marrow,
• inflammation in the body,
• integrity of the lymphatic system (to differentiate lymphatic obstruction from venous obstruction),
• lymphoscintigraphy of sentinel lymph nodes in oncological diseases (including sentinel node mapping in malignant melanoma, breast cancer, penile cancer, oral cavity squamous cell carcinoma, and vulvar cancer).

The use of radiolabelled NanoScan involves patient exposure to small doses of radiation. Your general practitioner and nuclear medicine physician will consider the benefits of using this radiopharmaceutical, which outweigh the risks associated with radiation exposure.

2. WHAT YOU SHOULD KNOW BEFORE USING NANOSCAN

When not to use NanoScan

• if the patient is allergic to human nanocolloid albumin or to any of the other components of this medicine (listed in section 6),
• during pregnancy, if the lymphoscintigraphy involves pelvic imaging. Lymph node scintigraphy is not recommended in patients with complete lymphatic obstruction due to the risk of radiation-induced necrosis at the injection site.

Warnings and precautions
Exercise special caution before using NanoScan if:

• the patient is pregnant or may be pregnant,
• the patient is breastfeeding,
• the patient has kidney or liver problems.

If any of these apply to you, inform your nuclear medicine physician. The physician will advise whether any special precautions are necessary after administration of this medicine. Speak with your nuclear medicine physician if you have any questions.

Before administration of NanoScan:

• Drink plenty of water before the procedure to ensure frequent urination during the first hours after the examination.

Children and adolescents
Inform the nuclear medicine physician if the patient or their child is under 18 years of age.

Medicines derived from human blood or plasma
Medicines derived from human blood or plasma are subject to specific procedures designed to reduce the risk of transmitting infections to patients. These include:

• careful selection of blood and plasma donors to exclude individuals at risk of carrying infections,
• testing of each donation and plasma pool for signs of viral/infectious agents,
• inclusion of manufacturing steps that can inactivate or remove viruses.

Despite these measures, the possibility of transmitting infection by medicines prepared from human blood or plasma cannot be completely excluded, including for unknown or emerging viruses and other infectious agents. There have been no reported cases of viral infections transmitted by albumins manufactured in accordance with the European Pharmacopoeia standards using an established production process. It is strongly recommended that the name and batch number of each administered dose of NanoScan be recorded to ensure traceability of every batch used.

Other medicines and NanoScan
Inform your nuclear medicine physician about all medicines currently taken, recently taken, or planned for use, as they may interfere with the interpretation of test results.
If a lymphatic system examination is required, discuss with your physician prior to the procedure and inform them about any previous X-ray or other imaging tests involving contrast agents, as these may affect test results.
Do not take any medication without first consulting your nuclear medicine physician.

Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your nuclear medicine physician before receiving this medicine.
Inform your nuclear medicine physician before administration of NanoScan if there is a possibility of pregnancy, if your menstrual period is delayed, or if you are breastfeeding.
In case of doubt, it is important to consult the nuclear medicine physician supervising the examination.
NanoScan should not be used during pregnancy.
If you are breastfeeding, inform your nuclear medicine physician, as they will advise you to interrupt breastfeeding until the radioactive substance has cleared from your body—this takes approximately 24 hours. Expressed milk should be discarded. Consult your nuclear medicine physician on when it is safe to resume breastfeeding.

Driving and operating machinery
There is a low likelihood that the use of NanoScan may adversely affect the ability to drive or operate machinery.

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

3. HOW TO USE THE MEDICINAL PRODUCT NANOSCAN

When using this medicinal product, strict regulations regarding the use, handling, and disposal of radiopharmaceuticals must be followed. NanoScan may only be administered in facilities under regulatory control. Only appropriately trained and qualified personnel may administer this product, who are required to take special precautions during handling and to inform the patient about the procedures being performed.

The nuclear medicine specialist supervising the administration of NanoScan will determine the amount to be administered for each patient. This is the minimum quantity necessary to obtain the required clinical information.

The usual recommended dose for adults is 5–500 MBq (Megabecquerel, a unit used to express radioactivity).

Dose adjustment is not necessary in patients with impaired kidney or liver function.

Children and adolescents
In children and adolescents, the dose is adjusted according to the patient's body weight.

Administration of NanoScan and the course of examination
NanoScan is administered after radiolabelling via intravenous or subcutaneous injection (one or more injection sites).

This product is not intended for regular or chronic administration.

After injection, the patient will be encouraged to drink fluids and will be asked to empty the bladder shortly before the examination.

Duration of the examination
The nuclear medicine specialist will inform the patient about the duration of the examination.

After administration of NanoScan, the following should be observed:

• Avoid close contact with young children and pregnant women during the first 24 hours after administration of the medicinal product.
• Urinate frequently to help eliminate the product from the body. The nuclear medicine specialist will inform the patient if any special precautions are required after receiving the medicinal product. If any questions arise, the patient should contact their nuclear medicine physician.

Administration of a higher than recommended dose of NanoScan
Overdose is unlikely, as the patient receives only a single dose of NanoScan, carefully prepared under the supervision of the nuclear medicine specialist overseeing the procedure. However, in the event of an overdose, appropriate treatment will be initiated. In particular, the supervising nuclear medicine specialist may recommend that the patient drink abundant fluids to facilitate the elimination of NanoScan from the body. For further questions regarding the use of NanoScan, patients should consult their nuclear medicine specialist overseeing the examination.

4. POSSIBLE ADVERSE REACTIONS

Like all medicinal products, this product can cause adverse reactions, although not everyone experiences them.

In assessing adverse reactions, the following frequency categories are used:

• 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
• Frequency not known: cannot be estimated from available data

Very rare:
Mild and transient hypersensitivity reactions, which may manifest as:
reactions at the site of administration/local skin reactions, rash, itching, immune system disorders, dizziness, hypotension.

When a radiopharmaceutical containing protein, such as NanoScan, is administered, hypersensitivity reactions may occur (frequency not known), including a very rare, life-threatening anaphylactic reaction.

This radiopharmaceutical emits low doses of ionizing radiation, which entails a low risk of developing cancer and hereditary abnormalities.

If any adverse reactions occur, inform your nuclear medicine physician, including any possible adverse reactions not listed in this leaflet.

Reporting of adverse reactions
If any adverse reactions occur, inform your physician, including any possible adverse reactions not listed in this leaflet. Adverse reactions can also be reported directly through the national reporting system of the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181c, 02-222 Warsaw,
Tel.: +48 22 49 21 301,
Fax: +48 22 49 21 309,
e-mail: [email protected]

Reporting adverse reactions helps to provide more information on the safety of the medicinal product.

5. HOW TO STORE NANOSCAN

The patient will not have to store this medicinal product. Radiopharmaceuticals are stored exclusively by authorized personnel under appropriate clinical conditions.
Storage of radiopharmaceuticals must comply with local regulations concerning radioactive substances.
This information is intended solely for medical personnel.
Do not use NanoScan after the expiry date stated on the carton and label.
NanoScan must not be used if a break in the integrity of the vial is observed.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What NanoScan contains
The active substance is human albumin in the form of a nanocolloid.
Each vial contains 500 micrograms of human albumin in the form of a nanocolloid.
Other ingredients are: tin(II) chloride dihydrate, sodium dihydrogen phosphate and disodium hydrogen phosphate,
glucose, hydrochloric acid, sodium hydroxide.

What NanoScan looks like and contents of the pack
This product is a kit for the preparation of a radiopharmaceutical agent.
Each vial contains a white or almost white powder intended for injection preparation.
NanoScan contains 6 vials. The contents of the vial must be dissolved in solution and combined with radioactive technetium before use. After adding the substance called sodium pertechnetate (Tc), technetium (Tc)-labelled albumin in the form of a nanocolloid is formed. This solution is ready for injection.

Pack sizes
1 pack contains 6 vials
Test pack: 2 vials
Hospital packs:
Package of 2 packs, each containing 6 vials
Package of 4 packs, each containing 6 vials
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation 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

This medicinal product is authorised for marketing in the European Economic Area under the following names:
Austria NanoScan 500 Mikrogramm
kit für ein radioaktives Arzneimittel
Belgium NANOSCINT 0,5 mg,
kit voor radiofarmaceutisch preparaat
Denmark NanoScan,
kit for radiopharmaceutical preparation
Netherlands NanoScan 500 microgram,
kit voor radiofarmaceutisch preparaat
Poland NanoScan, 500 micrograms
kit for the preparation of radiopharmaceutical
Germany NanoScan 500 Mikrogramm
Kit für ein radioaktives Arzneimittel
Italy Nanoalbumon 500 microgrammi
Kit per preparazione radiopharmaceutica
Romania NanoScan 500 micrograme
kit pentru preparate radiofarmaceutice
Spain Nanocoloides de albumina Radiopharmacy 500 microgramos
Equipo de Reactivos Para Preparacion Radiopharmaceutica
United Kingdom NanoScan 500 micrograms,
Kit for radiopharmaceutical preparation
17/09/2020

Marketing Authorisation Number:

Information intended for professional medical personnel only:

The full Product Characteristics Leaflet for NanoScan, 500 micrograms is available as a separate document.