Nanoscan

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

NanoScan, 500 micrograms kit for the preparation of a radiopharmaceutical albumin in the form of a nanocolloid labeled with technetium [Tc]

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a nuclear medicine doctor who will supervise the procedure.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should inform their doctor. See section 4.

Table of contents of the leaflet:

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

1. WHAT IS NANOSCAN AND WHAT IS IT USED FOR

This product is intended exclusively for diagnostic purposes.
NanoScan should be labeled with technetium [Tc], and the resulting product is used for scintigraphic examinations and evaluation of:

• bone marrow,
• inflammation in the body
• integrity of the lymphatic system (also known as lymphatic; and differentiation of lymphatic obstruction from venous obstruction,
• lymphoscintigraphy of the sentinel lymph node in cancer (in mapping the sentinel lymph node in malignant melanoma, breast cancer, penile cancer, and squamous cell carcinoma of the oral cavity and vulvar cancer).

The use of labeled NanoScan is associated with exposing the patient to small doses of radiation. The family doctor and the nuclear medicine specialist consider the benefits of using the radiopharmaceutical, which outweigh the risks associated with radiation.

2. WHAT YOU NEED TO KNOW BEFORE USING NANOSCAN

When not to use NanoScan

• during pregnancy, if the lymphoscintigraphy examination includes the pelvis. In patients with complete lymphatic obstruction, lymph node scintigraphy is not recommended due to the risk of postradiation necrosis at the injection site.

Warnings and precautions

Special caution should be exercised before using NanoScan if:

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

If this applies to a given patient, they should inform the nuclear medicine doctor. The doctor will inform the patient whether any special precautions are necessary after taking this medicine. You should discuss with your nuclear medicine doctor if you have any questions.

Before administering NanoScan:

• you should drink plenty of water before the examination to urinate as frequently as possible in the first hours after the examination.

Children and adolescents

You should inform the nuclear medicine doctor if the patient or their child is under 18 years old.

Medicines derived from human blood or plasma

When medicines are produced from human blood or plasma, certain principles are introduced to prevent the transmission of infections to patients. These principles include:

• careful selection of blood and plasma donors, ensuring that individuals who may transmit infections are excluded from this group,
• testing each donation and plasma pool for signs of virus/infection,
• including steps in the blood or plasma processing process that can inactivate or remove the virus. Despite the implementation of these measures, when administering medicines prepared from human blood or plasma, it is not possible to completely exclude the possibility of transmitting an infection. This also applies to any unknown or emerging viruses and other types of infections. There have been no reports of viral infections transmitted through albumin manufactured in accordance with the requirements of the European Pharmacopoeia (European Pharmacopoeia) in an established production process. It is strongly recommended that each time a patient receives a dose of NanoScan, the name and batch number be recorded to register each batch of the medicine used.

Other medicines and NanoScan

You should tell the nuclear medicine doctor about all medicines you are currently taking, have recently taken, or plan to take, as they may interfere with the interpretation of the results.
If the patient needs to undergo a lymphatic system examination, they should discuss this with their doctor before the examination and inform them about any previous X-ray or other imaging examination using a contrast agent. This may affect the result of the examination.
Before taking any medicine, please ask your nuclear medicine doctor.

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, thinks they may be pregnant, or plans to become pregnant, they should consult their nuclear medicine doctor before taking this medicine.
The doctor should be informed about the possibility of pregnancy, delayed menstruation, or breastfeeding before administering NanoScan.
In case of doubts, it is essential to consult a nuclear medicine doctor who will supervise the examination. If the patient is pregnant, they should not use NanoScan during this period.
If the patient is breastfeeding, they should inform their nuclear medicine doctor, who will advise them to stop breastfeeding until the radioactive medicine has left the body. This takes about 24 hours. The expressed milk should be discarded. The patient should consult their nuclear medicine doctor about when to resume breastfeeding.

Driving and using machines

There is a small probability that using NanoScan may adversely affect the ability to drive vehicles or operate machines.

NanoScan contains sodium.

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

3. HOW TO USE NANOSCAN

When using this medicine, you should follow strict rules for use, handling, and disposal of radiopharmaceuticals. NanoScan should only be used in controlled areas. The medicine can only be administered by properly trained and qualified personnel in the safe use of this medicine. These personnel are required to take special precautions when handling the medicine and inform the patient about the procedures being performed.
The nuclear medicine specialist supervising the administration of the medicine for each patient determines the amount of NanoScan to be administered. This is the smallest amount necessary to obtain the required clinical information.
The usual recommended dose for an adult is 5 - 500 MBq (Megabecquerel, a unit used to express radioactivity).
It is not necessary to reduce the dose in case of impaired kidney or liver function.

Children and adolescents

In children and adolescents, the amount of medicine is adjusted according to the patient's body weight.

Administration of NanoScan and the course of the examination

NanoScan is administered after radiolabeling by intravenous or subcutaneous injection (one or more injection sites).
This product is not intended for regular or continuous administration.
After injection, the patient will be offered something to drink and asked to urinate immediately before the examination.

Duration of the examination

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

After administering NanoScan, you should:

• avoid close contact with small children and pregnant women for the first 24 hours after administration of the medicine,
• urinate frequently to eliminate the product from the body. The nuclear medicine doctor will inform the patient if any special precautions are necessary after receiving the medicine. If you have any questions, you should contact your nuclear medicine doctor.

Using a higher dose of NanoScan than recommended

Overdose is unlikely, as the patient receives only a single dose of NanoScan, carefully prepared under the control of a nuclear medicine doctor supervising the examination. However, in case of overdose, the doctor will implement appropriate treatment. In particular, the nuclear medicine doctor supervising the procedure may recommend that the patient drink plenty of fluids to facilitate the elimination of NanoScan from the body. If you have any further questions about using NanoScan, you should consult a nuclear medicine specialist supervising the examination.
4.
Like all medicines, this medicine can cause side effects, although not everybody gets them
During the assessment of side effects, the following frequency data were used as a basis:

• very common: more than 1 in 10 patients
• common: 1-10 in 100 patients
• uncommon: 1-10 in 1,000 patients
• rare: 1-10 in 10,000 patients
• very rare: less than 1 in 10,000 patients
• frequency not known: the frequency of side effects cannot be estimated from the available data

Very rare:
Mild and transient hypersensitivity reactions, which may manifest as symptoms such as:
reactions at the injection site/local skin reactions, rash, itching, immune system disorders (immunologic), dizziness, decreased blood pressure.
When a patient is given a radiopharmaceutical containing protein, such as NanoScan, hypersensitivity reactions, including a very rare and life-threatening anaphylactic reaction, may develop (with an unknown frequency).
This radiopharmaceutical emits low doses of ionizing radiation, which is associated with a low risk of cancer and genetic disorders.
If you experience any side effects, you should tell your nuclear medicine doctor, including other possible side effects not listed in this leaflet.

Reporting side effects

If you experience any side effects, you should tell your doctor, including other possible side effects not listed in this leaflet. Side effects can also be reported directly via the national reporting system to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181c, 02-222 Warsaw,
Phone: +48 22 49 21 301,
Fax: +48 22 49 21 309,
e-mail: ndl@urpl.gov.pl
Reporting side effects can help gather more information on the safety of the medicine.

5. HOW TO STORE NANOSCAN

The patient will not need to store this medicine. Radiopharmaceuticals are stored only by authorized personnel in appropriate clinical conditions.
The storage of radiopharmaceuticals is carried out in accordance with local regulations regarding radioactive substances.
This information is intended exclusively for medical personnel.
NanoScan should not be used after the expiry date stated on the carton and on the label.
NanoScan should not be used if the integrity of the vial is compromised.

6. CONTENTS OF THE PACKAGING 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
The other ingredients are: tin (II) chloride dihydrate, sodium dihydrogen phosphate, and disodium hydrogen phosphate, glucose, hydrochloric acid, sodium hydroxide

What NanoScan looks like and what the pack contains

This product is a kit for the preparation of a radiopharmaceutical.
Each vial contains a white or almost white powder intended for preparation of an injection.
NanoScan contains 6 vials. The contents of the vial must be dissolved in a solution and combined with radioactive technetium before use. After adding the substance called sodium pertechnetate (Tc) to the vial, technetium (Tc) labeled albumin in the form of a nanocolloid is formed. This solution is ready for injection.
Pack sizes
1 pack contains 6 vials
Sample packaging: 2 vials
Hospital packaging:
Pack of 2 packs containing 6 vials each
Pack of 4 packs containing 6 vials each
Not all pack sizes may be marketed

Marketing authorization holder and manufacturer:

Marketing authorization holder:
RADIOPHARMACY Laboratory Ltd
2040, Budaörs, Gyár st. 2. Hungary
Phone:
+36-23-886-950, +36-23-886-951
Fax:
+36-23-886-955
e-mail:
info@radiopharmacy-laboratory.eu
Manufacturer:
Medi-Radiopharma Ltd
2030 Érd, Szamos u. 10-12
Hungary

This medicinal product is authorized in the Member States of 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 mikrogramów
zestaw do sporządzania preparatu radiofarmaceutycznego
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

Date of last revision of the leaflet:

17/09/2020

Marketing authorization number:

22470
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Information intended exclusively for healthcare professionals:

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