Nanospect

Package Leaflet: Information for the Patient

NanoSPECT 0.5 mg, Kit for the Preparation of a Radiopharmaceutical

Technetium (Tc) labeled human albumin nanocolloid

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult the nuclear medicine doctor supervising the procedure.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, inform the nuclear medicine doctor who will supervise the procedure. See section 4.

Table of Contents of the Leaflet

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

1. What is NanoSPECT and what is it used for

The medicine is a radiopharmaceutical product intended exclusively for diagnostic purposes.
NanoSPECT should be labeled with technetium (Tc), and the resulting product is used for
diagnostic scintigraphy and evaluation of:

• bone marrow
• inflammatory conditions
• lymphatic system and differential diagnosis of venous and lymphatic stasis
• sentinel lymph nodes in cancer (sentinel lymph node mapping in melanoma, breast cancer, prostate cancer, penile cancer, oral cavity squamous cell carcinoma, and vulvar cancer).

The use of NanoSPECT results in exposure to a small dose of radioactivity. The treating doctor and the nuclear medicine doctor have considered the clinical benefits for the patient resulting from the examination using the radiopharmaceutical product and have determined that they outweigh the risk associated with radiation exposure.

2. Important information before using NanoSPECT

When not to use NanoSPECT:

• If the patient is allergic to human albumin nanocolloid or any of the other ingredients of this medicine (listed in section 6).
• During pregnancy, if lymphoscintigraphy involves the pelvic area.

Scintigraphy is not recommended in case of complete lymphatic obstruction due to the risk of radiation necrosis at the injection site.

Warnings and precautions

When to exercise special caution when using NanoSPECT

• if the patient is pregnant or suspects she may be pregnant
• if the patient is breastfeeding

In such cases, inform the nuclear medicine doctor. The nuclear medicine doctor will inform the patient about the need to take special precautions after administering this medicine. If you have any further questions, consult the nuclear medicine doctor.

Important information before administering NanoSPECT

Before starting the examination, drink plenty of water to urinate frequently in the first hours after the examination and eliminate the medicine from the body.

Children and adolescents

Inform the nuclear medicine doctor if the patient is under 18 years old.

Medicines obtained from human blood or plasma

When producing medicines from human blood or plasma, a series of measures are taken to prevent the transmission of infectious agents to patients. These include:

• careful selection of blood and plasma donors to exclude donors at risk of transmitting infection,
• testing each donation and plasma pool for the presence of viruses or infection,
• using processing steps for blood or plasma that allow for virus inactivation or removal. Nevertheless, when using medicines made from human blood or plasma, it is not possible to completely eliminate the risk of transmitting infectious agents. This also applies to new, unknown viruses and other infectious agents. There have been no reports of viral infections transmitted with albumins produced in accordance with the requirements described in the European Pharmacopoeia and documented processes. It is strongly recommended that when administering a dose of NanoSPECT to a patient, the name and batch number of the medicine should be recorded, so that the administered batches can be traced.

NanoSPECT and other medicines

Iodine-containing contrast agents used during lymphangiography (a type of X-ray examination) may interfere with the image of lymphatic system scintigraphy using technetium (Tc) labeled human albumin nanocolloid (NanoSPECT).
Inform the nuclear medicine doctor about all medicines currently being taken or recently taken, as well as any medicines the patient plans to take, as they may interfere with the interpretation of the images.
If lymphatic system scintigraphy is necessary, inform the doctor about previous X-ray examinations or contrast agent use, as they may affect the result of the examination.
Before using any medicine, consult the nuclear medicine doctor.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, consult the nuclear medicine doctor before administering this medicine.
It is essential to inform the nuclear medicine doctor before administering NanoSPECT if the patient suspects she may be pregnant, has delayed menstruation, or is breastfeeding.
In case of doubts, consult the nuclear medicine doctor supervising the procedure.
If the patient is pregnant:
Do not use NanoSPECT during pregnancy.
If the patient is breastfeeding:
If the patient is breastfeeding, inform the nuclear medicine doctor, who will recommend stopping breastfeeding until the radioactivity has been eliminated from the body. This takes about 24 hours. Express and discard breast milk. Ask the nuclear medicine doctor when breastfeeding can be resumed.

Driving and using machines

It is unlikely that NanoSPECT will affect the ability to drive and use machines.

NanoSPECT contains sodium

The medicinal product contains less than 1 mmol of sodium (23 mg) per vial, which means the medicine is considered "sodium-free".

3. How to use NanoSPECT

There are strict regulations regarding the use and disposal of radiopharmaceutical products and handling them. NanoSPECT is used exclusively in places where special control applies. Only trained and qualified personnel may come into contact with the medicine and administer it. These personnel will exercise special caution to ensure safe use of the medicine and will inform the patient about the actions they perform.
The nuclear medicine doctor supervising the procedure will decide what dose of NanoSPECT to administer in a given case. This will be the smallest dose necessary to obtain the required information.
The recommended dose typically administered to adults is from 5 to 500 MBq (megabecquerels, which are units of radioactivity) and is determined based on the patient's body weight and the type of examination being performed.
No dose reduction is necessary in patients with impaired renal or hepatic function.
Use in children and adolescents
The dose administered to children and adolescents will be adjusted according to the child's body weight.

Administration of NanoSPECT and procedure

NanoSPECT is administered intravenously (in a single injection) or subcutaneously after labeling (in one or more injection sites).
The medicine is not intended for regular or continuous administration.
After injection, the patient will be given a drink, and before the examination, they will be asked to urinate.

Duration of the procedure

The nuclear medicine doctor will inform the patient about the typical duration of the procedure.

After administering NanoSPECT:

• for 24 hours after administration, avoid close contact with small children and pregnant women
• urinate frequently to eliminate the medicine from the body

The nuclear medicine doctor will inform the patient about the need to take special precautions after administering this medicine. If you have any further questions, consult the nuclear medicine doctor.

Overdose of NanoSPECT

Overdose is almost impossible, as the patient receives only one dose of NanoSPECT, strictly controlled by the nuclear medicine doctor supervising the procedure.
However, in case of overdose, appropriate treatment will be initiated.
In particular, the nuclear medicine doctor responsible for the procedure may recommend drinking a large amount of fluids to facilitate the elimination of NanoSPECT from the body.
In case of any doubts about the use of NanoSPECT, consult the nuclear medicine doctor supervising the procedure.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following categories of frequency of occurrence are used to assess side effects:
Very common:
occur in more than 1 in 10 patients
Common:
occur in 1 to 10 in 100 patients
Uncommon:
occur in 1 to 10 in 1,000 patients
Rare:
occur in 1 to 10 in 10,000 patients
Very rare:
occur in less than 1 in 10,000 patients
Unknown:
frequency cannot be estimated from the available data
Very rare:
minor and transient hypersensitivity reactions, with the following symptoms:
at the injection site/on the skin:
local reactions, rash, itching
immune system disorders:
dizziness, low blood pressure
If a patient is given a radiopharmaceutical product containing protein, such as NanoSPECT, hypersensitivity reactions may occur, including very rare and life-threatening anaphylaxis, whose frequency is unknown.
This radiopharmaceutical product results in exposure to a small dose of ionizing radiation, which carries a small risk of cancer and congenital anomalies.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, inform the nuclear medicine doctor.
Side effects can also be reported directly through the national reporting system to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will allow for more information to be collected on the safety of the medicine.

5. How to store NanoSPECT

This medicine is not stored by the patient. It is stored under specialized supervision in an appropriate location. Radiopharmaceuticals should be stored in accordance with national regulations regarding radioactive materials.
The following information is intended for healthcare professionals only.
Do not use NanoSPECT after the expiry date stated on the label.
The expiry date refers to the last day of the month stated.

Storage conditions

There are no special requirements for the storage temperature of this medicine.

Shelf life after first opening and radiolabeling

After radiolabeling: 12 hours. There are no special requirements for the storage temperature of this medicine after radiolabeling.
The ready-to-use suspension for injection should be stored in accordance with national regulations regarding radioactive materials.
From a chemical and physical point of view, the product remains stable for 12 hours at 25 °C. From a microbiological point of view, unless the method of opening/radiolabeling/dilution precludes the risk of microbial contamination, the product should be used immediately.
If not used immediately, the user is responsible for the storage time and conditions during use.

6. Contents of the pack and other information

What NanoSPECT contains

The active substance is human albumin nanocolloid. One vial contains 0.5 mg of human albumin nanocolloid.
Other ingredients:
Zinc(II) chloride dihydrate
Glucose
Poloxamer 238
Disodium phosphate dihydrate
Sodium phytate
Hydrochloric acid
Sodium hydroxide

What NanoSPECT looks like and contents of the pack

The medicine is a kit for the preparation of a radiopharmaceutical.
Each vial contains a white or off-white lyophilisate for the preparation of a suspension for injection.
After adding the radioactive substance, technetium (Tc) sodium pertechnetate, to the vial, technetium (Tc) labeled human albumin nanocolloid is formed. The suspension is ready for injection.
The pack contains 5 glass vials of 10 ml in a cardboard box.

Marketing authorization holder and manufacturer

ROTOP Pharmaka GmbH
Bautzner Landstrasse 400
01328 Dresden
Germany
Phone:
+49 351 - 26 310 100
Fax:
+49 351 - 26 310 303
Email: [email protected]

Date of last revision of the leaflet: 08/2023

The following information is intended for healthcare professionals only:
The full Summary of Product Characteristics (SmPC) of the medicinal product NanoSPECT is included in the package as a separate document, providing healthcare professionals with access to additional scientific and practical information on the administration and use of this radiopharmaceutical product.
Read the SmPC.

Other sources of information

Detailed information about this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: www.urpl.gov.pl.