Nanospect
PolandTable of Contents
Package leaflet: Information for the patient
NanoSPECT 0.5 mg, kit for the preparation of a radiopharmaceutical preparation
Technetium (Tc) labelled nanocolloidal albumin
Please read all of this leaflet carefully before using the medicine, because it contains
important information for the patient.
- Keep this leaflet, so that you can read it again if necessary.
- If you have any questions, please consult the nuclear medicine physician supervising the procedure.
- If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform the nuclear medicine physician supervising the procedure. See section 4.
Table of contents
- What NanoSPECT is and what it is used for
- Important information before using NanoSPECT
- How to use NanoSPECT
- Possible side effects
- How to store NanoSPECT
- Contents of the pack and other information
1. What NanoSPECT is and what it is used for
NanoSPECT is a radiopharmaceutical medicinal product intended solely for diagnostic use.
NanoSPECT should be labelled with technetium (Tc), and the resulting product is used for diagnostic imaging and evaluation by scintigraphy of:
- bone marrow
- inflammatory conditions
- the lymphatic system and differential diagnosis of venous and lymphatic congestion
- sentinel lymph nodes in oncological diseases (sentinel lymph node mapping in melanoma, breast cancer, prostate cancer, penile cancer, oral squamous cell carcinoma, and vulvar cancer).
Use of NanoSPECT results in exposure to a small dose of radioactivity. The referring physician and the nuclear medicine physician have considered the clinical benefits to the patient of performing the investigation using a radiopharmaceutical and have concluded that they outweigh the risks associated with radiation exposure.
2. Important information before using NanoSPECT
When not to use NanoSPECT:
- If the patient is allergic to human nanocolloidal albumin or to any of the other ingredients of this medicine (listed in section 6).
- During pregnancy, if lymphoscintigraphy involves the pelvic region.
Lymphoscintigraphy is not recommended in cases of complete lymphatic obstruction due to the risk of post-radiation necrosis at the injection site.
Warnings and precautions
When to exercise particular caution when using NanoSPECT
- if the patient is pregnant or suspects she may be pregnant
- if the patient is breastfeeding
- in case of kidney or liver disease
In such cases, inform the nuclear medicine physician. The nuclear medicine physician will inform the patient about the need to take special precautions after administration of this medicine. For any further questions, please consult the nuclear medicine physician.
Important information before administration of NanoSPECT
Before starting the examination, drink plenty of water to ensure frequent urination during the first hours after completion of the examination.
Children and adolescents
Inform the nuclear medicine physician if the patient is under 18 years of age.
Medicinal products derived from human blood or plasma
A number of measures are taken during the manufacturing of medicinal products from human blood or plasma to prevent transmission of infectious agents to patients. These include:
- careful selection of blood and plasma donors to exclude donors with a risk of transmitting infection,
- testing of each individual donation and plasma pool for the presence of viruses or infection,
- implementation of blood or plasma processing steps that allow for virus inactivation or removal. Nevertheless, when using medicinal products prepared from human blood or plasma, it is not possible to completely eliminate the risk of transmission of infectious agents. This also applies to new, unknown viruses and other infectious agents. There have been no reports of viral infections transmitted with albumins manufactured according to the requirements described in the European Pharmacopoeia and documented processes. It is strongly recommended that each time a dose of NanoSPECT is administered to a patient, the name and batch number of the medicine be recorded, so that documentation of administered batches is available.
NanoSPECT and other medicines
Iodine-containing contrast agents used during lymphangiography (a type of X-ray examination) may interfere with lymphoscintigraphy images obtained using technetium (Tc)-labelled nanocolloidal albumin (NanoSPECT).
Inform the nuclear medicine physician about all medicines currently used or recently used, as well as any medicines the patient plans to use, because they may interfere with image interpretation.
If lymphoscintigraphy is required, inform the physician about previous X-ray examinations or use of contrast agents, as they may affect the test results.
Before using any medicine, consult the nuclear medicine physician.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult the nuclear medicine physician before receiving this medicine.
It is essential to inform the nuclear medicine physician before administration of NanoSPECT if the patient suspects she may be pregnant, has missed her period, or is breastfeeding.
In case of any doubt, consult the nuclear medicine physician supervising the procedure.
If the patient is pregnant:
NanoSPECT should not be used during pregnancy.
If the patient is breastfeeding:
If the patient is breastfeeding, she must inform the nuclear medicine physician, who will advise discontinuation of breastfeeding until radioactivity has been eliminated from the body. This takes approximately 24 hours. Expressed milk should be discarded. Ask the nuclear medicine physician when breastfeeding can be resumed.
Driving and operating machinery
It is unlikely that NanoSPECT will affect the ability to drive or operate machinery.
NanoSPECT contains sodium
The medicinal product contains less than 1 mmol of sodium (23 mg) per vial; therefore, the medicine is considered "sodium-free".
3. How to use NanoSPECT
Strict regulations apply to the use and disposal of radiopharmaceuticals and to handling them.
NanoSPECT must be used only in facilities where special control measures are in place. Only trained and qualified personnel with expertise in safe handling may come into contact with the medicinal product and administer it. These individuals take special precautions to ensure safe use of the product and will inform the patient about the procedures being performed.
The nuclear medicine physician supervising the procedure will decide the appropriate dose of NanoSPECT for each individual case. This will be the lowest dose necessary to obtain the required diagnostic information.
The recommended dose typically administered to adults ranges from 5 to 500 MBq (megabecquerels, the unit of radioactivity), and is determined based on the patient's body weight and the type of examination being performed.
Dose reduction is not necessary in patients with impaired renal or hepatic function.
Use in children and adolescents
In children and adolescents, the administered dose will be adjusted according to the child's body weight.
Administration of NanoSPECT and performance of the procedure
NanoSPECT is administered intravenously (as a single injection) or subcutaneously after localization (into one or more injection sites).
This medicinal product is not intended for regular or continuous administration.
After injection, the patient will be given a drink and will be asked to empty the bladder shortly before the scan.
Duration of the procedure
The nuclear medicine physician will inform the patient about the typical duration of the procedure.
After administration of NanoSPECT:
- Avoid close contact with young children and pregnant women for 24 hours after administration.
- Urinate frequently to help eliminate the medicinal product from the body.
The nuclear medicine physician will inform the patient about any special precautions necessary after administration of this medicinal product. If you have further questions, please consult the supervising nuclear medicine physician.
Administration of a higher than recommended dose of NanoSPECT
Overdose is highly unlikely, as the patient receives only a single dose of NanoSPECT, strictly controlled by the supervising nuclear medicine physician.
However, in the event of an overdose, appropriate treatment will be initiated.
In particular, the nuclear medicine physician responsible for the procedure may recommend drinking large amounts of fluids to facilitate elimination of NanoSPECT from the body.
If you have any doubts regarding the use of NanoSPECT, please consult the nuclear medicine physician supervising the procedure.
4. Possible adverse reactions
Like all medicines, this medicinal product can cause adverse reactions, although not everyone experiences them.
The following frequency categories are used to assess adverse reactions:
Very common: affects more than 1 in 10 people
Common: affects 1 to 10 in 100 people
Uncommon: affects 1 to 10 in 1,000 people
Rare: affects 1 to 10 in 10,000 people
Very rare: affects less than 1 in 10,000 people
Not known: frequency cannot be estimated from available data
Very rare:
mild and transient hypersensitivity reactions, with the following symptoms:
at the site of administration/on the skin:
local reactions, rash, itching
immune system disorders:
dizziness, low blood pressure
If a radiopharmaceutical product containing protein, such as NanoSPECT, is administered to a patient, hypersensitivity reactions may occur, including life-threatening anaphylaxis, the frequency of which is not known.
This radiopharmaceutical product results in exposure to a small dose of ionizing radiation, which carries a small risk of cancer and congenital abnormalities in the fetus.
Reporting of adverse reactions
If any adverse reactions occur in a patient, including any adverse reactions not listed in this leaflet, the nuclear medicine physician should be informed.
Adverse reactions can also be reported directly via the national reporting system to the Department for Monitoring Adverse Reactions of Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicinal product.
5. How to store NanoSPECT
This medicinal product is not intended to be stored by the patient. It is stored under specialist
supervision in an appropriate location. Radiopharmaceuticals must be stored in accordance with
national regulations concerning radioactive materials.
The following information is intended solely for medical personnel.
Do not use NanoSPECT after the expiry date stated on the label.
The expiry date refers to the last day of the stated month.
Storage conditions
No special requirements regarding storage temperature for this medicinal product.
Shelf-life after first opening and radiolabelling
After radiolabelling: 12 hours. No special requirements regarding storage temperature for this
medicinal product after radiolabelling.
The ready-to-use injection suspension must be stored in accordance with national regulations
concerning radioactive materials.
From a chemical and physical point of view, the product remains stable for 12 hours at 25 °C.
From a microbiological standpoint, unless the method of opening/radiolabelling/dilution excludes
the risk of microbiological contamination, the product should be used immediately.
If not used immediately, the responsibility for the storage duration and conditions during use
lies with the user.
6. Contents of the packaging and other information
What NanoSPECT contains
The active substance is human serum albumin, nanocolloid. Each vial contains 0.5 mg of human nanocolloid albumin.
Other components:
Tin(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 medicinal product is a kit for the preparation of a radiopharmaceutical agent.
Each vial contains a white or almost white lyophilisate for the preparation of an injectable suspension.
After adding a radioactive substance, i.e. sodium pertechnetate ( Tc), technetium ( Tc)-labelled albumin nanocolloids are formed. The suspension is then ready for injection.
The pack contains 5 glass vials with a capacity of 10 ml, packed in a cardboard box.
Marketing Authorisation Holder and Manufacturer
ROTOP Pharmaka GmbH
Bautzner Landstrasse 400
01328 Dresden
Germany
Tel.: +49 351 - 26 310 100
Fax: +49 351 - 26 310 303
E-mail: [email protected]
The following information is intended for healthcare professionals only:
A complete Package Leaflet (SmPC) for the medicinal product NanoSPECT is included in the product packaging as a separate document, allowing healthcare professionals to access additional scientific and practical information regarding the administration and use of this radiopharmaceutical product.
Please read the SmPC carefully.
Other sources of information
Detailed information on this medicinal product is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: www.urpl.gov.pl .