Patient leaflet - NANOSCAN 500MICROGRAMS KIT FOR RADIOPHARMACEUTICAL PREPARATION
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
NanoScan 500 micrograms, kit for radiopharmaceutical preparation nanocolloidal technetium (99mTc) albumin
Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
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– Keep this leaflet. You may need to read it again.
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– If you have any further questions, ask your Nuclear Medicine doctor who will supervise the procedure.
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– If you get any side effects talk to your Nuclear Medicine doctor.
This includes any possible side effects not listed in this leaflet. See section 4.
In this leaflet:
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1. What NanoScan is and what it is used for
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2. What you need to know before NanoScan is used
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3. How NanoScan is used
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4. Possible side effects
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5. How NanoScan is stored
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6. Contents of the pack and other information
1. what nanoscan is and what it is used for
This medicine is a radiopharmaceutical product for diagnostic use only.
NanoScan should be radiolabelled with technetium (99mTc) and the obtained product is used for scintigraphic imaging and assessment of – bone marrow
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– inflammation in the body
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– the integrity of the lymphatic system and differentiation of venous from lymphatic obstruction.
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– sentinel lymph nodes in tumor diseases (sentinel node mapping in melanoma, breast carcinoma, penile carcinoma, squamous cell carcinoma of the oral cavity and vulvar carcinoma);
The use of radiolabelled NanoScan does involve exposure to small amounts of radioactivity. Your doctor and the Nuclear medicine doctor have considered that the clinical benefit that you will obtain from the procedure with the radiopharmaceutical overweights the risk due to radiation.
2. what you need to know before nanoscan is used nanoscan must not be used
- if you are allergic to nanocolloidal human albuminor any of the other ingredients of this medicine (listed in section 6.)
- during pregnancy if you should do a lymphoscintigraphy involving the pelvis. In patients with complete lymph obstruction, lymph node scintigraphy is not advisable because of the danger of radiation necrosis at the site of injection.
Warnings and precautions
Take special care with NanoScan
- if you are pregnant or believe you may be pregnant
- if you are breastfeeding
- if you have a kidney or liver disease.
You should inform your Nuclear Medicine doctor in case those apply to you. Your Nuclear Medicine doctor will inform you if you need to take any special precautions after using this medicine. Talk to your Nuclear Medicine doctor if you have any questions.
Before administration of NanoScan you should:
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– drink plenty of water before the start of the examination in order to urinate as often as possible during the first hours after the study.
Children and adolescents
Talk to your Nuclear Medicine doctor, if you or your child are under 18 years old.
Medicines made from human blood or plasma
When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients. These include:
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– careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded,
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– the testing of each donation and pools of plasma for signs of virus/infections,
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– the inclusion of steps in the processing of the blood or plasma
that can inactivate or remove viruses.
Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded. This also applies to any unknown or emerging viruses or other types of infections. There are no reports of virus infections with albumin manufactured to European Pharmacopoeia requirements by established processes.
It is strongly recommended that every time you receive a dose of NanoScan the name and batch number of the medicine are recorded in order to maintain a record of the batches used.
Other medicines and NanoScan
Tell your Nuclear Medicine doctor if you are using, have recently used or might use any other medicines since they may interfere with the interpretation of the images.
If you must have made a scan of your lymph system, talk to your doctor before your scan, if you previously have been investigated by x-ray or scan with contrast agents. This can influence the outcome.
Please ask your Nuclear Medicine doctor before taking any medicines.
Pregnancy and breast-feeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your Nuclear Medicine doctor for advice before you are given this medicine.
You must inform the Nuclear Medicine doctor before the administration of NanoScan if there is a possibility you might be pregnant, if you have missed your period or if you are breast-feeding.
When in doubt, it is important to consult your Nuclear Medicine doctor who will supervise the procedure. If you are pregnant, Do not use NanoScan during pregnancy.
If you are breast-feeding, please tell your Nuclear Medicine doctor, as he/she will advise you to stop doing so until the radioactivity has left your body. This takes about 24 hours. The expressed milk should be discarded.
Please ask your Nuclear Medicine doctor when you can resume breastfeeding.
Driving and using machines
It is considered unlikely that NanoScan will affect your ability to drive or operate machines.
NanoScan contains Sodium
This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium- free’
3. HOW NANOSCAN IS USED
There are strict laws on the use, handling and disposal of radiopharmaceutical products. NanoScan will only be used in special controlled areas. This product will only be handled and given to you by people who are trained and qualified to use it safely. These persons will take special care for the safe use of this product and will keep you informed of their actions.
The Nuclear medicine doctor supervising the procedure will decide on the quantity of NanoScan to be used in your case. It will be the smallest quantity necessary to get the desired information.
The quantity to be administered usually recommended for an adult ranges from 5 to 500 MBq (Mega Becquerel, the united used to express radioactivity).
Dosage reductions in renal or hepatic impairment are not necessary.
Use in children and adolescent
In children and adolescents, the quantity to be administered will be adapted to the child’s weight.
Administration of NanoScan and conduct of the procedure
NanoScan is given after radiolabeling as an injection into a vein or as subcutaneous injection (one or more injection sites).
This product is not intended for regular or continuous administration.
After injection, you will be offered a drink and asked to urinate immediately preceding the test.
Duration of the procedure
Your Nuclear medicine doctor will inform you about the usual duration of the procedure.
After administration of NanoScan, you should:
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– avoid any close contact with young children and pregnant women for the initial 24 hours following the administration
urinate frequently in order to eliminate the product from your body
The Nuclear Medicine doctor will inform you if you need to take any special precautions after receiving this medicine. Contact your Nuclear Medicine doctor if you have any questions.
If you have been given more NanoScan than you should
An overdose is unlikely, because you will only receive a dose of NanoScan precisely controlled by the Nuclear medicine doctor supervising the procedure. However, in the case of an overdose, you will receive the appropriate treatment. In particular, the Nuclear Medicine doctor in charge of the procedure may recommend that you drink abundantly in order to facilitate the elimination of NanoScan from your body. Should you have any further question on the use of NanoScan, please ask your Nuclear medicine doctor who supervises the procedure.
4. possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
During the evaluation of side effects the following frequency data are taken as a basis:
very common: more than 1 patient out of 10
very rare: Less than 1 patient out of 10000
not known: frequency cannot be estimated from
available data
Very rare:
slight and temporary hypersensitivity reactions, which can express symptoms as at the administration area/skin local reactions, rush, itching
immune system disease vertigo, blood pressure decrease
When a protein-containing radiopharmaceutical such as NanoScan is administered to a patient, hypersensitivity reactions may develop, including very rare life-threatening anaphylaxis, with frequency not known.
This radiopharmaceutical will deliver low amounts of ionising radiation associated with the least risk of cancer and hereditary abnormalities.
If you get any side effects talk to your nuclear medicine doctor. This includes any possible side effects not listed in this leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system:
United Kingdom
The Yellow Card Scheme at:.
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW NanoScan IS STORED
You will not have to store this medicine. This medicine is stored under the responsibility of the specialist in appropriate premises. Storage of radiopharmaceuticals will be in accordance with national regulation on radioactive materials.
The following information is intended for the specialist only.
NanoScan must not be used after the expiry date which is stated on the carton and the label.
NanoScan must not be used if the integrity of this vial is compromised.
6. contents of the pack and other informationthe active substance is nanocolloidal human albumin.
Each vial contains 500 micrograms human albumin nanocolloids
The other ingredients are:
Stannous Chloride Dihydrate, Sodium dihydrogen phosphate dihydrate, di-Sodium hydrogen phosphate dihydrate, Glucose-monohydrate Hydrochloric acid, Sodium hydroxide
What NanoScan looks like and contents of the pack
The product is a kit for radiopharmaceutical preparation.
Each vial contains white or almost white powder for preparation of an injection.
NanoScan consists of six vials. The content of the vial has to be dissolved in a solution and combined with radioactive technetium before use as an injection. Once the radioactive substance sodium pertechnetate (99mTc) is added to the vial, technetium (99mTc) albumin nanocolloids are formed. This solution is ready for injection.
Pack sizes:
1 pack contains 6 vials
Sample package: 2 vials
Hospital packs:
Bundle pack of 2 packs of 6 vials
Bundle pack of 4 packs of 6 vials
Not all packs sizes may be marketed
Marketing authorisation holder and manufacturer
Marketing authorisation holder:
RADIOPHARMACY Laboratory Ltd
2040, Budaors, Gyar st. 2. Hungary
Tel: +36–23–886–950, +36–23–886–951
Fax: +36–23–886–955
e-mail:
Manufacturer:
Medi-Radiopharma Ltd
2030 Erd, Szamos u. 10–12.
Hungary
This medicinal product is authorised in the member states of the EEA under the following names:
| Austria | NanoScan 500 Mikrogramm kit fur ein radioaktives Arzneimittel |
| Belgium | NANOSCINT 0,5 mg, kit voor radiofarmaceutisch preparaat |
| Denmark | NanoScan, kit for radiopharmaceutical preparation |
| The Netherlands | NanoScan 500 microgram, kit voor radiofarmaceutisch preparaat |
| Poland | NanoScan, 500 mikrogramow zestaw do sporzadzania preparatu radiofarmaceutycznego |
| Germany | NanoScan 500 Mikrogramm Kit fur ein radioaktives Arzneimittel |
| Italy | Nanoalbumon 500 microgrammi Kit per preparazione radiopharmaceutical |
| Romania | NanoScan 500 micrograme kit pentru preparate radiofarmaceutice |
| Spain | Nanocoloides de albumina Radiopharmacy 500 microgramos Equipo de Reactivos Para Preparacion Radiopharmaceutica |
| United Kingdom | NanoScan 500micrograms, Kit for radiopharmaceutical preparation |
This leaflet was last revised in
28/04/2020
Marketing Authorisation Number
PL 40129/0002
The following Information is only for Physicians and Health Care Professionals
The complete SmPC of NanoScan 500micrograms is provided as a separate document.