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NANOSCAN 500MICROGRAMS KIT FOR RADIOPHARMACEUTICAL PREPARATION

Active substance(s): HUMAN SERUM ALBUMIN / HUMAN SERUM ALBUMIN / HUMAN SERUM ALBUMIN

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
NanoScan, kit for radiopharmaceutical preparation
Human Serum Albumin nano sized colloid
Read all of this leaflet carefully before you are given this
medicine because it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your Nuclear medicine
doctor who will supervise the procedure.
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:
1. What NanoScan is and what it is used for
2. What you need to know before NanoScan is used
3. How NanoScan is used
4. Possible side effects
5. How NanoScan is stored
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.
Before treatment with NanoScan your doctor will explain to you the
procedure you are about to undergo, and radioactive medicine you
will be given.
NanoScan kit is a sterile preparation for studies of bone marrow
scintigraphy, lymphoscintigraphy and sentinel node
lymphoscintigraphy in melanoma malignum and in breast cancer.
NanoScan belongs to a group of medicines called
radiopharmaceutical agents. After labelling with 99mTc-pertechnetate
the Nuclear medicine doctor injects you into the vein (intravenous)
or into the skin (subcutaneous) for visualisation and detection under
a scintillation camera.
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 NanoScan or any of the other
ingredients of this medicine (listed in section 6.)

if you are pregnant and you should undergo a
lymphoscintigraphy with Tc-labelled NanoScan

if you have a history of hypersensitivity to human albumine
Warnings and precautions
Take special care with NanoScan

if you are pregnant or believe you may be pregnant

if you are under 18 years of age

if you are breast-feeding

if you have a kidney or liver disease.
Please tell your Nuclear medicine doctor, if you have undergone a
lymphangiography with iodinated contrast media before you are
receiving 99mTc-NanoScan
Please tell your Nuclear medicine doctor, if you know that you are
suffering on a kidney and/or liver disease and/or a malfunction of
your gallbladder. Your doctor will explain to the details of the
applied doses and procedures.
Before administration of NanoScan you should:
- 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 are under 18 years old.
Other medicines and NanoScan
Tell your Nuclear medicine doctor if you are taking or might take any
other medicines.
NanoScan with food and drink
Please do not drink alcohol, before you undergo this investigation.
Pregnancy and breast-feeding
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. Please ask your Nuclear
medicine doctor before taking any medicine.
If you are pregnant
The Nuclear medicine doctor will only administer this product during
pregnancy, if a benefit is expected which would outweigh the risks.
If you are breast-feeding
Tell your doctor if you are breastfeeding as he may delay the
investigation until breastfeeding is completed or ask you to stop
breastfeeding for a short while until the radioactivity is no longer in
your body. He may ask you to use formula feedings to substitute
breastfeeding for 13 hours following the administration of NanoScan.
Breast milk produced within that time should be discarded.
Please ask your Nuclear medicine doctor when you can resume
breast-feeding.
Driving and using machines
It is considered unlikely that NanoScan will affect your ability to
drive or operate machines.
NanoScan contains Sodium
This product contains 0.046 mmol Sodium 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 40 to 500 MBq (Mega Becquerel, the united used to
express radioactivity).
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 as an injection into a vein or as subcutaneous
injection. NanoScan should only be given by a qualified personal.
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:
not take any other medicines until advised by your Nuclear
medicine doctor

-

urinate frequently in order to eliminate the label
(radionuclide) from your body

If you have been given more NanoScan than you should
An overdose is unlikely, because you will only receive single or
multiple doses 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.
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 mjedicine can cause side effects, although not
everybody gets them.
The following table presents how the frequencies are reflected in this
section:
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1000 people)
Very rare (may affect up to 1 in 10000 people)
not known (frequency cannot be estimated from the available data)
Rare
Frequency not known
(cannot be estimated
from the available data)

Protein allergic (hypersensitive) reaction
Hereditary defects, Cancer induction,
Hypersensitivity reactions (including
very rare life-threatening severe allergic
reaction
of
the
whole
body
(anaphylaxis)).

What NanoScan looks like and contents of the pack
Kit for radiopharmaceutical preparation
NanoScan is a white powder
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, Budaörs, Gyár st. 2. Hungary
Tel:
+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 authorised in the member states of the
EEA under the following names:
Austria

NanoScan 500 Mikrogramm
kit für ein radioaktives Arzneimittel

Belgium

NANOSCINT 0,5 mg,
kit voor radiofarmaceutisch preparaat

▪ local allergic reaction mostly at the site of injection

Denmark

This radiopharmaceutical will deliver low amounts of ionising
radiation associated with the least risk of cancer and hereditary
abnormalities.

NanoScan,
kit for radiopharmaceutical preparation

The 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 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

Tell your doctor if you notice any of the following side-effects:
▪ hypersensitive-type reactions with pain in chest, rigor and collapse.

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: www.mhra.gov.uk/yellowcard.
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 will not be used after the expiry date which is stated on
the carton and the label. The expiry date refers to the last day of that
month.
NanoScan must not be used if it is noticed any particulate matter.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What NANOSCAN CONTAINS
The active substance is Human Serum Albumin nano sized colloid
Each vial contains 500 micrograms Human Serum Albumin nano
sized colloid
The other ingredients are:
Stannous Chloride Dihydrate, Sodium dihydrogen phosphate
dihydrate, di-Sodium hydrogen phosphate dihydrate, Glucosemonohydrate Hydrochloric acid, Sodium hydroxide

This leaflet was last revised in
21/12/2015
The following Information is only for Physicians and Health Care
Professionals
The complete SmPC of NanoScan 500micrograms is provided as a
separate document.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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