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NANOSCAN 500MICROGRAMS KIT FOR RADIOPHARMACEUTICAL PREPARATION

Active substance(s): HUMAN SERUM ALBUMIN

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PACKAGE LEAFLET: INFORMATION FOR THE USER
NanoScan 500 micrograms, Kit for radiopharmaceutical
preparation
Human Serum Albumin nano sized colloid
Read all of this leaflet carefully before you will be administered
this medicine.
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 any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet,
please tell your Nuclear medicine doctor who has
supervised the procedure.
In this leaflet:
1. What NanoScan is and what it is used for
2. Before NanoScan is used
3. How NanoScan is used
4. Possible side effects
5. How NanoScan is stored
6. Further 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 99mTcpertechnetate 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 overcomes the
risk due to radiation.
This medicine has been prescribed for you only personally by your
doctor.

2. BEFORE NANOSCAN IS ADMINISTERED
NanoScan must never be used
 if you are allergic (hypersensitive) to the active substance
or any of other ingredients of NanoScan
 if you are pregnant and you should undergo a
lymphscintigraphy with Tc-labelled NanoScan
 if you have a history of hypersensitivity to human
albumine

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
Children and adolescents
Please speak to your Nuclear medicine doctor, if you are under 18
years old.

Please tell your Nuclear medicine doctor, if you have undergone a
lymphoangiography 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.
Taking other medicines
Please tell your Nuclear medicine doctor who will supervise the
procedure, if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
Please tell your Nuclear medicine doctor, if you have undergone a
lymphoangiography and iodinated contrast media have been used.
Using 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 breastfeeding.
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
Please ask your Nuclear medicine doctor when you can resume
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.
Before NanoScan administration you should:
- drink plenty of water and to be well hydrated before the start of
the examination in order to urinate as often as possible during the
first hours after the study.
Driving and using machines
It is considered unlikely that NanoScan will affect your ability to
drive or operate machinery.
Important information about some of the ingredients of
NanoScan
This product contains 0.046 mmol Sodium per vial, i. e. essentially
“Sodium free”.

3. HOW WILL NANOSCAN BE USED?
There are strict laws on the use, handling and disposal of
radiopharmaceutical products. NanoScan will only be used in a
hospital or specialist physician in Nuclear medicine. 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
In children and adolescents, the quantity to be administered will be
adapted to the child’s body mass.
Administration of NanScan 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.

If you notice any side effects, or if you notice any side effects not
listed in this leaflet, please tell your Nuclear medicine doctor who
supervises the procedure.
5. HOW X 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 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 will not be used if it is noticed any particulate matter.

6. FURTHER INFORMATION
Duration of the procedure
Your Nuclear medicine doctor will inform you about the usual
duration of the procedure.
If you have been administered more NanoScan than you should
An overdose is almost impossible, 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.
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

4. POSSIBLE SIDE EFFECTS
Like all medicines, NanoScan can cause side effects, although not
everybody gets them.
The following table presents how the frequencies are reflected in
this section:
Very common (1/10)
Common (1/100 to <1/10)
Uncommon (1/1,000 to <1/100)
Rare (1/10,000 to <1/1,000)
Very rare (<1/10,000)
not known (cannot be estimated from the available data)
Rare
Protein allergic (hypersensitive) reaction
Frequency not
known (cannot
be estimated
from the
available data)

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

Tell your doctor if you notice any of the following side-effects:
▪ hypersensitive-type reactions with pain in chest, rigor and
collapse.
▪ local allergic reaction mostly at the site of injection
This administered radiopharmaceutical will deliver low amounts of
ionising radiation with very low risk of cancer and hereditary
abnormalities.

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 Phosphate Monobasic & Sodium Phosphate Dibasic,
Glucose, Hydrochloric acid, Sodium hydroxide
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:
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 leaflet was last approved in
(DDMMYYYY)
Revision date
02/2015
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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