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NANOTOP 0.5 MG KIT FOR RADIOPHARMACEUTICAL PREPARATION

Active substance(s): HUMAN ALBUMIN

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Package leaflet: Information for the patient

Nanotop 0.5 mg
Kit for radiopharmaceutical preparation
Active substance: Human albumin, colloidal particles
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.
What is in this leaflet
1.
2.
3.
4.
5.
6.

What Nanotop is and what it is used for
What you need to know before Nanotop is used
How Nanotop is used
Possible side effects
How Nanotop is stored
Contents of the pack and other information

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 infection.
There are no reports of viral infections with albumin manufactured to
European Pharmacopoeia requirements by established processes.
It is strongly recommended that every time you receive a dose of
Nanotop 0.5 mg kit for radiopharmaceutical preparation the name
and batch number of the medicine are recorded in order to maintain
a record of the batches used.
Other medicines and Nanotop
Iodinated contrast media used in lymphoangiography may interfere
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with lymphatic scanning using
Tc nano-sized albumin colloid.
Tell your nuclear medicine doctor if you are taking/using, have recently taken/used or might take/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.
Pregnancy and breast-feeding
You must inform the nuclear medicine doctor before the administration of Nanotop if there is a possibility you might be pregnant, if you
have missed your period or if you are breast-feeding.

1. What Nanotop is and what it is used for

When in doubt, it is important to consult your nuclear medicine doctor
who will supervise the procedure.

This medicine is a radiopharmaceutical product for diagnostic use
only.

If you are pregnant:

It is used for scintigraphic imaging and assessment of
• sentinel lymph nodes in tumor diseases (Sentinel Node Mapping)
• the integrity of the lymphatic system and differentiation of venous
from lymphatic obstruction
The use of Nanotop 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, outweighs the risk due to radiation.
2. What you need to know before Nanotop is used
Nanotop must not be used:



if you are allergic to Nanotop or to any of the excipients of
this medicine (listed in section 6).
during pregnancy.

In patients with complete lymph obstruction, lymph node scintigraphy
is not advisable because of the danger of radiation necroses at the
site of injection.
Warnings and precautions
Take special care with Nanotop
- if you are breast-feeding
Before administration of Nanotop 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

Do not use Nanotop during pregnancy.
If you are breast-feeding
If you are breast-feeding, please tell your doctor, as he/she may
advise you to stop doing so until the radioactivity has left your body.
The expressed milk should be discarded. Please ask your nuclear
medicine doctor when you can resume breast-feeding.
Driving and using machines
It is considered unlikely that Nanotop will affect your ability to drive
or to use machines.
Nanotop contains sodium
This medicinal product contains less than 1 mmol sodium (23 mg)
per vial, i.e. essentially ‘sodium-free’.
3. How Nanotop is used
There are strict laws on the use, handling and disposal of
radiopharmaceutical products. Nanotop 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 Nanotop 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 200 MBq (megabecquerel, the unit used to express
radioactivity).
Dosage reductions in renal or hepatic impairment are not necessary.

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:



careful selection of blood and plasma donors to make sure
those at risk of carrying infections are excluded,
the testing of each donation and pools of plasma for signs of
virus/infections,

Use in children and adolescents
In children and adolescents, the quantity to be administered will be
adjusted to the child’s weight.
Administration of Nanotop and conduct of the procedure
After radiolabelling the drug is administered subcutaneously (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.

Shelf life after first opening and radiolabelling

Duration of the procedure

After radiolabelling: 6 hours. Do not store above 25°C after radiolabelling.

Your nuclear medicine doctor will inform you about the usual duration
of the procedure.

The ready for use injection suspension has to be stored according to
the national regulations for radioactive material.

After administration of Nanotop, you should

6. Contents of the pack and other information

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 Nanotop than you should
An overdose is almost impossible because you will only receive a
single dose of Nanotop precisely controlled by the nuclear medicine
doctor supervising the procedure. However, in the case of an overdose, you will receive the appropriate treatment.
If you have further questions regarding the application of the
medicinal product, ask your nuclear medicine doctor who will
supervise the procedure.
4. Possible side effects
Like all medicines, Nanotop 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:
common:
uncommon:
rare:
very rare:
not known:

more than 1 patient out of 10
1 to 10 patient out of 100
1 to 10 patient out of 1000
1 to 10 patient out of 10000
Less than 1 patient out of 10000
frequency cannot be estimated from
available data

What Nanotop contains
The active substance is
1 vial contains 0.5 mg human albumin, colloidal particles
The country of origin of the blood plasma is Belgium
The excipients are
Stannous chloride, dihydrate
Glucose
Poloxamer 238
Disodium phosphate dihydrate
Sodium phytate

What Nanotop looks like and contents of the pack
The pack consists of 5 glass vials of 10 ml in a cardboard box.
Each vial contains white or almost white lyophylisate for preparation
of an injection suspension.
Marketing Authorisation Holder and Manufacturer
ROTOP Pharmaka AG
Bautzner Landstraße 400
01328 Dresden
Germany
Tel: +49 (0) 351 – 26 310 100
Fax: +49 (0) 351 – 26 310 303
E-Mail: service@rotop-pharmaka.de

Very rare:

This medicinal product is authorised in the Member States of the
EEA under the following names:

slight and temporary hypersensitivity reactions, which can express
symptoms

United Kingdom
Austria

at the administration area/skin

Finland
France

local reactions, rush, itching
as immune system disease
vertigo, blood pressure decrease
This radiopharmaceutical will deliver low amounts of ionising radiation associated with the least risk of cancer and hereditary abnormalities.
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When a protein-containing radiopharmaceutical such as
TcNanotop is administered to a patient, hypersensitivity reactions may
develop.
Reporting of side effects
If you get any side effects talk to your nuclear medicine doctor. This
includes any possible side effects not listed in this leaflet. You can
also report side effects directly via 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 Nanotop is stored
You will not have to store this medicine. This medicine is stored
under the responsibility of the specialist in appropriate facilities.
Storage of radiopharmaceuticals will be in accordance with national
regulation on radioactive materials.
The following information is intended for the specialist only.
Nanotop must not be used after the expiry date which is stated on
the label.
Storage conditions:
Do not store above 25 °C.

Germany
Italy
Norway
Portugal
Sweden
Spain

Nanotop
NANOTOP 0,5 mg Kit für ein radioaktives
Arzneimittel
ROTOP-NanoHSA
ROTOP-NanoHSA 0,5 mg
Trousse pour préparation radiopharmaceutique
NANOTOP
NANOTOP
Nanotop
NANOTOP
NanoHSA
ROTOP-NanoHSA 500 microgramos
equipo de reactivos para preparación
radiofarmacéutica

This leaflet was last revised in February 2014.
-------------------------------------------------------------------------------------------The following information is intended for medical or healthcare
professionals only:
The complete SmPC of {(Invented) name} is provided as a separate
document in the product package, with the objective to provide
healthcare professionals with other additional scientific and practical
information about the administration and use of this
radiopharmaceutical.
Please refer to the SmPC.

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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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