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HEPATATE

Active substance(s): STANNOUS FLUORIDE

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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. What Hepatate is and what it is used for
2. What you need to know before Hepatate is used
3. How Hepatate is used
4. Possible side effects
5. How Hepatate is stored
6. Contents of the pack and further information
1. WHAT HEPATATE IS AND WHAT IT IS USED
FOR
This medicine is a radiopharmaceutical product for
diagnostic use only.
This product is a powder which, when mixed with a
solution of the radioactive substance sodium pertechnetate [99mTc] forms a technetium [99mTc] colloidal
tin injection.
• A colloid is a suspension of very fine particles in
water.
• Technetium [99mTc] colloidal tin is a radiopharmaceutical product which is used to help to make a
diagnosis. When injected, it temporarily collects in a
particular organ of the body. Because the substance
contains a small amount of radioactivity it can be de-

tected from outside the body using special cameras,
and a picture, known as a scan, can be taken. This
scan will show exactly the distribution of the radioactivity within the organ and the body. This can give the
physician valuable information about structure and
function of that organ.
When injected, technetium [99mTc] colloidal tin circulates in the blood and collects in the liver and the
spleen. A scan will then help your physician to determine the ability of these organs to eliminate particles
of foreign material such as bacteria and denatured
protein from the blood.
The use of technetium [99mTc] colloidal tin 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
HEPATATE IS USED

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

Hepatate must not be used
• if you are allergic (hypersensitive) to stannous
fluoride or any of the other ingredients of Hepatate
(listed in section 6).

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.

Warnings and precautions
Take special care with Hepatate
• if you are pregnant or believe you may be pregnant
• if you are breast-feeding
• Hepatate should only be used and administered by
authorized persons.

If you are breast-feeding
Tell your nuclear medicine doctor if you are breastfeeding as he may delay the investigation until breastfeeding is completed or ask you to stop breast-feeding
for a short while until the radioactivity is no longer in
your body. Please ask your nuclear medicine doctor
when you can resume breast-feeding.

Using other medicines
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.
It is particularly important to tell your doctor if you
are taking any of the following:
• cancer chemotherapy drugs
• contraceptives
• tetracyclines (antibiotic used to treat a variety of
bacterial infections)
• drugs which affect blood flow in the liver, such as
some anaesthetics.
Pregnancy and breast-feeding
You must inform the nuclear medicine doctor before
the administration of Hepatate if there is a possibility
you might be pregnant, if you have missed your period
or if you are breast-feeding.

Driving and using machines
Technetium [99mTc] colloidal tin has no effect on
your fitness to drive or operate machinery.
3. HOW HEPATATE IS USED
There are strict laws on the use, handling and disposal
of radiopharmaceutical products. Hepatate 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 Hepatate 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
from 15 MBq for small children, up to a maximum
of 185 MBq (Megabecquerel - the unit in which
radioactivity is measured).
Use in children and adolescents
In children and adolescents, the quantity to be
administered will be adapted to the child’s weight.
Administration of Hepatate and conduct of the
procedure
The solution is administered by injection into a vein.
One injection is sufficient to provide your doctor with
the information needed.
Duration of treatment
Scans may be taken at any time following injection.
Your nuclear medicine doctor will inform you about
the usual duration of the procedure.
After administration of Hepatate
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 Hepatate than you
should
An overdose is unlikely since technetium [99mTc]
colloidal tin is administered by a nuclear medicine

doctor under strictly controlled conditions. However,
in the case of an overdose, you will receive the
appropriate treatment.

• on rare occasions skin reaction may occur. The
majority of the reactions are relatively mild and your
physician will decide on any necessary treatment.

Should you have any further question on the use of
Hepatate, please ask the nuclear medicine doctor who
supervises 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.

4. POSSIBLE SIDE EFFECTS

5. HOW HEPATATE 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.

Like all medicines, Hepatate can cause side effects,
although not everybody gets them.
Hepatate will deliver low amounts of ionising
radiation associated with the least risk of cancer and
hereditary abnormalities.
Technetium [99mTc] colloidal tin may very
occasionally produce side effects.
The following side effects have been reported:
• malaise, lowered heart rate and blood pressure
• swelling of the skin (often of the face)
• central chest or back pain with shortness of breath,
occasionally complicated with true bronchospasm

The following information is intended for the specialist
only.
Hepatate must not be used after the expiry date which
is stated on the label.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Hepatate contains
• The active substance is Stannous fluoride. Each vial
contains 0.125 mg of stannous fluoride.
• The other ingredients are Sodium fluoride &
Poloxamer 188.
What Hepatate looks like and contents of the
pack
The product is supplied in a clear Type I Ph.Eur.glass
vial sealed with a chlorobutyl rubber
closure and metal overseal.

Marketing
Authorisation Holder
and Manufacturer
Marketing
Authorisation Holder
MEDIAM
85 rue Nelson Mandela
59120 LOOS
France
Manufacturer
GIPHARMA S.r.l.
Strada Cresentino
13040 Saluggia
Italy
This leaflet was last
approved in {11/2011}.
The following
information is
intended for medical
or healthcare
professionals only:
Please refer to the
SmPC.

MEDIAM

PATIENT INFORMATION
LEAFLET
Hepatate
Kit for the preparation of
Technetium [99mTc]
Colloidal Tin Injection Ph.Eur.
Stannous fluoride

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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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