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MEDI-EXAMETAZIME 500 MCG KIT FOR RADIOPHARMACEUTICAL PREPARATION

Active substance(s): EXAMETAZIME

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PACKAGE LEAFLET: INFORMATION FOR THE
PATIENT
MEDI-EXAMETAZIM 500 micrograms
Kit for radiopharmaceutical preparation
Exametazime

Children
Talk to your nuclear medicine doctor if you are under 18 years old.
Other medicines and Medi-Exametazim
Tell your nuclear medicine doctor if you are taking, have recently
taken or might take any other medicines since they may interfere with
the interpretation of the images.
Medi-Exametazim with food and drink and alcohol
Please avoid excessive stimulants (such as caffeine, cola, and energy
drinks), alcohol, smoking, and any drugs known to affect cerebral
blood flow prior to imaging.

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 Medi-Exametazim is and what it is used for
2. What you need to know before Medi-Exametazim is used
3. How Medi-Exametazim is used
4. Possible side effects
5. How Medi-Exametazim is stored
6. Contents of the pack and other information
1. What Medi-Exametazim is and what it is used for
This medicine is a radiopharmaceutical product for diagnostic use
only.
Medi-Exametazim 500microgramms kit for radiopharmaceutical
preparation is a ‘radiopharmaceutical’ medicine. It is given before a
scan and helps a special camera see inside a part of your body.
• It contains an active ingredient called ‘exametazime’. This is
mixed with another ingredient called ‘technetium’ before it is
used. Once injected it can be seen from outside your body by a
special camera used in the scan.
• The scan can help your doctor see how much blood is flowing
through the brain. This may be important to know after a stroke,
if you have fits or epilepsy, Alzheimer's disease or a similar type
of dementia. It may also be used in people who have migraine
(headaches).
• The scan can help your doctor investigate fever when the reason
for the fever is not known.
• The scan can also help your doctor investigate sites of infection,
such as in your abdomen (the area around your stomach).
• Some other people are given this medicine to see swelling
(inflammation) in the bowel.
Your nuclear medicine doctor will explain which part of your body
will be scanned.
The use of Medi-Exametazim 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.
2. What you need to know before Medi-Exametazim is used
Medi-Exametazim must not be used
- if you are allergic to Exametazime or any of the other ingredients of
this medicine (listed in section 6).
Warnings and precautions
Take special care with Medi-Exametazim
- if you are pregnant or believe you may be pregnant
- if you are breast-feeding
- if you have a kidney or liver disease
Manipulation of human cells (labelling of leucocytes) carries the risk
of potential transmission of infections (HBV, HIV, etc)
You 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 Medi-Exametazim 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.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, 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 Medi-Exametazim 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
The nuclear medicine doctor will only administer this product during
pregnancy if a benefit is expected which could outweigh the risks.
If you are breastfeeding
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 12 hours. 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 Medi-Exametazim will affect your
ability to drive or to use machines.
Important information about some of the ingredients of
Medi-Exametazim
Medi-Exametazim contains Sodium Chloride.
According to the time of conditioning injection for the patient, the
content of sodium may in some cases be greater than 1 mmol. This
should be taken into account in patients on low sodium diet
3. HOW MEDI-EXAMETAZIM IS USED
There are strict laws on the use, handling and disposal of
radiopharmaceutical products. Medi-Exametazim 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 Medi-Exametazim to be used in your case. It will
be the smallest quantity necessary to get the desired information.
The quantity usually recommended to be administered for an adult
ranges depending on the test to be performed, and ranges between
200 and 350 MBq (megabequerel, the unit used to express
radioactivity).
Use in children and adolescents
In children and adolescents, the quantity to be administered will be
adapted to the child’s weight.
Administration of Medi-Exametazim and conduct of the
procedure
Medi-Exametazim is administered intravenously.
One injection is sufficient to conduct the test that your doctor needs.
After injection, you will be offered a drink and asked to urinate
immediately preceding the test.
The ready-to-use solution will be injected to you in a vein before the
scintigraphy is taken. The scanning may take place within 30 minutes
or up to 24 hours after injection, depending on the test.
Duration of the procedure
Your nuclear medicine doctor will inform you about the usual
duration of the procedure.

After administration of Medi-Exametazim, you should:
− avoid any close contact with young children and pregnant
women for the 12 hours following the injection.
− 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 Medi-Exametazim than you should
An overdose is almost impossible because you will only receive a
single dose of 99mTc exametazime 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 99mTc exametazime from your body.
Should you have any further question on the use of MediExametazim, please ask the 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.
The frequencies of undesirable effects are defined as follows:
Very common: affects more than 1 user in 10,
Common: affects 1 to 10 users in 100,
Uncommon: affects 1 to 10 users in 1,000,
Rare: affects 1 to 10 users in 10,000,
Very rare: affects less than 1 user in 10,000,
Not known: frequency cannot be estimated from the available data.
Frequency not known
Allergic reactions:
If you have an allergic reaction when you are in hospital or a clinic
having the scan, tell the doctor or nurse straight away. The signs may
include:
• skin rash or itching or flushing
• swelling of the face
• difficulty in breathing.
In more serious cases reactions may include:
• passing out (unconsciousness), feeling dizzy or lightheaded.
Other side effects include:
Frequency not known
• itchy lumpy rash
• headache
• feeling dizzy
• flushing
• feeling sick (nausea)
• being sick (vomiting)
• general feeling of being unwell, weak or tired
• unusual feelings of numbness, tingling, prickling burning or
creepingon skin.
This radiopharmaceutical will deliver low amounts of ionising
radiation with very low 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
5. HOW MEDI-EXAMETAZIM 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.
Medi-Exametazim must not be used after the expiry date which is
stated on the carton (Expiry date).
Medi-Exametazim must not be used if it is noticed any visible signs
of deterioration.
Unlabelled product:
Store at 2-8°C.
Do not freeze.
Store in the original package in order to protect from light.

After radio-labelling:
Do not store above 25°C after radiolabelling.
Do not refrigerate or freeze
6. Contents of the pack and other information
What MEDI-EXAMETAZIM contains
The active substance is exametazime.
One vial contains 500 mg exametazime.
The other ingredients are: Stannous (II) Chloride Dihydrate,
Tetrasodium Pyrophosphate Decahydrate. Nitrogene
What Medi-Exametazim looks like and contents of the pack
The product is a kit for radiopharmaceutical preparation.
Medi-Exametazim is a white lyophilised powder. An injection is
prepared from the vial immediately before it is injected.
Medi-Exametazim consists of exametazime which 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) exametazime is
formed. This solution is ready for use.
Each pack contains 3 or 6 multidose vials.
Sample pack: 1 multidose vial
Bundle pack of 2 packs of 6 multidose vials
Bundle pack of 4 packs of 6 multidose vials
Not all pack sizes may be marketed.
Marketing authorisation holder and manufacturer:
Marketing Authorisation Holder:
RADIOPHARMACY LABORATORY Ltd
2040 Budaörs, Gyár st. 2 Hungary
(Budaörs Industrial and Technology Park Gutenberg st. 125)
Phone: +36-23-886-950, 886-951
Fax:
+36-23-886-955
e-mail: info@radiopharmacy-laboratory.eu
Manufacturer:
Medi-Radiopharma Ltd
H-2030 Érd Szamos u. 10-12
Hungary
Phone: +36-23-521-261
Fax: +36-23-521-260
e-mail: mediradiopharma-ltd@mediradiopharma.hu
This medicinal product is authorised in the Member States of the
EEA under the following names:
This leaflet was last revised in 08/2012

Other sources of information
------------------------------------------------------------------------------The following information is intended for healthcare professionals
only:
The complete SmPC of Medi-Exametazim 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.

304v01/ET

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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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