Package leaflet: Information for the user MONTEK 10

Package leaflet: Information for the user
MONTEK 10-40 GBq Radionuclide generator
Sodium pertechnetate 99mTc
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 who has supervised the procedure.
. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What MONTEK is and what it is used for
2. What you need to know before MONTEK is used
3. How MONTEK is used
4. Possible side effects
5. How MONTEK is stored
6. Contents of the pack and other information
1. What MONTEK is and what it is used for
This medicine is a radiopharmaceutical product for diagnostic use only.
The actual product is a system so called “generator” which creates a solution with a radioactive content.
This solution is used in the diagnostic study.
The solution from the generator contains a small amount of radioactivity and may be directly
administered to you or used for labelling of various compounds in order to investigate your disease.
MONTEK is used for the investigation of the
 Thyroid glands
 Salivary glands
 Brain
 Gastrointestinal track
 Tear ducts
The doctor may use this medicine for other purposes. If you have any questions ask your doctor.
The use of MONTEK 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 MONTEK is used
MONTEK must not be used
 If you are allergic to sodium pertechnetate 99mTc or to any of the other ingredients of MONTEK
(listed in section 6) or to any of the components of the labelled radiopharmaceutical.
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 If you are using a 99mTc labeled pharmaceutical preparation, you should read
information on contraindications in the SmPC and PIL of the kit for
radiopharmaceutical preparation.
Warnings and precautions
Talk to your Nuclear Medicines doctor before using Montek
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If you are pregnant or believe you may be pregnant
If you are breastfeeding
If you are under 18 years old
If you suffer from any renal function disorder. The specialist may ask you to drink plenty of fluids
and to empty your bladder regularly during the first six hours after administration to minimise
radiation exposure.
The solution from MONTEK is milked and administered by trained personnel. The hospital is
responsible for handling and disposal of radioactive medicinal products. This product will only be
handled and administered by people who are trained and qualified in the safe handling of radioactive
material.
Your doctor will inform you if you need to take any other special precautions after use of this product.
Other medicines and MONTEK
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, since they may
interfere with the interpretation of images:
 medicine such as atropine or isoprenaline (for heart disease)
 painkillers
 thyroid hormones (to treat thyroid hormone deficiency)
 thiocyanate (antithyroid agent)
 antacids
 sulfonamides (for infections)
 substances containing tin-II ions
 laxatives
 iodine based contrast media
 barium sulphate
 methotrexate (for cancer and other maligne diseases)
 perchlorate (antithyroid agent)
MONTEK with food and drink
Your doctor may ask you to drink plenty of fluids.
Pregnancy and breast-feeding
You must inform the Nuclear Medicine doctor before the administration of MONTEK 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.
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your Nuclear
Medicine doctor for advice before taking this medicine.
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Your doctor will usually not give you sodium (99mTc) pertechnetate 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 ask your Nuclear Medicine doctor for advice before taking this medicine.
You should not be breastfeeding if you are using this medicine, as small amounts of radioactivity can
pass to the milk. Your doctor may delay the investigation until breast-feeding is completed or may ask
you to stop breast-feeding. If it is not possible to delay the investigation you should:
 Discard the expressed milk
 Stop breast-feeding at least for 12 hours.
Please ask your Nuclear medicine doctor when you can resume breast-feeding.
Before MONTEK administration 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.
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You should be fasting for 3 to 4 hours before Meckel's diverticulum scintigraphy to keep
the small bowel peristalsis low.
Driving and using machines
It is considered unlikely that MONTEK will affect your ability to drive or to use machines.
MONTEK contains sodium
This product contains 3.54 mg/ml sodium. This should be taken into consideration by patients who are
on a controlled sodium diet.
3. How MONTEK is used
There are strict laws on the use, handling and disposal of radiopharmaceutical products. MONTEK 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 MONTEK 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 2 to 800 MBq (Mega Becquerel, the
united 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 MONTEK and conduct of the procedure
MONTEK is administered to your body either into your vein or to your eyes according to the problem.
The dose will be decided by your doctor.
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.
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Duration of the procedure
Your Nuclear medicine doctor will inform you about the usual duration of the procedure.
After administration of MONTEK, you should:
- urinate frequently in order to eliminate the product from your body.
If you have been given more MONTEK than you should
An overdose is unlikely because you will only receive a single dose of MONTEK precisely controlled
by the Nuclear medicine doctor supervising the procedure. However, in the case of an overdose, you
will receive the appropriate treatment.
It is not known what the effect of an overdose is.
Your doctor will instruct you to drink a lot of fluid and urinate frequently in case of overdose.
Should you have any further questions on the use of MONTEK, 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.
Your doctor has considered that the clinical benefit that you will obtain form the procedure with the
radiopharmaceutical overcomes the risk due to radiation.
This administered radiopharmaceutical will deliver low amount of ionizing radiation with very low risk
of cancer and heriditary abnormalities.
Possible side effects are listed below - the frequency is not known as it cannot be estimated from the
available data:
- allergic reactions, with symptoms such as
- skin rash, itching
- hives
- swelling at various locations, e.g. of the face
- shortage of breath
- redness of the skin
- coma
- circulatory reactions, with symptoms such as
- rapid heart beat, slow heart beat
- fainting
- blurred vision
- dizziness
- headache
- flushing
- gastrointestinal disorders, with symptoms such as
- being sick (vomiting)
- feeling sick (nausea)
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- diarrhoea
- injection site reactions, with symptoms such as
- skin inflammation
- pain
- swelling
- redness
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 national reporting system listed in Appendix
V*. By reporting side effects you can help provide more information on the safety of this
medicine.
5. How MONTEK 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.
This information is intended for the specialist only.
Store the generator and the eluate, Sodium Pertechnetate (99m Tc) Injection below 25o C in the
original package. Do not freeze.
Should be used within 8 hours of elution.
MONTEK will not be used after the expiry date which is stated on the label
6. Contents of the pack and other information
What MONTEK 10-40 GBq Radionuclide generator contains:
 The active substances are:
The mother nuclide is:
Sodium (99 Mo) molybdate
10-40 GBq/generator
(No carrier added)
at the activity reference date
The daughter nuclide is:
Sodium (99mTc) pertechnetate
8.3-33.9 GBq
 The other ingredients are:
Aluminium oxide
Molybdenum trioxide
Sodium hydroxide
Hydrogen peroxide 30 %
Sodium hydroxide 1 M (pH adjustment)
Hydrochloric acid 4 M (pH adjustment)
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Hydrochloric acid 1 M (pH adjustment)
Sodium chloride 9 mg/ml (0.9%) solution for injection
Water for injections
What MONTEK looks like and contents of the pack
The product covers a generator with radioactive content, 10 evacuated vials, 5 vials with 5 ml sodium
chloride 9 mg/ml (0.9%) solution for injection or 5 vials with 10 ml sodium chloride 9 mg/ml (0.9%)
solution for injection, 10 antiseptic pads
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Monrol Europe S.R.L.
Pantelimon, Str. Gradinarilor, nr.1
ILFOV
Romania
Manufacturer
Institute of Isotopes Co., Ltd.
Konkoly Thege M. str. 29 – 33
H-1121 Budapest
Hungary
This medicinal product is authorised in the Member States of the EEA under the following
names:
Denmark: MONTEK
Germany: MONTEK 10-40 GBq Radionuclide generator
Romania: MONTEK 10-40 GBq generator de radionuclizi
Bulgaria: MONTEK
Greece: MONTEK
This leaflet was last revised in {MM/YYYY}.
[To be completed nationally]
The following information is intended for healthcare professionals only:
The complete SmPC of MONTEK 10-40 GBq Radionuclide generator is provided in the product
package, with the objective to provide healthcare professional with other additional scientific and
practical information about the administration and use of this radiopharmaceutical.
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