Elumatic Iii Technetium Generator
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Package leaflet: Information for the patient
ELUMATIC III 2-20 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. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What ELUMATIC III is and what it is used for
2. What you need to know before the solution of technetium (99mTc) obtained from ELUMATIC III is used
3. How the solution of technetium (99mTc) obtained from ELUMATIC III is used
4. Possible side effects
5. How ELUMATIC III is stored
6. Contents of the pack and other information
CIS bio internalionai, Member of IB A Molecular group of companies
P4!09pH 11/2013
1. What ELUMATIC 111 is and what it is used tor
This medicine is a radiopharmaceutical product for diagnostic use only.
Elumatic Hi is a technetium (99mTc) generator, an apparatus that generates a water solution of radioactive technetium (99mTc) in the form of sodium pertechnetate.
The solution of technetium ("mTc) obtained is a diagnostic radiopharmaceutical i.e. a radioactive medicine used for diagnostic purposes only. It is used alone or in combination with another product in order to obtain a radiopharmaceutical preparation (in such a case, please refer to the appropriate leaflet).
When administered, this radioactive solution, temporarily collects in a particular organ of the body. Because the substance contains a small amount of radioactivity it can be detected 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 the structure and function of that organ.
Solution of technetium (99mTc) is used to produce scans of a number of different parts of the body. In particular, technetium ("mTc) is used to examine thyroid glands, salivary glands, gastrointestinal tract, brain, heart, vascular system and lacrymal duct.
Your nuclear medicine doctor will explain to you for what kind of examination she/he is using technetium ("mTc) sodium pertechnetate.
The use of the solution of technetium (99mTc) obtained from Elumatic Ml 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 ELUMATIC Ml is used
When it is used in combination with another product, you should consult the appropriate leaflet.
The solution of technetium (99mTc) obtained from Elumatic Ml must not be used:
• If you are allergic to sodium pertechnetate or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Take special care with the solution of technetium (99mTc) obtained from Elumatic III o If you have an allergy because some cases of allergic type reactions have been reported after administration of technetium (99mTc).
• If you are pregnant or believe you may be pregnant (.
° If you are breast-feeding (
o If you are under 18 years old
6. Contents of the pack and other information What Elumatic III contains
• The active substance is sodium pertechnetate (99mTc).
• The other ingredients are sodium chloride, sodium nitrate and water for injections.
What Elumatic III looks like and contents of the pack
You will not have to get or handle this medicine. The following data is for your information only.
Elumatic III is a radionuclide generator used for the preparation of a clear and colourless sterile solution for injection.
A radionuclide generator is a device containing all the components necessary for the preparation of a solution for injection of sodium pertechnetate (99raTc).
Generators supplied to your nuclear medicine doctor produce between 2 to 20 GBq (gigabecquerel, the unit used to express radioactivity of technetium (99mTc)).
Marketing Authorisation Holder and Manufacturer
CIS bio international B.P.32
91192 Gif-sur-Yvette Cedex FRANCE
This leaflet was last revised in 11/2013.
Other sources of information
Detailed information on this medicine is available on the website of the Medicines and Healthcare products Regulatory Agency http://www.mhra.gov.uk
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The following information is intended for healthcare professionals only:
The complete SmPC of Elumatic 111 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.
P4l09pH 1 1/2013
Before administration of the solution of technetium (99mTc) you should:
- In gastrointestinal tract scintigraphy (Meckel’s diverticulum scintigraphy), you should be fasting for 3 to 4 hours prior to examination.
- Drink plenty of water before the start of the examination in order to urinate as aften as possible during the first hours after the study.
In certain indications, a pretreatment with thyroid-blocking agents or reducing agents may be necessary.
Children and adolescents
Talk to your nuclear medicine doctor if you are under 18 years old.
Other medicines and solution of technetium (99mTc)
Tell your nuclear medicine doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription, since they may affect the quality of the images obtained from technetium (99mTc) examinations.
Particular examples are:
• Medicines used to treat cancer (methotrexate),
• Medicines used to treat heart conditions (atropine, isoprenaline),
• Medicines used to reduce or eliminate pain (analgesics - pain killers)
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 the solution of technetium (99mTc) 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 would outweigh the risks.
If you are breast-feeding
Tell your nuclear medicine doctor if you are breast-feeding as she/he may delay the examination until breast-feeding is completed or ask you to stop breast-feeding for a short while until the radioactivity is no longer in your body and to discard the expressed milk.
Please ask your nuclear medicine doctorwhen you can resume breast-feeding.
Driving and using machines
It is considered unlikely that technetium (99mTc) will affect your ability to drive or to use machines.
Sodium pertechnetate solution contains 3.6 mg/mL of sodium. Depending on the volume injected, the limit of 1 mmol (23 mg) of sodium per dose administered may be exceeded. This must be taken into account if you are on a low-salt diet.
3. How ELUMATIC 111 is used
There are strict laws on the use, handling and disposal of radiopharmaceutical products. Elumatic III 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 solution of technetium (99mTc) 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 MBq to 925 MBq (megabecquerel, 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 the solution of technetium (99mTc) and conduct of the procedure
Depending on the purpose of the examination, the solution of technetium (99mTc) is administered by injection into a vein of your arm, or as drops into your eye.
One injection is sufficient to provide your nuclear medicine doctor with the information needed.
Duration of the procedure
Your nuclear medicine doctor will inform you about the usual duration of the procedure.
Scans may be taken at any time, from the time of the injection and up to 24h after injection, depending on the type of study to be performed.
After administration of the solution of technetium (99mTc), you should 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 solution of technetium (99mTc) than you should
An overdose is unlikely because you will only receive a single dose of solution of technetium (99fflTc) precisely controlled by the nuclear medicine doctor supervising the procedure. However, in the case of an overdose, you will receive the appropriate treatment, and will be asked to drink plenty of water and to take laxatives to increase the elimination of the product from your body.
Should you have any further question on the use of Elumatic III, 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.
Frequency not known
• Allergic reactions, including hives (urticaria), swelling of the face (facial oedema), low blood pressure, itching (pruritus), abnormal heart rhythms (cardiac arrhythmia) and coma.
• In case of escape of the product outside of the vein, local reactions can be observed.
This radiopharmaceutical will deliver low amounts of ionising radiation associated with the least risk of cancer and hereditary abnormalities.
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.
Website: www.mhra.qov.uk/vellowcard.
By reporting side effects you can help provide information on the safety of this medicine.
5. How ELUMATIC 111 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.
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