Elumatic Iii Technetium Generator
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1. IDENTIFICATION OF THE MEDICINAL PRODUCT
Name of the Medicinal Product
ELUMATIC III®
TECHNETIUM [99mTc] GENERATOR Qualitative Composition
The product is a solution in water of radioactive Technetium [99mTc] in the form of sodium pertechnetate.
Quantitative Composition
Technetium [99mTc] is continously being produced from radioactive molybdenum [99Mo]. The sterile technetium generator allows the separation and collection of technetium [99mTc] sodium pertechnetate injection.
Generators supplied to your physician produce between 2 to 20 GBq (Gegabecquerel -the unit in which radioactivity is measured) of technetium [99mTc] sodium pertechnetate.
Pharmaceutical Form
Technetium [99mTc] generator.
Pharmaco-Therapeutic Group
Technetium [99mTc] sodium pertechnetate is a diagnostic radiopharmaceutical for isotopic exploration. This is a product which, when injected, temporarily collects in a particular organ of the body and can be used for preparation of other radiopharmaceuticals. 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.
Name and Address of the Marketing Authorisation Holder
CIS bio international B.P. 32
91192 Gif-sur-Yvette Cedex FRANCE
Marketing authorisation n° : PL/11876/0013
Name and Address of the Manufacturer
CIS bio international B.P. 32
91192 Gif-sur-Yvette Cedex FRANCE
2. WHEN IS THE PRODUCT USED ?
When it is used to prepare other products, you should consult the appropriate leaflet.
Technetium [99mTc] sodium pertechnetate is used to produce scans of a number of different parts of the body.
In particular, technetium [99mTc] sodium pertechnetate is used to examine thyroid glands, salivary glands, gastrointestinal tract, brain, heart and vascular system, lacrymal duct.
Your physician will explain for which particular purpose he is using technetium [99mTc] sodium pertechnetate.
3. WARNINGS
When should this Product not be used ?
There are no specific circumstances when this product may not be used.
IN CASE OF DOUBT IT IS ESSENTIAL TO CONSULT YOUR PHYSICIAN Special Warnings
The use of technetium [99mTc] sodium pertechnetate does involve administration of small amounts of radioactivity. The risk this involves is very small and your physician will not consider carrying out the investigation unless he believes that the risk is outweighed by the potential benefit of the study.
Because some cases of allergic type reactions have been reported after administration of technetium [99mTc], you should tell your physician if you have an allergic disease.
Precautions for Use
Because technetium [99mTc] sodium pertechnetate is administered as a single dose by trained personnel there are no precautions which are your responsibility. Because there are strict laws covering the use, handling and disposal of radioactivity, technetium [99mTc] sodium pertechnetate will always be used in a hospital or a similar setting. It will only be handled and administered by people who are trained and qualified in the safe handling of radioactive material.
Your physician will inform you if you need to take any further special precautions after use of this product.
IN CASE OF DOUBT DO NOT HESITATE TO CONSULT YOUR PHYSICIAN
Interactions with other Medicinal Products and other Forms of Interaction
Some other medicines may affect the quality of the results obtained from technetium [99mTc] sodium pertechnetate examinations as methotrexate.
IN ORDER TO AVOID POSSIBLE INTERACTIONS WITH OTHER MEDICINAL PRODUCTS, ANY OTHER CURRENT MEDICATION MUST BE NOTIFIED TO YOUR PHYSICIAN
Pregnancy - Lactation
It is important to tell your physician if there is any possibility that you are pregnant. Special consideration is given to the use of radiopharmaceuticals during pregnancy.
Your physician will only use this product if he considers that the benefit outweighs the risk.
Tell your physician if you are breast-feeding as he may delay the investigation 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.
Effects on Ability to Drive or to Operate Machinery
Technetium [99mTc] sodium pertechnetate has no effect on your fitness to drive or to operate machinery.
Sportsmen and Sportswomen
[99mTc] sodium
Safe Use of the
There are no particular precautions for the use of technetium pertechnetate by people engaged in active sport.
List of those Excipients, Knowledge of which is Important for the Medicinal Product in certain Patients
This product contains no ingredients which might necessitate special consideration being given to it's use for particular types of patients.
4. HOW IS THIS PRODUCT USED ?
Dosage
Your physician will decide on the amount of technetium [99mTc] sodium pertechnetate to be used. Doses may be between 2 MBq to 800 MBq (Megabecquerel - the unit in which radioactivity is measured), depending on the type of investigation.
Lower doses may be used for children.
Method and Route of Administration
Administration is by injection into a vein or , when used to prepare other products, by inhalation. Technetium [99mTc] sodium pertechnetate may be also administered as drops into the eye.
Frequency of Administration and Appropriate time of Administration
Usually, a single administration is sufficient to provide your physician with the information needed.
Duration of treatment
Scans may be taken at any time after injection, depending on the type of study to be performed.
Action to be taken in the case of an overdose
Since technetium [99mTc] sodium pertechnetate is administered by a physician under strictly controlled conditions there is little chance of possible overdose.
Action to be taken when one or more doses have not been taken
Not applicable in the case of this medicinal product.
Risk of withdrawal effects No such risks occur with this product
5. INDESIRABLE EFFECTS
In a very small number of patients, an allergic type reaction has been notified.
INFORM YOUR PHYSICIAN IF YOU EXPERIENCE ANY UNDESIRABLE EFFECTS
6. STORAGE
The product label includes the appropriate storage conditions and the expiry date for the batch of product. Hospital personnel will ensure that the product is stored correctly and not administered to you after the stated expiry date.
7. DATE OF LAST REVISION OF THE PACKAGE LEAFLET
04/2006