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ELUMATIC III TECHNETIUM GENERATOR

Active substance(s): MOLYBDENUM-99 / TECHNETIUM-99M / MOLYBDENUM-99 / TECHNETIUM-99M

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Transcript
PATIENT INFORMATION LEAFLET

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
There are no particular precautions for the use of technetium [99mTc] sodium
pertechnetate by people engaged in active sport.
List of those Excipients, Knowledge of which is Important for the Safe Use of 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

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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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