Ultra-Technekow Fm
DRN 4329 UltratechneKow FM United Kingdom Page 1 of 2
Package leaflet: Information for the user
Ultra-TechneKowFM
radionuclide generator
Active substance: technetium [99mTc]
Read all of this leaflet carefully before you start using this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Ultra-TechneKow FM is and what it is used for
2. Before you use Ultra-TechneKow FM
3. How to use Ultra-TechneKow FM
4. Possible side effects
5. How to store Ultra-TechneKow FM
6. Further information
a What Ultra-TechneKow FM is and what I ■ it is used for
This medicine is for diagnostic use only.
Ultra-TechneKow FM is used through a scan to examine various body parts such as the:
• thyroid glands
• salivary glands » brain
® heart ® vessels
® lining of the stomach or the eyes
• stomach and/or bowel bleeding
This medicine is a generator containing a radioactive substance, from which another radioactive substance can be received. The latter can be mixed with a non-radioactive substance and when administered into the body it collects in certain organs.
The radioactive substance can be photographed from outside the body, using special cameras which take a scan. This scan shows the distribution of radioactivity within the organ and body. This also gives the doctor valuable information about the structure and function of that organ.
2. Before you use Ultra-TechneKow FM
Do not use Ultra-TechneKow FM
® No absolute limitations are known.
Take special care with Ultra-TechneKow FM
This medicine does involve treatment with radioactivity. Your doctor will only give you this medicine if the benefit outweighs the risk.
Ultra-TechneKow FM is given by specialists, who will take responsibility for any necessary precautions.
Your doctor will inform you if you need to take any special precautions after using this medicine. Contact your doctor if you have any questions.
Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
The following medicines can particularly influence the Ultra-TechneKow FM examination:
• methotrexate, a medicine to treat cancer, severe joint inflammations and psoriasis
• atropine, used for example
- to reduce stomach, bowel or gall bladder spasms
- to reduce pancreas secretions
- in ophthalmology
- before administering an anaesthesia
- to treat reduced heart beat or
- as an antidote
• isoprenaline, a medicine to treat reduced heart beat
• pain killers
Pregnancy and breast-feeding
• Pregnancy
Tell your doctor if you are pregnant or think you could be. Your doctor will only administer Ultra-TechneKow FM during pregnancy if it is absolutely necessary, as it could harm the unborn child.
• Breast-feeding
Tell your doctor if you are breast-feeding as he may delay treatment until breast-feeding is finished. He may also ask you to stop breast-feeding and discard this milk, until the radioactivity is no longer in your body.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Ultra-TechneKow FM is unlikely to impair the ability to drive and operate machinery.
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3 „ How to use Ultra-TechneKow FM
Ultra-TechneKow FM will always be used in a hospital or similar setting. It will only be administered to you by qualified people trained to safe handle radioactive material.
Your doctor will decide the Ultra-TechneKow FM amount to be used. The dose administered will depend on the procedure.
The lowest dose possible will be used to produce adequate X-ray images.
The usual dose is:
Approximate doses for adults are:
• 2-925 MBq, injected into a vein or given as drops into the eye MBq is the unit used to measure radioactivity, and defines the activity of a quantity of radioactive material.
Children under 18 years
Lower doses are used for children according to their body weight or body surface area.
How many scans
One injection is usually sufficient.
Drink and urinate as much as possible before and after treatment. This will prevent active substance gathering in the bladder.
If you use more Ultra-TechneKow FM than you should
It is unlikely that overdose will occur as this medicine is given under control by a doctor. However, if this happens you will receive appropriate treatment from your doctor.
If you have any further questions on the use of this product, ask your doctor.
0b Further information
What Ultra-TechneKow contains
• The active substance is technetium [99mTc] in form of a solution of sodium pertechnetate,
A system containing molybdenum ["Moj is supplied, from which technetium [99mTc] can be derived and collected in a vial. Such a system can incorporate various amounts of radioactivity, ranging from 2150 to 43000 MBq. The exact amount of activity collected in the vial depends on the overall activity of the system and on the number of millilitres 'tapped'.
• There are no other ingredients.
What Ultra-TechneKow FM looks like and contents of the pack
Ultra-TechneKow FM is a generator containing an aluminiumoxide column charged with molybdenum ["Moj and locked between two filters. The shielded generator with the built-in station and the outlet holder are packed in a hermetically sealed tin.
Marketing Authorisation Holder and Manufacturer
• Marketing Authorisation Holder
Mallinckrodt Medical B.V., Westerduinweg 3 1755 LE Petten, The Netherlands
PL 12288/0017
• Manufacturer
Mallinckrodt Medical B.V., Westerduinweg 3 1755 LE Petten, The Netherlands
This leaflet was last approved in 11/2014.
Possible side effects
4.
Like all medicines, Ultra-TechneKow FM can cause side effects, although not everybody gets them.
Frequency unknown, from the data available ® allergic reactions, with symptoms such as
- rash, hives, itching -swelling of the face
- widening of blood vessels causing flushing or a drop in blood pressure
- irregular heart beat -coma
Hospital staff will treat these reactions, if they occur.
• cancer, however the risk is very low as low doses are used in this investigation
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. How to store Ultra-TechneKow FM
Do not use Ultra-TechneKow FM after the expiry date stated on the label.
Hospital staff will ensure correct storage temperature, between 1-25°C.
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