Ultra-Technekow Fm
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UltraTechneKow FM
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 UltraTechneKow FM is and what it is used for
2. Before you use UltraTechneKow FM
3. How to use UltraTechneKow FM
4. Possible side effects
5. How to store UltraTechneKow FM
6. Further information
IWhat UltraTechneKow FM is and what ■ it is used for
This medicine is for diagnostic use only.
UltraTechneKow FM is used through a scan to examine various body parts such as the:
• thyroid glands • salivary glands
• apprearance of stomach tissue in an abnormal location (Meckel Diverticulum)
• brain
• heart and blood vessels • stomach and/or bowel bleeding • Tear ducts of the eyes
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 UltraTechneKow FM
Do not use UltraTechneKow FM
If you are
• .allergic (hypersensitive) to technetium of any of the other ingredients (listed in section 6)
Take special care with UltraTechneKow FM
This medicine does involve treatment with radioactivity. Your doctor will only give you this medicine if the benefit outweighs the risk.
UltraTechneKow 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 UltraTechneKow 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 UltraTechneKow 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/she may delay treatment until breast-feeding is finished. He/she 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
UltraTechneKow FM does not affect your ability to drive and operate machinery.
3. How to use UltraTechneKow FM
UltraTechneKow FM will always be used in a hospital or similar setting. It will only be administered to you by qualified people trained to safely handle radioactive material.
Your doctor will decide the amount of the radioactive substance from the UltraTechnekow FM generator 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 and the elderly 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.
Method of use
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 more UltraTechneKow FM is given than it 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.
Drinking and urinating as much as possible will help remove the radioactive substance more quickly
If you have any further questions on the use of this product, ask your doctor._
4. Possible side effects
Like all medicines, UltraTechneKow FM can cause side effects, although not everybody gets them.
Frequency unknown, from the data available
• allergic reactions, with symptoms such as
- skin rash, itching
- hives
- swelling at various locations. e.g. of the face
- shortness of breath
- erythmia
- 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
- vomiting
- nausea
- diarrhoea
• injection site reactions, with symptoms such as
- skin inflammation
- pain
- swelling
- erythema
Hospital staff will treat these reactions, if they occur.
• cancer, or hereditary defects are linked to exposure to radiation, 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 UltraTechneKow FM
UltraTechneKow FM generator must be kept in an Ultra-TechneKow Safe (with sufficient lead protection) or behind an adequate laboratory shield
Do not use Ultra-TechneKow FM after the expiry date stated on the label. Hospital staff will ensure correct storage temperature, below 25°C.
6. Further information
What UltraTechneKow contains
• The active substance is technetium [99mTc] in form of a solution of sodium pertechnetate.
A system containing molybdenum [99Mo] is supplied, from which technetium [99TC] 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 milliliters 'tapped'.
• The other ingredients are: sodium chloride and water for injections.
What UltraTechneKow FM looks like and contents of the pack
UltraTechneKow FM is a generator containing an aluminiumoxide column charged with molybdenum [99Mo]. The shielded generator is packed in a hermetically sealed tin
Marketing Authorisation Holder and Manufacturer
• Marketing Authorisation Holder
Covidien (UK) Commercial Ltd.
154 Fareham Road, Gosport Hampshire, PO13 0AS United Kingdom
Tel: +44(0)1329224411, Fax: +44(0)1329224390 PL 32873/0017
• Manufacturer
Mallinckrodt Medical B.V., Westerduinweg 3 1755 LE Petten, The Netherlands
This leaflet was last approved in 09/2012.
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16 CON 4329 United Kingdom PIL 14092012