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Package leaflet: Information for the user

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


What 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
• 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.


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.

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
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

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.



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

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


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


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.


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.

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.
16 CON 4329 United Kingdom PIL 14092012


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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.