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TECHNESCAN MAG3

Active substance(s): BETIATIDE / BETIATIDE / BETIATIDE

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DRN 4334

Package leaflet: Information for the user

TechneScan® MAG3
powder for solution for injection
Active substance: Betiatide
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 TechneScan® MAG3 is and what it is used for
2. Before you use TechneScan® MAG3
3. How to use TechneScan® MAG3
4. Possible side effects
5. How to store TechneScan® MAG3
6. Further information

1.

What TechneScan® MAG3 is and what it
is used for

This medicine is for diagnostic use only.

TechneScan® MAG3 is used through a scan to examine the:
• kidneys,
• urine output and
• bladder.
This medicine is a powder. When mixed by qualified people, with a solution
of the radioactive substance, sodium pertechnetate (99mTc) it forms
Technetium [99mTc] tiatide. When injected into the body it collects in certain
organs such as, the kidneys.
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 TechneScan® MAG3

Do not use TechneScan® MAG3

if you have/are
• allergic (hypersensitive) to betiatide or any of the other ingredients

Take special care with TechneScan ® MAG3

This medicine does involve treatment with radioactivity. Your doctor
will only give you this medicine if the benefit outweighs the risk.
TechneScan ® MAG3 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.
TechneScan ® MAG3 is not known to influence or be influenced by
other medicines commonly used during the investigations mentioned
above.

Pregnancy and breast-feeding
• Pregnancy
Tell your doctor if you are pregnant or think you could be. Your
doctor will only administer TechneScan® MAG3 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 for 8 hours 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

TechneScan ® MAG3 is unlikely to impair the ability to drive and
operate machinery.

3.

How to use TechneScan® MAG3

TechneScan® MAG3 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 TechneScan ® MAG3 amount to be used.
The dose administered will depends on the procedure you are having
and other factors such as your age.
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:
• 37-185 MBq, injected into a vein
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 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 TechneScan® MAG3 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.

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4.

Possible side effects

Like all medicines, TechneScan® MAG3 can cause side effects, although
not everybody gets them.
Side effects can occur with the following frequencies:
rare, occurs in 1 to 10 per 10,000 users
• mild allergic reactions, with signs such as hives, swelling of the eyelids,
itching, nausea or headache
Your hospital staff will treat these reactions, if they occur.
Frequency unknown, from the data available
• minor fainting episodes
Reporting of side effects
If you get any side effects, talk to your nuclear medicine doctor. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the national reporting system:
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the
safety of this medicine.

5.

How to store TechneScan® MAG3

6.

Further information

Do not use TechneScan® MAG3 after the expiry date stated on the label.
Hospital staff will ensure correct storage temperature, between 2-8°C
as stated on the label.

What TechneScan® MAG3 contains
• The active substance is betiatide.
Each vial contains 1 mg betiatide.

• The other ingredients are: disodium tartrate, tin(II)chloride and
hydrochloric acid.

What TechneScan® MAG3 looks like and contents of the pack

TechneScan® MAG3 is packaged in 10 ml type 1 Ph.Eur glass vials closed
with a butyl rubber stopper and sealed with an aluminium crimp cap. It is
supplied in one pack that contains 5 vials.

Marketing Authorisation Holder and Manufacturer
• Marketing Authorisation Holder
Mallinckrodt Medical B.V., Westerduinweg 3
1755 LE Petten, The Netherlands
PL 12288/0014
• Manufacturer
Mallinckrodt Medical B.V., Westerduinweg 3
1755 LE Petten, The Netherlands

This leaflet was last approved in 08/2015.

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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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