Technescan Mag3
DRN 4334 Technescan MAG3 United Kingdom Page 1 of 2
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
IWhat 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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17CON 4334 United Kingdom SPC 24102014/ 17CON 4334 United Kingdom PIL24102014
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
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 TechneScan® MAG3
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.
0# Further information
What TechneScan® MAG3 contains
• The active substance is betiatide.
Each vial contains 1 mg betiatide.
• The other ingredients are: disodium tartrate, tin(ll)chloride and nitrogen
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 suppiied in one pack that contains 5 viais.
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 11/2014.
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17 CON 4334 United Kingdom SPC 24102014 /17 CON 4334 United Kingdom PIL 24102014