Medine.co.uk

Technescan Lyomaa

DRN 4378 Page 1 of 2

Technescan LyoMAA United Kingdom

Package leaflet: Information for the user

TechneScan® LyoMAA

powder for injection

Active substance: Macroaggregates of human serum albumin

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® LyoMAA is and what it is used for

2.    Before you use TechneScan® LyoMAA

3.    Howto useTechneScan®LyoMAA

4.    Possible side effects

5.    How to store TechneScan® LyoMAA

6.    Further information

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 TechneScan LyoMAA examination:

•    heparin, a medicine to prevent blood clotting

•    busulfan, cyclophosphamide, bleomycin, medicines to treat cancer

•    methotrexate, a medicine to treat cancer, severe joint inflammations and psoriasis

•    medicines which widen the airways, used for example to treat asthma

•    heroin

   nitrofurantoin, an antibiotic

   methysergide, used to prevent severe migraine

   magnesium sulphate, used to treat magnesium deficiency or as laxative

Pregnancy and breast-feeding

•    Pregnancy

Tell your doctor if you are pregnant or think you could be. Your doctor will only administer TechneScan® LyoMAA 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 12 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® LyoMAA is unlikely to impair the ability to drive and operate machinery.


IWhat TechneScan® LyoMAA is and - what it is used for

This medicine is for diagnostic use only.

TechneScan® LyoMAA is used through a scan to examine the:

• lungs

• blood flowthrough the veins.

This medicine is a powder. When mixed by qualified people, with a solution of the radioactive substance, sodium pertechnetate (99mTc) it forms Technetium [99mTc] human serum albumin macroaggregates. When injected into the body it collects in certain organs such as, the lungs.

Macroaggregates of human serum albumin are proteins found in human blood.

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® LyoMAA

Do not use TechneScan® LyoMAA

if you are

•    allergic (hypersensitive) to any of the ingredients

Take special care with TechneScan® LyoMAA

Inform your doctor if you have:

•    heart diseases

•    breathing problems and high lung blood pressure

In each case, your doctor will inject the dose slowly into the vein to prevent serious side effects.

This medicine does involve treatment with radioactivity. Your doctor will only give you this medicine if the benefit outweighs the risk.

TechneScan® LyoMAA 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.

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|d How to use TechneScan® LyoMAA

TechneScan® LyoMAA 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® LyoMAA 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:

• 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 weight or body surface.

How many scans

One injection is usually sufficient.

Drink as much as possible before and after treatment. This will prevent active substance gathering in the bladder.

If you use more TechneScan® LyoMAA 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.

0h Further information

What TechneScan®LyoMAA contains

•    The active substance is macroaggregates of human serum albumin.

Each vial contains 2 mg macroaggregates of human serum albumin.

Blood used to produce this medicine has been screened using officially required tests against specific viral infections such as hepatitis B and C, HIV.

•    The other ingredients are: sodium chloride, sodium acetate, stannous chloride dihydrate and human serum albumin.

What TechneScan® LyoMAA looks like and contents of the pack

TechneScan® LyoMAA is packaged in 10 ml type 1 Ph.Eur glass vials closed with a bromobutyl rubber stopper. 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 12288/0013

•    Manufacturer

Mallinckrodt Medical B.V., Westerduinweg 3 1755 LE Petten, The Netherlands

This leaflet was last approved in 11/2014.

4a Possible side effects

Like all medicines, TechneScan® LyoMAA can cause side effects, although not everybody gets them.

Frequency unknown, from the data available

•    allergic reactions, range from rashes on the injection site to possible chest pains, muscle tightness and collapse

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 TechneScan® LyoMAA

Do not use TechneScan® LyoMAA after the expiry date stated on the label. Hospital staff will ensure correct storage temperature as stated on the label:

•    powder should be stored at 2-8°C

•    prepared product should be stored at 15-25 °C for no longer than 12 hours.

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26 CON 4378 United Kingdom SPC 24102014 / 22 CON 4378 United Kingdom PIL24102014