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Gallium (Ga67) Citrate Injection

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DRN 3103 Gallium Citrate (Ga-67) Injection United Kingdom Page 1 of 2

Package leaflet: Information for the user

Gallium Ga67 Citrate

solution for injection

Active substance: 67Ga as gallium citrate

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 Gallium Ga67 Citrate is and what it is used for

2.    Before you use Gallium Ga67 Citrate

3.    How to use Gallium Ga67 Citrate

4.    Possible side effects

5.    How to store Gallium Ga67 Citrate

6.    Further information

IWhat Gallium Ga67 Citrate is and what . it is used for

This medicine is for diagnostic use only.

Gallium Ga67 Citrate is used through a scan to locate and examine:

• different tumours and • specific inflammations, especially of the lung.

This medicine contains a radioactive substance which when taken, 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 Gallium Ga67 Citrate

Do not use Gallium Ga67 Citrate

•    if you are allergic (hypersensitive) to 67Ga as gallium citrate or any of the other ingredients

•    in children under 3 years

Take special care with Gallium Ga67 Citrate

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

Gallium Ga67 Citrate is given in one single dose 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 influence the Gallium Ga67 Citrate examination:

   medicines to treat mental disorders with active substance names mostly ending in “azine” such as, promethazine, fluphenazine, chlorprothixine

•    certain medicines to treat cancer, radiotherapy and iron

   amitriptyline, imipramine or similar substances, medicines to treat depression

   medicines used to reduce activity in the immune responses including cortisone

   X-ray contrast mediums

   metoclopramide: a medicine to treat nausea and vomiting

   reserpine: a medicine to treat high blood pressure via the central nervous system

   methyldopa: a medicine to treat high blood pressure or heart problems

   contraceptive pill: an orally taken medicine to prevent pregnancy

   stilboestrol: a medicine to treat prostate cancer

   insulin

Your doctor will take special care if a laxative additionally needs to be recommended.

Pregnancy and breast-feeding

   Pregnancy

Tell your doctor if you are pregnant or think you could be. Your doctor will only administer Gallium Ga67 Citrate 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 until the radioactivity is no longer in your body.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Gallium Ga67 Citrate is unlikely to impair the ability to drive and operate machinery.

3. How to use Gallium Ga67 Citrate

Gallium Ga67 Citrate 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 Gallium Ga67 Citrate amount to be used. The dose administered depends also on the disease. The lowest dose possible will be used to produce adequate X-ray images

The usual dose is:

Approximate dose for adults and the elderly is:

• 37 - 260 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

Gallium Ga67 Citrate must not be used in children under 3 years as it contains benzyl alcohol.

Lower doses are used for children aged between 3 and 18 years. Method of use

One injection is usually sufficient. In some cases the administration of a laxative is recommended.

Scans are usually taken between 24 to 92 hours after injection, depending on the type of investigation.

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

If you use more Gallium Ga67 Citrate 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.

Drinking 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.

6. Further information

What Gallium Ga67 Citrate contains

•    The active substance is 67Ga as gallium citrate

One millilitre of Gallium Ga67 Citrate contains 37 MBq.

•    The other ingredients are: sodium citrate, benzyl alcohol, sodium chloride and water for injection.

What Gallium Ga67 Citrate looks like and contents of the pack

Gallium Ga67 Citrate is packaged in type 1 Ph.Eur glass vials closed with a butyl rubber stopper and sealed with an aluminium crimp cap. It is supplied in one vial containing 2.2, 3.3, 5.5 or 10.0 ml.

Marketing Authorisation Holder and Manufacturer

   Marketing Authorisation Holder

Mallinckrodt Medical B.V., Westerduinweg 3 1755 LE Petten, The Netherlands PL 12288/0018

   Manufacturer

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

This leaflet was last approved in 02/2015.

4. Possible side effects

Like all medicines, Gallium Ga67 Citrate can cause side effects, although not everybody gets them.

Side effects can occur with the following frequencies: very rare, occurs in fewer than 1 per 10,000 users:

•    mild allergic reactions, with symptoms such as warm sensation, flushes, rash, hives or itching

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 Gallium Ga67 Citrate

Do not use Gallium Ga67 Citrate after the expiry date stated on the label. Hospital staff will ensure correct storage temperature, between 15-25°C as stated on the label. However, if more than one dose is intended for use, the vial should be stored between 2-8°C after the first dose is taken.

03103006BYS07b / 17 CON 3103 United Kingdom SPC 16022015 / 18 CON 3103 United Kingdom PIL 16022015