Skip to Content

GALLIUM (GA67) CITRATE INJECTION

Active substance(s): GALLIUM CITRATE GA 67

View full screen / Print PDF » Download PDF ⇩
Transcript
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

1.

What 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.


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

DRN 3103

3.

Gallium Citrate (Ga-67) Injection United Kingdom

How to use Gallium Ga67 Citrate

6.

Page 2 of 2

Further information

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

What Gallium Ga67 Citrate contains

The usual dose is :

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.

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.

 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

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

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

This leaflet was last approved in 02/2015.

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.

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 1525°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

Expand view ⇕

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.

Hide