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GALLIAPHARM 0.74 - 1.85 GBQ RADIONUCLIDE GENERATOR

Active substance(s): GALLIUM (GA 68) CHLORIDE / GERMANIUM (68GE) CHLORIDE

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B. PACKAGE LEAFLET FOR RADIOPHARMACEUTICALS

1

Packa
age leaflet: Informatio
on for the patient
p
GalliaPhaarm, 0.74 -11.85 GBq, raadionuclidee generator
Germaniu
um (68Ge) chhloride / Gaallium (68Gaa) chloride

This medicine is
i subject to
o additionall monitorin
ng. This willl allow quiick identificcation of
new saffety informaation. You can
c help byy reporting any
a side efffects you m
may get. Seee the end
of sectioon 4 for how
w to report side effects .

Read aall of this leeaflet careffully beforee you are given
g
this medicine bbecause it contains
c
importaant information for you.




K
Keep this leeaflet. You may need too read it agaain.
IIf you havve any furtther questiions, ask your
y
nucleaar medicinee doctor who
w
will
ssupervise thhe procedurre.
IIf you get any side efffects talk tto your nucclear mediccine doctor.. This inclu
udes any
ppossible sidde effects no
ot listed in tthis leaflet. See section
n 4.

What iss in this leaaflet:
1.
2.
3.
4.
5.
6.

Whaat GalliaPhaarm is and what
w it is useed for.
Whaat you need to
t know beffore the me dicine radio
olabelled wiith GalliaPhharm is used
d.
How
w the mediciine radiolabelled with G
GalliaPharm
m is used.
Possiible side efffects.
How
w GalliaPharrm is stored
d
Conttents of the pack and otther informaation

harm is and
d what it iss used for
1. What GalliaPh
maceutical prroduct for diagnostic
d
use
u only.
This meedicine is a radiopharm
o be used onn its own.
GalliaPhharm is not intended to
GalliaPhharm is a germanium
g
(68Ge) / galllium (68Ga)) radionucliide generatoor, a devicee used to
68
obtain a solution off gallium ( Ga) chloridde.
The obttained galliuum (68Ga) chloride
c
soluution is useed for radiollabelling, a technique in
i which
68
a substaance is taggeed (radiolab
belled) withh a radioactiive compound, here G
Ga.
GalliaPhharm is useed to label certain
c
mediicines that have
h
been specially
s
deeveloped forr the use
with thee active subbstance gallium (68Ga) chloride. These
T
mediccines act as carriers to take the
radioacttive 68Ga too where it is needed. T
These may be
b substancces that havve been dessigned to
recognisse a particuular type of
o cell in thhe body, in
ncluding tumour cells (cancer). The
T low
amount of radioacttivity admin
nistered can be detected
d outside off the body byy special caameras.
Please rrefer to thee package leaflet of thhe medicinee that is to be radiolabbelled with gallium
(68Ga) cchloride. Thhe nuclear medicine ddoctor will explain
e
to you
y what tyype of exam
mination
will be pperformed with
w this product.

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The use of a 68Ga-labelled medicinal product does involve exposure to small amounts of
radioactivity. Your doctor and the nuclear medicine doctor have considered that the clinical
benefit that you will obtain from the procedure with the radiopharmaceutical overcomes the
risk due to radiation.
2. What you need to know before the medicine radiolabelled with GalliaPharm is used
The medicine radiolabelled with GalliaPharm must not be used
if you are allergic to gallium (68Ga) chloride or any of the other ingredients of this medicine
(listed in section 6).
If you are using a 68Ga-labelled medicinal product, you should read information on
contraindications in the package leaflet of the product to be radiolabelled.
Warnings and precautions
For information concerning special warnings and special precautions for use of 68Ga labelled
medicinal products please refer to the Package Leaflet of the medicinal product to be
radiolabelled.
Children and adolescents
Please speak to your nuclear medicine doctor if you are under 18 years old.
Other medicines and medicines radiolabelled with GalliaPharm
Tell your nuclear medicine doctor if you are taking, have recently taken or might take any
other medicines since they may interfere with the interpretation of the images.
It is not known whether gallium (68Ga) chloride may interact with other medicines as
specified studies have not been carried out.
For information concerning interactions associated with the use of 68Ga labelled medicinal
products refer to the Package Leaflet of the medicinal product to be radiolabelled.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a
baby, ask your nuclear medicine doctor for advice before you are given medicines
radiolabelled with GalliaPharm.
You must inform the nuclear medicine doctor before the administration of medicines
radiolabelled with GalliaPharm if there is a possibility you might be pregnant, if you have
missed your period or if you are breast-feeding.
When in doubt, it is important to consult your nuclear medicine doctor who will supervise the
procedure.
If you are pregnant
The nuclear medicine doctor will only administer this product during pregnancy if a benefit is
expected which would outweigh the risks.

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If you are breast-feeding
You will be asked to stop breast-feeding. Please ask your nuclear medicine doctor when you
can resume breast-feeding.
Driving and using machines
There could be effects on your ability to drive and to use machines due to the medicine used
in combination with GalliaPharm. Please read the package leaflet of that medicine carefully.
3. How the medicine radiolabelled with GalliaPharm is used
There are strict laws on the use, handling and disposal of radiopharmaceutical products.
GalliaPharm will only be used in special controlled areas. This product will only be handled
and given to you by people who are trained and qualified to use it safely. These persons will
take special care for the safe use of this product and will keep you informed of their actions.
The nuclear medicine doctor supervising the procedure will decide on the quantity of
medicine radiolabelled with GalliaPharm to be used in your case. It will be the smallest
quantity necessary to achieve the appropriate outcome, depending on the final product and its
intended use. Please read the package leaflet of the medicine that is to be radiolabelled for
more information.
Administration of the medicine radiolabelled with GalliaPharm and conduct of the
procedure
You will not get the pure GalliaPharm, but another product radiolabelled with GalliaPharm.
GalliaPharm must be used only in combination with another medicine which has been
specifically developed for being combined (radiolabelled) with GalliaPharm. You will only be
given the final radiolabelled product.
Duration of the procedure
Your nuclear medicine doctor will inform you about the usual duration of the procedure after
the administration of the medicine radiolabelled with GalliaPharm.
After administration of the medicine radiolabelled with GalliaPharm has been
performed
The nuclear medicine doctor will inform you if you need to take any special precautions after
receiving the medicine radiolabelled with GalliaPharm. Contact your nuclear medicine doctor
if you have any questions.
If you have been given more medicine radiolabelled with GalliaPharm than you should
An overdose is unlikely, because you will only receive the medicine radiolabelled with
GalliaPharm precisely controlled by the nuclear medicine doctor supervising the procedure.
However, in the case of an overdose, you will receive the appropriate treatment.
Should you have any further question on the use of this product, please ask the nuclear
medicine doctor who supervises the procedure.

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4. Possible side effects
Like all medicines, the medicine radiolabelled with GalliaPharm can cause side effects,
although not everybody gets them.
After the medicine radiolabelled with GalliaPharm is administered, it will deliver low
amounts of ionising radiation with the least risk of cancer and hereditary abnormalities.
If you notice any side effects, please tell your nuclear medicine doctor who supervises the
procedure. This includes any possible side effects not listed in this leaflet. You can also report
side effects directly via 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 GalliaPharm is stored
You will not have to store this medicine. This medicine is stored under the responsibility of
the specialist in appropriate premises. Storage of radiopharmaceuticals will be in accordance
with national regulation on radioactive materials.
The following information is intended for the specialist only.
The radionuclide generator must not be used after the expiry date stated on the container after
“EXP”.
Do not dismantle the stainless steel case. Do not store above 25°C.
The gallium (68Ga) chloride solution obtained with GalliaPharm must be used immediately.
6. Contents of the pack and other information
What GalliaPharm contains
The active substances are:

Germanium (68Ge) chloride (mother nuclide)
Gallium (68Ga) chloride (daughter nuclide)

The radionuclide generator contains at calibration date:
Germanium (68Ge) chloride / Gallium (68Ga) chloride
The other ingredients are:

0.74 – 1.85 GBq

Titanium dioxide (matrix)
Sterile ultrapure 0.1 mol/l hydrochloric acid (solution for

elution)
What GalliaPharm looks like and contents of the pack
You will not need to obtain or handle this medicine.
Marketing Authorisation Holder and Manufacturer
Eckert & Ziegler Radiopharma GmbH
Robert-Rössle-Str. 10
13125 Berlin
Germany

5

This medicinal product is authorised in the Member States of the EEA under the
following names:
Country

Product name

Austria

Czech Republic

GalliaPharm 0,74 - 1,85 GBq Radionuklidgenerator
GalliaPharm, 0.74 – 1.85 GBq, radionuclidegenerator
GalliaPharm, 0,74 à 1,85 GBq, générateur radiopharmaceutique
GalliaPharm, 0,74 - 1,85 GBq, Radionuklidgenerator
GalliaPharm

Denmark

GalliaPharm

Finland

GalliaPharm

France

GalliaPharm

Germany

GalliaPharm

Ireland

GalliaPharm

Italy

Germanio cloruro (68Ge)/Gallio cloruro (68Ga) GalliaPharm

Latvia

GalliaPharm

Netherlands

GalliaPharm, 0,74 - 1,85 GBq, radionuclidegenerator

Norway

GalliaPharm

Poland

GalliaPharm

Sloval Republic

GalliaPharm

Spain

GalliaPharm 0,74 – 1,85 GBq generador de radionúclido
Germanium(Ge-68)tetraklorid/Gallium(Ga-68)triklorid Eckert &
Ziegler
GalliaPharm

Belgium

Sweden
United Kingdom

This leaflet was last revised on 07/2017.
----------------------------------------------------------------------------------------------------------------The following information is intended for medical or healthcare professionals only:
The complete SmPC of GalliaPharm is provided as a separate document in the product
package, with the objective to provide healthcare professionals with other additional scientific
and practical information about the administration and use of this radiopharmaceutical.
Please refer to the SmPC.

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