Gallium (Ga67) Citrate injection

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Gallium (67 ga) citrate

Διαθέσιμο από:

Curium Netherlands B.V.

Φαρμακολογική κατηγορία (ATC):

V09HX; V09HX01

INN (Διεθνής Όνομα):

Gallium (67 ga) citrate

Δοσολογία:

37 megabecquerel(s)/millilitre

Φαρμακοτεχνική μορφή:

Solution for injection

Τρόπος διάθεσης:

Product subject to Restricted Prescription (C)

Θεραπευτική περιοχή:

Other diagnostic radiopharmaceuticals for inflammation and infection detection; gallium (67Ga) citrate

Καθεστώς αδειοδότησης:

Marketed

Ημερομηνία της άδειας:

2000-03-31

Φύλλο οδηγιών χρήσης

Package leaflet: Information for the user
GALLIUM (GA67) CITRATE INJECTION
67
Ga 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
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
in
the
drug
class
“phenothiazines”

certain MEDICINES TO TREAT CANCER, RADIOTHERAPY

IRON as this may affect test results

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
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 i

Αρχείο Π.Χ.Π.

HealthProductsRegulatoryAuthority
25November2020
CRN00C1K7
Page1of6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gallium(Ga67)Citrateinjection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Compositionpermlatactivityreferencedateandtime.

67
Gaasgalliumcitrate 37MBq
Thequalitativecompositionisinconformitywiththemonograph555oftheEuropeanPharmacopoeia.Gallium[
67
Ga]isa
radionuclide(Atomicnumber31;atomicweight67)andhasaphysicalhalf-lifeof3.3days(78.3hours).Itdecaystostablezinc
byelectroncaptureemittinggammaenergiesof93keV(38%),185keV(21%)and300keV(16.8%).Asmallbutclinically
insignificantamountof
66
Gaispresentasanaturalcontaminant_(see section 11,
Dosimetry)._
_Excipient: Contains 9mg/ml benzyl alcohol_
Forafulllistofexcipients,seesection6.1.
3 PHARMACEUTICAL FORM
Solutionforinjection. 
Clear,colourlesssolution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Thismedicinalproductisfordiagnosticuseonly. 
Non-specific tumour imaging and/or localising agent.
Galliummaybeusedinconjunctionwithotherimagingmodalitiesinthediagnosis,stagingandsubsequentmanagementof
malignantlymphomassuchasHodgkinandnon-Hodgkinlymphoma.Itmayalsobeofsubsequentuseinestablishing
responsetochemotherapy.
67
Gaimagingcanbehelpfulinthediagnosisofbronchialneoplasmbyestablishingtheextentof

mediastinalspread.Ithasalsobeenusedtoascertainthedegreeofdisseminationofothermalignantprimarieswithvarying
reliability.
Localisation of inflammatory lesions.
Galliummaybeused