Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
Gallium (67 ga) citrate
Curium Netherlands B.V.
V09HX; V09HX01
Gallium (67 ga) citrate
37 megabecquerel(s)/millilitre
Solution for injection
Product subject to Restricted Prescription (C)
Other diagnostic radiopharmaceuticals for inflammation and infection detection; gallium (67Ga) citrate
Marketed
2000-03-31
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 Belgenin tamamını okuyun
HealthProductsRegulatoryAuthority 25November2020 CRN00C1K7 Page1of6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gallium(Ga67)Citrateinjection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Compositionpermlatactivityreferencedateandtime. 67 Gaasgalliumcitrate 37MBq Thequalitativecompositionisinconformitywiththemonograph555oftheEuropeanPharmacopoeia.Gallium[ 67 Ga]isa radionuclide(Atomicnumber31;atomicweight67)andhasaphysicalhalf-lifeof3.3days(78.3hours).Itdecaystostablezinc byelectroncaptureemittinggammaenergiesof93keV(38%),185keV(21%)and300keV(16.8%).Asmallbutclinically insignificantamountof 66 Gaispresentasanaturalcontaminant_(see section 11, Dosimetry)._ _Excipient: Contains 9mg/ml benzyl alcohol_ Forafulllistofexcipients,seesection6.1. 3 PHARMACEUTICAL FORM Solutionforinjection. Clear,colourlesssolution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Thismedicinalproductisfordiagnosticuseonly. Non-specific tumour imaging and/or localising agent. Galliummaybeusedinconjunctionwithotherimagingmodalitiesinthediagnosis,stagingandsubsequentmanagementof malignantlymphomassuchasHodgkinandnon-Hodgkinlymphoma.Itmayalsobeofsubsequentuseinestablishing responsetochemotherapy. 67 Gaimagingcanbehelpfulinthediagnosisofbronchialneoplasmbyestablishingtheextentof mediastinalspread.Ithasalsobeenusedtoascertainthedegreeofdisseminationofothermalignantprimarieswithvarying reliability. Localisation of inflammatory lesions. Galliummaybeused Belgenin tamamını okuyun