Monographie du produit PDF 9695b1c9
pre216113ENGLISHDRAXIMAGEGLUCEPTATEKitforthePreparationofTechnetiumTc99mGluceptateInjectionBrainandKidneyImagingAgentorStannousGluceptateInjectionCardiacBloodPoolImagingAgentDIAGNOSTICForIntravenousUseDESCRIPTIONThekitconsistsofreactionvialswhichcontainthesterilenonpyrogenicnonradioactiveingredientsnecessarytoproduceeitherTechnetiumTc99mGluceptateInjectionfordiagnosticuseinkidneyandbrainimagingorStannousGluceptateInjectionfordiagnosticuseincardiacbloodpoolimagingBothdiagnosticproductsareadministeredbyintravenousinjectionEach10mLreactionvialcontains25mgofcalciumgluceptatetcomplexedwith3mgofstannouschloridedihydrateinlyophilizedformunderanatmosphereofnitrogenThepHhasbeenadjustedwithsodiumhydroxideandorhydrochloricacidTechnetiumTc99mGluceptateInjectionforBrainandKidneyImagingTheadditionofSodiumPertechnetateTc99mInjectiontoproduceTechnetiumTc99mGluceptateInjectionresultsintherapidlabelingofcalciumgluceptatewhichisessentiallyquantitativeandwhichremainsstablethroughouttheusefullifeofthepreparationNobacteriostaticpreservativeispresentTheprecisestructureofthereactionvialcomplexorofitstechnetiumlabeledformisnotknownatthistimefelIPCCROHsCHOHCaapROLEHsCHOHCalciumGluceptateStannousGluceptateInjectionforCardiacBloodPoolImagingThecontentsofthekitmaybereconstitutedwithsterilenonpyrogenicpreservativefreenormalsalinetoformStannousGluceptateInjectionforcardiacbloodpoolimagingandadministered10to30minutesbeforeinjectingSodiumPertechnetateTc99mInjectionACTIONTechnetiumTc99mGluceptateInjectionforBrainandKidneyImagingWheninjectedintravenouslyTechnetiumTc99mGluceptateInjectionisrapidlyclearedfromthebloodThebloodclearancecurveistriexponentialwiththetwofastercomponentsaccountingformorethan90oftheinjecteddoseInpatientswithnormalrenalfunctionlessthan15oftheinitialactivityremainsinthebloodafteronehourAbout40oftheinjecteddoseisexcretedintheurineinonehourwhileabout70isexcretedin24hoursInpatientswithrenaldiseasethebloodclearanceandurineexcretionoftheradiopharmaceuticalaredelayedUpto15oftheinjecteddoseisretainedinthekidneyswiththeremainderbeingexcretedintheurineTherenalretentionisgreaterinthecortexthaninthemedullaThismaybeduetothebindingoftheradiopharmaceuticaltotheproximalordistalconvolutedtubuleswhichareprimarilylocatedintherenalcortexTechnetiumTc99mGluceptateInjectiontendstoaccumulateinintracraniallesionswithexcessiveneovascularityoranalteredbloodbrainbarrierItdoesnotaccumulateinthechoroidplexusorsaliva
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