CONRAY 280

Main information

  • Trade name:
  • CONRAY 280
  • Dosage:
  • 14/50
  • Pharmaceutical form:
  • Solution for Injection
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CONRAY 280
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1679/002/001
  • Authorization date:
  • 06-01-2012
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Conray280mg/mlSolutionforInjection

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Thesolutionforinjectioncontainsmeglumineiotalamate60%w/v(formedinsitubyreactionofiotalamicacidand

meglumine)equivalenttoorganicallyboundiodine:280mgperml.

Concentrationofiotalamicacid:0.74millimole/ml.

Each50mlbottlecontainstheequivalentof14gorganicallyboundiodine.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Solutionforinjection

Colourlesstopaleyellowaqueoussolution.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Thismedicinalproductisfordiagnosticuseonly.

X-raycontrastmediumusedfortheopacificationofvascularandrenalsystemsandfemalegenitaltract.

4.2Posologyandmethodofadministration

Routeofadministration:Byintravenous,intra-uterineorintra-arterialinjectionorinjectiondirectlyintothechamberof

theheart,dependingontheprocedure.

RecommendedDosage:

IntravenousUrography

Adults:40to80ml.

Intheabsenceofpreliminarydehydration40to100mlmaybeused.

Infantsandchildren:

Under12kg: 2ml/kgbodyweight.

Over12kg: 1.5ml/kg.Minimumof24ml.

Over10yearsofage:Lowerrangeofadultdosage.

Angiocardiography

Maybeusedasatestdoseinpositioningcathetertip.Volumesofupto20mlhavebeenusedforthispurposepriorto

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 08/02/2012 CRN 2111302 page number: 1

Splenography

Adults:20-40ml.

FemoralVenography

InferiorVenaCavography:

Adults:20to60ml.

Hysterosalpingography:

Adults:About10mlisusuallyrequired,administeredbyslowinjectionintotheuterinecervicalcanalviaasyringeor

suitablecannula.

4.3Contraindications

Useinpatientswithseverehepaticorrenaldysfunction.

Useinpatientswithmanifesthyperthyroidism.

Useinprovenorsuspectedhypersensitivitytoiodinecontainingmedia.

Thisproductmustnotbeusedformyelography.

Hypersensitivitytotheactivesubstanceortoanyoftheexcipients.

4.4Specialwarningsandprecautionsforuse

Theuseofthesecontrastmediashouldbecarriedoutunderthesupervisionoftrainedpersonnelwhose

experiencequalifiestheminthesafeconductofsuchexaminationsasmayberequired.

Ifradiologicalexaminationsarerequiredinwomenofchildbearingcapacity,theyshouldbesoarrangedastobe

carriedoutinthe10daysimmediatelyfollowingtheonsetofbleedinginthemenstrualcycle.

Sincethoseagentsforintravenousadministrationareusuallysaltsofmoderatelystrongorganicacids,solublein

waterwithacomparativelylowviscosityinsolution,theyarereadilyexcretedbythekidneyandhaveadiureticeffect.

Cautionisrequiredinpatientswithpre-existingrenaldiseaseastheinjectionofConraymayleadtoatransient

decreaseinrenalfunctioninsuchpatients.Acuterenalfailurehasbeenreportedinsinglecases.

Adequatehydrationpriortoinjectionisessentialtominimiserenaleffects.Highdoseurographyshouldnotbeusedin

thepresenceofdehydration.

Thepossibilityofaggravationofdehydrationoreventheproductionofhypovolaemiashouldbeborneinmindif

theseagentsaretobeusedinpatientssufferingfromdebilityordehydration,orininfantsandyoungchildren.

Adequatehydrationmaybeofassistanceinpatientswithmultiplemyelomabutuseoftheseagentsrequiresgreat

cautioninthisconditionparticularlyifassociatedwithrenaldysfunctionorextensiveproteinuria.

Contrastagentsshouldbeusedwithcautioninpatientsinpoorgeneralhealth,withcirculatoryorcardiac

insufficiency,bronchialasthma,orthosewithahistoryofallergy,atopy,epilepsy,alcoholism,thyrotoxicosisorwho

arereceivingneuroleptics.Theymaybeathigherriskfromdevelopinganaphylaxisorcardiovascularcollapse.

Considerationshouldbegiventotheuseofnon-ioniccontrastmediainsuchpatients.

IncreasedattentionisneededifpatientswithmyastheniagravishavetoundergoacontrastenhancedX-ray

examination.ThereareliteraturereportsdescribingtheworseningofsymptomsafterConrayadministration.

Followingtheuseofanycontrastmediumofthistype,thereistheremotepossibilityofseveresensitivity

reactions,e.g.anaphylactoidreactions,occurring.Whentheydo,theytendtooccurinthefirst15minutesfollowing

injectionandthepatientshouldbekeptunderobservationduringthisperiod.Equipmentandmedicationsappropriate

foremergencytreatmentofreactionsshouldalwaysbeimmediatelyavailable.

ThePatientshouldremaininthehospitalenvironment(butnotnecessarilytheradiologydepartment)foronehour

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 08/02/2012 CRN 2111302 page number: 2

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

IodinatedX-raycontrastmediamayreducethecapacityoftheuptakeofiodinebythethyroidgland.Forthis

reasontheresultsofPBI(proteinboundiodine)andradioactiveiodineuptakestudies,whichdependoniodine

estimation,willnotaccuratelyreflectthyroidfunctionforupto16daysfollowingadministrationofiodinatedX-ray

contrastmedia.However,thyroidfunctiontestsnotdependingoniodineestimations,e.g.T3resinuptakeandtotalor

freethyroxine(T4)assaysarenotaffected.

AcuterenalfailurehasbeenassociatedwithlacticacidosisinpatientsreceivingMetforminatthetimeofanX-

rayinvestigationinvolvingparenteraladministrationofiodinatedcontrastmedia.Therefore,Metforminshouldbe

withheldforatleast48hourspriorandsubsequenttotheprocedure.

4.6Fertility,pregnancyandlactation

ThereisinadequateevidenceastothesafetyofConrayinhumanpregnancy.Thepregnantfemaleshouldnotbe

submittedtoX-raysunlesstheradiologistconsidersitessential.

Itisnotknownwhetheriotalamicacicisexcretedintohumanbreastmilk.However,manyinjectablecontrastagents

areexcretedunchangedinbreastmilkinanamountofapproximately1%.Althoughithasnotbeenestablishedthat

adverseeventsduetoConrayoccurtonursedinfants,cautionshouldbeexercisedwhenintravascularX-raycontrast

mediaareadministeredtonursingwomenbecauseofpotentialadverseevents,andconsiderationshouldbegivento

discontinuingnursingforoneday.

4.7Effectsonabilitytodriveandusemachines

Thereisnoknowneffectontheabilitytodriveandoperatemachines.However,becauseoftheriskofearlyreactions

drivingoroperatingmachineryisnotadvisablefor1hourfollowingthetimeofinjection.

4.8Undesirableeffects

Milddiscomfortiscommonlyobservedinatotalof10%to50%ofpatients.Itmayconsistofoneormoreofthe

followingsymptoms,e.g.:

Sensationsofheatorcold,painduringtheinjection,oratransienttasteperversion.Othersideeffectsmayoccurina

totalofapproximately12%ofthepatients.Themostfrequentsymptomsarenausea(4-5%),urticaria(3-3.5%),pruritus

(2.8-3.2%),vomiting(1.8-2.2%),andrhinitis(1.5-2%).Allfurthersymptomsarelikelytooccurinlessthan1%ofthe

patients.Adverseeffects,whichmayoccurinrelationwiththeuseofConray,aregenerallyindependentofthedose

administered.Theyaremildormoderateinthemajorityofcases,rarelyseriousorlife-threatening.However,evenmild

adverseeventsmaybethefirstindicationsofaserious,generalreaction,whichmayoccurinrarecasesaftertheuseof

anyiodinatedX-raycontrastmedium.Contrastmedium-relatedhypersensitivityreactionscanalsooccurwithadelay

ofsomehoursuptoseveraldays.Commonsymptomsofdelayedreactionsarepruritusandurticaria.

Inthesubsequentcompilation,allsymptomsarelistedwhichhavebeenreporteduptonowinrelationwiththeuseof

Conray,andwhichareprobablyorpossiblyrelatedtoConray.

BloodandLymphaticsystemdisorders:

Rare(0.01%-0.1%): RES,stimulated.

Veryrare(<0.01%): Thrombocytopenia.

Endocrinedisorders:

Veryrare(<0.01%): Sialoadenitis.

Psychiatricdisorders:

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 08/02/2012 CRN 2111302 page number: 3

Nervoussystemdisorders:

Verycommon(>10%):Hotflushes.

Occasional(0.1%-1%):Palpitation.

Rare(0.01%-0.1%: Dizziness;mouthdry;pallor;paraesthesia;sweatingincreased;tasteperversion.

Veryrare(<0.01%): Agitation;ataxia;confusion;convulsions;disorientation;dysphasia;incontinence;

musclecramps;paralysis;scotoma;speechdisorder;stupor;tremor.

Eyedisorders:

Rare(0.01%-0.1%): Conjunctivitis;lacrimationabnormal.

Veryrare(<0.01%): Transientcorticalblindness;visualdisorder.

Earandlabyrinthdisorders:

Veryrare(<0.01%): Tinnitus.

Cardiacdisorders:

Rare(0.01%-0.1%): Tachycardia,cardiacarrest.

Veryrare(<0.01): Arrhythmias;bradycardia;circulatoryfailure;ECGabnormal;extrasystoles;myocardial

ischemia;ventricularfibrillation.

Vasculardisorders:

Occasional(0.1%-1%):Hypotension.

Rare(0.01%-0.1%): Syncope;vasodilation.

Veryrare(<0.01%): Cerebrovasculardisorder;cyanosis;hypertension;phlebitis;vasospasm.

Respiratory,thoracicandmediastinaldisorders:

Common(1%-10%): Rhinitis.

Occasional(0.1%-1%):Coughing;dyspnoea;pharyngitis.

Rare(0.01%-0.1%): Larynxoedema;throattightness.

Veryrare(<0.01%): Apnoea;bronchospasm;hypoxia;pulmonaryoedema;stridor.

Gastrointestinaldisorders:

Common(1%-10%): Nausea;vomiting.

Rare(0.01%-0.1%): Dysphagia.

Veryrare(<0.01%): Diarrhoea;hypersalivation;tongueoedema.

Skinandsubcutaneoustissuedisorders:

Common(1%-10%): Pruritus;urticaria.

Occasional(0.1%-1%):Erythema;rashes.

Rare(0.01%-0.1%): Angioedema.

Musculoskeletal,connectivetissueandbonedisorders:

Veryrare(<0.01%): Backpain,rhabdomyolysis.

Renalandurinarydisorders:

Veryrare(<0.01%): Acuterenalfailure;BUNincrease;decreaseinrenalfunction;decreasedcreatinineclearance

oliguriaandanuria.

GeneralDisordersandadministrationsiteconditions:

Verycommon(>10%):Pain.

Common(1%-10%): Anaphylactoidreactions.

Occasional(0.1%-1%):Abdominalpain;faceoedema.

Rare(0.01%-0.1%): Asthenia;chestpain;chills;generallocalreactionslikee.g.pain,rash,orswelling,hayfever;

periorbitaloedema.

Veryrare(<0.01%): Anaphylacticshock;cellulitis(injectionsite);fatigue;fever;headache;injectionsitenecrosis;

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 08/02/2012 CRN 2111302 page number: 4

Adversesymptomsmaybeclassifiedasfollows:

Pseudo-allergicintolerancereactionslikee.g.nauseaandvomiting,skinrashes,dyspnoea,hayfever,

paraesthesiaorhypotension.Seriousanaphylacticreactionsgenerallyaffectthecardiovascularandrespiratorysystem.

Thesemaycauselife-threateningconditionsincludinganaphylacticshock,cardiacandrespiratoryarrest,orpulmonary

oedema.Patientswithahistoryofallergyareatincreasedriskofdevelopinghypersensitivityreactions.

Localreactionsattheinjectionsitelikee.g.rashes,swelling,vasospasmandinflammation.

Vasovagalreactionslikee.g.dizzinessorsyncope,whichmaybecausedeitherbythecontrastmedium

administration,orbytheprocedure.

Cardiologicsideeffectsduringcardiaccatheterisationlikee.g.anginapectoris,ECGchanges,cardiac

arrhythmias,conductivitydisordersandcoronaryspasm,whichmaybecausedbythecontrastmediumadministration,

orbythecatheterisationprocedure.

Nephrotoxicreactionsinpatientswithpre-existingrenaldamageorrenalvasopathylikee.g.decreaseinrenal

functionwithcreatinineelevation.Theseadverseeffectsaretransientinthemajorityofthecases.Insinglecases,acute

renalfailurehasbeenobserved.

Neurotoxicreactionsafterintra-arterialinjectionofthecontrastmediumlikee.g.visualdisorders,confusion,

paralysis,convulsions,orfits.Thesesymptomsaregenerallytransientandabatespontaneouslywithinseveralhours,or

days.Patientswithpre-existingdamageoftheblood-brain-barrierareatincreasedriskofdevelopingneurotoxic

reactions.

Inthecaseofinadvertentextravasation,serioustissuereactionsincludingulcerationmayoccurinrarecasesthe

extentofwhichisdependentontheamountandstrengthofthecontrastmediumsolution,whichisdistributedinthe

tissue.

4.9Overdose

Overdoseisunlikelyinclinicalpractice,butintheeventofinadvertentoverdosage,itisimportanttokeepthepatient

wellhydrated,otherwisetreatmentshouldbesymptomaticwithparticularreferencetothecardiovascularsystem.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Watersoluble,nephrotropic,highosmolariodinatedX-raycontrastmedia.

ATCcode:V08AA04.

Conrayisahighosmolar,ionicX-raycontrastmedium.Theorganicallyboundiodineofthecontrastagentpermits

radiographicvisualisationofinternalstructures.

5.2Pharmacokineticproperties

Afterintravascularinjection,Conraywillquicklybedistributedwithintheextracellularspace.Simultaneously,itwill

beeliminatedbyglomerularfiltrationwithameanhalf-lifeofabout80minutes.Thereisalowlevelofbindingto

serumandplasmaproteins.Renaleliminationdecreaseswithrenalimpairment,vicariouspathwaysbecomemore

importantunderthesecircumstances.Thesearethehepatobiliarypathway,theintestinalmucousmembraneandthe

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 08/02/2012 CRN 2111302 page number: 5

5.3Preclinicalsafetydata

TherewerenofindingsinthepreclinicaltestingofConraywhichcouldbeofrelevancefortheprescriberin

recognisingthesafetyofthisproductusedfortheauthorisedindications,andwhichisnotalreadyincludedinother

sectionsoftheSPC.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Sodiumcalciumedetatedihydrate

Sodiumdihydrogenphosphatemonohydrate

Waterforinjections

6.2Incompatibilities

ThismedicinalproductmustnotbemixedwithothermedicinalproductsexceptthosementionedinSection6.6.

6.3Shelflife

5years.

6.4Specialprecautionsforstorage

Donotstoreabove25 o

C.Donotfreeze.ProtectfromX-rays.

Keepcontainerintheoutercartoninordertoprotectfromlight.

6.5Natureandcontentsofcontainer

Conray280ispackagedinuncolouredbottlescomposedoftypeIglass(Ph.Eur.)fittedwitha32mmlatex-free

bromobutylrubberstopperandaluminiumcapseals.

50ml(boxesof10).

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Thedrugshouldnotbeusedifthereareparticlesinitoradiscolourationcanbeobserved.IncaseConrayisfrozenor

crystalsarevisibleithastobeexaminedwhetherthecontainerisdamaged.Ifitisundamagedthecrystalsshouldbe

resolvedbywarminguptoroomtemperatureandvigorousshaking.

Conrayisdeliveredinsingle-doseunits.Remainingcontrastmediumshouldbediscardedaftertheexamination.

ApartfromWaterforInjectionsandDextroseorSaline,Conrayshouldnotbemixedwithanyothersubstance.

7MARKETINGAUTHORISATIONHOLDER

Covidien(UK)CommercialLtd

4500Parkway

Whiteley

Fareham

HampshirePO157NY

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 08/02/2012 CRN 2111302 page number: 6

8MARKETINGAUTHORISATIONNUMBER

PA1679/2/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:07May1996

Dateoflastrenewal:07May2011

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 08/02/2012 CRN 2111302 page number: 7