BARICAT

Main information

  • Trade name:
  • BARICAT Cachet 49.2 Mg/Ml
  • Dosage:
  • 49.2 Mg/Ml
  • Pharmaceutical form:
  • Cachet
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BARICAT Cachet 49.2 Mg/Ml
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1022/016/001
  • Authorization date:
  • 12-11-2010
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

BariCat49.2mg/mlconcentratefororalsuspension

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachdoseof225mlofundilutedsuspensioncontains11.07gofbariumsulfate(49.2mg/ml).

Excipients:

Eachdoseof225mlundilutedsuspensioncontains16gsorbitol(E420)(assorbitol,liquid(crystallising)).

Eachdoseof225mlofundilutedsuspensioncontains110.25mgofmethylparahydroxybenzoate(E218).

Eachdoseof225mlofundilutedsuspensioncontainsapproximately206mgofsodium.

Eachdoseof225mlofundilutedsuspensioncontainsapproximately50mgofpotassium.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Concentratefororalsuspension.

Awhiteviscous,aqueoussuspensionwithasweetorangeflavour,withoutgrittiness.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Thismedicinalproductisfordiagnosticuseonly.

BariCatshouldbeused,followingdilutionasinstructed,toopacifythegastro-intestinaltractpriortocomputerised

axialtomography.

4.2Posologyandmethodofadministration

Fororaladministration.

Theconcentrateisdilutedwithwatertoobtainadesiredconcentration.

Recommendeddilutionsareshowninsection6.6.

Adultsincludingtheelderly:350-450mlofdilutedsuspension30minutespriortothescanandthesamevolume5

minutespriortothescan,orasdirectedbythephysician.

Children:ThequantityofBariCatgivenshouldbedetermined,fromexperience,bythephysicianandwillbe

dependentontheageandweightofthechild.

4.3Contraindications

ImmuneSystemDisorders

Hypersensitivitytobariumsulfateortoanyoftheexcipients.

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Patientswithanyofthefollowing:

aknownorsuspectedfistula,perforationorobstructioninanypartofthegastrointestinaltract

gastrointestinalhaemorrhage

gastrointestinalischaemia

megacolonortoxicmegacolon

necrotisingenterocolitis

severeconstipation

severeimpairedgastricemptying

mustnotreceiveBariCat.

BariCatmustnotbeusedforinfantswithswallowingdisorders.

SurgicalandMedicalProcedures

Bariumsulfatemustnotbeadministeredimmediatelybeforeorimmediatelyaftergastrointestinalsurgery,including

snarepolypectomyor'hot'colonicbiopsy.Ifpostproceduralleakageisexpectedtheproductmustnotbeused.Donot

useduringanduptofourweeksafterradiotherapytotherectumorprostate.

Injury,PoisoningandProceduralComplications

Donotuseiftherearenewinjuriesorchemicalburnsofthegastrointestinaltract.

4.4Specialwarningsandprecautionsforuse

Thisproductshouldbeadministeredunderthesupervisionofaphysician.

Diagnosticprocedureswhichinvolvetheuseofradiopaquecontrastagentsshouldbecarriedoutunderthedirectionof

personnelwiththerequisitetrainingandwithathoroughknowledgeoftheparticularproceduretobeperformed.

Hypersensitivity

Ahistoryofbronchialasthma,atopy,asevidencedbyhayfeverandeczema,afamilyhistoryofallergy,oraprevious

reactiontoacontrastagentwarrantspecialattention.

Asstatedinsection4.8,seriousadversereactions,includingdeath,havebeenreportedwiththeadministrationof

bariumsulfateformulationsandareusuallyassociatedwiththetechniqueofadministration,theunderlying

pathologicalconditionand/orpatienthypersensitivities.Anaphylacticandallergicreactionshavebeenreportedduring

doublecontrastexaminationsinwhichglucagonhasbeenused.Rapidrecognition,assessment,anddiagnosisare

crucialtotheeffectiveimplementationoftreatment.Imagingfacilitiesshouldbestaffedwithwell-trainedpersonnel

forthediagnosisandtreatmentofhypersensitivityreactions.

Perforation

Inpatientswithaseriousstenosisatanylevelofthegastro-intestinaltract,especiallyifitisdistaltothestomach,and

inthepresenceofconditionsandailmentsthatincreasetheriskofperforationsuchascarcinomas,inflammatory

intestinaldisease,diverticulitisanddiverticulosisandamoebiasis,carefulconsiderationoftherisksandbenefitsofthe

administrationofabariumsulfatesuspensionisrequired.

Aspiration

Forpatientswhoarepronetoaspiration(thenewborn,elderlyandstrokepatients),itisrecommendedthatthe

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Vomitingfollowingoraladministrationofbariumsulfatemayleadtoaspirationpneumonitis.Oraladministrationof

bariumsulfatesuspensionbyaninfantsuckingabottleandadministrationoflargequantitiesbycatheterarereportedto

belikelytoresultinaspirationintothetracheobronchialtree.Cardiopulmonaryarrestleadingtofatalityhasbeen

reportedininfantsfollowingaspiration.Aspirationofsmalleramountsmaycauserespiratorytractinflammationand

pneumonia.

Ingestionofbariumisnotrecommendedinpatientswithahistoryoffoodaspiration.Ifbariumproceduresarerequired

inthesepatientsorinpatientsinwhomintegrityoftheswallowingmechanismmaybecompromised,proceedwith

caution.Ifthisproductisaspiratedintothelarynx,furtheradminstrationshouldbeimmediatelydiscontinued.

FluidOverload

Bariumsulfatesuspensionshavebeenreportedtocausefluidoverloadduetowaterabsorption.

Childrenandpatientswithimpairedrenalfunctionarethemostsusceptibletowaterintoxification,asarechildrenwith

Hirschsprung'sDisease.

ItissuggestedtonotfilltheentirecolonwhenevaluatingachildwithHirschsprung'sDisease;useonlytheamountof

fluidnecessaryforthediagnosis.

PreparatoryenemasinpatientswithHirschsprung'sDiseaseshouldbeavoided.

Intravasation

Bariumsulfatemayalsointravasateintothevenousdrainageofthelargebowelandenterthecirculationasa"barium

embolus".Thiscomplicationoccursrarely,butcanleadtopotentiallyfatalcomplication,includingsystemicand

pulmonaryembolism,disseminatedintravascularcoagulation,septicaemiaandprolongedseverehypotension.Itis

morelikelytooccurinelderlypatients,duetothinningoftherectalwallandvaginalthinningwithage,andinthose

withcolorectaldisease,whenintraluminalpressureovercomestheresistanceofthecolonicwallaffectedbycolitis,

diverticulitisorintestinalobstruction.Thediagnosisshouldbeconsideredinanypatientwhocollapsesduringor

shortlyafterabariumprocedure,andinthosewhobecomesuddenlyunwellinthehoursfollowingtheprocedure.The

diagnosiscanbeconfirmedbysimpleplainradiography;CTscanningmayalsobeusefultodetectdisseminationof

bariumsulfate.

ConstipationorDiarrhoea

BariCatshouldbeusedwithcareifthepatientisdehydrated,suffersfromanyconditionorisonanyothertreatment

thatcancauseconstipation,orifthepatienthashistoryofconstipation.Inthissituationamildbulklaxativeshouldbe

administeredfollowingcompletionoftheX-rayexamination.Increasedintakeofliquidsisrecommendedafteroralor

rectaladministrationofbariumsulfatetopreventsevereconstipationandtheriskofimpaction.

Conversely,sinceBariCatcontainssorbitol,administrationmayhaveamildlaxativeeffect.Thecalorificvalueof

sorbitolis2.6kcal/g.

OtherPossibleComplications

Apprehensivepatientsmaydevelopweakness,pallor,tinnitus,diaphoresisandbradycardiafollowingthe

administrationofanydiagnosticagent.Suchreactionsareusuallyunpredictableandarebesttreatedbyhavingthe

patientlieflatforanadditional10-30minutesunderobservation.

Patientpreparationfordiagnosticgastrointestinalexaminationsfrequentlyrequirescatharticsandaliquiddiet.The

variouspreparationscanresultinwaterlossforthepatient.Patientsshouldberehydratedquicklyfollowingabarium

sulfatesuspensionexaminationofthegastrointestinaltract.Salinecatharticsarerecommendedonaroutinebasisin

patientswithahistoryofconstipationunlessclinicallycontraindicated.

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Barolithsconsistofinspissatedbariumassociatedwithfaeces.Theyareoftenasymptomatic,butmaybeassociated

withabdominalpain,appendicitis,bowelobstructionorperforation.Patientswhoareelderly,withimpaired

gastrointestinalmotility,colonobstruction,electrolyteimbalance,dehydrationoronalowresiduedietmaybeatriskof

developingbaroliths.Toreducethisrisk,adequatehydrationshouldbemaintainedduringandinthedaysfollowing

bariumsulfateprocedure.Theuseoflaxatives(especiallyincaseofconstipation)shouldbeconsidered.

HereditaryFructoseIntolerance

BariCatcontainssorbitol.Patientswithrarehereditaryproblemsoffructoseintoleranceshouldnotusethismedicine.

Therefore,itshouldonlybeusedinbabiesandsmallchildrenafterconsultationwiththedoctor,duetothepossibility

ofunknownhereditaryfructoseintolerance.

PatientsonaControlledSodiumorPotassiumDiet

BariCatcontainsapproximately206mgsodiumperdoseof225mlundilutedsuspension.Careshouldbetakenin

patientsonacontrolledsodiumdiet,especiallyinthecasesofrepeatedadministration.

Italsocontainsapproximately50mgpotassiumperdoseof225mlundilutedsuspension.Careshouldbetakenwith

patientswhohavereducedkidneyfunctionorthoseonacontrolledpotassiumdiet.

OtherExcipients

BariCatcontainsmethylparahydroxybenzoate(E218),whichmaycauseallergicreactions,sometimesdelayed.

Children,ElderlyandDebilitatedPatients

Aswithanybariumsulfatepreparation,careshouldbetakenwhenadministeringBariCattochildren,theelderlyorthe

debilitated.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Nointeractionstudieshavebeenperformed.

Bariumsulfateisbiologicallyinertandtherearenoknowninteractionswithothermedicinalproducts.However,the

presenceofbariumsulfateformulationsinthegastrointestinaltractmayaltertheabsorptionoftherapeuticagentstaken

concomitantly.Inordertominimiseanypotentialchangeinabsorption,theseparateadministrationofbariumsulfate

fromthatofothermedicinesshouldbeconsidered.

Otherexaminationsofthesameareaofthegastrointestinaltractwithanothercontrastagentmaybecomplicatedbythe

presenceofbariumsulfate(residue)inthegastrointestinaltractuptoseveraldaysfollowingtheexaminationwith

bariumcontrastmedia.

4.6Fertility,pregnancyandlactation

Pregnancy

Thereisnodatafromtheuseofbariumsulfateinpregnantwomen.Animalstudiesareinsufficientwithrespectto

reproductivetoxicity(seesection5.3).Becausebariumsulfateisnotabsorbedbythedigestivetract,BariCatcanbe

usedduringpregnancy.However,itisstressedthatradiographicproceduresmaydamagethefoetus,particularlyduring

thefirsttrimesterofpregnancy.Anyexaminationshouldonlybecarriedoutaftercarefulconsiderationofthe

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Lactation

Sincebariumsulfateisnotabsorbed,BariCatcanbeusedduringbreast-feeding.

4.7Effectsonabilitytodriveandusemachines

BariCathasnoknowneffectontheabilitytodriveandusemachines.

4.8Undesirableeffects

Undesirableeffectsmayoccurduringorafteraprocedurewithbariumsulfate.

Skinandsubcutaneousdisorderstogetherwithimmunesystemdisorders,reflectingallergicreactionseithertobarium

sulfateortheproductexcipients,areamongthemostcommonlyreportedeffects;forexampleurticaria,erythemaand

rash.

Gastrointestinaldisordersarealsooneofthemostfrequentlyreportedclassofundesirableeffects;forexample

diarrhoea,nausea,abdominalpain/distention,constipation.Gastrointestinalsignsandsymptomsarewidelyreported,it

isnotalwayspossibletodifferentiatebetweenpre-existingmedicalconditionsandproceduralcomplications.

Hypersensitivitypresentingwithawiderangeofsignsandsymptomsincludingskinandsubcutaneousreactionssuch

asurticaria,pruritus,rash,erythemaandfacialswellinghasbeenreported.Potentialhypersensitivityassociated

respiratorysignsandsymptomsincludingdyspnoea,pharyngealoedemaandthroattightnesshavealsobeenreported.

Withinthetablebelow,clinicallysignificantadversereactionsarelistediftheyhavebeenreportedpostauthorisation

ofallbariumsulfateformulations,andhavenotbeenreportedinclinicaltrials.Theirfrequencyisnotknown(cannot

beestimatedfromtheavailabledata).

MedDRASystemOrganClass MedDRAPreferredTerm

Infectionsandinfestations Appendicitis,Bacteraemia,Abscessintestinal,

Liverabscess,Peritonealinfectionand

Pneumonia.

Bloodandthelymphaticsystemdisorders Lymphadenopathy

Immunesystemdisorders Hypersensitivity,Anaphylacticreactionand

anaphylacticshock.

Metabolismandnutritiondisorders Hyperglycaemia(indiabeticpatients)

Psychiatricdisorders Agitation,Confusionalstate,Nervousness.

Nervoussystemdisorders Lossofconsciousness,Syncope,Syncope

vasovagal,Dizziness,Burningsensation,

Headache,Dysarthria,Hypotonia.

Eyedisorders* Eyedisorders,includingEyeswelling.

Earandlabyrinthdisorders Tinnitus.

Cardiacdisorders Bradycardia,Cyanosis,Tachycardia.

Vasculardisorders Hypotension,Pallor,Vasodilatation.

Respiratory,thoracicandmediastinal

disorders Bronchospasm,Dyspnoea,Laryngealoedema,

Pharyngealoedemaandpain,Throatirritationor

tightness,Cough.Whenadministeredorally,

Aspiration,Pneumoniaaspiration.

Gastrointestinaldisorders Constipationandinseverecasesgastrointestinal

blockage;

Gastrointestinalinflammation,ulcerationor

perforation;Abdominaldiscomfort,Abdominal

painanddistension;Diarrhoea;Colitisulcerative

maybeaggravated;Nausea;Vomitingand

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*Thesereactionsareassociatedwithallergicreactions.

Morerarelyanddependingontherouteofadministration,i.e.oralorrectal,thefollowingproceduralcomplications

havebeenreported:Infections(e.g.peritonitis)subsequenttoexistingornewgastrointestinalperforation.

Complicationsincludeadhesionsandgranuloma.Subsequenttoexistingorproceduralgastrointestinaltrauma,

intravasationofbariumsulfatewithraresubsequentvenousemboliformation,includingthehepaticportalvein,vena

cavaandpulmonaryembolismthatmaybefatalinapprox50%ofcases.

Followingoraladministration,aspiration,withpulmonarycomplications,mayoccurandmaybefatalinrarecases.

Pleaseseesection4.4formeasurestobetakentoavoidtheseadversereactions,andactionstotakeifsuchadverse

reactionsoccur.

Veryrarecasesofdeathassociatedwithbariumsulfateadministrationhavebeenreportedintheliterature.The

majorityofthedeathsrelatetoproceduralcomplicationsusuallycausedbyfailuretofollowgenerallyaccepted

radiologicalpractice.Somecaseshadahistoryindicatingthatbariumsulfateadministrationwashighlyunlikelytobe

aprimaryorevensecondarycausativefactorinpatientfatality.

4.9Overdose

Bariumsulfateisnontoxicandnotabsorbed.

Repeatedusewithinaveryshortperiodoftimehasledtoabdominalcramps,nausea,vomiting,diarrhoeaand

constipation.Thesesymptomsaretransitoryinnatureandmaybeallowedtoresolvewithoutmedicalinterventionor

maybetreatedaccordingtocurrentlyacceptedstandardsofcare.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

PharmacotherapeuticGroup:X-raycontrastmedia,bariumsulfatewithsuspendingagents,ATCCode:VO8BA01

BariumSulfateitselfhasnopharmacologicaleffects.Itservesonlytoopacifythegastro-intestinaltractduring

computerisedaxialtomography.

5.2Pharmacokineticproperties

Notapplicable.Bariumsulfate,theactiveconstituentofBariCatisnotabsorbedfromthegastrointestinaltract.

5.3Preclinicalsafetydata

TherearenopreclinicaldataconsideredrelevanttoclinicalsafetybeyonddataincludedinothersectionsoftheSPC.

Skinandsubcutaneoustissuedisorders* Erythema,DermatitisContact,Excessive

granulationtissue,Hyperhidrosis,Periorbital

oedema,Pruritus,Rash,Swellingface,Urticaria.

Renalandurinarydisorders Dysuria.

Generaldisordersandadministrationsite

conditions Malaise,Pain,Swelling,Asthenia,Pyrexia,Face

oedema.

Investigations Electrocardiogramabnormal.

Injuryandpoisoning Intravasationbybariumsulfate,associatedwith

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6.1Listofexcipients

Sorbitol,liquid(crystallising)(E420)

Pectin(E440)

Xanthangum(E415)

Simeticoneemulsion30%

Sodiumcitrate(E331)

Citricacidanhydrous(E330)

Potassiumsorbate(E202)

Methylparahydroxybenzoate(E218)

Artificialorangeflavour[includingnaturalandartificialflavoursandbutylatedhydroxyanisole(E320)]

Saccharinsodium(E954)

Sodiumcarrageenan(E407)

Polyoxyethyleneglycerylmono-oleate

Purifiedwater

6.2Incompatibilities

Notapplicable

6.3Shelflife

Unopened:2years.

Afterdilution:Theproductshouldbeusedimmediatelyafterdilutionandmustnotbestored.

6.4Specialprecautionsforstorage

Storebelow25°C.Donotfreeze.

6.5Natureandcontentsofcontainer

Highdensitypolyethylene(HDPE)bottlewithpolypropylenescrew-onclosureandtamperevidentsealcontaining225

mlofthesuspension.

6.6Specialprecautionsfordisposalandotherhandling

Donotacceptifthetamperevidentsealisbroken.

Theproductshouldbeshakenwellpriortouse.

ThedilutioninstructionsareprovidedinthePackageLeafletandareasfollows:-

Dilutioninstructions:

PourBariCatcontentsintoalitrecontainer.

Addwatertogivetotalvolumeof900ml.

Shakewell.

Thiswillyield900mlof12mg/mlbariumsulfatesuspension.

Alternatively,BariCatmaybemixedto

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AddBariCatcontentsintothemixingcontainerandadd

waterto700mllevel.Yields15mg/mlsuspension.

Addwatertothe600mllevel.Yields18mg/mlsuspension.

Addwatertothe500mllevel.Yields21mg/mlsuspension.

Thisproductisintendedforsingledoseuseonly.Theproductshouldbeadministeredimmediatelyfollowingdilution

andanyunusedproductshouldbediscarded.

Anyunused,openedproductorwastematerialshouldbedisposedofinaccordancewithlocalrequirements.

7MARKETINGAUTHORISATIONHOLDER

BraccoUKLimited

BraccoHouse

MercuryPark

WycombeLane

WooburnGreen

HighWycombe

BucksHP100HH

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA489/3/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:21 st

April1995

Dateoflastrenewal:10 th

March2010

10DATEOFREVISIONOFTHETEXT

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