GASTROMIRO 612.4 MG/ML ORAL OR RECTAL SOLUTION.

Main information

  • Trade name:
  • GASTROMIRO 612.4 MG/ML ORAL OR RECTAL SOLUTION.
  • Dosage:
  • 300
  • Pharmaceutical form:
  • Unknown
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • GASTROMIRO 612.4 MG/ML ORAL OR RECTAL SOLUTION.
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1022/013/001
  • Authorization date:
  • 10-04-2001
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Gastromiro612.4mg/mloralorrectalsolution.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlofsolutioncontains612.4mgiopamidolequivalentto300mgiodine.

Excipients:

Ethanol48.4mg/20ml,121mg/50ml,and242mg/100ml

Forfulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Oralorrectalsolution.

Aclear,particle-freesolutionwithanorangeodourandflavour.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Allformsofradiologicalinvestigationsofgastrointestinaltract,inparticular:-

Paediatricradiologyofthegastro-intestinaltract(GIT)wherethereisthepossibilityof:

i)Spillintotherespiratorytract,forexamplein:

swallowingdisorders

oesophagealobstructionwithaforeignbody,atresiaorstricture

tracheo-oesophagealfistula.

Spillintothemediastinum,pleura,peritoneumorretroperitonealtissues,forexampledueto

perforationoftheGIT.

iii. Inspissationoffluid,forexamplein:

Meconiumileusequivalent.

Intussusception.

Colonicobstruction.

Hirschsprung’sdisease.

Adultradiologyofthegastro-intestinaltract,suchas:

i)Suspecteduppergastro-intestinalperforationforexamplein:

Oesophagogastrectomy,endoscopy,partialgastrectomy,pneumonectomy,ingestionofforeignbody,

duodenalulceration,smallbowelresection,Whipplesprocedureandbluntabdominaltrauma.

iii)ComputerTomography(CT)oftheabdominalandpelvicregions,forexample:

a).Suspicionofexpandinglesionsofpancreas,liverandgallbladder.

b).Spaceoccupyingmetastaticlesionsoriginatingfromprostateorrecto-sigmoidalregioninpost-

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4.2Posologyandmethodofadministration

Adults:

Radiologyofgastro-intestinaltract

Oral: 40-100mlundiluted

Rectal: 200mlofa50%dilution,upto1000mlofa2%dilution

ComputedTomography

Oral:

AbdominalCT: 100mlofa17%dilution,upto600mlofa3%dilution.

Rectal-PelvicCT: 500-700mlofa3%dilution

InfantsandChildren:

Radiologyofgastro-intestinaltract

Oral: 10-100mlundilutedor,foruseininfants20-200mlofuptoa50%

dilutiontoprovideisotoniccontrastmedium

Rectal: 200mlof50-60%dilution

Elderly:

Dosagesasforadults.

DilutionofGastromiroshouldbecarriedoutusingsterilewater.Anyunusedsolutionshouldbediscardedafter6

hours.

4.3Contraindications

Provenorsuspectedhypersensitivitytoiodinecontainingpreparationsofthistype.Itmustnotbeusedforparenteral

administration.

4.4Specialwarningsandprecautionsforuse

Disturbancesinwaterorelectrolytebalancemustfirstbecorrected.Thisproductisformulatedforgastro-intestinaluse

onlyandshouldnotbeusedparenterally.

Careshouldalsobeexercisedinpatientswithseverefunctionalimpairmentoftheliver,kidneyormyocardium,severe

systemicdiseaseandinmyelomatosis.Insuchpatientsadequatehydrationshouldbemaintainedandparametersof

hepaticandrenalfunction,especiallyurinaryoutputshouldbemonitoredaftertheprocedure.

Patientswithhepato-renalinsufficiencyshouldnotbeexaminedunlessbenefitsclearlyoutweighrisksandre-

examinationshouldbedelayedfor5-7days.

Inpatientswithahistoryofadversereactionsduringsimilarinvestigationsadditionalcautionshouldbeexercisedand

theprocedureshouldonlybecarriedoutifbenefitsclearlyoutweighanyrisks.

X-rayexaminationofwomenshouldbeconductedasfaraspossibleduringthepre-ovulationphaseofthemenstrual

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4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.6Pregnancyandlactation

Thesafetyofiopamidolduringpregnancyandlactationhasnotbeendemonstratedclinically.Due,however,tothe

extremelylowabsorptionofiopamidolfromthegastro-intestinaltractitisunlikelythatafoetuscouldbeexposedto

significantlevels.Inanimalexperimentsiopamidolisneitherteratogenicnorfoetotoxic.Similarly,duringlactation

breastfedinfantsareunlikelytobeexposedtosignificantlevelsofiopamidol.However,theproductshouldnotbe

usedduringpregnancyorwhenbreastfeedingunlessconsideredessential.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

SystemiceffectsareraresinceGastromiroisonlypoorlyabsorbedfromthealimentarytract.Owingtoslight

hypertonicityGastromiromayoccasionallycausevomitinganddiarrhoeaininfantsandchildren.

4.9Overdose

Thecontrastagentisnotabsorbedfromthegastrointestinaltract,thereforeanysystemicaccumulationofthecontrast

mediumfollowingoverdosagewillnotoccur.Anytreatmentshouldbesymptomatic.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Iopamidolisacontrastmediumbelongingtothenewgenerationofnon-ioniccompoundswhosesolubilityisduetothe

presenceofhydrophilicsubstituentsinthemolecule.Thisresultsinasolutionoflowosmolalitywhencomparedwith

ionicmedia.

IopamidolhasbeenshowntobeeffectiveasanX-raycontrastmediuminneuroradiology,angiography,venography,

arthrography,urography,

cerebralangiography,andleftventriculography,coronaryarteriography,andinvestigationsofthegastrointestinaltract.

Itstoxicity,particularlycardiacandCNStoxicityarelessthanthoseofnon-ioniccontrastmedia.

5.2Pharmacokineticproperties

Serumiopamidolconcentrationcurvesconformtoanopentwocompartmentpharmacokineticmodelwithfirstorder

elimination.Iopamidolisverypoorlyabsorbed(about1-2%)afteroralorrectaladministration.

Distributionvolumeisequivalenttoextracellularfluid.

Followingparenteraladministrationeliminationisalmostcompletelythroughthekidneys.Lessthan1%ofthe

administereddosehasbeenrecoveredinthefaecesuptoseventytwohoursafterdosing.Renaleliminationisrapid

anduptohalftheadministereddosemayberecoveredintheurinewithinthefirsttwohoursofdosing.

Thereisnoevidenceofbiotransformation.

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5.3Preclinicalsafetydata

Inanimals,Gastromirowaswelltoleratedafterrepeatedoraladministration.After4weeksadministrationof

Gastromiroequivalentto9gI/kgday,i.e.about20timeshigherthantherecommendedclinicaldose,nosevere

symptomsofsub-acuteintoxicationwereobservedinrats.FollowingintraperitonealinjectionofGastromiroinrats,

iopamidolwasrapidlyclearedandalmosttotallyeliminatedbytherenalroutewithinthefirst24hours.

Theintraperitonealacutetoxicitywasrelativelylow.Necroscopicexaminationrevealednoirritanteffectsonthe

peritonealmembrane.Gastromiroalsoshowedgoodlocaltolerabilityafterbothlocalintratrachealinstallationand

systemicadministration.Itthereforeoffersagoodmarginofsafetyforexaminationsinwhichthereistheriskofan

accidentalinspirationofthediagnosticmedium.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Orangeflavour*

Sodiumcyclamate

Redcuraçaoflavour*

Disodiumedetate

Saccharinsodium

Citricacidmonohydrate

Waterforinjections

*containsethanol

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

Unopened:3years.

6.4Specialprecautionsforstorage

Donotstoreabove25ºC.

Keepbottleintheoutercarton.

6.5Natureandcontentsofcontainer

Thecontainersareamberglassbottles(TypeIII)withaluminiumscrewcaps,guaranteeseals,andelastomerinserts.

Boxesof1bottle20ml

Boxesof1bottle50ml

Boxesof1bottle100ml

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

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ThedosageofGastromiroshouldbeadjustedaccordingtoage,bodyweight,thesegmentofthedigestivetracttobe

examinedandtheX-rayprocedure.

Thebottleonceopenedhastobeusedimmediately.Solutionsnotusedinoneexaminationsessionmustbediscarded.

Gastromiroformulationisacolourlesstopaleyellowsolutioncontainingundissolvedsolids.Discardincaseof

discolouration.

7MARKETINGAUTHORISATIONHOLDER

BraccoUKLtd

BraccoHouse

MercuryPark

WycombeLane

WooburnGreen

HighWycombe

BucksHP100HH

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA1022/013/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: 10April1990

Dateoflastrenewal: 10April2006

10DATEOFREVISIONOFTHETEXT

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