EPIPEN

Main information

  • Trade name:
  • EPIPEN Solution for Injection 0.3 Mg/Dose
  • Dosage:
  • 0.3 Mg/Dose
  • Pharmaceutical form:
  • Solution for Injection
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • EPIPEN Solution for Injection 0.3 Mg/Dose
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1255/002/002
  • Authorization date:
  • 22-09-2006
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACT1995,asamended

MedicinalProducts(ControlofPlacingontheMarket)Regulations,2007,asamended

PA1255/002/002

CaseNo:2079103

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

ALK-AbelloA/S

BogeAlle6-8,DK-2970Horsholm,Denmark

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

EpiPen0.3mg,solutionforinjection

theparticularsofwhicharesetoutintheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsasmaybespecifiedin

thesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom06/07/2010until24/10/2011.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

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Date Printed 06/07/2010 CRN 2079103 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

EpiPen0.3mg,solutionforinjection.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

1mlcontains1mgadrenaline(Epinephrine).Asingledose(0.3ml)contains0.3mg(300microgram)adrenaline

(Epinephrine).

Excipient:SodiumMetabisulphite.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Solutionforinjection.

Clearandcolourlesssolutioninapre-filledpen(Auto-Injector).

4CLINICALPARTICULARS

4.1TherapeuticIndications

TheAuto-Injectorsareindicatedintheemergencytreatmentofasevereanaphylacticshockorallergicreactionto

allergense.g.insectstingsorbites,foodsordrugs.

4.2Posologyandmethodofadministration

Usualadultdoseforallergicemergenciesis0.3mgadrenalineforintramuscularuse.

Intheabsenceofclinicalimprovementorifdeteriorationoccursaftertheinitialtreatment,asecondinjectionwithan

additionalEpiPenAuto-Injectormaybenecessary.Therepeatedinjectionmaybeadministeredafterabout5–15

minutes.

Thepatientmustconsultaphysicianafterinjectioninordertohaverelevantactionstakenforfurtherevaluationand/or

treatment.

4.3Contraindications

TherearenoknownabsolutecontraindicationstotheuseofEpiPenduringanallergicemergency.

4.4Specialwarningsandprecautionsforuse

Adrenalineisordinarilyadministeredwithextremecautiontopatientswhohaveaheartdisease.Adrenalineshould

onlybeprescribedtothosepatients,butalsothosesufferingfromdiabetes,hyperthyroidism,hypertensionandelderly

individualsifthepotentialbenefitjustifiesthepotentialrisk.

Accidentalinjectionintohandsorfeetresultinginperipheralischaemiahasbeenreported.Patientsmayneedtreatment

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EpiPencontainssodiummetabisulphitewhichmayrarelycauseseverehypersensitivityreactionsincluding

anaphylacticsymptomsandbronchospasminsusceptiblepeople,especiallythosewithahistoryofasthma.Patients

withtheseconditionsmustbecare-fullyinstructedinregardtothecircumstancesunderwhichEpipenshouldbeused.

TheAuto-Injectorsshouldbeinjectedintotheanterolateralaspectofthethigh.Patientsshouldbeadvisednottoinject

intothebuttock.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Cautionisindicatedinpatientsreceivingdrugsthatmaysensitisethehearttoarrhythmias,includingdigitalis,

mercurialdiureticsorquinidine.Theeffectsofadrenalinemaybepotentiatedbytricyclicantidepressantsand

monoamineoxidaseinhibitors(MAO-inhibitors).

Adrenalineinhibitsthesecretionofinsulin,thusincreasingthebloodglucoselevel.Itmaybenecessaryfordiabetic

patientsreceivingadrenalinetoincreasetheirdosageofinsulinororalhypoglycaemicdrugs.

Observe.The-stimulatingeffectcanbeinhibitedbysimultaneoustreatmentwith-blockingdrugs.

4.6Pregnancyandlactation

Clinicalexperienceinthetreatmentofpregnantwomenislimited.Asadrenalineisasubstancethatnaturallyoccursin

thebody,itisunlikelythatthisdrugwouldhaveanydetrimentaleffectsonfertility.

Adrenalineshouldbeusedduringpregnancyonlyifthepotentialbenefitsjustifythepotentialriskforthefoetus.

4.7Effectsonabilitytodriveandusemachines

Itisnotrecommendedthatpatientsshoulddriveorusemachinesfollowingadministrationofadrenaline,sincepatients

willbeaffectedbysymptomsoftheanaphylacticshock.

4.8Undesirableeffects

Sideeffectsassociatedwithadrenaline'salphaandbetareceptoractivitymayincludesymptomssuchastachycardia

andhypertensionaswellasundesirableeffectsonthecentralnervoussystem.Usualsideeffectsarehyperhidrosis,

nausea,vomiting,headache,dizziness,asthenia,tremorandanxiety.Cardiacarrhythmiamayfollowadministrationof

adrenaline.Peripheralischaemiafollowingaccidentalinjectionofthepensinhandsorfoothavebeenreported(see4.4

Warningsandprecautions).

Inrarecasesstresscardiomyopathyhasbeenseeninpatientstreatedwithadrenaline.

4.9Overdose

Overdoseorinadvertentintravascularinjectionofadrenalinemaycausecerebralhaemorrhageresultingfromasharp

riseinbloodpressure.Fatalitiesmayalsoresultfrompulmonaryoedemabecauseofperipheralvascularconstriction

togetherwithcardiacstimulation.

Pulmonaryoedemamaybetreatedwith-blockingagentssuchasphentolamine.Incaseofarrhythmiasthesemaybe

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5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Cardiacstimulantsexcl.cardiacglycosides.

ATCcode:C01CA24.

Adrenalineisacatecholaminewhichstimulatesthesympatheticnervoussystem(bothalphaandbetareceptors)by

whichcardiacrate,cardiacoutputandcoronarycirculationisraised.Adrenalinethroughitsactiononbetareceptorson

bronchialsmoothmusclescausesbronchialsmoothmusclerelaxationwhichalleviateswheezinganddyspnoea.

Adrenalineisrapidlyinactivatedandmuchofthedoseofadrenalineisaccountedforbyexcretionofmetabolitesinthe

urine.

5.2Pharmacokineticproperties

Adrenalineisanaturallyoccurringsubstanceproducedbytheadrenalmedullaandsecretedinresponsetoexertionor

stress.ItisrapidlyinactivatedinthebodymostlybytheenzymesCOMT(Catechol-O-Methyltransferase)andMAO

(MonoAmineOxidase).Theliverisrichintheseenzymesandisanimportant,althoughnotessential,tissueinthe

degradationprocess.Muchofthedoseofadrenalineisaccountedforbyexcretionofmetabolitesintheurine.

AccordingtoRemington’sPharmaceuticalSciences,theplasmahalf-lifeofadrenalineisabout2.5min.However,by

subcutaneousorintramuscularroutes,localvasoconstrictionretardsabsorption,sothattheeffectsoccurinsidiousand

lastmuchlongerthanthehalf-lifewouldpredict.Massagearoundtheinjectionareaisadvised.

5.3Preclinicalsafetydata

Adrenalinehasbeenutilisedinthetreatmentofallergicemergenciesformanyyears.Nopreclinicalstudieshavebeen

performedinconnectionwiththisapplication.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

SodiumChloride

SodiumMetabisulfite

HydrochloricAcid(forpHadjustment)

WaterforInjections

6.2Incompatibilities

Adrenalineanditssaltsarerapidlydestroyedinsolutionwithoxidisingagents.Oxidationcanbeinhibitedbyaddition

ofanti-oxidants.Thesolutiondarkensincolouruponexposuretoairorlight.

6.3ShelfLife

18months.

6.4Specialprecautionsforstorage

Keepcontainerintheoutercartoninordertoprotectfromlight.Donotstoreabove25 °

C.Donotrefrigerateorfreeze.

Checkthesolutionperiodicallythroughtheviewingwindowoftheunittomakesurethesolutionisclearand

colourless.DiscardandreplacetheAuto-Injectorifthesolutionisdiscolouredorcontainsaprecipitate,oratthelatest

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6.5Natureandcontentsofcontainer

Theimmediatecontainer/closuresystemconsistsofaglasscartridgesealedbyarubberplungeratoneendandby

rubberdiaphragmwhichhasbeeninsertedintoanaluminiumhubwithattachedstainlesssteelneedleattheotherend.

Theglasscartridgecontainstheproduct.

TheAuto-Injectoradministrationdevice:

Glasscartridgecontainer:

TypeI,BorosilicateGlass

Diaphragm-Stopper:

PH701/50/Black(butylrubberplunger)

Needle-Hub-Sheath:

Needle: SiliconisedType304stainlesssteel

Hub: Anodised3003aluminiumalloy

Sheath: Syntheticpolyisoprene

Packsize:Auto-injectorsingledosecontaining2ml.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Forsingleuseonly.TheAuto-Injectorsmustbediscardedimmediatelyafteruse.

DuringinstructionofthepatientincorrectuseoftheEpiPentheprescribingdoctormayusean“EpiPenTRAINER”.

TheEpiPenAuto-Injectorcontains2mlofadrenalineinjection1mg/mlwhichisdesignedtodeliverasingledose(0.3

ml)of0.3mgadrenalinewhenactivated.AfteractivationoftheAuto-Injector1.7mlremainsintheAuto-Injector.

Donotremovegreysafetycapuntilreadyforuse.

UndernocircumstancesplacetheblackendoftheEpiPenAuto-Injectoronornearyourthumbs,fingersorhands.

Accidentalinjectionintohandsorfingersresultinginperipheralischaemiahasbeenreported.Seesection4.4,special

warningsandprecautionsforuse.TheEpiPenAuto-Injectorshouldbeusedontheouterthigh.Theinjectionis

activatedimmediatelytheblackendoftheEpiPenAuto-Injectorcomesintocontactwithanyskinorothersurface.

TheEpiPenAuto-Injectorsaredesignedforeasyusebythelaypersonandhastobeconsideredasafirstaid.The

Auto-Injectorshouldsimplybejabbedfirmlyagainsttheouterportionofthethighfromadistanceofapproximately10

cm.Thereisnoneedformorepreciseplacementintheouterportionofthethigh.WhenEpiPenAuto-Injectorisjabbed

againstthethigh,itreleasesaspringactivatedplunger,pushingconcealedneedleintothethighmuscleandexpellinga

doseofadrenaline:

GraspEpiPenAuto-Injectorindominanthand,withthumbclosesttogreysafetycap.

Withtheotherhandpulloffgreysafetycap.

HoldtheEpiPenAuto-Injectorinadistanceofapproximately10cmawayfromtheouterthigh.Theblacktip

shouldpointtowardstheouterthigh.

Jabfirmlyintotheouterthigh,sothattheEpiPenAuto-Injectorisatarightangleto(ata90degreeangle)the

outerthigh.

Holdinplacefor10seconds.TheEpiPenAuto-Injectorshouldberemovedandsafelydiscarded.

Massagetheinjectionareafor10seconds.

AsmallairbubblemayoccurintheEpiPenAuto-Injector.Ithasnoinfluenceoneithertheuseortheefficacyofthe

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Instructionforuseisenclosedinthepackage.

7MARKETINGAUTHORISATIONHOLDER

ALK-AbellóA/S

BøgeAllé6-8

2970Hørsholm

Denmark

8MARKETINGAUTHORISATIONNUMBER

PA1255/002/002

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:22September2006

Dateoflastrenewal:25October2006

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 06/07/2010 CRN 2079103 page number: 6