EPIPEN JUNIOR

Main information

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

Documents

Localization

  • Available in:
  • EPIPEN JUNIOR
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1255/002/001
  • 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

PA1255/002/001

CaseNo:2079103

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

ALK-AbelloA/S

BogeAlle6-8,DK-2970Horsholm,Denmark

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

EpiPenJunior0.15mg,solutionforinjection

theparticularsofwhicharesetoutintheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsasmaybespecifiedin

thesaidRegulationsaslistedonthereverseofthisdocument.

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

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

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

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

EpiPenJunior0.15mg,solutionforinjection

2QUALITATIVEANDQUANTITATIVECOMPOSITION

1mlcontains0.5mgadrenaline(Epinephrine).Asingledose(0.3ml)contains0.15mg(150microgram)adrenaline

(Epinephrine).

Excipient:SodiumMetabisulphite.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Solutionforinjection.

Clearandcolourlesssolutioninapre-filledpen(Auto-injector).

4CLINICALPARTICULARS

4.1TherapeuticIndications

TheAuto-Injectorsareindicatedintheemergencytreatmentofasevereanaphylacticshockorallergicreactionto

allergense.g.insectstingsorbites,foodsordrugs.

4.2Posologyandmethodofadministration

Usualpaediatricdoseforallergicemergenciesis0.15mgadrenalineforintramuscularusedependinguponthebody

weightofthepatient(0.01mg/kgbodyweight).However,theprescribingphysicianhastheoptionofprescribingmore

orlessthantheseamountsbasedoncarefulassessmentofeachindividualpatientandrecognisingthelife-threatening

natureofreactionsforwhichthisisbeingprescribed.Thephysicianshouldconsiderusingotherformsofinjectable

adrenalineiflowerdosesarefelttobenecessaryforsmallchildren.

Intheabsenceofclinicalimprovementorifdeteriorationoccursaftertheinitialtreatment,asecondinjectionwithan

additionalEpiPenJuniorAuto-Injectormaybenecessary.Therepeatedinjectionmaybeadministeredafterabout5–

15minutes.

Thepatientmustconsultaphysicianafterinjectioninordertohaverelevantactionstakenforfurtherevaluationand/or

treatment.

4.3Contraindications

TherearenoknownabsolutecontraindicationstotheuseofEpiPenJuniorduringanallergicemergency.

4.4Specialwarningsandprecautionsforuse

Adrenalineisordinarilyadministeredwithextremecautiontopatientswhohaveaheartdisease.Adrenalineshould

onlybeprescribedtothosepatients,butalsothosesufferingfromdiabetes,hyperthyroidism,hypertensionandelderly

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 06/07/2010 CRN 2079103 page number: 2

Accidentalinjectionintohandsorfeetresultinginperipheralischaemiahasbeenreported.Patientsmayneedtreatment

followingtheaccidentalinjection.

EpiPenJuniorcontainssodiummetabisulphitewhichmayrarelycauseseverehypersensitivityreactionsincluding

anaphylacticsymptomsandbronchospasminsusceptiblepeople,especiallythosewithahistoryofasthma.Patients

withtheseconditionsmustbecare-fullyinstructedinregardtothecircumstancesunderwhichEpipenJuniorshouldbe

used.

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

Notrelevant.

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

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 06/07/2010 CRN 2079103 page number: 3

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Cardiacstimulantsexcl.cardiacglycosides.

ATC-code: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

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 06/07/2010 CRN 2079103 page number: 4

byexpirationdate.TheexpirydateisindicatedonthelabelandtheAuto-Injectorshouldnotbeusedafterthisdate.

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-Injectorcontains2mlofadrenalineinjection0.5mg/mlwhichisdesignedtodeliverasingledose

(0.3ml)of0.15mgadrenalinewhenactivated.AfteractivationoftheAuto-Injector1.7mlremainsintheAuto-

Injector.

Donotremovegreysafetycapuntilreadyforuse.

UndernocircumstancesplacetheblackendoftheEpiPenAuto-Injectoronornearyourthumbs,fingersorhands.

Accidentalinjectionintohandsorfingersresultinginperipheralischaemiahasbeenreported.Seesection4.4,special

warningsandprecuationforuse.TheEpiPenAuto-Injectorshouldbeusedontheouterthigh.Theinjectionisactivated

immediatelytheblackendoftheEpiPenAuto-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.

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 06/07/2010 CRN 2079103 page number: 5

AsmallairbubblemayoccurintheEpiPenAuto-Injector.Ithasnoinfluenceoneithertheuseortheefficacyofthe

product.

Instructionforuseisenclosedinthepackage.

7MARKETINGAUTHORISATIONHOLDER

ALK-AbellóA/S

BøgeAllé6-8

2970Hørsholm

Denmark

8MARKETINGAUTHORISATIONNUMBER

PA1255/002/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:22September2006

Dateoflastrenewal: 25October2006

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

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