ANAPEN

Main information

  • Trade name:
  • ANAPEN Solution for Injection 500 Microgram
  • Dosage:
  • 500 Microgram
  • Pharmaceutical form:
  • Solution for Injection
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ANAPEN Solution for Injection 500 Microgram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1072/001/003
  • Authorization date:
  • 05-08-2011
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Anapen500microgramsin0.3mlsolutionforinjectioninapre-filledsyringe

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmililitrecontains1.7mgofadrenaline(epinephrine)

Onedoseof0.3mlcontains500microgramsofadrenaline(epinephrine)

Excipients:sodiummetabisulphite(E223),sodiumchloride

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Solutionforinjection

Clearcolourlesssolutionpracticallyfreefromparticles.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Emergencytreatmentforacuteallergicreactions(anaphylaxis)causedbypeanutsorotherfoods,drugs,insectbitesor

stings,andotherallergensaswellasexercise-inducedoridiopathicanaphylaxis.

4.2Posologyandmethodofadministration

Useonlybytheintramuscularroute.

Anapenconsistsofapre-filledsyringeofadrenaline(epinephrine)containedinanauto-injectiondevice.Thewholeis

referredtoasanauto-injector.

OneAnapeninjectionshouldbeadministeredintramuscularlyimmediatelyontheappearanceofthesignsand

symptomsofanaphylactisshock.Thesemayoccurwithinminutesofexposuretotheallergenandaremostcommonly

manifestedbyurticaria,flushingorangioedema;moreseverereactionsinvolvethecirculatoryandrespiratorysystems.

InjectAnapenonlyintotheanterolateralaspectofthethigh,notthebuttock.Theinjectedareamaybelightlymassaged

for10secondsfollowinginjection.

Theeffectivedoseistypicallyintherange0.005-0.01mg/kgbuthigherdosesmaybenecessaryinsomecases.

Useinadults:Theusualdoseis300micrograms.LargeradultsmayrequireAnapen500microgramstoreversethe

effectofanallergicreaction.Insomecircumstancesasingledoseofadrenaline(epinephrine)maynotcompletely

reversetheeffectsofanacuteallergicreactionandforsuchpatientsarepeatinjectionmaybegivenafter10-15

minutes.

Useinchildren:Anapen500microgramsisnotrecommendedforuseinchildren.

Anapenauto-injectorisintendedforimmediateselfadministrationbyapersonwithahistoryofanaphylaxisandis

designedtodeliverasingledoseof500micrograms(0.3ml)adrenaline(epinephrine).Forstabilityreasons0.75mlis

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4.3Contraindications

Hypersensitivitytoadrenaline(epinephrine)ortoanyoftheexcipients(seesection4.4forfurtherinformationon

sulphites)

4.4Specialwarningsandprecautionsforuse

Anapencontainssodiummetabisulphitewhichcancauseallergic-typereactionsincludinganaphylacticsymptomsand

bronchospasminsusceptiblepeople,especiallythosewithahistoryofasthma.Patientswiththeseconditionsmustbe

carefullyinstructedinregardtothecircumstancesunderwhichAnapenshouldbeused.

AllpatientswhoareprescribedAnapenshouldbethoroughlyinstructedtounderstandtheindicationsforuseandthe

correctmethodofadministration.Anapenisindicatedasemergencysupportivetherapyonlyandpatientsshouldbe

advisedtoseekimmediatemedicalattentionfollowingadministration.

Usewithcautioninpatientswithheartdiseasee.g.coronaryheartandcardiacmusclediseases(anginamaybe

induced),corpulmonale,cardiacarrythmiasortachycardia.Thereisariskofadversereactionsfollowingadrenaline

(epinephrine)administrationinpatientswithhyperthyriodism,cardiovasculardisease(severeanginapectoris,

obstructivecardiomyopathyandventriculararrhythmiaandhypertension),phaeochromocytoma,highintraocular

pressure,severerenalimpairment,prostaticadenomaleadingtoresidualurine,hypercalcemia,hypokalemia,diabetes

orinelderlyorpregnantpatients.Repeatedlocalinjectioncanresultinnecrosisatsitesofinjectionfromvascular

constriction.Accidentalintravascularinjectionmayresultincerebralhaemorrhageduetoasuddenriseinblood

pressure.Accidentalinjectionintohandsorfeetmaycauselossofbloodflowtoadjacentareasduetovasoconstriction.

Thismedicinalproductcontainslessthan1mmolsodium(23mg)perdose.i.e.essentiallysodiumfree.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Theeffectsofadrenaline(epinephrine)maybepotentiatedbytricyclicantidepressantsmixednoradrenargic-

serotoninergicantidepressantslikevenlafaxine,sibutramineormilnacipranandmonoamineoxidaseinhibitors(sudden

bloodpressureincreaseandpossiblecardiacarrhythmia).

COMTblockingagent,thyroidhormones,theophylline,oxytocin,parasympatholytics,certainantihistamines

(diphenydramine,chlorpheniramine),levodopaandalcohol.

Severehypertensionandbradycardiamayoccurwhenadrenaline(epinephrine)isadministeredwithnon-selectivebeta-

blockingmedicinalproducts.Concurrenttherapywithsympathomimeticsmaypotentiatetheeffectsofadrenaline

(epinephrine).

UseAnapenwithcautioninpatientsreceivingmedicinalproductswhichmaysensitisethehearttoarrhythmias,e.g.

digitalis,quinidine,halogenatedanaesthetics.

Thepressoreffectsofadrenaline(epinephrine)maybecounteractedbyadministrationofrapidlyactingvasodilatorsor

alphaadrenergicblockingmedicinalproducts.Anti-anaphylacticeffectscanbeantagonisedbybeta-blockingagents,

especiallynon-selectivebetablockers.

Adrenaline(epinephrine)inhibitsinsulinsecretionanddiabeticspatientsmayrequireupwardadjustmentoftheir

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4.6Fertility,pregnancyandlactation

Therearenoadequateorwellcontrolledstudiesofadrenaline(epinephrine)inpregnantwomen.Adrenaline

(epinephrine)shouldonlybeusedinpregnancyifthepotentialbenefitjustifiesthepotentialrisktothefoetus.

Adrenaline(epinephrine)maydramaticallyreduceplacentalbloodflow,althoughanaphylacticshockwilldothistoo.

Adrenaline(epinephrine)isnotorallybioavailable;anyadrenaline(epinephrine)excretedinbreastmilkwouldnotbe

expectedtohaveanyeffectonthenursinginfant.

4.7Effectsonabilitytodriveandusemachines

Itisnotrecommendedthatpatientsshoulddriveorusemachinesfollowingadministrationofadrenaline(epinephrine),

sincepatientswillbeaffectedbysymptomsoftheanaphylacticshock.

4.8Undesirableeffects

Theoccurenceofundesirableeffectsdependsonthesensitivityoftheindividualpatientandthedoseapplied.

Commonadversereactionsevenatlowdosesduetoadrenaline(epinephrine)includepalpitations,tachycardia,

sweating,nausea,vomiting,respiratorydifficulty,pallor,dizziness,weakness,tremor,headache,apprehension,

nervousness,anxiety,coldnessofextremities.

Lessfrequentlyreportedeffectsincludehallucinations,syncopes,hyperglycaemia,hypokalaemia,metabolicacidosis,

mydriasis,difficultyinmicturitionwithurinaryretention,muscletremor.

Adversereactionswhichoccurathigherdosesorinsusceptibleindividualsarecardiacarrhythmias(ventricular

fibrillation/cardiacarrest),suddenriseofbloodpressure(sometimesleadingtocerebralhaemorrhage),aswellas

vasoconstriction(e.g.intheskin,mucoustissuesandkidneys)

Anapencontainsasulphitethatmaycauseallergic-typereactionsincludinganaphylacticreactionsorlife-threateningor

lesssevereasthmaticepisodesincertainsusceptiblepatients.

4.9Overdose

Overdoseoraccidentalintravascularinjectionofadrenaline(epinephrine)maycausecerebralhaemorrhagefroma

suddenriseofbloodpressure.Deathmayresultfromacutepulmonaryoedemaarisingfromperipheralvascular

constrictionandcardiacstimulation.

Thepressoreffectsofadrenaline(epinephrine)maybecounteractedbyrapidlyactingvasodilatorsoralphaadrenergic

blockingmedicinalproducts.Shouldprolongedhypotensionfollowsuchmeasures,itmaybenecessarytoadminister

anotherpressormedicinalproduct,suchasnoradrenaline.

Acutepulmonaryoedemawithrespiratoryembarrassmentfollowingadrenaline(epinephrine)overdoseshouldbe

managedbyadministrationofarapidlyactingalphaadrenergicblockingmedicinalproductsuchasphentolamine

and/orwithintermittentpositivepressurerespiration.

Adrenaline(epinephrine)overdosemayalsoresultintransientbradycardiafollowedbytachycardia;thesecanbe

followedbypotentiallyfatalcardiacarrhythmiaswhichmaybetreatedbybetaadrenergicblockingmedicinalproducts.

Thesemustbeprecededoraccompaniedbyanalpha-adrenergicblockertocontrolthealpha-mediatedeffectsonthe

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5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:adrenergicanddopaminergicagents,adrenaline(epinephrine)

ATCcode:C01CA24

Adrenaline(epinephrine)isanaturallyoccuringcatecholaminesecretedbytheadrenalmedullainresponsetoexertion

orstress.Itisasympathomimeticaminewhichisapotentstimulantofbothalphaandbetaadrenergicreceptorsandits

effectsontargetorgansare,therefore,complex.Itisthemedicinalproductofchoicetoproviderapidreliefof

hypersensitivityreactionstoallergiesortoidiopathicorexerciseinducedanaphylaxis.

Adrenaline(epinephrine)hasastrongvasoconstrictoractionthroughalphaadrenergicstimulation.Thisactivity

counteractsthevasodilationandincreasedvascularpermeabilityleadingtolossofintravascularfluidandsubsequent

hypotension,whicharethemajorpharmacotoxicologicalfeaturesinanaphylactisshock.Throughitsstimulationof

bronchialbetaadrenergicreceptors,adrenaline(epinephrine)hasapowerfulbronchodilatoractionwhichalleviates

wheezinganddyspnoea.Adrenaline(epinephrine)alsoalleviatespruritus,urticariaandangioedemaassociatedwith

anaphylaxis.

5.2Pharmacokineticproperties

Adrenaline(epinephrine)israpidlyinactivatedinthebody,mostlyintheliverbytheenzymesCOMTandMAO.Much

ofadoseofadrenaline(epinephrine)isexcretedasmetabolitesinurine.Theplasmahalflifeisabout2-3minutes.

However,whengivenbysubcutaneousorintramuscularinjection,localvasoconstrictionmaydelayabsorptionsothat

theeffectsmaylastlongerthanthehalflifesuggests.

5.3Preclinicalsafetydata

Adrenaline(epinephrine)hasbeenwidelyusedintheclinicalmanagementofallergicemergenciesformanyyears.

Therearenopre-clinicaldataofrelevancetotheprescriberwhichareadditionaltothatalreadyincludedinother

sectionsoftheSPC.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Sodiumchloride

Sodiummetabisulphite(E223)

Hydrochloricacid(forpHadjustment)

Waterforinjections.

6.2Incompatibilities

Intheabsenceofcompatibilitystudies,thismedicinalproductmustnotbemixedwithothermedicinalproduct.

6.3Shelflife

2years

6.4Specialprecautionsforstorage

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6.5Natureandcontentsofcontainer

Anapenconsistsofaprefilledsyringecontainedinasingleuseauto-injectiondevice

Thesyringecontainsadrenaline(epinephrine)solution.Theauto-injectiondevicedelivers0.3mlofthissolution.

Theimmediatecontainerisaglasssyringesealedbyarubberplungeratoneend,andattheotherendbyarubber

needleshield.

Syringe

BD(BectonDickinson)borosilicateglasstype1,27G1/2”

Plunger

BD(BectonDickinson)blackchlorobutylrubberPH701/50

Inapacksizeof1

6.6Specialprecautionsfordisposalandotherhandling

Instructionsforuse

A.PartsoftheAnapenAutoinjector:

BeforeusingtheAnapenAuto-Injector,thepatientneedstoknowaboutthepartsoftheAuto-Injector.Theseareshown

inthepicture.

Rotatingcoveroversolutionwindow:Thepatientrotatesthecoveroverthesolutionwindowstolineupthe

lenseswiththesolutionwindowsontheautoinjectorbody.

Solutionwindow:Thepatientlooksthroughthelensintothiswindowbeforetheinjectiontocheckthatthe

solutionisclearandreadytouse.

Injectionindicator:Beforetheinjection,thepatientcanseeawhiteplasticplungerthroughthewindow.This

meansthattheAnapenAuto-Injectorhasnotbeenfiredbymistakeortamperedwith.Aftertheinjection,the

injectionindicatorturnsred.ThisindicatesthattheAnapenAuto-Injectorhasbeenfiredcorrectly.

Blackneedleshield(reversible):ThisprotectstheneedlewhenthepatientisnotusingtheAnapenAuto-

Injector.Thepatientpullstheneedleshieldoffbeforetheinjection.Aftertheinjection,thepatientturnstheblack

needleshieldaroundandputsitbackontothesameendofAnapenAuto-Injector,tocovertheneedle.

Greysafetycap:Thiscoverstheredfiringbutton.Itstopsthebuttonfrombeingpushedbymistake.

ThepatientmustnotremovetheblackneedleshieldorthegreysafetycapuntiltheyneedtousetheAnapen

Auto-Injector.

B.CheckingtheAnapenAuto-Injector

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C.UsingtheAnapenAuto-Injector

Iftheblackneedleshieldhasbeenremoved,thepatientmustnotputtheirthumb,fingersorhandovertheopenend

(needleend)oftheAnapenAuto-Injector.

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Seekmedicaladvice.GiveusedAnapentothehospitalorpharmacistforproperdisposal.

7MARKETINGAUTHORISATIONHOLDER

LincolnMedicalLtd

Unit8WiltonBusinessCentre

Wilton

Salisbury

SP20AH

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA1072/001/003

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:5August2011

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