Alustal Fat Hen Pollen Extract

Main information

  • Trade name:
  • Alustal Fat Hen Pollen Extract 10 IC/mL Solution for injection
  • Dosage:
  • 10 IC/mL
  • Pharmaceutical form:
  • Solution for injection
  • Units in package:
  • Vial, glass, multi-dose, 11mL (5mL fill volume), 5 mL
  • Class:
  • Prescription
  • Prescription type:
  • Prescription
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • Stallergenes

Documents

Localization

  • Available in:
  • Alustal Fat Hen Pollen Extract 10 IC/mL Solution for injection
    New Zealand
  • Language:
  • English

Other information

Status

  • Source:
  • Medsafe - Medicines Safety Authority - New Zealand
  • Authorization number:
  • 10829
  • Authorization date:
  • 28-05-2002
  • Last update:
  • 27-09-2017

Summary of Product characteristics: dosage,interactions,side effects

ALUSTAL–SINGLEALLERGENS

ALUSTAL–DISPENSEDMIXTURES

ImportantNote

Careshouldalwaysbetakentoensurethatthecorrectdosagescheduleisused.

NameoftheMedicine

ArangeofvariousALUSTALallergenextractsareregisteredinNewZealandeither

asasingleallergenextractorcombinationallergenextracts.Theseincludemite

extracts,pollenextractsandanimalextracts.

Description

ALUSTALispreparedfromfreeze-driedallergenextractsadsorbedontoaluminium

hydroxidegel.Thefreeze-driedallergenextractsarepreparedbyammonium

bicarbonateextractionoftheallergensourcematerialse.g.pollen,mites.Specific

allergen(s)areselectedbythephysicianforSpecificImmunotherapyTreatment(SIT)

fortheindividualpatient.

Each5mLvialcontainsspecificallergenextract(s)insuspensionandareavailablein

variousconcentrations.Differentconcentrationsareidentifiedbydifferentcoloured

capsonthevials.

Yellowcap:0.1IR/mL or 0.1IC/mL

Greencap: 1.0IR/mL or 1.0IC/mL

Bluecap: 10.0IR/mL or 10.0IC/mL

IR(IndexofReactivity):Anallergenextractissaidtohaveatitreof100IR/mLifin

aprick-testperformedusingaStallerpoint in30subjectssensitisedtotheallergen

inquestion,itproducesawhealmeasuring7mmindiameter(geometricmean).Skin

reactivityinthesesubjectsissimultaneouslydemonstratedbyapositiveresponseto

aprick-testwithcodeinephosphate9%orhistaminedihydrochloride10mg/mL.

IC(IndexofConcentration):AnallergenextracthasanIndexofConcentrationof

100IC/mLwhenitsmanufacturingparametersleadtothesamedilutionratioas

thoseofstandardizedextractsat100IR/mLfromthesamefamily,takenasa

reference.

Whenthefamilydoesnotcontainanystandardizedreferenceextract,thevalue100

IC/mLcorrespondstoanextractwherethedilutionratioisestablishedaccordingto

medicalexperience.

FurtherInformation:

Otheringredientsincludealuminiumhydroxide,sodiumchloride,phenol,mannitol

andwaterforinjection.

Pharmacology

PrescriptionOnlyMedicine

Pharmacotherapeuticgroup:V(various);C1Allergy(desensitization);P1Allergens

andAntigens.

ATCclassification:V01

Actions:TheprecisemechanismofSITisnotknown.

Pharmacodynamics:Thefollowingbiologicalchangeshavebeendemonstrated:

appearanceofspecificantibodies(IgG)whichactasblockingantibodies

reductionofspecificplasmaIgElevelsinsomecases

changeinthebehaviourofcellsinvolvedinallergicreaction

favourablechangeinTH2andTH1lymphocyteactivities,leadingtothe

production ofcytokines(decreaseinIL-4andincreaseinIFN )thatregulate

IgEproduction.

AtthesametimeSpecificImmunotherapystimulatesanimmuneresponsewhichis

maintainedoverlongperiodsbyimmunologicalmemory .

SITactsdirectlyuponthepatient’simmunesystem,providinglasting

hyposensitisationandpreventingprogressionoftheallergytomoresevereforms.

SITismoreeffectiveiftreatmentisinitiatedatanearlyage.Thus,inchildrenSIT

maybestartedfromtheageof5years.Itshouldbeadministeredtochildrenor

youngadultsassoonasitisjustifiedbytheseverityoftheallergicsymptoms.When

immunotherapyiscontemplatedforveryyoungchildren,consultationwithaspecialist

paediatricimmunologist/allergistisessential.Thephysicianwhoadministersthe

injectionsshouldbeabletotreatasystemicreactionappropriately.Inadultsaged

over50years,SITremainsindicatedincasesofrecentsensitisation.

Indications

ALUSTALtreatmentisindicatedforpatientswithType1allergy(GellandCoombs

classification),particularlypresentingasseasonalorperennialrhinitis,conjunctivitis,

rhinoconjunctivitiswithorwithoutassociatedasthma.

Contraindications

DonotgiveSITtopatientswithunstableasthma,severeimmunodeficiency,

malignantdisease,orautoimmunedisease.SITiscontraindicatedforpatientson

treatmentwithbeta-blockers.AnyinjectionsincludingSITshouldbeavoidedin

patientswithableedingtendency.

ItisnotadvisabletouseSITduringpregnancy:pregnancyisnotconsideredasa

contraindicationtothecontinuationofimmunotherapybuttreatmentshouldnotbe

startedduringpregnancy.Ifapatientbecomespregnantduringinitialtreatment,stop

injections;ifapatientbecomespregnantduringmaintenancetherapy,treatmentmay

continueifwelltolerated.Thereisnodataavailableontheexcretionofallergen

extractsinhumanmilkoranyeffectonbreast-fedinfants.

ClinicalTrials

Inaclinicaltrial,threepatientsatthemaintenancedosageofbeevenom(100

microgrampervenom)showednosystemicreactionfollowinganinsectsting

challenge.Theremainingtenpatientswerenotchallenged.Thepatientsin

thisstudyreachedmaintenance(100microgrampervenom)usuallywithin

21/2to31/2monthsafterbeginningtherapy.Whetherefficacyoftherapyis

influencedbythetimerequiredtoreachmaintenancehasnotyetbeen

determined.

Precautions

BeforestartingSIT,patientsshouldhavetheirsymptomscontrolled,ifnecessaryby

administrationofadequatesymptomatictreatment.

1.Immunotherapyshouldonlybeadministeredbytrainedpersonnelfamiliar

withtherecognitionofearlysignsofallergicreactionsandcompetentinthe

managementofsystemicreactions.Amedicalpractitionershouldalwaysbe

onthepremiseswhereimmunotherapyisadministered.BeforegivinganSIT

injection,thepractitionershouldensurethatanemergencykitisimmediately

available,containingaqueousepinephrinehydrochloride(adrenaline)1:1000,

equipmentforadministeringoxygen,equipmentforadministeringintravenous

fluids,oralairway,aninjectablecorticosteroid,aninjectableantihistamine,

vasopressor,stethoscopeandsphygmomanometer,tourniquets,syringes,

hypodermicandlarge-boreneedles.

2.SHAKEVIALGENTLYBEFOREWITHDRAWINGDOSE

3.Properasepticprecautionsshouldbetakenduringwithdrawalofdose

includingswabbingofbungswithasuitableantiseptic.

4.Theinjectionshouldbepostponedifthepatienthasacold,influenza,or

febrileillness.

5.Absoluteaccuracyofdosageisessential.Double-checkboththevialstrength

andamountdrawnupeverytime.

6.Injectslowlyusingdeepsubcutaneousroute.Alwayspullbacksyringe

plungerbeforeinjectingtoensureneedleisnotinabloodvessel.DONOT

INJECTINTOABLOODVESSELORINTRAMUSCULARLY.

7.PATIENTSSHOULDBEKEPTUNDERMEDICALOBSERVATIONFORAT

LEAST30MINUTESAFTERTREATMENT.

Themajorityofseriousreactionswillbeginwithin30minutesafteran

injection.Patientsmustbeinstructedtoavoidanyactivitythatmayincrease

bloodflowthroughtheinjectionsitee.g.strenuousexercise,hotbaths,sauna,

applicationoflocalheatorrubbing,fortheremainderoftheday.Patients

shouldbeinstructedtoseekmedicaladviceimmediatelyifsymptomsdevelop

afterleavingtheclinic.Themorerapidlysymptomsbegin,themoresevere

theyarelikelytobeandthemorerapidlytreatmentmeasuresshouldbegin.

8.SpecialcareshouldbetakeninthetreatmentofpatientswithASTHMAas

theymaybemoresusceptibletosevereadversereactions.Patientswith

asthmamustbesupervisedbyaspecialistwithexpertiseandexperiencewith

theadministrationofimmunotherapytothosewithasthma.Before

consideringimmunotherapyforpatientswithasthma,establishserialbaseline

lungfunctionvalues.Iftherehasbeenarecentexacerbationofasthma,as

assessedclinicallyand/orbymeasurementofPeakExpiratoryFlowRate

(PEFR),treatmentshouldbehaltedandrestartedaftersymptomatic

improvement.

9.Inmanypatientswithasthmalungfunctionisworstinthemorningand

thereforeinsuchpatientsitmaybepreferabletogivetheinjectioninthe

afternoon.

10.Riskofaccumulationofaluminiumfromaluminiumhydroxidepreparations(as

foranyaluminiumhydroxidevaccine)intotissues(centralnervoussystem,

bones)shouldbekeptinmind,especiallyincaseofrenalinsufficiency.

Alwaysaskthepatientandrecordanylocalorsystemicreactionthatoccurredafter

leavingtheclinicafterthepreviousinjection.Ifnecessary,adjustthedoseofthenext

injectionappropriately.

Interactions:Nodruginteractionshaveeverbeendescribed.

Alustalispresumedtobeunlikelytoproduceaneffectontheabilitytodriveoruse

machinery.

AdverseEffects

Adverseeffects-PostMarketingexperience

SystemOrganClass(SOC) Frequency Sideeffects

Respiratory,thoracicandmediastinal

disorders Common Dyspnea,asthma,

Rhinitis,laryngealoedema

Skin and subcutaneous tissues

disorders

Skin and subcutaneous tissues

disordersNEC Common

Veryrare Pruritus, urticaria, facial

erythema,angioedema

Pre-existingatopiceczema

outbreaks

Injectionsite Common Localreaction

Immunesystemdisorders Uncommon Anaphylacticshock

Eyedisorders Uncommon Conjunctivitis

Musculoskeletaldisorders Veryrare Myalgia within serum

sicknesslikesyndrome

GeneraldisordersNEC Veryrare Headache,asthenia

Adverseeffects–ClinicalTrialExperience

SystemOrganClass(SOC) Frequency Sideeffects

Respiratory,thoracicandmediastinal

disorders Common Asthma, bronchospasm,

rhinitis

Skin and subcutaneous tissues

disorders Common Rash,urticaria

Injectionsite Common Injectionsitereactions

EyeDisorders Uncommon conjunctivitis

Aswithallformsofhyposensitisationtherapy,localand/orsystemicreactionsmay

occur.InjectionsofALUSTALmaybeassociatedwithsomeitchingandrednessat

theinjectionsite.Prolongedpain,orpainradiatingupthearmisusuallytheresultof

intramuscularinjection.Thetolerateddoseisnotnecessarilyconstant,butmayvary

overtime,dependingontheindividual’sspecificreactivityandenvironment.

Managementofadversereactions:

LocalReactions:SkinreactionsduetoAluminiumHydroxidehavebeenreported.

Someregressspontaneously,whileothers,muchmorerarely,canprogresstothe

formationofsubcutaneousnodules.Localreactions(>2to3cmindiameter)with

erythema,oedemaandpruritusarerelativelycommon,anddonotinvariably

necessitatemodificationofthetreatmentschedule.However,theymaystillactasa

reminderthatcautionisrequired.

Amajorlocalreaction( 5cmindiameter)shouldbetreatedwithanoral

antihistamine.Supervisionofthepatientshouldbeextended,reducethenextdose

tothatpreviouslytolerated.Ifnecessary,increasethesubsequentdosesbysmaller

increments.Anotherdoseshouldneverbegivenuntilalllocalreactionresultingfrom

thepreviousdosehasdisappeared.

DISCONTINUEINJECTIONSIFREACTIONSIZEINCREASES.

OtherReactions:

Immediate-typereactions:

-Apatientexperiencingasthmaafteraninjectionmustbeobserveduntilstable.

-Ifanasthmaattackoccursafteraninjection,bronchodilatorsmustbeused,if

necessarytogetherwithaparenteralcorticosteroid.

-Systemicreactions(pruritus,gianturticariaorangioedema)shouldbetreatedby

intramuscularinjectionof0.5to1mLof1/1000epinephrine(adrenaline),if

necessarytogetherwithanintravenouscorticosteroid.Inviewofthepossibilityof

progressiontoshock,intensiveandprolongedmonitoringinahospitalsettingis

required.

-Laryngealdyspnoeashouldalsobetreatedwithintramuscularinjectionof

epinephrine(adrenaline),admissiontohospitalisadvisable.

-Incaseofanaphylacticshock,thetreatmentshouldbeadministeredasinan

emergencyandthepatientshouldbeadmittedtoaspecialisedunit(seeAnaphylaxis

sectionbelow).

SevereDelayedreactions:

-Aserumsicknesstypeofreactionmayoccur,witharthralgia,myalgia,urticarial

rashes,nausea,lymphadenopathy,andfever.Thisisextremelyrare;howeverSIT

shouldbediscontinuedifanyoftheseoccur.

Anaphylaxis

Anaphylacticshockconsistsofsomeofthefollowing:widespreadurticaria,angio-

oedemaofthefaceandglottis,pallor,cough,wheezing,bronchospasm,faintness

andhypotension,bradycardia,hyperemesis,shock.

Laypatientflatandelevatethelegs.Treatimmediately.

Give0.5mL1/1000epinephrine(adrenaline)intramuscularly,neartheinjection

siteatonce.Ifnecessary,repeat1/1000epinephrine(adrenaline)

intramuscularlyat3-5minuteintervalstoamaximumof2.0mLin15minutes.

Ensuremaintenanceofadequateairway.

Giveantihistamine.

Ifnecessaryusefullsupportivemeasuressuchas,intravenoussalineor

plasmaexpandersforhypotension,oxygen,externalcardiacmassage.

Ifbronchospasmissevere,IsoprenalineSulphateorSalbutamolInhalermay

alsobeusedandifnecessary10-20mLofAminophyllineInjectionB.P.byslow

intravenousinjectionatarateof2mLperminute.

viii Aparenteralsteroidsuchas200-600mgHydrocortisoneInjectionB.P.,

intravenously,mayhelptopreventpersistentbronchospasm.

Patientsexperiencingananaphylaxisreactionshouldbeadmittedtohospital

forclosemonitoringforatleast24hours.

STOPTREATMENTINPATIENTSWITHSEVEREREACTIONS

DosageandAdministration

Treatmentisgivenintwophases:

Initialtreatmentatescalatingdosage(weeklyinjections);

Maintenancetreatmentatconstantdosage(monthlyinjections)

Beforeeachinjection:

Theexpirydateonthevialshouldbechecked;

Itshouldbeconfirmedthatthevialtobeusedisthesameasthatprescribed

(composition,patient’sname,concentration).Thevialshouldbeshaken

gentlybeforethequantitytobeinjectediswithdrawn

Thenormalrulesofasepsisshouldbeobserved.

Disposable1mL“tuberculin”syringeswith1/100graduationsshouldbeused;

Theinjectionshouldbepreciselytherequireddose.

Thedosageforchildrenisthesameasforadults.Becauseofthesmallersizeof

childrenlargervolumesofsolutionmayproduceexcessivediscomfort.Thereforein

ordertoachievethetotaldoserequired,thevolumeofthedosemayneedtobe

dividedintomorethanoneinjection.

Dosagedoesnotvarywithage,butmustbeadjustedtothereactivityofthe

individualpatient.

1. InitialTreatment:EscalationofDosage.Theproductisinjectedexclusively

bythedeepsubcutaneousroute,atprogressivelyescalatingdosage,atarateofone

injectionperweekuptothemaximumtolerated,accordingtothefollowingtreatment

schedule:

Week Injection Vial(concentration) Volume Frequency

0.1IR/mLor

0.1IC/mL

(Yellowcap) 0.10

0.20

0.40

0.80 1 injection per

week

1IR/mLor

1IC/mL

(Greencap) 0.10

0.20

0.40

0.80 1 injection per

week

10IR/mLor

10IC/mL

(Bluecap) 0.10

0.20

0.40

0.60

0.80

0.80

0.80

0.80 1 injection per

week

(First

monthly

dose) Maintenance

Therapy 10IR/mLor

10IC/mL

(Bluecap) Maximum

tolerated

dose Every2weeks,

thenmonthlyorat

longer intervals

notexceeding

6weeks

ImportantNote:Thistreatmentscheduleisaguidelineonly.Itmustbe

modifieddependingonthepatient’sconditionandanyreactionsthatoccur.

Ideally,SITwithPollenallergensshouldbeginbeforepollenseason.

2. MaintenanceTreatment:Constantdose.[Maintenance–1vial10IR/mL

orIC/mL(Bluecap)]Thehighesttolerateddose(Max.0.8mL)intheinitial

treatmentcourseisthenrepeatedatintervaloftwoweeks,thenmonthlyorat

longerintervals,notexceeding6weeksbetweensuccessiveinjections.Ifthe

intervalislonger,thedoseshouldbereadjusted.Itshouldberemembered

thattheabovetreatmentscheduleisaguidelineonly.Itmustbemodified

dependingonthepatient’sconditionandanyreactionsthatoccur.When

changingvialsforapatientonmaintenancetherapy,thefirstdoseofthe

newvialshouldbe50%ofthelastdose(i.e.,lastdosegivenat0.8mLof10.0

IR/mL,newvialdoseshouldbe0.4mLof10.0IR/mL;thenfollowedbyregular

monthlydosesof0.8mL).ForPollenallergens,itmaybenecessaryto

reducethemaintenancedosagebyhalfduringpollenseasonbutonlyif

reactionsoccur.

ImportantNote:Administermaintenancetherapyonlyaftertreatmentwith

theinitialallergensethasbeencompletedandwithin6weeksoftheprevious

finaldose.

Durationoftreatment:Asageneralrule,SITwithALUSTALshouldbe

continuedforbetween3and5years.

Overdosage

SeeabovePrecautions

PresentationandStorageConditions

Initialtreatmentset:3vials,eachvialcontainingeither0.1,1.0and10.0IR/mLor

IC/mL.

Maintenance:asinglevialcontaining10.0IR/mLorIC/mL.

AvailableConcentrations:Vialcontaining5mLofsuspension.

Yellowcap: 0.1IR/mLor0.1IC/mL

Greencap: 1.0IR/mLor1.0IC/mL

Bluecap: 10.0IR/mLor10.0IC/mL

Specialprecautions:

Storeat2–8 o C(Refrigerate.DoNotFreeze)

Thevialmaybestoredforupto6monthsopened.Donotuseaftertheexpirydate.

NameandAddressofSponsor:

EbosGroupLtd

324CashelStreet

Christchurch

NewZealand

Version2.2

DateofDatasheetpreparation:10January2012

ALUSTALALLERGENEXTRACTAVAILABILITYINAUSTRALIAANDNEWZEALAND

REGISTRATION

NAME ACTIVEINGREDIENT AUSTRALIA

AUSTR NEW

ZEALAND

Mites

ALUSTALHouseDustMites

Extract DermatophagoidespteronyssinusandDermatophagoidesfarinae

bodyextracts AUSTR132680(M)

AUSTR132725(I) 

ALUSTAL European Dust

MiteExtract Dermatophagoidespteronyssinusbodyextract AUSTR132678(M)

AUSTR132723(I) TT50-6900a(I)

TT50-6900b(M)

ALUSTALAmerican Dust

MiteExtract Dermatophagoidesfarinaebodyextract) AUSTR132679(M)

AUSTR132724(I) TT50-6900/1a(I)

TT50-6900/1b(M)

Animals

ALUSTAL Cat Epithelia

Extract Felineepitheliumextract  TT50-6901a(I)

TT50-6901b(M)

ALUSTAL Dog Epithelia

Extract Canineepitheliumextract  TT50-6901/1a(I)

TT50-6901/1b(M)

ALUSTALHorseEpithelia

Extract Equineepitheliumextract  TT50-6901/2a(I)

TT50-6901/2b(M)

ALUSTAL Feathers Mix

Extract Chickenfeather/Duckfeather/Goosefeatherextract  TT50-6901/3a(I)

TT50-6901/3b(M)

Pollens

ALUSTAL Birch Pollen

Extract Betulaalbapollenextract  TT50-6902a(I)

TT50-6902b(M)

ALUSTALOleaceaePollen

MixExtract Fraxinusexcelsior/Oleaeuropaea/

Ligustrumvulgarepollenextracts  TT50-6902/1a(I)

TT50-6902/1b(M)

ALUSTALPlantain Pollen

Extract Plantagolanceolataextract AUSTR132838(M)

AUSTR132839(I) TT50-6902/3a(I)

TT50-6902/3b(M)

ALUSTALFatHenPollen

Extract Chenopodiumalbumextract  TT50-6902/4a(I)

TT50-6902/4b(M)

ALUSTAL Sorrel Pollen

Extract Rumexacetosapollenextract  TT50-6902/5a(I)

TT50-6902/5b(M)

ALUSTAL Wheat Pollen

Extract Triticumaestivumpollenextract AUSTR132836(M)

AUSTR132837(I) 

ALUSTALBermudaGrass

Extract Cynodondactylonpollenextract AUSTR132834(M)

AUSTR132835(I) 

ALUSTALRyeGrassExtract Loliumperennepollenextract AUSTR132843(M)

AUSTR132844(I) 

ALUSTALOliveTreeExtract Oleaeuropeapollenextract AUSTR132840(M)

AUSTR132841(I) 

ALUSTALExtractofThree

Grasses Dactylisglomerata/Loliumperenne/Phleumpratensepollen

extracts AUSTR132845(M)

AUSTR132846(I) 

ALUSTALExtractofFive

Grasses Dactylisglomerata/Poapratensis/Loliumperenne/

Anthoxanthumodoratum/Phleumpratensepollenextracts AUSTR132847(M)

AUSTR132848(I) TT50-6902/6a(I)

TT50-6902/6b(M)

ALUSTALExtractofTwelve

Grasses Agrostistenuis/CynodondactylonBromusinermis/Dactylis

glomerata/Festucaelatior/Poapratensis/Arrhenatherum

elatius/Loliumperenne/Anthoxantumodoratum/Phleum

pratense / Avenafatua/Holcuslatanuspollenextracts AUSTR132849(M)

AUSTR132850(I) 

PatientVerification

Thefollowingtablehasbeenprovidedtoallowthepatientandphysicianto

verifythatthevialspecificallyforthepatientisbeingusedattimeof

treatment.

Injection Date Vial

(concentration) Physician’s

Initial Patient’s

Initial

0.1IR/mLor

0.1IC/mL

(Yellowcap) 2

1IR/mLor

1IC/mL

(Greencap)

1IR/mLor 6

10IR/mLor

10IC/mL

Injection Date Vial

(concentration) Physician’s

Initial Patient’s

Initial

10IR/mLor

10IC/mL

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