Alustal Horse Epithelia Extract

Main information

  • Trade name:
  • Alustal Horse Epithelia 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 Horse Epithelia Extract 10 IC/mL Solution for injection
    New Zealand
  • Language:
  • English

Other information

Status

  • Source:
  • Medsafe - Medicines Safety Authority - New Zealand
  • Authorization number:
  • 10811
  • 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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Europe - EFSA - European Food Safety Authority Publications

10-11-2018

Outcome of the consultation with Member States and EFSA on the basic substance application for propolis extract (admissibility accepted when named water‐soluble extract of propolis) for use in plant protection as fungicide and bactericide

Outcome of the consultation with Member States and EFSA on the basic substance application for propolis extract (admissibility accepted when named water‐soluble extract of propolis) for use in plant protection as fungicide and bactericide

Published on: Fri, 09 Nov 2018 00:00:00 +0100 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the evaluation of applications received by the European Commission concerning basic substances. In this context, EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States and EFSA on the basic substance application for propolis extract are presented. The context of the evaluation ...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos (hop strobiles) when used as a sensory feed additive for all animal species. The additive is specified to containing 40% beta acids and less than 0.2% alpha acids. Known substances of conce...

Europe - EFSA - European Food Safety Authority Publications

14-9-2018

Peer review of the pesticide risk assessment of the active substance azadirachtin (Margosa extract)

Peer review of the pesticide risk assessment of the active substance azadirachtin (Margosa extract)

Published on: Thu, 13 Sep 2018 00:00:00 +0200 The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, Germany, for the pesticide active substance azadirachtin are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the additional representative use of azadir...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Update of the Xylella spp. host plant database

Update of the Xylella spp. host plant database

Published on: Mon, 10 Sep 2018 00:00:00 +0200 Following a request from the European Commission, EFSA periodically updates the database on the host plants of Xylella spp. While previous editions of the database (2015 and 2016) dealt with the species Xylella fastidiosa only, this database version addresses the whole genus Xylella, including therefore both species X. fastidiosa and Xylella taiwanensis. The database now includes information on host plants of Xylella spp. retrieved from scientific literature...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre

Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre

Published on: Tue, 28 Aug 2018 00:00:00 +0200 Botanicals and preparations derived from these are among the substances frequently added to foods and food supplements, yet the safety of many botanicals has not been systematically assessed. In the context of the EU‐FORA fellowship programme, the fellow performed an assessment on the safety of the botanical Gymnema sylvestre, in accordance with EFSA's guidance on the assessment of safety of botanicals. Although preparations of G. sylvestre are marketed as f...

Europe - EFSA - European Food Safety Authority Publications

13-6-2018

World Variety Produce, Inc. Voluntarily Recalls Spicy Edamame Because Of Undeclared Allergens

World Variety Produce, Inc. Voluntarily Recalls Spicy Edamame Because Of Undeclared Allergens

World Variety Produce, Inc. of Los Angeles, CA is voluntarily recalling Spicy Edamame 7oz, because it contains the undeclared shellfish/crustacean allergen “Oyster Extract” ingredient within the spicy sauce packet. People who have an allergy or severe sensitivity to shellfish run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

5-6-2018

Camellia sinensis (green tea) extract

Camellia sinensis (green tea) extract

Safety advisory - potential risk of harm to the liver

Therapeutic Goods Administration - Australia

1-6-2018

FDA Adverse Event Reporting System (FAERS): Latest Quarterly Data Files

FDA Adverse Event Reporting System (FAERS): Latest Quarterly Data Files

FDA Adverse Event Reporting System (FAERS) - Quarterly Data Extract (QDE): The Quarterly Data Extract files, contain raw data extracted from the FAERS database for the indicated time ranges (not cumulative), in ASCII or SGML formats.

FDA - U.S. Food and Drug Administration

23-5-2018

Ethanol Extraction Recalls Alcohol Product Because of Possible Health Risk

Ethanol Extraction Recalls Alcohol Product Because of Possible Health Risk

Lake Michigan Distilling Company, LLC of La Porte, Indiana, doing business as Ethanol Extraction, is recalling its 95% Ethyl Alcohol product (“Product”) because of possible contamination with methanol, a highly toxic type of alcohol that can cause serious and sometimes fatal damage if ingested by humans or animals.

FDA - U.S. Food and Drug Administration

8-5-2018

What to Know When Buying or Using a Breast Pump

What to Know When Buying or Using a Breast Pump

Breast pumps are medical devices regulated by the U.S. Food and Drug Administration. They can be used to extract milk, maintain or increase a woman's milk supply, and relieve engorged breasts (among other indications). But, to protect mothers and their babies, there are important safety considerations to know before using one.

FDA - U.S. Food and Drug Administration

30-4-2018

Stonewall Kitchen Voluntarily Recalls a Limited Amount of Basil Pesto Aioli due to Mislabeling and Undeclared Presence of the Dairy Allergen, Egg

Stonewall Kitchen Voluntarily Recalls a Limited Amount of Basil Pesto Aioli due to Mislabeling and Undeclared Presence of the Dairy Allergen, Egg

Stonewall Kitchen is voluntarily recalling a limited amount of 10.25oz Basil Pesto Aioli with an Enjoy By date of 28 Sep 2019 which may contain the undeclared allergen egg, as we may have inadvertently placed the label for our Basil Pesto on a small portion of our most recent production run.

FDA - U.S. Food and Drug Administration

27-4-2018

ANSES assesses the efficacy and safety of alternatives to antibiotics in animal husbandry and considers the need for a specific status for these products

ANSES assesses the efficacy and safety of alternatives to antibiotics in animal husbandry and considers the need for a specific status for these products

Today, the Agency is publishing an inventory of alternatives to antibiotics aimed at reducing their use in animal husbandry and based on an original method for evaluating the diverse scientific publications in the field. In its report, ANSES identifies numerous products and substances including compounds, plants, plant extracts and micro-organisms, which are used as alternatives to antibiotics. However, it emphasises the diversity of the data available to assess their safety and efficacy, and their abili...

France - Agence Nationale du Médicament Vétérinaire

12-4-2018

Cookwell & Company Issues Allergy Alert for Undeclared Soy, Wheat and Fish Allergen in Charred Tomato & Basil Sauce with a “Best By” Date of “10 Nov 18”

Cookwell & Company Issues Allergy Alert for Undeclared Soy, Wheat and Fish Allergen in Charred Tomato & Basil Sauce with a “Best By” Date of “10 Nov 18”

Cookwell & Company Is voluntarily recalling potentially up to 6,522 units of its Four J Charred Tomato & Basil Sauce because it may contain undeclared soy, wheat and fish. People who have an allergy or severe sensitivity to these allergens may run the risk of a serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

20-3-2018

Nutra Organics Green Tea Extract capsules

Nutra Organics Green Tea Extract capsules

Safety alert- Nutra Organics Green Tea Extract capsules

Therapeutic Goods Administration - Australia

4-1-2019


New product information wording: extracts from PRAC recommendations on signals adopted at the 26-29 November 2018 PRAC

New product information wording: extracts from PRAC recommendations on signals adopted at the 26-29 November 2018 PRAC

New product information wording: extracts from PRAC recommendations on signals adopted at the 26-29 November 2018 PRAC

Europe - EMA - European Medicines Agency

26-11-2018


Withdrawn application: HopGuard Gold, purified semi-solid extract from Humulus lupulus L. containing approximately 48% of beta acids as potassium salts, Date of withdrawal: 12/04/2018, Initial authorisation

Withdrawn application: HopGuard Gold, purified semi-solid extract from Humulus lupulus L. containing approximately 48% of beta acids as potassium salts, Date of withdrawal: 12/04/2018, Initial authorisation

Withdrawn application: HopGuard Gold, purified semi-solid extract from Humulus lupulus L. containing approximately 48% of beta acids as potassium salts, Date of withdrawal: 12/04/2018, Initial authorisation

Europe - EMA - European Medicines Agency