Alustal European Dust Mite Extract

Main information

  • Trade name:
  • Alustal European Dust Mite Extract Solution for injection
  • Pharmaceutical form:
  • Solution for injection
  • Units in package:
  • Vial, glass, multi-dose, 11mL vial (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 European Dust Mite Extract Solution for injection
    New Zealand
  • Language:
  • English

Other information

Status

  • Source:
  • Medsafe - Medicines Safety Authority - New Zealand
  • Authorization number:
  • 10798
  • Authorization date:
  • 28-05-2002
  • Last update:
  • 27-09-2017

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

CONSUMERMEDICINEINFORMATION

ALUSTAL ®

Pronounced(al-u-stal)

Contains the active

ingredients of different

allergens

Tableofcontents

Whatisintheleaflet.......p.1

WhatAlustalisusedforp.1

BeforeyouaregivenAlustal

........................................p.1

HowAlustalisgiven.......p.2

Whileyouarereceiving

Alustal............................p.3

Sideeffects.....................p.3

AfterusingAlustal.........p.4

Productdescription.......p.4

Presentation..................p.4

____________________

Whatisinthisleaflet

____________________

Thisleafletanswerssome

commonquestionsabout

Alustalallergenextracts.

Itdoesnotcontainallofthe

availableinformation.

Itdoesnottaketheplaceof

talkingtoyourdoctoror

pharmacist.

Allmedicineshaverisks

andbenefits.Yourdoctor

hasweighedtherisksof

givingyouAlustalallergen

extractsagainsttheexpected

benefitsitwillhaveforyou.

Ifyouhaveanyconcerns

aboutbeinggiventhis

medicine,askyour

doctororpharmacist.

____________________

WhatAlustalisusedfor

____________________

Alustalbelongstoagroup

ofmedicinescalledanti-

allergypreparationsandis

usedinthetreatmentof

seasonal or perennial

rhino-conjunctivitiswithor

withoutassociatedasthma.

Alustal is given asa

subcutaneoustreatmentand

thisisoftenreferredtoas

(Subcutaneous

ImmunotherapyTreatment)

Howitworks:

Alistofallergenavailable

Australia and New

Zeelandisprovidedatthe

endofthisleaflet..The

exacttypewilldependon

yourallergyandwhatyour

doctoridentifiesasthe

causeofyourallergy.The

treatment with

allergen extracts is to

preventthemoresevere

allergic reactions you

experience.

Alustalworksbyslowly

increasingyourtoleranceto

specific allergens and

decreasestheseverityof

yourallergicreactions.

Theinjectionisspecifically

designed according to

individualpatientneeds.

Alustalhelpstoincrease

yourtolerancetoallergens

decrease the

severityofyourallergic

reactions.

Askyourdoctorifyou

haveanyquestionswhy

Alustal has been

prescribedforyou.

Alustalisnotaddictive.This

medicineisavailableonly

withadoctor’sprescription

andadministeredundera

____________________

Before you are given

Alustal

____________________

Whenyoumustnotbe

givenAlustal

Do not start Alustal

treatmentif:

-Youhaveunstableasthma,

severeimmunodeficiency,

malignant disease, or

autoimmune disease.

Injection should be

avoided if you have

bleedingtendency.

-You are currently

receivingtreatmentwith

beta-blockers (often in

medicines for blood

pressure or heart

conditions),asyoumaybe

unresponsivetotheusual

dosesofadrenalineusedto

treat anaphylactic

reactions.

-Youhaveproblemswith

your kidneys - renal

insufficiency-asthismay

increase the risk of

accumulation of

aluminium from

aluminium hydroxide

preparations(asforany

aluminium hydroxide

vaccine) into tissues

(centralnervoussystem,

bones)

-Thepackageshowssigns

oftampering.

-Theexpirydate(EXP)

printedonthepackhas

passed.

Ifyoureceiveinjectionsof

this medicine after the

expirydatehaspassed,it

maynotworkaswell.

ItisnotadvisabletouseSIT

during pregnancy:

pregnancyisnotconsidered

CONSUMERMEDICINEINFORMATION

asacontraindicationtothe

continuation of

immunotherapy but

treatmentshouldnotbe

startedduringpregnancy.If

apatientbecomespregnant

duringinitialtreatment,stop

injections; if a patient

becomespregnantduring

maintenance therapy,

treatmentmaycontinueif

welltolerated.

Thereisnodataavailableon

theexcretionofallergen

extractsinhumanmilkor

anyeffectonbreast-fed

infants.

Ifyouarenotsureifyou

shouldbetakingAlustal,

talktoyourdoctor

Before you start your

treatmentwithAlustal:

Tellyourdoctorif:

-Youhaveanyotherhealth

problems,especiallythe

following:

-Asthma or other

respiratoryproblems.

-You have, or have

previouslyhad,aserious

immunologicaldisease.

-Youhave a bleeding

tendency.

-Youhaveanautoimmune

disease.Yourdoctorwill

decideiftheriskfrom

allergen exposure is

greaterthantheriskof

exacerbating the

autoimmunedisease.

-Youhaveacutefever,

uncontrolled allergic

symptoms and recent

exacerbationofasthma.

Yourdoctorcandecideto

delaytreatment.

Ifyouhavenottoldyour

above,tellhim/herbefore

youstarttreatmentwith

Alustal.

Takingothermedicines

Tellyourdoctorifyou

taking any other

medicines,includingany

thatyouhaveboughtfrom

apharmacy,supermarket

orhealthfoodshop.

Somemedicinesmay

interfere with Alustal.

Thesemedicinesinclude:

Beta-blockers (blood

pressure or heart

medications), including

topicallyadministeredbeta-

blockers, are known

interferewithtreatmentof

anaphylactic reactions.

Theymaymakeyouless

responsivetotheusual

doses of epinephrine

(adrenaline)usedtotreat

anaphylacticreactions.

Yourdoctorwilladvise

you.

Yourdoctororpharmacist

hasmoreinformationon

medicinestobecarefulwith

oravoidwhiletakinganyof

theAlustal.

your doctor or

pharmacistifyouarenot

sureifyourmedicineisone

oftheoneslistedabove.

______________________

HowAlustalisgiven

______________________

Howmuchisgiven

Yourtreatmentschedule

willinclude:

Initial treatment and

maintenancetreatment:

Yourdoctorwilltellyou

howmuchmedicinewillbe

Normally initial

treatmentwillbeweekly

injections lasting for

approximately14weeks.

Thiswillbeofthe

allergenthatyouare

allergictoinincreasing

concentrationsuptothe

highestdoseyoucan

tolerate.

Maintenance treatment

will be of monthly

injectionsofthehighest

concentrationthatyou

cantoleratecomfortably.

Where two different

coursesarebeinggiven

concurrently,thetwo

extractsmustneverbe

mixedwithinthesame

syringe.

Injectionsofthetwo

extractsmaybegivenat

thesamevisit,butin

separatearms.However

mixturesofallergensmay

havebeenprescribedfor

youbyyourDoctor,these

willalreadybemixedand

given in a single

injection.Butthedoctor

mayneedtogivemore

thanoneinjectionifyou

arebeingtreatedformore

thanoneallergy.

HowAlustalisgiven

Alustalisgivenasan

injectionundertheskin

(subcutaneously)Itisnot

injectedintoabloodvessel

orintramuscularly.

HowlongtohaveAlustal

for

Treatmentormaintenance

shouldcontinuefor3to5

yearsdependingonthe

CONSUMERMEDICINEINFORMATION

severityoftheallergyand

responsetotreatment.

Ifyoumissadose:

Ifyoumissadose,talkto

yourdoctorandarrange

anothervisitassoonas

possible.

Ifyouaregiventoomuch

(overdose)

Overdose is unlikely

becauseyourdoctorwill

giveyouthismedicineby

injection.Ifyouthinkthat

youmayhavebeengiven

much Alustal,

immediatelytellyourdoctor

orgotoAccidentand

Emergencyatyournearest

hospital. Symptomssuch

ogeneralizedrash,

oitching,

oswellingoflips,face,

tongueorotherpartsof

thebody,

oshortness of breath,

respiratoryorcardiac

distress (including

asthma),

oseizures,

mayoccur.Ifyouhaveany

concerns,askyourdoctor.

______________________

Whileyouare receiving

Alustal

______________________

Thingsyoumustdo

Tellalldoctors,dentists

andpharmacistswhoare

treatingyou,thatyouare

receivingAlustal.

Tellyourdoctorifyoufeel

the treatment is not

Keep all of your

appointments with your

doctorsothatyourprogress

canbechecked.Itis

importanttohaveyour

follow-updosesofAlustal

attheappropriatetimesto

make sure the

immunotherapyhasthebest

chanceofworking.

Thingsyoumustnotdo

Itisrecommendedtoavoid

activity that may

increasebloodflowthrough

theinjectionsitesuchas

strenuous exercise, hot

baths,sauna,applicationof

localheatorrubbing,forthe

remainderoftheday.

Thingstobecarefulof

must avoid

strenuousactivityfor

theremainderofthe

Youmustwaitinthe

doctor’swaitingroom

foratleast30minutes

followingyourAlustal

injection.Themajority

ofseriousreactionswill

begin within 30

minutes after an

injection. Patients

shouldbeinstructedto

seekmedicaladvice

immediately if

symptoms develop

afterleavingtheclinic.

more rapidly

symptomsbegin,the

moreseveretheyare

likelytobeandthe

morerapidlytreatment

measuresshouldbegin.

Alustalispresumedto

beunlikelytoproduce

aneffectontheability

drive or use

______________________

Sideeffects

______________________

Alustal allergen extracts

helpsmostpeoplewith

allergiesbuttheymayhave

unwantedsideeffectsina

fewpeople.

Allmedicinescanhaveside

effects.Sometimestheyare

serious,mostofthetime

theyarenot.Youmayneed

medicaltreatmentifyouget

someofthesesideeffects.

Contactyourdoctoror

nurse immediately if

symptomsofanallergic

reactionoccur.

Tell your doctor or

pharmacistassoonas

possibleifyoudonotfeel

well while you are

receivingAlustal.

Tell your doctor

immediatelyifyounotice

anyofthefollowingand

theyworryyou:

CommonSideEffects

Itchingandrednessat

theinjectionsite.

Shortnessofbreath,

Asthma,

Rhinitis,

Laryngealswelling,

Swellingoflips,face,

tongueorotherpartsof

thebody,

Itching,

UncommonSideEffects

Anaphylacticshock

Conjunctivitis

VeryRareSideeffects

Pre-existing atopic

eczemaoutbreaks

Myalgiawithinserum

sicknesslikesyndrome

Headache, weakness,

lackofstrength

CONSUMERMEDICINEINFORMATION

Ofthese,themoreserious

effectscaninclude

ogeneralizedrash,

oitching,

oswellingoflips,face,

tongueorotherpartsof

thebody,

oshortnessofbreathor

tightness (including

asthma)

oseizures

Tell your doctor

immediately or go to

AccidentandEmergency

atyournearesthospitalif

younoticeanyofthe

above:

Serioussideeffectsarerare.

Thisisnotacompletelistof

allpossiblesideeffects.

Othersmayoccurinsome

peopleandtheremaybe

somesideeffectsnotyet

known.

Tellyourdoctorifyou

noticeanythingelsethatis

makingyoufeelunwell,

evenifitisnotonthislist.

your doctor or

pharmacisttoanswerany

questionsyoumayhaveand

toexplainanythingyoudo

notunderstandonthislist.

Donotbealarmedbythis

listofpossiblesideeffects.

Youmaynotexperienceany

ofthem.

______________________

After using Alustal

______________________

Storage

Alustalisusuallystoredin

doctor’s surgery.

However,ifyouneedto

oKeepitwherechildren

cannotreachit

oKeepitintheoriginal

pack

oKeep it in the

refrigerator(between2°

to8°C).Donotfreeze.

Disposal

Yourdoctorwilldisposeof

anyunfinishedmedicineif

thevialshavepassedtheir

expirydate.

______________________

Productdescription

______________________

WhatAlustallookslike

Each5mLvialcontains

specificallergenextract(s)

suspension and are

available in various

concentrations for many

differentallergens.Your

Doctorwillchoosethe

correctallergentotreatyour

allergy.Otheringredientsin

allergen suspensions

include aluminium

hydroxide,sodiumchloride,

phenol,manitolandwater

forinjections.

ALUSTALpresentation

Initialtreatmentset:3vials,

eachvialcontainingeither

0.1,1.0and10.0IR/mLor

IC/mL.

Maintenanceset:asingle

vialcontaining10.0IR/mL

orIC/mL.

AvailableConcentrations:

Vialcontaining5mLof

suspension.

Yellowcap: 0.1IR/mL

or0.1IC/mL

Greencap: 1.0IR/mL

Bluecap: 10.0IR/mL

or10.0IC/mL

(IR/mListheIndexof

ReactivitypermL)

(IC/mListheIndexof

ConcentrationpermL)

Ingredients

Alustal products contain

eitherasingleallergen

extractoracombinationof

allergenextractswithinthe

miteorpollengroupof

allergens.

ALUSTALispreparedfrom

freeze-dried allergen

extracts adsorbed onto

aluminiumhydroxidegel.

Thefreeze-driedallergen

extractsarepreparedby

ammonium bicarbonate

extractionoftheallergen

sourcematerialse.g.pollen,

mites.Specificallergen(s)

areselectedbythephysician

forSpecificImmunotherapy

Treatment(SIT)forthe

individualpatient.

____________________

Sponsor

______________________

DistributedinAustralia

forHelex-APtyLtdby:

LinkMedicalProductsPty

5ApolloStreet

WarriewoodNSW2102

AUSTRALIA

Ph:1800824166

Fax:1800824199

Distributed and

RegisteredinNewZealand

by:

EBOSGroupLtd

324CashelStreet

CHRISTCHURCH

NEWZEALAND

Ph:6494153267

Fax:0800262262

CONSUMERMEDICINEINFORMATION

ALUSTALALLERGENEXTRACTAVAILABILITYINAUSTRALIAANDNEWZEALAND

REGISTRATION

NAME ACTIVEINGREDIENT AUSTRALIA

AUSTR NEW

ZEALAND

Mites

ALUSTALHouseDust

MitesExtract DermatophagoidespteronyssinusandDermatophagoides

farinaebodyextracts AUSTR132680

AUSTR132725(I) 

ALUSTALEuropeanDust

MiteExtract Dermatophagoidespteronyssinusbodyextract AUSTR132678

AUSTR132723(I) TT50-6900a(I)

TT50-6900b(M)

ALUSTALAmericanDust

MiteExtract Dermatophagoidesfarinaebodyextract) AUSTR132679

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

TT50-6900/1b(M)

Animals

ALUSTALCatEpithelia

Extract Felineepitheliumextract  TT50-6901a(I)

TT50-6901b(M)

ALUSTALDogEpithelia

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

TT50-6901/1b(M)

ALUSTALHorseEpithelia

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

TT50-6901/2b(M)

ALUSTALFeathersMix

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

TT50-6901/3b(M)

Pollens

ALUSTALBirchPollen

Extract Betulaalbapollenextract  TT50-6902a(I)

TT50-6902b(M)

ALUSTAL Oleaceae

PollenMixExtract Fraxinusexcelsior/Oleaeuropaea/

Ligustrumvulgarepollenextracts  TT50-6902/1a(I)

TT50-6902/1b(M)

ALUSTALPlantainPollen

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)

ALUSTALSorrelPollen

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

TT50-6902/5b(M)

ALUSTALWheatPollen

Extract Triticumaestivumpollenextract AUSTR132836(M)

AUSTR132837(I) 

ALUSTALBermudaGrass

Extract Cynodondactylonpollenextract AUSTR132834(M)

AUSTR132835(I) 

ALUSTAL Rye Grass

Extract Loliumperennepollenextract AUSTR132843(M)

AUSTR132844(I) 

ALUSTAL Olive Tree

Extract Oleaeuropeapollenextract AUSTR132840(M)

AUSTR132841(I) 

ALUSTAL Extract of

ThreeGrasses Dactylisglomerata/Loliumperenne/Phleumpratense

pollenextracts AUSTR132845(M)

AUSTR132846(I) 

ALUSTALExtractofFive

Grasses Dactylisglomerata/Poapratensis/Loliumperenne/

Anthoxanthumodoratum/Phleumpratensepollenextracts AUSTR132847(M)

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

TT50-6902/6b(M)

ALUSTAL Extract of

TwelveGrasses Agrostistenuis/Cynodondactylon/Bromusinermis/

Dactylisglomerata/Festucaelatior/Poapratensis/

Arrhenatherumelatius/Loliumperenne/Anthoxantum

odoratum/Phleumpratense / Avenafatua/Holcuslatanus

pollenextracts AUSTR132849(M)

AUSTR132850(I) 

X=NotAvailable;I=Initialtreatment;M=Maintenancetreatment

CONSUMERMEDICINEINFORMATION

PatientVerification

Thefollowingtablehasbeenprovidedtoallowthepatientandphysiciantoverifythatthe

vialspecificallyforthepatientisbeingusedattimeoftreatment.

Injection Date Vial

(concentration) Physician’s

Initial Patient’s

Initial

1

0.1IR/mLor

0.1IC/mL

(Yellowcap) 2

3

4

5

1IR/mLor

1IC/mL

(Greencap) 6

7

8

9

10IR/mLor

10IC/mL

(Bluecap) 10

11

12

13

14

15

10IR/mLor

10IC/mL

16

17

18

19

20

21

22

23

24

25

26

27

28

29

30

31

32

CONSUMERMEDICINEINFORMATION

Injection Date Vial

(concentration) Physician’s

Initial Patient’s

Initial

33

34

35

36

10IR/mLor

10IC/mL

37

38

39

40

41

42

43

44

45

46

47

48

49

50

51

52

53

CMIVer.9.0

DateofPreparation:10January2012

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Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐OC)

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐OC)

Published on: Wed, 14 Nov 2018 The food enzyme maltogenic amylase (glucan 1,4‐a‐maltohydrolase; EC 3.2.1.133) is produced with a genetically modified Bacillus subtilis strain NZYM‐OC by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production microorganism and recombinant DNA. This maltogenic amylase is intended to be used in baking processes. Based on the maximum use levels recommended, dietary exposure to the food enzyme–...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐SO)

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐SO)

Published on: Wed, 14 Nov 2018 The food enzyme maltogenic amylase (glucan 1,4‐α‐maltohydrolase; EC 3.2.1.133) is produced with a genetically modified Bacillus subtilis strain NZYM‐SO by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production microorganism and recombinant DNA. This maltogenic amylase is intended to be used in baking processes. Based on the maximum use levels, dietary exposure to the food enzyme–total organi...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Safety evaluation of the food enzyme acetolactate decarboxylase from a genetically modified Bacillus licheniformis (strain NZYM‐JB)

Safety evaluation of the food enzyme acetolactate decarboxylase from a genetically modified Bacillus licheniformis (strain NZYM‐JB)

Published on: Wed, 14 Nov 2018 The food enzyme acetolactate decarboxylase (α‐acetolactate decarboxylase; EC 4.1.1.5) is produced with a genetically modified Bacillus licheniformis strain NZYM‐JB by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This acetolactate decarboxylase is intended to be used in distilled alcohol production and brewing processes. Residual amounts of total organi...

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

1-11-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme endo‐1,4‐β‐xylanase (EC 3.2.1.8) is produced with the genetically modified Bacillus subtilis strain LMG S‐24584 by Puratos N. V. The genetic modifications do not give rise to safety concerns. The Panel noted that, although the production strain was not detected in the food enzyme, recombinant DNA was present in all batches of the food enzyme tested. The food enzyme is intended to be used in baking processes. Based on the maximum use levels re...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety evaluation of the food enzyme glucan 1,4‐α‐glucosidase from a genetically modified Aspergillus niger (strain NZYM‐BW)

Safety evaluation of the food enzyme glucan 1,4‐α‐glucosidase from a genetically modified Aspergillus niger (strain NZYM‐BW)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme glucan 1,4‐α‐glucosidase (EC 3.2.1.3) is produced with the genetically modified Aspergillus niger strain NZYM‐BW by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The glucan 1,4‐α‐glucosidase food enzyme is intended to be used in distilled alcohol production and starch processing for the production of glucose syrups. Residu...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM‐BF)

Safety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM‐BF)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme glucoamylase (glucan 1,4‐α‐glucosidase; EC 3.2.1.3) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This glucoamylase is intended to be used in brewing processes and in starch processing for glucose syrups production. Residual amounts of total organic s...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme alpha‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This α‐amylase is intended to be used in starch processing for glucose syrups production, beverage alcohol (distilling) processes and baking proces...

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

11-10-2018

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Published on: Wed, 10 Oct 2018 00:00:00 +0200 The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of thermally oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (TOSOM) (E 479b) when used as a food additive. The Scientific Committee on Food (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) derived an acceptable daily intake (ADI) of 25 and 30 mg/kg body weight (bw) per day, respectively. There was n...

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

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

29-8-2018

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Published on: Thu, 16 Aug 2018 00:00:00 +0200 4,15‐Diacetoxyscirpenol (DAS) is a mycotoxin primarily produced by Fusarium fungi and occurring predominantly in cereal grains. As requested by the European Commission, the EFSA Panel on Contaminants in the Food Chain (CONTAM) assessed the risk of DAS to human and animal health related to its presence in food and feed. Very limited information was available on toxicity and on toxicokinetics in experimental and farm animals. Due to the limitations in the avai...

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

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

28-8-2018

EU/3/18/2067 (Omeros London Limited)

EU/3/18/2067 (Omeros London Limited)

EU/3/18/2067 (Active substance: Recombinant human monoclonal antibody against mannan-binding lectin-associated serine protease-2) - Orphan designation - Commission Decision (2018)5737 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/044/18

Europe -DG Health and Food Safety

19-7-2018

EU/3/12/1083 (Global Regulatory Limited)

EU/3/12/1083 (Global Regulatory Limited)

EU/3/12/1083 (Active substance: Humanised single chain monoclonal antibody against CD37) - Transfer of orphan designation - Commission Decision (2018)4839 of Thu, 19 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/128/12/T/02

Europe -DG Health and Food Safety

2-6-2018

EU/3/14/1350 (Novartis Europharm Limited)

EU/3/14/1350 (Novartis Europharm Limited)

EU/3/14/1350 (Active substance: Recombinant human monoclonal antibody of the IgG1 kappa class against human macrophage colony-stimulating factor) - Transfer of orphan designation - Commission Decision (2018)3630 of Sat, 02 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/107/14/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/13/1205 (Novartis Europharm Limited)

EU/3/13/1205 (Novartis Europharm Limited)

EU/3/13/1205 (Active substance: Human monoclonal antibody against human interleukin 13) - Transfer of orphan designation - Commission Decision (2018)3042 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/118/13/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/12/1034 (Novartis Europharm Limited)

EU/3/12/1034 (Novartis Europharm Limited)

EU/3/12/1034 (Active substance: Humanised monoclonal antibody against P-selectin) - Transfer of orphan designation - Commission Decision (2018)3040 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/026/12/T/02

Europe -DG Health and Food Safety

16-5-2018

EU/3/08/605 (Novartis Europharm Limited)

EU/3/08/605 (Novartis Europharm Limited)

EU/3/08/605 (Active substance: Recombinant human monoclonal antibody to human Nogo-A protein of the IgG4/kappa class) - Transfer of orphan designation - Commission Decision (2018)3035 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMEA/OD/059/08/T/01

Europe -DG Health and Food Safety