Euthanimal 20%

Main information

  • Trade name:
  • Euthanimal 20%
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Euthanimal 20%
    Germany
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Pentobarbital
  • Therapeutic area:
  • Cats, Cattle, Dogs, Goats, Horses, Pigs, Sheep

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • NL/V/0177/001
  • Authorization date:
  • 29-05-2013
  • EU code:
  • NL/V/0177/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

ANNEXI

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Euthanimal20%,200mg/mlsolutionforinjection(BE,BG,CY,DK,EE,FI,HU,LT,LV,MT,NL,PT,RO,SI,UK)

Euthanimal200mg/ml,solutionforinjection(CZ,DE,ES,IE,PL,SE).

Euthanimal20%,200mg/mlsolutionforinjectionforpigs,goats,sheep,cattle,horses,catsanddogs(IT)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontains

Activesubstance:

sodiumpentobarbital200mg(equivalentto182mgpentobarbital)

Preservative:

Benzylalcohol(E1519)20.0mg

Ethanol 80.0mg

Forthefulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Solutionforinjection.

Clearredsolution

4. CLINICALPARTICULARS

4.1 Targetspecies

Pigs,goats,sheep,cattle,horses,catsanddogs

4.2 Indicationsforuse,specifyingthetargetspecies:

ForEuthanasia.

4.3 Contraindications

Donotuseforanaesthesia.

Carcassesandedibleproductsofanimalsinjectedwiththisproductmayneverenterthefood

chainandotheranimalsmaynevereat(partsof)thecarcass(seesection4.11)

4.4 Specialwarningsforeachtargetspecies

Intravenousinjectionofpentobarbitalhastheabilitytocauseinductionexcitementinseveralspeciesof

animalandadequatesedationshouldbeappliedifdeemednecessarybytheveterinarysurgeon.Measures

mustbetakentoavoidperivascularadministration(e.g.byusingintravenouscatheter).

Checkregularly,uptoabout10minutespost-administration,iflivesignsreturn(respiration,heartbeat,

cornealreflex).Inclinicaltrialsithasbeenestablishedthatthismightoccur.Ifsuchlivesignsreturn,itis

advisedtorepeattheadministrationusingbetween0.5and1timestheprescribeddose.

Avoiduseinanimalsweighingmorethan120kgduetothelargeinjectionvolumerequiredanddifficulty

achievingrapidadministration.

Toreducetheriskofinductionexcitement,euthanasiashouldbeperformedinaquietarea.

ParticularlyInhorsesandcattle,theveterinarysurgeonshouldconsiderpremedicationwithanappropriate

sedativetoproduceprofoundsedationbeforeeuthanasiaandanalternativemethodofeuthanasiais

recommendedtobeavailableshoulditbecomenecessary.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

None.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproducttoanimals

Pentobarbitalisapotenthypnoticandasedative,andthuspotentiallytoxicinman.Itcanbeadsorbed

systemicallythroughtheskinandifswallowed.Particularcareshouldbetakentoavoidaccidentalingestion

andself-injection

Systemicuptake(includingabsorptionviaskinoreye)ofpentobarbitalcausessedation,sleepinductionand

respiratorydepression.Moreover,thisproductmaybeirritatingtotheeyeandcancauseirritationtotheskin

aswellashypersensitivityreactions(duetothepresenceofpentobarbitalandbenzylalcohol).Embryotoxic

effectscannotbeexcluded.

Avoiddirectcontactwiththeskinandeyes,includinghand-to-eyecontact.

Avoidaccidentalself-injectionoraccidentalinjectionofasecondprofessionalwhenadministeringtheproduct.

Peoplewithknownhypersensitivitytopentobarbitalshouldavoidcontactwiththeveterinarymedicinal

product

Handletheproductwithutmostcare,especiallywomenofchildbearingpotential.Wearprotectivegloves.This

medicineshouldonlybeadministeredbyveterinariansandshouldonlybeusedinthepresenceofanother

professionalthatcanassistincaseofaccidentalexposure.Instructtheprofessionalifnotamedical

professionalabouttherisksoftheproduct.

Accidentalspillageontheskinorintheeyemustbewashedoffimmediatelywithplentyofwater;Iftherehas

beenseriousskinoreyecontactorincaseofaccidentalself-injection,seekmedicaladviceimmediatelyand

showthepackageleafletorthelabeltothephysician.Incaseof accidentalingestion,washoutmouthand

obtainmedicalattentionimmediately.ButDONOTDRIVEassedationmayoccur.

Afteradministrationofthisproduct,collapsewilloccurwithin10seconds.Incasetheanimalisstandingat

timeofadministration,careshouldbetakenbythepersonadministeringtheveterinarymedicinalproductand

anyotherpersonspresenttokeepacertaindistancefromtheanimaltoavoidinjury.

Thisproductisflammable,keepawayfromsourcesofignition.Donotsmoke.

Informationforthehealthprofessionalincaseofexposure:

Emergencymeasuresshouldbedirectedtowardmaintenanceofrespirationandcardiacfunction.Insevere

intoxicationmeasurestoenhanceeliminationofabsorbedbarbituratemaybenecessary.

4.6 Adversereactions(frequencyandseriousness)

Deathmaybedelayediftheinjectionisadministeredperivascularlyorintoorgans/tissueswithlowcapacity

forabsorption.Barbituratescanbeirritatingwhenadministeredperivascularly.

Common:

Vocalisation

Muscletwitching

Rare:

Excitation

Legmovements

Defecationandurineloss

Gasping(incattle),mostlyduetounderdosing

Veryrare:

Convulsions

Contractionofthediaphragm

Vomiting

Oneorfewgaspingrespirationoccuraftercardiacarrest

4.7 Useduringpregnancy,lactationorlay

Nospecificinformationisavailable.Theuseofthisproductinpregnantanimalsislefttothejudgementofthe

veterinarian.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

CNSdepressants(narcotics,phenothiazines,antihistamines,etc.)mayincreasetheeffectofpentobarbital..

4.9 Amountstobeadministeredandadministrationroute

Cattle,horses,pigs,goats,sheep,catsanddogs:

100mg/kg(correspondingto0.5ml/kg)throughquickintravenousinjection.Forlargeranimals,theuseofa

pre-insertedintravenouscatheterisadvocated

Ifcardiacarrestisnotestablishedafter2minutes,aseconddoseneedstobeadministered,preferablyviafast

intravenousinjectionorifthisisnotfeasible,viaintra-cardiacinjection;intra-cardiacinjectionisonly

acceptableafterpriordeepsedationoranaesthesia.

Asthevialcannotbepuncturedmorethan20times,theusershouldchoosethemostappropriatevialsize.

4.10 Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Intheeventofaccidentaladministrationtoananimalnotpresentedforeuthanasia,measuressuchasartificial

respiration,administrationofoxygenandtheuseofanalepticsareappropriate.

4.11 Withdrawalperiod(s)

Notapplicable

Appropriatemeasuresneedtobetakentoassurethatcarcassesandedibleproductsofanimals

injectedwiththisproductdonotenterthefoodchain,andarenotusedforhumanconsumption.

Otheranimalsmaynevereat(partsof)thecarcass,astheymightbeexposedtoalethaldoseof

pentobarbital.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Barbituratesintendedforeuthanasia.

ATCvetcode:QN51AA01.

5.1 Pharmacodynamicproperties

Pentobarbitalisashort-actingsedativeandhypnotic.Itcausesdepressionofthecentralnervoussystemby

GABAreceptormodulation,imitatingtheactionofGamma-aminobutyricacid.

Barbituratessuppressinparticularthereticularactivatingsystem(RAS)inthebrain,whichnormallyensures

alertness.Theimmediateeffectisthelossofconsciousnessfollowedbydeepanaesthesiafollowedby,athigh

rates,rapiddepressionoftherespiratorycentre.Breathingstopsandisquicklyfollowedbycardiacarrestand

rapiddeath.

.

5.2 Pharmacokineticparticulars

Afterintravenousadministrationfastdistributionoverthetissueswilloccur.

Pentobarbitalismainlyeliminatedthroughtheliverbybiotransformation,particularlybytheCytochromeP

system,aswellasbyexcretioninthekidneysandredistribution.Inpigsredistributioninfattytissuemight

causereducedplasmaconcentrationsandprolongedaction.

Barbituratesmaydiffusethroughtheplacentainfoetaltissue,andtracesofbarbituratesmaybepresentinthe

breastmilk.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Ethanol96%

Propyleneglycol

Benzylalcohol(E1519)

Ponceau4R(E124)Waterforinjection

6.2 Incompatibilities

Intheabsenceofincompatibilitystudies,thisveterinarymedicinalproductmustnotbemixedwithother

veterinarymedicinalproducts.

6.3 Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:2years

Shelflifeafterfirstopeningtheimmediatepackaging:28days.

6.4. Specialprecautionsforstorage

Thismedicinalproductdoesnotrequireanyspecialstorageconditions

6.5 Natureandcompositionofimmediatepackaging

12vialsof100mlor6vialsof250ml,typeIIglassinjectionvialwithabromobutylrubberstopperand

aluminiumcap.

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwastematerials

derivedfromtheuseofsuchproducts

Thismedicinalproductisdangeroustohumansandanimals.Disposeofanyunusedproductandempty

containersinaccordancewithguidancefromyourlocalwasteregulationauthority

7. MARKETINGAUTHORISATIONHOLDER

AlfasanNederlandBV

Kuipersweg9,Woerden

Tel:0348-416945

Fax:0348–423577

E-mail:alfasan@wxs.nl

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10 DATEOFREVISIONOFTHETEXT

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Medicinefortheexclusiveuseoftheveterinarysurgeon.Notforsaletothepublic.

Theadministrationandcustodyofthemedicineshouldonlybecarriedoutbytheveterinarysurgeon.

ANNEXIII

LABELLINGANDPACKAGELEAFLET

A.LABELLING

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

{Polystyrenepackage}

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Euthanimal20%,200mg/mlsolutionforinjection(BE,BG,CY,DK,EE,FI,HU,LT,LV,MT,NL,PT,RO,SI,UK)

Euthanimal200mg/ml,solutionforinjection(CZ,DE,ES,IE,PL,SE).

Euthanimal20%,200mg/mlsolutionforinjectionforpigs,goats,sheep,cattle,horses,catsanddogs(IT)

{Sodiumpentobarbital}

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Eachmlcontains

Activesubstance:

sodiumpentobarbital200mg(equivalentto182mgpentobarbital).

Preservative:

Benzylalcohol(E1519)20.0mg

Ethanol 80.0mg

3. PHARMACEUTICALFORM

Solutionforinjection

4. PACKAGESIZE

12vialsof100ml

6vialsof250ml

5. TARGETSPECIES

Pigs,goats,sheep,cattle,horses,catsanddogs

6. INDICATION(S)

ForEuthanasia

7. METHODANDROUTE(S)OFADMINISTRATION

Cattle,horses,pigs,goats,sheep,catsanddogs:

100mg/kg(correspondingto0.5ml/kg)viafastintravenousinjection.

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Notapplicable.

Readthepackageleafletbeforeuse

9. SPECIALWARNING(S),IFNECESSARY

Donotuseforanaesthesia.

Readthepackageleafletbeforeuse.

Accidentalinjectionisdangerous.

10. EXPIRYDATE

EXP{month/year}

Oncebroached,useby28days.

11. SPECIALSTORAGECONDITIONS

Thismedicinalproductdoesnotrequireanyspecialstorageconditions

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSORWASTEMATERIALS,IFANY

Thismedicinalproductisdangeroustohumansandanimals.Disposeofanyunusedproductandempty

containersinaccordancewithguidancefromyourlocalwasteregulationauthority.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSORRESTRICTIONSREGARDING

SUPPLYANDUSE,IFAPPLICABLE

Foranimaltreatmentonly.

Medicinefortheexclusiveuseoftheveterinarysurgeon.Notforsaletothepublic.

Theadministrationandcustodyofthemedicineshouldonlybecarriedoutbytheveterinarysurgeon.

14. THEWORDS“KEEPOUTOFTHESIGHTANDREACHOFCHILDREN”

Keepoutofthesightandreachofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

AlfasanNederlandBV

Kuipersweg9,Woerden

Tel:0348-416945

Fax:0348–423577

E-mail:alfasan@wxs.nl

16. MARKETINGAUTHORISATIONNUMBER(S)

17. MANUFACTURER’SBATCHNUMBER

Charge:

PARTICULARSTOAPPEARONIMMEDIATEPACKAGINGUNIT

{Glassvial}

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Euthanimal20%,200mg/mlsolutionforinjection(BE,BG,CY,DE,DK,EE,FI,HU,LT,LV,MT,NL,PT,RO,SI,UK)

Euthanimal200mg/ml,solutionforinjection(CZ,DE,ES,IE,PL,SE).

Euthanimal20%,200mg/mlsolutionforinjectionforpigs,goats,sheep,cattle,horses,catsanddogs(IT)

{Sodiumpentobarbital}

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Eachmlcontains

Activesubstance:

sodiumpentobarbital200mg(equivalentto182mgpentobarbital).

Preservative:

Benzylalcohol(E1519)20.0mg

Ethanol 80.0mg

3. PHARMACEUTICALFORM

Solutionforinjection

4. PACKAGESIZE

100ml

250ml

5. TARGETSPECIES

Pigs,goats,sheep,cattle,horses,catsanddogs

6. INDICATION(S)

ForEuthanasia

7. METHODANDROUTE(S)OFADMINISTRATION

Cattle,horses,pigs,goats,sheep,catsanddogs:

100mg/kg(correspondingto0.5ml/kg)viafastintravenousinjection.

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Notapplicable.

Readthepackageleafletbeforeuse.

9. SPECIALWARNING(S),IFNECESSARY

Donotuseforanaesthesia.

Readthepackageleafletbeforeuse.

Accidentalinjectionisdangerous.

10. EXPIRYDATE

EXP{month/year}

Oncebroached,useby28days.

Oncebroached,useby__.__.____

11. SPECIALSTORAGECONDITIONS

Thismedicinalproductdoesnotrequireanyspecialstorageconditions

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSORWASTEMATERIALS,IFANY

Thismedicinalproductisdangeroustohumansandanimals.

Disposeofanyunusedproductandemptycontainersinaccordancewithguidancefromyourlocalwaste

regulationauthority.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSORRESTRICTIONSREGARDING

SUPPLYANDUSE,IFAPPLICABLE

Foranimaltreatmentonly.

Medicinefortheexclusiveuseoftheveterinarysurgeon.Notforsaletothepublic.

Theadministrationandcustodyofthemedicineshouldonlybecarriedoutbytheveterinarysurgeon.

14. THEWORDS“KEEPOUTOFTHESIGHTANDREACHOFCHILDREN”

Keepoutofthesightandreachofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

AlfasanNederlandBV

Kuipersweg9,Woerden

Tel:0348-416945

Fax:0348–423577

E-mail:alfasan@wxs.nl

16. MARKETINGAUTHORISATIONNUMBER(S)

17. MANUFACTURER’SBATCHNUMBER

Charge:

B.PACKAGELEAFLET

PACKAGELEAFLETFOR:

Euthanimal20%,200mg/mlsolutionforinjection(BE,BG,CY,DK,EE,FI,HU,LT,LV,MT,NL,PT,RO,SI,UK)

Euthanimal200mg/ml,solutionforinjection(CZ,DE,ES,IE,PL,SE).

Euthanimal20%,200mg/mlsolutionforinjectionfor

pigs,goats,sheep,cattle,horses,catsanddogs(IT)

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERANDOFTHEMANUFACTURING

AUTHORISATIONHOLDERRESPONSIBLEFORBATCHRELEASE,IFDIFFERENT

Marketingauthorisationholderandmanufacturerresponsibleforbatchrelease:

AlfasanNederlandBV

Kuipersweg9,Woerden

Tel:0348-416945

Fax:0348–423577

E-mail:alfasan@wxs.nl

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Euthanimal20%,200mg/mlsolutionforinjection(BE,BG,CY,DK,EE,FI,HU,LT,LV,MT,NL,PT,RO,SI,UK)

Euthanimal200mg/ml,solutionforinjection(CZ,DE,ES,IE,PL,SE).

Euthanimal20%,200mg/mlsolutionforinjectionforpigs,goats,sheep,cattle,horses,catsanddogs(IT)

Sodiumpentobarbital.

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

Eachmlcontains

Activesubstance:

sodiumpentobarbital200mg(equivalentto182mgpentobarbital)

Preservatives:

Benzylalcohol(E1519)20.0mg

Ethanol 80.0mg

4. INDICATION(S)

ForEuthanasia

5. CONTRAINDICATIONS

Donotuseforanaesthesia.

Carcassesandedibleproductsofanimalsinjectedwiththisproductmayneverenterthefood

chainandotheranimalsmaynevereat(partsof)thecarcass(seesection10)

6. ADVERSEREACTIONS

Deathmaybedelayediftheinjectionisadministeredperivascularlyorintoorgans/tissueswithlowcapacity

forabsorption.Barbituratescanbeirritatingwhenadministeredperivascularly

Common:

Vocalisation

Muscletwitching

Rare:

Excitation

Legmovements

Defecationandurineloss

Gasping(incattle),mostlyduetounderdosing

Veryrare:

Convulsions

Contractionofthediaphragm

Vomiting

Oneorfewgaspingrespirationoccuraftercardiacarrest

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthispackageleaflet,pleaseinformyour

veterinarysurgeon.

7. TARGETSPECIES

Pigs,goats,sheep,cattle,horses,catsanddogs.

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOFADMINISTRATION

Cattle,horses,pigs,goats,sheep,catsanddogs:

100mg/kg(correspondingto0.5ml/kg)viafastintravenousinjection.Forlargeranimals,theuseofapre-

insertedintravenouscatheterisadvocated

Ifcardiacarrestisnotestablishedafter2minutes,aseconddoseneedstobeadministered,preferablyviafast

intravenousinjectionorifthisisnotfeasible,viaintra-cardiacinjection;intra-cardiacinjectionisonly

acceptableafterpriordeepsedationoranaesthesia.

Avoiduseinanimalsweighingmorethan120kgduetothelargeinjectionvolumerequiredanddifficulty

achievingrapidadministration.

Asthevialcannotbepuncturedmorethan20times,theusershouldchoosethemostappropriatevialsize.

9. ADVICEONCORRECTADMINISTRATION

Intravenousinjectionofpentobarbitalhastheabilitytocauseinductionexcitementinseveralspeciesof

animalandadequatesedationshouldbeappliedifdeemednecessarybytheveterinarysurgeon.Measures

mustbetakentoavoidperivascularadministration(e.g.byusingintravenouscatheter).

Toreducetheriskofinductionexcitement,euthanasiashouldbeperformedinaquietarea.

Particularlyinhorsesandcattle,theveterinarysurgeonshouldconsiderpremedicationwithanappropriate

sedativetoproduceprofoundsedationbeforeeuthanasiaandanalternativemethodofeuthanasiais

recommendedtobeavailableshoulditbecomenecessary.

10. WITHDRAWALPERIOD

Notapplicable.

Appropriatemeasuresneedtobetakentoassurethatcarcassesandedibleproductsofanimalsinjectedwith

thisproductdonotenterthefoodchain,andarenotusedforhumanconsumption.Otheranimalsmaynever

eat(partsof)thecarcass,astheymightbeexposedtoalethaldoseofpentobarbital.”

11. SPECIALSTORAGEPRECAUTIONS

Keepoutofthesightandreachofchildren

Thismedicinalproductdoesnotrequireanyspecialstorageconditions Donotuseaftertheexpiry

datestatedonthelabelafter‘’exp’’.

Shelflifeafterfirstopeningofthecontainer:28days.

Whenthevialisbroachedforthefirsttime,thedateonwhichanyproductremaininginthevialistobediscarded

shouldbefilledoutinthespaceprovidedonthelabel.

12. SPECIALWARNING(S)

Specialprecautionsforuseinanimals:

Checkregularly,uptoabout10minutespost-administration,iflivesignsreturn(respiration,heartbeat,

cornealreflex).Inclinicaltrialsithasbeenestablishedthatthismightoccur.Ifsuchlivesignsreturn,itis

advisedtorepeattheadministrationusingbetween0.5and1timestheprescribeddose.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproducttoanimals:

Medicinefortheexclusiveuseoftheveterinarysurgeon.Notforsaletothepublic.

Theadministrationandcustodyofthemedicineshouldonlybecarriedoutbytheveterinarysurgeon.

Pentobarbitalisapotenthypnoticandasedative,andthuspotentiallytoxicinman.Itcanbeadsorbed

systemicallythroughtheskinandifswallowed.Particularcareshouldbetakentoavoidaccidentalingestion

andself-injection

Systemicuptake(includingabsorptionviaskinoreye)ofpentobarbitalcausessedation,sleepinductionand

respiratorydepression.Moreover,thisproductmaybeirritatingtotheeyeandcancauseirritationtotheskin

aswellashypersensitivityreactions(duetothepresenceofpentobarbitalandbenzylalcohol).Embryotoxic

effectscannotbeexcluded.

Avoiddirectcontactwiththeskinandeyes,includinghand-to-eyecontact.

Avoidaccidentalself-injectionoraccidentalinjectionofasecondprofessionalwhenadministeringtheproduct.

Peoplewithknownhypersensitivitytopentobarbitalshouldavoidcontactwiththeveterinarymedicinal

product

Handletheproductwithutmostcare,especiallywomenofchildbearingpotential.Wearprotectivegloves.This

medicineshouldonlybeadministeredbyveterinariansandonlybeusedinthepresenceofanother

professionalthatcanassistincaseofaccidentalexposure.Instructtheprofessionalifnotamedical

professionalabouttherisksoftheproduct.

Accidentalspillageontheskinorintheeyemustbewashedoffimmediatelywithplentyofwater;Iftherehas

beenseriousskinoreyecontactorincaseofaccidentalself-injection,seekmedicaladviceimmediatelyand

showthepackageleafletorthelabeltothephysician.Incaseof accidentalingestion,washoutmouthand

obtainmedicalattentionimmediately.ButDONOTDRIVEassedationmayoccur.

Afteradministrationofthisproduct,collapsewilloccurwithin10seconds.Incasetheanimalisstandingat

timeofadministration,careshouldbetakenbythepersonadministeringtheveterinarymedicinalproductand

anyotherpersonspresenttokeepacertaindistancefromtheanimaltoavoidinjury

Thisproductisflammable,keepawayfromsourcesofignition.Donotsmoke.

Informationforthehealthprofessionalincaseofexposure:

Emergencymeasuresshouldbedirectedtowardmaintenanceofrespirationandcardiacfunction.Insevere

intoxicationmeasurestoenhanceeliminationofabsorbedbarbituratemaybenecessary.

Pregnancy:

Nospecificinformationonpregnantanimalsisavailable.Theuseofthisproductinpregnantanimalsislefttothe

judgementoftheveterinarian.

Interactionwithothermedicinalproductsandotherformsofinteraction:

CNSdepressants(narcotics,phenothiazines,antihistamines,etc.)mayincreasetheeffectofpentobarbital.

Overdose(symptoms,emergencyprocedures,antidotes):

Intheeventofaccidentaladministrationtoananimalnotpresentedforeuthanasia,measuressuchasartificial

respiration,administrationofoxygenandtheuseofanalepticsareappropriate.

Incompatibilities:

Intheabsenceofincompatibilitystudies,thisveterinarymedicinalproductmustnotbemixedwithother

veterinarymedicinalproducts.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTORWASTEMATERIALS,IFANY

Thismedicinalproductisdangeroustohumansandanimals.Disposeofanyunusedproductandempty

containersinaccordancewithguidancefromyourlocalwasteregulationauthority.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

15. OTHERINFORMATION

12vialsof100mlor6vialsof250ml,

typeIIglassinjectionvialwithabromobutylrubberstopperandaluminiumcap.

Itispossiblethatnotallpackagingsizesmaybemarketed.

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The European Union summary report on trends and sources of zoonoses, zoonotic agents and food-borne outbreaks in 2017

The European Union summary report on trends and sources of zoonoses, zoonotic agents and food-borne outbreaks in 2017

Published on: Wed, 12 Dec 2018 This report of the European Food Safety Authority and the European Centre for Disease Prevention and Control presents the results of zoonoses monitoring activities carried out in 2017 in 37 European countries (28 Member States (MS) and nine non-MS). Campylobacteriosis was the commonest reported zoonosis and its EU trend for confirmed human cases increasing since 2008 stabilised during 2013–2017. The decreasing EU trend for confirmed human salmonellosis cases since 2008 end...

Europe - EFSA - European Food Safety Authority Publications

11-12-2018

International Lubricants, Inc. recalls Kool-It Evaporator & Heater Foam Cleaner

International Lubricants, Inc. recalls Kool-It Evaporator & Heater Foam Cleaner

The recalled product does not have proper consumer chemical hazard labelling as required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

30-11-2018

The European Union summary report on surveillance for the presence of transmissible spongiform encephalopathies (TSEs) in 2017

The European Union summary report on surveillance for the presence of transmissible spongiform encephalopathies (TSEs) in 2017

Published on: Thu, 29 Nov 2018 This report presents the results of surveillance on transmissible spongiform encephalopathies (TSEs) in bovine animals, sheep, goats, cervids and other animal species, as well as genotyping in sheep, carried out in 2017 in the European Union (EU) according to Regulation (EC) 999/2001, and in Iceland, Norway and Switzerland. In total, 1,312,714 cattle were tested by the 28 EU Member States (MSs) which is a decrease of 3% compared with 2016; 18,526 were tested by the three n...

Europe - EFSA - European Food Safety Authority Publications

29-11-2018

MPS Canada Corporation recalls various Consumer chemical products in pressurized containers

MPS Canada Corporation recalls various Consumer chemical products in pressurized containers

The recalled products were not destined for the Canadian marketplace and do not have mandatory hazard labelling as required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act. Improper labelling could result in unintentional exposure to these products and lead to serious illness, injury or death.

Health Canada

27-11-2018

Risk assessment of new sequencing information for genetically modified soybean A2704‐12

Risk assessment of new sequencing information for genetically modified soybean A2704‐12

Published on: Mon, 26 Nov 2018 The GMO Panel has previously assessed genetically modified (GM) soybean A2704‐12. This soybean was found to be as safe and nutritious as its conventional counterpart with respect to potential effects on human and animal health and the environment in the context of its intended uses. On 5 June 2018, the European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for GM soybean A2704‐12 and to indicate whether the previous c...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Fresenius Kabi Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9% Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex

Fresenius Kabi Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9% Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex

Fresenius Kabi USA is voluntarily recalling 163 lots of Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial and Sodium Chloride Injection, USP, 0.9%, 20 mL fill in a 20 mL vial to the user level. The product insert states that stoppers for both the 10mL and the 20mL vials do not contain natural rubber latex; the tray label for the two vial sizes and the vial label for the 20mL vial also state that the stoppers do not contain latex. The product is being recalled because the stoppers contain n...

FDA - U.S. Food and Drug Administration

21-11-2018

VaperBC recalls 100 mg Nicotine Base Liquid Nicotine

VaperBC recalls 100 mg Nicotine Base Liquid Nicotine

These vaping products do not meet requirements of the Consumer Chemicals and Containers Regulations, 2001 (CCCR, 2001) under the Canada Consumer Product Safety Act.

Health Canada

21-11-2018

Enforcement Report for the Week of November 21, 2018

Enforcement Report for the Week of November 21, 2018

Recently Updated Records for the Week of November 21, 2018 Last Modified Date: Tuesday, November 20, 2018

FDA - U.S. Food and Drug Administration

21-11-2018

Implementation and verification of PBPK modelling codes of TCDD in rats and humans into Berkeley Madonna

Implementation and verification of PBPK modelling codes of TCDD in rats and humans into Berkeley Madonna

Published on: Tue, 20 Nov 2018 The goal of the current work was to implement and verify previously published rat and human PBPK modelling codes for TCDD into Berkeley Madonna. The US‐EPA has used these PBPK models in the reassessment of TCDD. A procurement contract has been set up to explore the possibilities to adequately run the models and reproduce previously published results. The implementation of the available codes in Berkeley Madonna was carried out at RIKILT‐WUR under the framework agreement wi...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Extensive Literature Search, Selection for Relevance and Data Extraction of Studies Related to the Toxicity of PCDD/Fs and DL‐PCBs in Experimental Animals

Extensive Literature Search, Selection for Relevance and Data Extraction of Studies Related to the Toxicity of PCDD/Fs and DL‐PCBs in Experimental Animals

Published on: Tue, 20 Nov 2018 Polychlorinated dibenzodioxins (PCDD), polychlorinated dibenzofurans (PCDFs) and dioxin‐like polychlorinated biphenyls (DL‐PCBs) are detected ubiquitously in the environment, diet and human tissues. The European Food Safety Authority (EFSA) CONTAM Panel received a mandate from the European Commission for a scientific opinion on the risks for human and animal health related to the presence of dioxins and DL‐PCBs in food and feed. To support preparatory work for the hazard i...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Published on: Tue, 20 Nov 2018 The feed additive Monteban® G100, containing the active substance narasin, an ionophore anticoccidial, is intended to control coccidiosis in chickens for fattening at a dose of 60–70 mg/kg complete feed. Narasin is produced by fermentation. Limited data on the taxonomic identification of the production strain did not allow the proper identification of strain NRRL 8092 as Streptomyces aureofaciens. The FEEDAP Panel cannot conclude on the absence of genetic determinants for ...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Extensive literature search, selection for relevance and data extraction of studies related to the toxicity of PCDD/Fs and DL‐PCBs in humans

Extensive literature search, selection for relevance and data extraction of studies related to the toxicity of PCDD/Fs and DL‐PCBs in humans

Published on: Tue, 20 Nov 2018 To enable the hazard identification and characterisation in the risk assessment for humans related to the seventeen 2,3,7,8‐substituted dioxins (PCCDs) and furans (PCDFs) and the twelve dioxin‐like polychlorinated biphenyls (DL‐PCBs), EFSA outsourced an extensive literature search (ELS), followed by selection for relevance and extraction of relevant data for consideration in the risk assessment. Two tailored search strategies for Web of Science (WoS) and PubMed for identif...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Risk for animal and human health related to the presence of dioxins and dioxin-like PCBs in feed and food

Risk for animal and human health related to the presence of dioxins and dioxin-like PCBs in feed and food

Published on: Tue, 20 Nov 2018 The European Commission asked EFSA for a scientific opinion on the risks for animal and human health related to the presence of dioxins (PCDD/Fs) and DL‐PCBs in feed and food. The data from experimental animal and epidemiological studies were reviewed and it was decided to base the human risk assessment on effects observed in humans and to use animal data as supportive evidence. The critical effect was on semen quality, following pre‐ and postnatal exposure. The critical s...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Setting of an import tolerance for mandipropamid in cocoa beans

Setting of an import tolerance for mandipropamid in cocoa beans

Published on: Tue, 20 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Agro GmbH submitted a request to the competent national authority in Austria to set a maximum residue level (MRL) for the active substance mandipropamid in cocoa beans imported from Nigeria and Cameroon. The data submitted in support of the request were found to be sufficient to derive a MRL proposal of 0.06 mg/kg. Adequate analytical methods for enforcement are available to control the res...

Europe - EFSA - European Food Safety Authority Publications

20-11-2018

November 20, 2018: Rochester Man Pleads Guilty to Smuggling Counterfeit Cialis and Viagra into the United States

November 20, 2018: Rochester Man Pleads Guilty to Smuggling Counterfeit Cialis and Viagra into the United States

November 20, 2018: Rochester Man Pleads Guilty to Smuggling Counterfeit Cialis and Viagra into the United States

FDA - U.S. Food and Drug Administration

20-11-2018

Vijf winnaars van energieneutrale sportprojecten kunnen aan de slag

Vijf winnaars van energieneutrale sportprojecten kunnen aan de slag

Op 20 november zijn de vijf winnaars van de Innovation Challenge Energieneutrale Sportaccommodaties, vanuit het programma Sportinnovator, bekendgemaakt. De innovatieve ideeën voor energiebesparing bij sportaccommodaties hebben groen licht gekregen. Ze ontvangen hiervoor steun van het ministerie van Volksgezondheid, Welzijn en Sport om innovatie in de sport te bevorderen. Onderstaande initiatieven krijgen 100.000 euro om het idee in de praktijk door te voeren.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

20-11-2018

Modification of the existing maximum residue levels for pyraclostrobin in soyabean

Modification of the existing maximum residue levels for pyraclostrobin in soyabean

Published on: Mon, 19 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in France to modify the existing maximum residue level (MRL) for the active substance pyraclostrobin in soyabean. The data submitted in support of the request were found to be sufficient to derive MRL proposals for soyabean. The applicant provided a new validated analytical method to control residues of pyraclostrobin on the commodity u...

Europe - EFSA - European Food Safety Authority Publications

20-11-2018

Modification of the existing maximum residue levels and setting of import tolerances for pyraclostrobin in various crops

Modification of the existing maximum residue levels and setting of import tolerances for pyraclostrobin in various crops

Published on: Mon, 19 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted two requests to the competent national authority in Germany. The first one, to modify the existing maximum residue levels (MRL) for the active substance pyraclostrobin in various crops and to set import tolerances for sugar canes and American persimmons; the second one to set import tolerances for pineapples and passion fruits/maracujas. The data submitted in support of the request...

Europe - EFSA - European Food Safety Authority Publications

20-11-2018

Peer review of the pesticide risk assessment of the active substance (EZ)‐1,3‐dichloropropene

Peer review of the pesticide risk assessment of the active substance (EZ)‐1,3‐dichloropropene

Published on: Mon, 19 Nov 2018 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, Spain, for the pesticide active substance (EZ)‐1,3‐dichloropropene 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 representative uses of (EZ)‐1,3‐dichloropropene ...

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

Assessment of genetically modified soybean MON 89788 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐011)

Assessment of genetically modified soybean MON 89788 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐011)

Published on: Fri, 16 Nov 2018 Following the submission of application EFSA‐GMO‐RX‐011 under Regulation (EC) No 1829/2003 from Monsanto Europe, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide‐tolerant genetically modified soybean MON 89788, for food and feed uses, excluding cultivation within the European Union....

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

Review of the existing maximum residue levels for tau‐fluvalinate according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for tau‐fluvalinate according to Article 12 of Regulation (EC) No 396/2005

Published on: Fri, 16 Nov 2018 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance tau‐fluvalinate. To assess the occurrence of tau‐fluvalinate residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008 as well as the European authorisations reported by Member St...

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for picolinafen

Evaluation of confirmatory data following the Article 12 MRL review for picolinafen

Published on: Fri, 16 Nov 2018 The applicant BASF Agro B.V. submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for picolinafen in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, a new validated analytical method for enforcement of the residue in dry/high starch‐, high water content‐, high acid content‐ and high oil content commodities ...

Europe - EFSA - European Food Safety Authority Publications

16-11-2018

Setting of an import tolerance for pyraclostrobin in rice

Setting of an import tolerance for pyraclostrobin in rice

Published on: Thu, 15 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in Germany to set an import tolerance for the active substance pyraclostrobin in rice. The data submitted in support of the request were found to be sufficient to derive a maximum residue level (MRL) proposal for rice. Based on the risk assessment results, EFSA concluded that the short‐term intake of residues resulting from the use of p...

Europe - EFSA - European Food Safety Authority Publications

16-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for pyraclostrobin

Evaluation of confirmatory data following the Article 12 MRL review for pyraclostrobin

Published on: Thu, 15 Nov 2018 The applicant BASF SE submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for pyraclostrobin in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, residues trials supporting the existing use of pyraclostrobin on table grapes authorised in southern EU Member States and an analytical method for analysing residues of pyraclostrobin in ...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Assessment of genetically modified LLCotton25 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐010)

Assessment of genetically modified LLCotton25 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐010)

Published on: Wed, 14 Nov 2018 Following the submission of application EFSA‐GMO‐RX‐010 under Regulation (EC) No 1829/2003 from Bayer, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide‐tolerant genetically modified LLCotton25, for food and feed uses, import and processing, excluding cultivation within the EU. The d...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Assessment of genetically modified maize MZHG0JG for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2016‐133)

Assessment of genetically modified maize MZHG0JG for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2016‐133)

Published on: Wed, 14 Nov 2018 The scope of application EFSA‐GMO‐DE‐2016‐133 is for food and feed uses, import and processing of genetically modified (GM) maize MZHG0JG in the European Union. Maize MZHG0JG was developed to confer tolerance to the herbicidal active substances glyphosate and glufosinate‐ammonium. The molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the identified differences in the agronomic/phenotypic and com...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Published on: Wed, 14 Nov 2018 The coccidiostat Monimax® (monensin sodium and nicarbazin) is considered safe for chickens for fattening and chickens reared for laying at the highest use level of 50 mg monensin and 50 mg nicarbazin/kg complete feed. This conclusion is extended to chickens reared for laying. For both active substances, the metabolic pathways in the chicken are similar to those in the turkey and rat. Nicarbazin, when ingested, is rapidly split in its two components dinitrocarbanilide (DNC)...

Europe - EFSA - European Food Safety Authority Publications

14-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for cyazofamid

Evaluation of confirmatory data following the Article 12 MRL review for cyazofamid

Published on: Tue, 13 Nov 2018 The applicant ISK Biosciences Europe N.V. submitted a request to the competent national authority in France to evaluate the confirmatory data that were identified in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. The data gap which was related to information on freezer storage conditions for the residue trials reported on potatoes, tomatoes and cucurbits with edible and inedible peel was considered satisfactorily addressed...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

Peer review of the pesticide risk assessment of the active substance napropamide‐M

Peer review of the pesticide risk assessment of the active substance napropamide‐M

Published on: Mon, 12 Nov 2018 00:00:00 +0100 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State the United Kingdom for the pesticide active substance napropamide‐M 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 representative uses of napropamid...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

Setting of import tolerances for teflubenzuron in grapefruits, mandarins and broccoli

Setting of import tolerances for teflubenzuron in grapefruits, mandarins and broccoli

Published on: Mon, 12 Nov 2018 00:00:00 +0100 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF Agro BV submitted a request to the competent national authority in the United Kingdom to set import tolerances for the active substance teflubenzuron in grapefruits and mandarins imported from Brazil and for broccoli imported from Paraguay. The data submitted were found to be sufficient to derive maximum residue level (MRL) proposals for grapefruits and broccoli. The MRL derived ...

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

9-11-2018

Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release

Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release

Vaccine lot release information updated on 3/3/2010.

FDA - U.S. Food and Drug Administration

9-11-2018

First Choice Vapor recalls Unflavoured 100 mg Nicotine Base E-Liquids

First Choice Vapor recalls Unflavoured 100 mg Nicotine Base E-Liquids

These vaping products do not meet requirements of the Consumer Chemicals and Containers Regulations, 2001 (CCCR, 2001) under the Canada Consumer Product Safety Act.

Health Canada

8-11-2018

Theme event on big data and medicine

Theme event on big data and medicine

The U.S. Food and Drug Administration, FDA, The European Medicines Agency, EMA, and Novo Nordisk are among the speakers when The Danish Medicines Agency on 20 November 2018 puts focus on big data and medicine under the event heading “From Big Data to Real World Evidence”.

Danish Medicines Agency

7-11-2018

Nature's Ultimate recalls NuWrench and NuStainless Products

Nature's Ultimate recalls NuWrench and NuStainless Products

The recalled products are not provided with the required child-resistant containers required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

7-11-2018

Murray Wholesale Cash & Carry recalls King Universal Butane Fuel

Murray Wholesale Cash & Carry recalls King Universal Butane Fuel

The recalled products do not have proper hazard labelling as required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

6-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for kresoxim‐methyl

Evaluation of confirmatory data following the Article 12 MRL review for kresoxim‐methyl

Published on: Fri, 02 Nov 2018 00:00:00 +0100 The applicant BASF SE submitted a request to the competent national authority in Belgium to evaluate the confirmatory data that were identified for kresoxim‐methyl in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the confirmatory data requirement, a new study on the storage stability of kresoxim‐methyl residues in animal matrices was submitted. The data gap was considered ...

Europe - EFSA - European Food Safety Authority Publications

6-11-2018

Setting of import tolerances for haloxyfop‐P in linseed and rapeseed

Setting of import tolerances for haloxyfop‐P in linseed and rapeseed

Published on: Fri, 02 Nov 2018 00:00:00 +0100 In accordance with Article 6 of Regulation (EC) No 396/2005, the Australian Government Department of Agriculture and Water Resources submitted two requests to the competent national authority in Denmark to set import tolerances for the active substance haloxyfop‐P in linseed and rapeseed. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for linseed and rapeseed. Adequate analytical metho...

Europe - EFSA - European Food Safety Authority Publications

5-11-2018

Vanpak Limited recalls David Ross Extra purified Butane gas

Vanpak Limited recalls David Ross Extra purified Butane gas

The recalled products do not have proper hazard labelling as required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act. Improper labelling could result in unintentional exposure to these products and lead to serious illness, injury or death.

Health Canada

31-10-2018

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Published on: Tue, 30 Oct 2018 00:00:00 +0100 In compliance with Article 43 of Regulation (EC) No 396/2005, EFSA received a mandate from the European Commission to provide an update of the reasoned opinion on the review of existing maximum residue levels (MRLs) for imazalil published on 5 September 2017, taking into account the additional information provided on the toxicity of the metabolites R014821, FK‐772 and FK‐284. EFSA did not derive MRL proposals from the post‐harvest uses reported on citrus fru...

Europe - EFSA - European Food Safety Authority Publications

29-10-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new consideration of labeling for sesame allergies

Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new consideration of labeling for sesame allergies

Food allergies have touched the lives of most of us. Thousands of Americans experience life-threatening, food-related reactions each year, and an estimated 20 people die from them annually. In some cases, such reactions occur despite a careful reading of packaged food labels by conscientious consumers. To me, that’s unacceptable. The FDA is committed to advancing our efforts to help ensure that Americans have access to the information they need about common allergens in packaged foods.

FDA - U.S. Food and Drug Administration

25-10-2018

BLL Enterprises Inc. recalls Fluid Film Rust & Corrosion Protection Aerosol

BLL Enterprises Inc. recalls Fluid Film Rust & Corrosion Protection Aerosol

The recalled products do not have proper hazard labelling required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

24-10-2018

G & C Raw, LLC is Expanding Recall to Include All Product Lots Manufactured from February 27, 2018 Through July 20, 2018, Because of Possible Listeria Monocytogenes Health Risk

G & C Raw, LLC is Expanding Recall to Include All Product Lots Manufactured from February 27, 2018 Through July 20, 2018, Because of Possible Listeria Monocytogenes Health Risk

G & C Raw, of Versailles, OH is recalling all products lots manufactured from February 27, 2018 through July 20, 2018, as a precaution because they have the potential to be contaminated with Listeria monocytogenes

FDA - U.S. Food and Drug Administration

23-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for pendimethalin

Evaluation of confirmatory data following the Article 12 MRL review for pendimethalin

Published on: Mon, 22 Oct 2018 00:00:00 +0200 The applicant BASF Agro BV submitted a request to the competent national authority in the Netherlands to evaluate the confirmatory data that were identified in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, residue trials on strawberries, onions, garlic, tomatoes, peppers, cucumbers, artichokes, leeks and rape seeds were submitted. The data gaps are considere...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for dimethomorph

Evaluation of confirmatory data following the Article 12 MRL review for dimethomorph

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The applicant BASF SE submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for dimethomorph in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The submitted residue data on raspberries were satisfactorily addressing the data gaps on raspberries and blackberries. Considering the new information provided, it is appropri...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for pyraflufen‐ethyl

Evaluation of confirmatory data following the Article 12 MRL review for pyraflufen‐ethyl

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The applicant, Nichino Europe Co. Ltd., submitted application request to the competent national authority in the Netherlands to evaluate confirmatory data that were identified for pyraflufen‐ethyl in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The submitted data were sufficient to confirm the MRLs for citrus fruits, tree nuts, pome fruits, stone fruits, table and wine grapes, curra...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Published on: Fri, 19 Oct 2018 00:00:00 +0200 EFSA was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide [FL‐no: 16.133], in the Flavouring Group Evaluation 411 (FGE.411), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intende...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β‐unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β‐unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of 74 flavouring substances from subgroup 1.1.1 of FGE.19 in the Flavouring Group Evaluation 200 Revision 1 (FGE.200 Rev1). In FGE.200, genotoxicity studies were provided for one representative substance, namely hex‐2(trans)‐enal [FL‐no: 05.073], and for other two substances in the same subgroup, namely 2‐dodecenal [FL‐no: 05.03...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Modification of the existing maximum residue levels for mepiquat in cotton seeds and animal commodities

Modification of the existing maximum residue levels for mepiquat in cotton seeds and animal commodities

Published on: Mon, 15 Oct 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant, BASF SE, submitted an application to the competent national authority in Greece to modify the existing maximum residue level (MRL) for the active substance mepiquat in cotton seeds. The data submitted in support of the application were found to be sufficient to derive a MRL proposal for cotton seeds and the previously derived MRL proposals for animal commodities were found to be stil...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for teflubenzuron

Evaluation of confirmatory data following the Article 12 MRL review for teflubenzuron

Published on: Mon, 15 Oct 2018 00:00:00 +0200 The applicant BASF Agro BV submitted a request to the competent national authority in United Kingdom to evaluate the confirmatory data that were identified for teflubenzuron in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, a new metabolism study on leafy crops, a study investigating the nature of residues under standard hydrolytic conditions and a validated ...

Europe - EFSA - European Food Safety Authority Publications

6-10-2018

Modification of the existing maximum residue level for epoxiconazole in beetroots

Modification of the existing maximum residue level for epoxiconazole in beetroots

Published on: Fri, 05 Oct 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Agriculture & Horticulture Development Board submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue level (MRL) for the active substance epoxiconazole in beetroots. The data submitted in support of the request were found to be sufficient to derive a MRL proposal for beetroots. Adequate analytical methods for enforcement are...

Europe - EFSA - European Food Safety Authority Publications

4-10-2018

Nederland organiseert wereldwijde conferentie tegen antibioticaresistentie

Nederland organiseert wereldwijde conferentie tegen antibioticaresistentie

Samen met de Wereldgezondheidorganisatie (WHO) zal Nederland in april 2019 een wereldwijde ministeriële conferentie organiseren over de strijd tegen antibioticaresistentie. Dat heeft minister Bruno Bruins (Medische Zorg) bekend gemaakt tijdens de G20-bijeenkomst in Argentinië. Bij deze bijeenkomst maakte Bruins afspraken met zijn collega’s uit de grootste 20 economieën van de wereld over een gezamenlijke aanpak van gezondheidsvraagstukken. Mede door jarenlange inzet van Nederland, staat antibioticaresist...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

2-10-2018

Review of the existing maximum residue levels for cyflufenamid according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for cyflufenamid according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 01 Oct 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance cyflufenamid. To assess the occurrence of cyflufenamid residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (in...

Europe - EFSA - European Food Safety Authority Publications

5-12-2018

TGA presentation: Webinar: Advertising therapeutic goods in 2019: The Code basics – 20 November

TGA presentation: Webinar: Advertising therapeutic goods in 2019: The Code basics – 20 November

The slides from TGA's webinar on Advertising Code Basics have been published

Therapeutic Goods Administration - Australia

28-11-2018

PHEBURANE (Eurocept International BV)

PHEBURANE (Eurocept International BV)

PHEBURANE (Active substance: Sodium Phenylbutyrate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8043 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2500/T/20

Europe -DG Health and Food Safety

26-11-2018

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health technologies.

FDA - U.S. Food and Drug Administration

26-11-2018

Today’s statement highlights increased expectations for information required in 510(k) submissions; each averages 1,185 pages, compared to 475 pages in 2009. Reviewers spend more time reviewing applications, but time to decision has become more efficient

Today’s statement highlights increased expectations for information required in 510(k) submissions; each averages 1,185 pages, compared to 475 pages in 2009. Reviewers spend more time reviewing applications, but time to decision has become more efficient

Today’s statement highlights increased expectations for information required in 510(k) submissions; each averages 1,185 pages, compared to 475 pages in 2009. Reviewers spend more time reviewing applications, but time to decision has become more efficient https://go.usa.gov/xPHdE 

FDA - U.S. Food and Drug Administration

26-11-2018

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009.  https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https://go.usa.gov/xPHdn 

FDA - U.S. Food and Drug Administration

16-11-2018

Latuda (Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.)

Latuda (Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.)

Latuda (Active substance: lurasidone) - Centralised - Renewal - Commission Decision (2018)7674 of Fri, 16 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2713/R/20

Europe -DG Health and Food Safety

14-11-2018

Jinarc (Otsuka Pharmaceutical Netherlands B.V.)

Jinarc (Otsuka Pharmaceutical Netherlands B.V.)

Jinarc (Active substance: tolvaptan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7604 of Wed, 14 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2788/T/20

Europe -DG Health and Food Safety