Euthanimal

Main information

  • Trade name:
  • Euthanimal 40%
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Euthanimal 40%
    Ireland
  • 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/0177/002
  • Authorization date:
  • 29-05-2013
  • EU code:
  • NL/V/0177/002
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

ANNEXI

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Euthanimal40%,400mg/mlsolutionforinjection(BE,BG,CY,DK,EE,FI,HU,LT,LV,MT,NL,PT,RO,SI,UK)

Euthanimal400mg/ml,solutionforinjection(CZ,DE,ES,IE,PL,SE).

Euthanimal40%,200mg/mlsolutionforinjectionforpigs,goats,sheep,cattle,horses,catsanddogs(IT)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontains

Activesubstance:

sodiumpentobarbital400mg(equivalentto365mgpentobarbital)

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.

Carcassesandedibleproductsofanimalsinjectedwiththisproductmayneverenterthefoodchainandotheranimals

maynevereat(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.

Avoiduseinanimalsweighinglessthan20kgduetothehighlyconcentratednatureoftheproductand

increasedriskofpainandirritationifadministeredperivascularly.

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.

Theconcentrationofpentobarbitalintheproductissuchthattheaccidentalinjectionoringestionof

quantitiesassmallas1mlinhumanadultscanhaveseriousCNSeffects.Adoseofpentobarbitalsodiumof1g

(equivalentto2.5mlofproduct)hasbeenreportedtobefatalinhumans.Treatmentshouldbesupportive

withappropriateintensivetherapyandmaintenanceofrespiration.

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(correspondingto0.25ml/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.

Inviewoftheactivityofthisproduct,doubledosageisdiscouraged,asthiswillnotresultinafasterorbetter

euthanasia.

4.11 Withdrawalperiod(s)

Notapplicable

Appropriatemeasuresneedtobetakentoassurethatcarcassesandedibleproductsofanimalsinjectedwiththisproduct

donotenterthefoodchain,andarenotusedforhumanconsumption.Otheranimalsmaynevereat(partsof)the

carcass,astheymightbeexposedtoalethaldoseofpentobarbital.

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:1year

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

Euthanimal40%,400mg/mlsolutionforinjection(BE,BG,CY,DK,EE,FI,HU,LT,LV,MT,NL,PT,RO,SI,UK)

Euthanimal400mg/ml,solutionforinjection(CZ,DE,ES,IE,PL,SE).

Euthanimal40%,200mg/mlsolutionforinjectionforpigs,goats,sheep,cattle,horses,catsanddogs(IT)

{Sodiumpentobarbital}

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Eachmlcontains

Activesubstance:

sodiumpentobarbital400mg(equivalentto365mgpentobarbital).

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(correspondingto0.25ml/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:

PARTICULARSTOAPPEARONTHEIMMEDIATEPACKAGINGUNITS

{Glassvial}

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Euthanimal40%,400mg/mlsolutionforinjection(BE,BG,CY,DK,EE,FI,HU,LT,LV,MT,NL,PT,RO,SI,UK)

Euthanimal400mg/ml,solutionforinjection(CZ,DE,ES,IE,PL,SE).

Euthanimal40%,200mg/mlsolutionforinjectionforpigs,goats,sheep,cattle,horses,catsanddogs(IT)

{Sodiumpentobarbital}

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Eachmlcontains

Activesubstance:

sodiumpentobarbital400mg(equivalentto365mgpentobarbital).

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(correspondingto0.25ml/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.Disposeofanyunusedproductandempty

containersinaccordancewithguidancefromyourlocalwasteregulationauthority

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSORRESTRICTIONSREGARDING

SUPPLYANDUSE,IFAPPLICABLE

Foranimaltreatmentonly.

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:

Euthanimal40%,400mg/mlsolutionforinjection(BE,BG,CY,DK,EE,FI,HU,LT,LV,MT,NL,PT,RO,SI,UK)

Euthanimal400mg/ml,solutionforinjection(CZ,DE,ES,IE,PL,SE).

Euthanimal40%,400mg/mlsolutionforinjectionforpigs,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

Euthanimal40%,400mg/mlsolutionforinjection(BE,BG,CY,DK,EE,FI,HU,LT,LV,MT,NL,PT,RO,SI,UK)

Euthanimal400mg/ml,solutionforinjection(CZ,DE,ES,IE,PL,SE).

Euthanimal40%,400mg/mlsolutionforinjectionforpigs,goats,sheep,cattle,horses,catsanddogs(IT)

Sodiumpentobarbital.

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

Eachmlcontains:

Activesubstance:

sodiumpentobarbital400mg(equivalentto365mgpentobarbital)

Preservatives:

Benzylalcohol(E1519)20.0mg

Ethanol 80.0mg

4. INDICATION(S)

ForEuthanasia

5. CONTRAINDICATIONS

Donotuseforanaesthesia.

Carcassesandedibleproductsofanimalsinjectedwiththisproductmayneverenterthefoodchainandotheranimals

maynevereat(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(correspondingto0.25ml/kg)viafastintravenousinjection.Forlargeranimals,theuseofapre-

insertedintravenouscatheterisadvocated.

Ifcardiacarrestisnotestablishedafter2minutes,aseconddoseneedstobeadministered,preferablyviafast

intravenousinjectionorifthisisnotfeasible,viaintra-cardiacinjection;intra-cardiacinjectionisonly

acceptableafterpriordeepsedationoranaesthesia.

Avoiduseinanimalsweighinglessthan20kgduetothehighlyconcentratednatureoftheproductand

increasedriskofpainandirritationifadministeredperivascularly.

Inhorsesandcattle,premedicationwithanappropriatesedativemightbeusedtoproducesedationbefore

euthanasia.

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.

Theconcentrationofpentobarbitalintheproductissuchthattheaccidentalinjectionoringestionofquantitiesas

smallas1mlinhumanadultscanhaveseriousCNSeffects.Adoseofpentobarbitalsodiumof1g(equivalentto

2.5mlofproduct)hasbeenreportedtobefatalinhumans.Treatmentshouldbesupportivewithappropriate

intensivetherapyandmaintenanceofrespiration.

Pregnancy:

Nospecificinformationonpregnantanimalsisavailable.Theuseofthisproductinpregnantanimalsislefttothe

judgementoftheveterinarian.

Interactionwithothermedicinalproductsandotherformsofinteraction:CNSdepressants(narcotics,

phenothiazines,antihistamines,etc.)mayincreasetheeffectofpentobarbital.

Inviewoftheactivityofthisproduct,doubledosageisdiscouraged,asthiswillnotresultinafasterorbetter

euthanasia.

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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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

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

31-8-2018

Public Notification: PremierZen Gold 4000 contains hidden drug ingredient

Public Notification: PremierZen Gold 4000 contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use PremierZen Gold 4000, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

3-8-2018

Scientific guideline:  Ledipasvir/sofosbuvir film-coated tablet 90 mg/400 mg product-specific bioequivalence guidance, adopted

Scientific guideline: Ledipasvir/sofosbuvir film-coated tablet 90 mg/400 mg product-specific bioequivalence guidance, adopted

Ledipasvir/sofosbuvir film-coated tablet 90 mg/400 mg product-specific bioequivalence guidance

Europe - EFSA - European Food Safety Authority EFSA Journal

14-6-2018

Blokhuis: maak postnatale depressie bespreekbaar

Blokhuis: maak postnatale depressie bespreekbaar

In Nederland ontwikkelen jaarlijks ruim 23.400 vrouwen een depressie na de bevalling. Dat is 1 op de 8 moeders. Velen van hen durven hun situatie niet aan te kaarten. Zij zijn bang om gezien te worden als een slechte moeder (47,4%) en willen anderen niet belasten (52,2%), blijkt uit een peiling onder vrouwen die (signalen van) een postnatale depressie hebben gehad. Hierdoor blijft postnatale depressie, ook wel postpartum depressie (PPD) genoemd, te vaak onbesproken. Daarom geeft staatssecretaris Paul Blo...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

19-6-2015

Global operation against illicit medicines completed

Global operation against illicit medicines completed

A global medicine operation results in 156 arrests and shutdown of more than 2,400 websites.

Danish Medicines Agency

25-7-2018

#FDA issues updated safety communication for Zoll LifeVest 4000 regarding “Message Code 102,” and updated patient checklist.  https://go.usa.gov/xUEPn  #MedicalDevices

#FDA issues updated safety communication for Zoll LifeVest 4000 regarding “Message Code 102,” and updated patient checklist. https://go.usa.gov/xUEPn  #MedicalDevices

#FDA issues updated safety communication for Zoll LifeVest 4000 regarding “Message Code 102,” and updated patient checklist. https://go.usa.gov/xUEPn  #MedicalDevices

FDA - U.S. Food and Drug Administration

29-5-2018

EU/3/14/1400 (Orphan Europe S.A.R.L.)

EU/3/14/1400 (Orphan Europe S.A.R.L.)

EU/3/14/1400 (Active substance: (1S,4R,5R,7S)-3,4-dibenzyl-2-oxo-6,8-dioxa-3-azabyciclo[3.2.1]octane-7-carboxylic acid-L-lysine) - Transfer of orphan designation - Commission Decision (2018)3402 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/185/14/T/01

Europe -DG Health and Food Safety