Euthanimal 40%

Main information

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

Documents

Localization

  • Available in:
  • Euthanimal 40%
    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/0177/002
  • 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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Europe - EFSA - European Food Safety Authority Publications

28-11-2018

Information Update - Mylan-Valsartan medications voluntarily recalled as a precaution due to an impurity

Information Update - Mylan-Valsartan medications voluntarily recalled as a precaution due to an impurity

Mylan Pharmaceuticals ULC is voluntarily recalling four lots of Mylan-Valsartan tablets (40 mg, 80 mg, 160 mg and 320 mg strength) after testing found low levels of an impurity, N-nitrosodiethylamine (NDEA).

Health Canada

21-11-2018

Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Fou

Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Fou

Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is conducting a voluntary nationwide recall to the consumer level of select lots of Valsartan-containing products, including six lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, and 10mg/320mg strengths), seven lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg, and 320 mg strengths), and two lots of Valsartan and Hydrochlorothiazide Tablets, USP 320mg/25mg strength. ...

FDA - U.S. Food and Drug Administration

17-11-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Aspergillus oryzae (strain NZYM‐FA)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Aspergillus oryzae (strain NZYM‐FA)

Published on: Fri, 16 Nov 2018 The food enzyme is an endo‐1,4‐β‐xylanase (EC 3.2.1.8) produced with a genetically modified strain of Aspergillus oryzae 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 xylanase is intended to be used in baking and cereal‐based processes. Based on the proposed maximum use levels, dietary exposure to the food enzyme–total organic solids (TOS) was e...

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

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

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

12-10-2018

FDA advances investigation into whether more than 40 e-cigarette products are being illegally marketed and outside agency's compliance policy

FDA advances investigation into whether more than 40 e-cigarette products are being illegally marketed and outside agency's compliance policy

FDA advances investigation into whether more than 40 e-cigarette products are being illegally marketed and outside agency's compliance policy

FDA - U.S. Food and Drug Administration

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

19-9-2018

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

Published on: Tue, 18 Sep 2018 00:00:00 +0200 During the years 2012‐2016, the Dutch National Food Consumption survey was conducted in the Netherlands. For the survey, a random sample was drawn from consumer panels stratified by age and gender and maintained representative to the population with regard to region, address density and educational level. Complete results were obtained for 4,313 persons (response rate 65%); including toddlers, children, adolescents, adults and elderly. Pregnant or lactating ...

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

9-8-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg Due to The Detection of Trace Amounts of N-Nitrosodimethylamine (NDMA) Impurity, Found in an Active Pharmaceutical Ingredient (API)

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg Due to The Detection of Trace Amounts of N-Nitrosodimethylamine (NDMA) Impurity, Found in an Active Pharmaceutical Ingredient (API)

As a precautionary measure, Camber Pharmaceuticals, Inc. is voluntarily recalling all unexpired lots of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg to the hospital, retail and consumer level. This recall of multiple batches of Valsartan Tablets was prompted due to the detection of trace amounts of N-Nitrosodimethylamine (NDMA), a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, Unit – I (API manufacturer).

FDA - U.S. Food and Drug Administration

6-8-2018

G & C Raw, LLC Recalls Pat's Cat Turkey, and Ground Lamb Pet Food, because of Possible Listeria Monocytogenes Health Risk

G & C Raw, LLC Recalls Pat's Cat Turkey, and Ground Lamb Pet Food, because of Possible Listeria Monocytogenes Health Risk

G & C Raw, of Versailles, OH is recalling 30 1-lb containers of Pat's Cat Turkey Cat Food and 40 2-lb containers of Ground Lamb Dog Food because it has the potential to be contaminated with Listeria monocytogenes. Listeria monocytogenes can cause serious and sometimes fatal infections in animals eating the products.

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

13-7-2018

Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products

Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products

Prinston Pharmaceutical Inc. dba Solco Healthcare LLC. is recalling all lots of Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-Hydrochlorothiazide Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg to the retail level. This product recall is due to the detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA), made by the manufacturer – Zhejiang Huahai Pharmaceutical Co. Ltd. -- that is used in the manufacture of the subject product ...

FDA - U.S. Food and Drug Administration

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

12-6-2018

Ashley Furniture Industries , Inc. recalls Signature Design by Ashley Amnon Floor Lamp

Ashley Furniture Industries , Inc. recalls Signature Design by Ashley Amnon Floor Lamp

The lamp has incorrect lightbulb wattage information printed on a label on the sockets of the lamp. The incorrect labels indicate that each socket can support 40 W bulbs, however the product is only rated for each socket supporting a 25 W bulb. The use of lightbulbs with the incorrect wattage could potentially melt the power-switch, posing a burn hazard.

Health Canada

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

27-8-2018

Beromun (BELPHARMA s.a.)

Beromun (BELPHARMA s.a.)

Beromun (Active substance: Tasonermin (Tumor Necrosis Factor alfa-1a)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5699 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/206/T/40

Europe -DG Health and Food Safety

7-8-2018

ACMD meeting statement, Meeting 40, 12 April 2018

ACMD meeting statement, Meeting 40, 12 April 2018

Advisory Committee on Medical Devices meeting statement

Therapeutic Goods Administration - Australia

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

11-6-2018

Zydelig (Gilead Sciences Ireland UC)

Zydelig (Gilead Sciences Ireland UC)

Zydelig (Active substance: idelalisib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3765 of Mon, 11 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3843/T/40

Europe -DG Health and Food Safety

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

16-5-2018

Elonva (Merck Sharp and Dohme B.V.)

Elonva (Merck Sharp and Dohme B.V.)

Elonva (Active substance: corifollitropin alfa) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3049 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1106/T/40

Europe -DG Health and Food Safety