Pentoject, Pentobarbitone Sodium 20% W/V Solution For Injection
AN: 01452/2014
Revised: April 2015
SUMMARYOF PRODUCTCHARACTERISTICS
1. NAME OF THE VETERINARYMEDICINALPRODUCT
Pentoject,PentobarbitoneSodium 20%w/vSolutionforInjection
2. QUALITATIVEANDQUANTITATIVE COMPOSITION ActiveSubstance(s)
Pentobarbitone Sodium
Excipients
Tartrazine 1409 (E102)
For a full list of excipients, see section 6.1
20% w/v
0.004% w/v
3. PHARMACEUTICAL FORM
Solution for injection.
A clear, yellow solution.
4. CLINICAL PARTICULARS
4.1 Target species
Dogs, cats, other small animals, and mink.
4.2 Indications for use, specifying the target species
Euthanasia in the target species.
4.3 Contraindications
Not for use in anaesthesia.
4.4 Special warnings for each target species
None
4.5 Specialprecautionsfor use
i) Specialprecautionsforuseinanimals
Useonlyfor euthanasia.
ii) Specialprecautionsforthepersonadministeringtheveterinarymedicinal productto animals
Intheeventofaccidental self-administration,byinjectionor skinabsorption,seek URGENT medical attentionadvisingthemedical servicesofbarbituratepoisoning andshowthis advice.This isapotentdrugwhichis toxic inman–particular care shouldbetakentoavoidaccidental ingestionandself-injection.
Intheeventofaccidentthefollowingactionshouldbetaken:
Skin–Washimmediately withwater andthenthoroughly withsoapandwater. Eyes–Washimmediately withcoldwater andobtainmedical advice.
Ingestion –Obtainmedical attentionimmediately.Washoutmouth.Keepwarm andrest.
Accidental self- injection–ObtainURGENTmedical attention,advisingmedical servicesofbarbituratepoisoning. Donotleavepatientunattended.
AdvicetoDoctor–Maintainairways andgivesymptomatic andsupportivetreatment. Thisproductis notsterile.
iii) Other precautions
None
4.6 Adversereactions (frequencyand seriousness)
Bodyspasmsmayoccur insomeanimals whichmaydistress observers. Verylow frequencywhenanappropriatedoseis usedandadministeredrapidly.
4.7 Useduring pregnancy,lactation or lay
Notapplicable.
4.8 Interactionwith othermedicinalproductsand other formsof interaction
Notapplicable.
4.9 Amount(s) tobeadministeredand administration route
Toeffect,usually0.4ml/kgindebilitatedorelderlyanimals,or 0.6-0.8ml/kginyounger or morefitanimals.Thesedosages correspondto80mg/kgor 120-160mg/kg,respectively. Preferablybyrapidintravenous injection.
Theintravenous routeofadministrationshouldbetherouteofchoiceifpossiblebut alternatives suchas intraperitoneal or intramuscular are availablewhenvenepuncture is difficult toachieve(e.g.incats).Insomecircumstances theintrathoracic routemaybeused butthis is usuallythelastresort.Thereis arisk ofinjectionintothelungs whichcauses coughinganddistress.Directinjectionintoachamberoftheheart israpid,butitmaybe difficult toaccuratelylocatetheheart chamber inlarger dogs andrepeatedattemptscould causeunnecessarypainanddistress.
Whenitispredictedthateuthanasiamaybeproblematical (i.e.aggressivepatients),itis recommendedthatpremedicationwithanappropriatesedativebegiven.
4.10 Overdose(symptoms,emergencyprocedures,antidotes), if necessary
Ifaccidentallyadministeredtoananimalnotpresentedfor euthanasia,care shouldbe aimedatsupportingtherespiratoryandcardiovascular systems.Useofartificial respiration, oxygenandanalepticsare appropriate.
4.11 Withdrawalperiod
Notfor useinanimals intendedforhumanoranimal consumption.
5. PHARMACOLOGICAL PROPERTIES
Pharmacotherapeuticgroup:
Barbiturates ATC Vet Code: QN51AA01
5.1 Pharmacodynamicproperties
PentobarbitoneSodiumis abarbiturate.Injectionoflethal doses causes progressive depressionofthecentral nervous system,whichmaybeconsideredas passingthroughthe followingsequential phases:i)sedation,ii) intoxication,possibly withinvoluntary
excitement,iii)anaesthesia,(iv) respiratoryarrest andsubsequentcardiacfailure.
6. PHARMACEUTICALPARTICULARS
6.1 List ofexcipients
Tartrazine1409(E102) Glycerol
Industrial MethylatedSpirit
Waterfor Injections
6.2 Incompatibilities
Noneknown
6.3 Shelf life
Shelflifeoftheveterinarymedicinal productas packagedfor sale:3years
6.4 Specialprecautionsfor storage
Donotstoreabove25ºC. Protectfromlight.
Thisproductdoesnotcontainanyantimicrobial preservative.
Followingwithdrawal ofthefirstdoseusewithin28days. Discardunusedmaterial.
6.5 Nature and composition ofimmediate packaging
100ml,Amber,TypeIIglassvialwithacentre-holealuminium sealandachlorobutyl rubberbung.
500ml,Amber,TypeIIglassvialwithanaluminiumover sealandachlorobutyl rubber bung.
Notallpack sizes maybemarketed.
6.6 Specialprecautionsfor thedisposalofunused veterinarymedicinalproduct or waste materialsderived from the useofsuch products,ifappropriate
AnyunusedproductmustbedestroyedinaccordancewiththeMisuseofDrugs
Regulations (2001).
Anywastematerial shouldbedisposedofinaccordancewithlocal requirements.
7. MARKETING AUTHORISATION HOLDER
Animalcare Ltd
10 Great North Way
York Business Park
Nether Poppleton
York
Yorkshire
YO26 6RB
8. MARKETING AUTHORISATION NUMBER
Vm10347 / 4014
9. DATE OF FIRST AUTHORISATION
Date:21 October 1993
10. DATE OF REVISION OF THE TEXT
Date:April 2015
APPROVED 
24/04/15
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