BayCubis 325 mg/g powder for use in drinking water for chickens

Main information

  • Trade name:
  • BayCubis 325 mg/g powder for use in drinking water for chickens
  • Pharmaceutical form:
  • Powder for oral solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BayCubis 325 mg/g powder for use in drinking water for chickens
    Italy
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Phenoxymethylpenicillin
  • Therapeutic area:
  • Chicken

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • NL/V/0154/001
  • Authorization date:
  • 19-04-2011
  • EU code:
  • NL/V/0154/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SUMMARYOFPRODUCTCHARACTERISTICS

1.NAMEOFTHEVETERINARYMEDICINALPRODUCT

BayCubis,325mg/gpowderfororalsolutionforchickens(NL)

BayCubis,325mg/gPulverzumEingebenüberdasTrinkwasser(DE)

BayCubis,293mg/gpowderfororalsolutionforchickens(FR,IT)

2.QUALITATIVEANDQUANTITATIVECOMPOSITION

Pergram:

Activesubstance:

Phenoxymethylpenicillin 293mg

equivalenttopotassiumphenoxymethylpenicillin325mg

Excipient:

Forafulllistofexcipients,seesection6.1.

3.PHARMACEUTICALFORM

Powderfororalsolution.

Whitetooff-whitepowder.

4.CLINICALPARTICULARS

4.1 Targetspecies

Chickens.

4.2 Indicationsforuse,specifyingthetargetspecies

PreventionofmortalityatagrouplevelfromnecroticenteritisinchickenscausedbyClostridium

perfringenssusceptibletophenoxymethylpenicillin.

4.3 Contraindications

Donotuseincaseofhypersensitivitytotheactivesubstance.

4.4 Specialwarningsforeachtargetspecies

Theadministrationoftheproductmayleadtoanincreaseinmedicatedwaterconsumption.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Useoftheproductshouldbebasedonsusceptibilitytestingofthebacteriaisolatedfromchickens

thathavealreadydiedonthefarm.

Theproductshouldnotbeusedtocompensateforpoorhygieneandmanagementofthechicken

houses.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

PenicillinVmaycausehypersensitivityreactionsafterinjection,inhalation,oralingestion,skin

oreyecontact.HypersensitivitytopenicillinVmayleadtocross-sensitivitytootherpenicillins

andcephalosporins,andviceversa.Allergicreactionscausedbythesesubstancescansometimes

beserious.

Incaseofaccidentalingestionorserioussymptomsofhypersensitivityreactionssuchasskinrash

followingexposure,swellingoftheface,lipsoreyesordifficultywithbreathing,seekmedical

adviceimmediatelyandshowthepackageleaflettothephysician.

Peoplewithknownhypersensitivitytopenicillinsorcephalosporinsshouldavoidcontactwiththe

product.Incaseofdevelopmentofhypersensitivitysymptomsfollowingexposuretotheproduct,

allfurthercontactwiththeproduct(andothermedicinescontainingotherpenicillinsor

cephalosporins)shouldbeavoided.

Handlethisproductwithgreatcaretoavoidexposure,takingallrecommendedprecautions.Wear

protectiveclothing,imperviousglovesandeitheradisposablehalfmaskrespiratorconformingto

EuropeanStandardEN149oranon-disposablerespiratorconformingtoEuropeanStandard

EN140withafiltertoEN143whenmixingandhandlingtheproduct.Washhandsimmediately

afterhandlingtheproduct..

4.6 Adversereactions(frequencyandseriousness)

Althoughnoadversereactionshavebeenseenaftertheadministrationoftheproduct,penicillins

maycausevomiting,diarrhoeaandaltergutflorawithselectingresistantbacteria.

4.7Useduringpregnancy,lactationorlay

Studiesinlaboratoryanimalsandhumanshavenotproducedanyevidenceofeffectson

reproductivefunctionorfoetaldevelopment.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Donotcombinewithbacteriostaticantibiotics.

4.9 Amountstobeadministeredandadministrationroute

13.5–20mgpenicillinVperkgofbodyweightperday,

correspondingwith46–68mgoftheproductperkgofbodyweightperday,

for5days

Methodofadministration:oraluse,dissolveindrinkingwaterandusewithin12hours.

Themaximumsolubilityis250goftheproductperlitreofdrinkingwater.

Thefollowingcalculationshouldbemadetodeterminethequantityingramoftheproducttobe

addedin1000litresofwater:

mgproduct/kgbodyweight/dayxmeanbodyweightofindividualanimals(kg)xnumberofanimals

Totalwaterconsumptionofthehouse(litres)atthepreviousday

=mgproduct/lx1000=gproduct/1000lwater

Indispensingtheweightoftheproducttobeused,theuseofcalibratedweighingequipmentis

recommended.

Takingintoaccountthatsickanimalsmaydrinkless,itisrecommendedtostarttherapywiththe

higherdose,tocompensateforapossiblelowerintakeofmedicatedwater.

Toensurecorrectdosage,thebodyweightoftheanimalsshouldbedeterminedasaccuratelyas

possibletoavoidunderdosing.

Noothersourceofdrinkingwatershouldbeavailableduringthemedicationperiod.

Incasesofaltereddrinkingwaterconsumptioninpoultry,theconcentrationshouldbeadjustedso

thattherecommendeddosageisachieved.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

PenicillinVhasahightherapeuticindex.Theadministrationofthemedicateddrinkingwaterat

twoandfivetimestherecommendedtherapeuticdosefortwicetherecommendeddurationof

treatmentdidnotrevealanyadverseeffects.Insomeindividuals,administrationoffivetimesthe

recommendedtherapeuticdosefortwicetherecommendeddurationoftreatmentledtoan

increaseinwaterconsumption,adecreaseinfeedintakeandwateryfaeces.

4.11Withdrawalperiod

Meatandoffal: 2days.

Notpermittedforuseinlayingbirdsproducingeggsforhumanconsumption.

5.PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Beta-lactamantibacterials,penicillins

ATCvet-code:QJ01CE02

5.1 Pharmacodynamicproperties

Phenoxymethylpenicillin(penicillinV)isanarrow-spectrumpenicillinwithactivitymainly

againstgram-positivebacteria.

PenicillinV,asallotherpenicillins,exertsabactericidalactiononbacteriaduringthestageof

activemultiplication.Itformsanirreversiblebindingtopenicillin-binding-proteins(PBPs),

enzymesthatfacilitatetheformationofcross-linksofpeptidoglycanchainsinthesynthesisofthe

bacterialcellwall.Thisresultsinabnormalcellgrowthandcytolysisofthecell.

PenicillinVisanacid-stablederivateofbenzylpenicillinandhasalargelycomparablespectrum

ofactivity.

Developmentofresistanceismainlybasedontheformationofbeta-lactamase,anenzymethat

breaksopenthebeta-lactamring,renderingtheantibioticineffective.Crossresistanceexists

betweenpenicillinVandotherbeta-lactamantibiotics.

MinimumInhibitoryConcentrations(MICs)ofpenicillinVweredeterminedagainstClostridium

perfringensisolatesfromclinicalcasesofnecroticenteritisinchickensduring1998and1999.

TheMICforC.perfringensisolatedfromfaeces,liverandcaecumsampleswere<0.01–0.05

μg/ml.

5.2 Pharmacokineticproperties

ThemostimportantadvantageofpenicillinVincomparisonwithpenicillinGisthatitismore

stableinanacidenvironmentanditisthereforebetterabsorbedfromthegastrointestinaltract.

Followingoraluse,penicillinVforthemostpartescapesdecompositionbygastricjuices,asitis

stableatalowpH.

PenicillinViswelldistributedovermostofthetissues,leadingtoahighconcentrationinthe

kidneysandtheliver.PenicillinVispartiallydecomposedinthegastrointestinaltract.Asmall

portionoftheabsorbedamountismetabolisedinthebody.Forthemostpart,penicillinVis

excretedinunalteredactiveforminurineandfaeces.

Followingasingleadministrationoftheproductinpoultryatadoseof15mgofpenicillinV

potassium/kgbodyweightbyoralgavage,maximumplasmaconcentrationsof0.40±0.15mg/l

areachievedwithin1.7±1.0hoursafteradministration.PenicillinViswellabsorbedandhasan

absolutebioavailabilityof69%.

6.PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Lactosemonohydrate

6.2 Incompatibilities

Donotmixwithotherveterinarymedicinalproducts.

Contactofpenicillincontainingsolutionswithmetalsandtheuseofmetalsystemsfortheir

administrationisknowntoadverselyinfluencepenicillinstability.Thereforesuchsystemsshould

beavoidedandtheyshouldnotbeusedforthestorageofsolutions.

6.3 Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:

Securitainer:18months.

Compositecan:36months

Shelflifeafterfirstopeningtheimmediatepackaging:3months.

Shelflifeafterreconstitutionindrinkingwateraccordingtodirections:12hours.

6.4.Specialprecautionsforstorage

Storebelow25ºC.

Donotrefrigerateorfreeze.

Protectfromfrost.

Storeintheoriginalpackage.

6.5 Natureandcompositionofimmediatepackaging

- Securitainer:whitePPcylindricalcontainer,withwhiteHDPE/LDPEclosure,withthumb-

tabforopening.Thistypeofcontainerhastwodifferentsizes(650ml,1875ml)witha

contentof250g,1000gproductrespectively.

- Compositecan:three-layeredrectangularcontainer,whichconsistsofacardboardbasewith

aninnerliningofaluminium-paperandwithlabelontheoutside.Thistypeofcontainerhas

acontentof1kgofproduct.

Notallpacksizesmaybemarketed

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductsorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductshouldbedisposedofinaccordancewithlocalrequirements..

7. MARKETINGAUTHORISATIONHOLDER

BayerB.V.–AnimalHealthDivision

Energieweg1

3641RTMijdrechtTheNetherlands

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFTHEFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10.DATEOFREVISIONOFTHETEXT

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable.

LABELLINGANDPACKAGELEAFLET

A.LABELLING

<PARTICULARSTOAPPEARONTHEOUTERPACKAGE>

<PARTICULARSTOAPPEARONTHEIMMEDIATEPACKAGE>

Securitainer,Compositecan

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

BayCubis,325mg/gpowderfororalsolutionforchickens(NL)

BayCubis,325mg/gPulverzumEingebenüberdasTrinkwasser(DE)

BayCubis,293mg/gpowderfororalsolutionforchickens(FR,IT)

Potassiumphenoxymethylpenicillin

2. STATEMENTOFTHEACTIVEANDOTHERSUBSTANCES

Pergram:

Activesubstance:

Phenoxymethylpenicillin 293mg/g

equivalenttopotassiumphenoxymethylpenicillin325mg/g

3. PHARMACEUTICALFORM

Powderfororalsolution

4. PACKAGESIZE

250gramor1kg.

5. TARGETSPECIES

Chickens

6. INDICATION

PreventionofmortalityatagrouplevelfromnecroticenteritisinchickenscausedbyClostridiumperfringens

susceptibletophenoxymethylpenicillin.

7. METHODANDROUTEOFADMINISTRATION

Oraluse,afterdissolutionindrinkingwater

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Meatandoffal:2days.

Notpermittedforuseinlayingbirdsproducingeggsforhumanconsumption.

9. SPECIALWARNING(S)

Readthepackageleafletbeforeuse.

10. EXPIRYDATE

Exp<<EXPmonth/year>>

Shelflifeafterfirstopeningofthecontainer:3months

Shelflifeafterreconstitutionindrinkingwateraccordingtodirections:12hours.

Onceopened,useby:

11. SPECIALSTORAGECONDITIONS

Storebelow25ºC.

Donotrefrigerateorfreeze.

Protectfromfrost.

Storeintheoriginalpackage.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSORWASTE

MATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinalproduct

shouldbedisposedofinaccordancewithlocalrequirements.

13. THEWORDS"FORANIMALTREATMENTONLY"ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly-tobesuppliedonlyonveterinaryprescription.

14. THEWORDS"KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN"

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

BayerB.V.–AnimalHealthDivision

Energieweg1

3641RTMijdrechtTheNetherlands

16. MARKETINGAUTHORISATIONNUMBER(S)

17. MANUFACTURER'SBATCHNUMBER

Batch<<partijnummer>>

B.PACKAGELEAFLET

PACKAGELEAFLET

BayCubis,325mg/gpowderfororalsolutionforchickens(NL)

BayCubis,325mg/gPulverzumEingebenüberdasTrinkwasser(DE)

BayCubis,293mg/gpowderfororalsolutionforchickens(FR,IT)

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERANDOFTHE

MANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFORBATCHRELEASE,

IFDIFFERENT

Marketingauthorisationholder:

BayerB.V.–AnimalHealthDivision

Energieweg1

3641RTMijdrechtTheNetherlands

Manufacturerresponsibleforthebatchrelease:

DopharmaB.V.

Zalmweg24

4941VXRaamsdonksveerTheNetherlands

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

BayCubis,325mg/gpowderfororalsolutionforchickens

Potassiumphenoxymethylpenicillin

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

Pergram

Activesubstance:

Phenoxymethylpenicillin 293mg

equivalenttopotassiumphenoxymethylpenicillin325mg

Whitetooff-whitepowder

4. INDICATION

PreventionofmortalityatagrouplevelfromnecroticenteritisinchickenscausedbyClostridiumperfringens

susceptibletophenoxymethylpenicillin.

5. CONTRAINDICATIONS

Donotuseincaseofhypersensitivitytotheactivesubstance.

6. ADVERSEREACTIONS

Althoughnoadversereactionshavebeenseenaftertheadministrationoftheproduct,penicillinsmaycause

vomiting,diarrhoeaandaltergutflorawithselectingresistantbacteria.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinformyourveterinary

surgeon.

7. TARGETSPECIES

Chickens

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHOD(S)OFADMINISTRATION

13.5–20mgpenicillinVperkgofbodyweightperday,

correspondingwith46–68mgoftheproductperkgofbodyweightperday,for5days

Thisproductisadministeredtothechickensafterdissolutionindrinkingwater.

Thefollowingcalculationshouldbemadetodeterminethequantityingramoftheproducttobeadded

in1000litresofwater:

mgproduct/kgbodyweight/dayxmeanbodyweightofindividualanimals(kg)xnumberofanimals

Totalwaterconsumptionofthehouse(litres)atthepreviousday

=mgproduct/lx1000=gproduct/1000lwater

Indispensingtheweightoftheproducttobeused,theuseofcalibratedweighingequipmentis

recommended.

9. ADVICEONCORRECTADMINISTRATION

Takingintoaccountthatsickanimalsmaydrinkless,itisrecommendedtostarttherapywiththehigherdose,

tocompensateforapossiblelowerintakeofmedicatedwater.

Toensurecorrectdosage,thebodyweightoftheanimalsshouldbedeterminedasaccuratelyaspossibleto

avoidunderdosing.

Themaximalsolubilityis250goftheproductperlitreofdrinkingwater.

Noothersourceofdrinkingwatershouldbeavailableduringthemedicationperiod.

Incasesofaltereddrinkingwaterconsumptioninpoultrytheconcentrationshouldbeadjustedsothatthe

recommendeddosageisachieved.

Onlysufficientmedicateddrinkingwatershouldbepreparedtocoverdailyrequirements

Medicateddrinkingwatershouldberefreshedorreplacedevery12hours.

10. WITHDRAWALPERIOD

Meatandoffal:2days.

Notpermittedforuseinlayingbirdsproducingeggsforhumanconsumption.

11. SPECIALSTORAGEPRECAUTIONS

Keepoutofthereachandsightofchildren.

Storebelow25ºC.

Donotrefrigerateorfreeze.

Protectfromfrost.

Storeintheoriginalpackage.

Donotuseaftertheexpirydatestatedonthelabelafterexp.

Shelf-lifeafterfirstopeningofthecontainer:3months.

Shelf-lifeafterreconstitutionindrinkingwateraccordingtodirections:12hours.

Whenthecontainerisopenedforthefirsttime,usingthein-useshelf-lifewhichisspecifiedonthispackage

leaflet,thedateonwhichanyproductremaininginthecontainershouldbediscardedshouldbeworkedout.

Thisdiscarddateshouldbewritteninthespaceprovidedonthelabel.

12. SPECIALWARNINGS

Specialwarningsforeachtargetspecies

Theadministrationoftheproductmayleadtoanincreaseinmedicatedwaterconsumption.

Specialprecautionsforuseinanimals

Useoftheproductshouldbebasedonsusceptibilitytestingofthebacteriaisolatedfromchickensthathave

alreadydiedonthefarm.

Theproductshouldnotbeusedtocompensateforpoorhygieneandmanagementofthechickenhouses.

Operatorwarnings

PenicillinVmaycausehypersensitivityreactionsafterinjection,inhalation,oralingestion,skinoreye

contact.HypersensitivitytopenicillinVmayleadtocross-sensitivitytootherpenicillinsandcephalosporins,

andviceversa.Allergicreactionscausedbythesesubstancescansometimesbeserious.

Incaseofaccidentalingestionorserioussymptomsofhypersensitivityreactionssuchasskinrashfollowing

exposure,swellingoftheface,lipsoreyesordifficultywithbreathing,seekmedicaladviceimmediatelyand

showthepackageleaflettothephysician.

Peoplewithknownhypersensitivitytopenicillinsorcephalosporinsshouldavoidcontactwiththeproduct.In

caseofdevelopmentofhypersensitivitysymptomsfollowingexposuretotheproduct,allfurthercontactwith

theproduct(andothermedicinescontainingotherpenicillinsorcephalosporins)shouldbeavoided.

Handlethisproductwithgreatcaretoavoidexposure,takingallrecommendedprecautions.Wearprotective

clothing,imperviousglovesandeitheradisposablehalfmaskrespiratorconformingtoEuropeanStandard

EN149oranon-disposablerespiratorconformingtoEuropeanStandardEN140withafiltertoEN143when

mixingandhandlingtheproduct.Washhandsimmediatelyafterhandlingtheproduct.

Useduringpregnancy,lactationorlay

Studiesinlaboratoryanimalsandhumanshavenotproducedanyevidenceofeffectsonreproductive

functionorfoetaldevelopment.

Interactionswithothermedicinalproductsandotherformsofinteraction

Donotusetheproductincombinationwithbacteriostaticantibiotics.

Donotmixtheproductwithotherveterinarymedicinalproducts.

Overdose(symptoms,emergencyprocedures,antidotes)

PenicillinVhasahightherapeuticindex.Theadministrationofthemedicateddrinkingwaterattwoandfive

timestherecommendedtherapeuticdosefortwicetherecommendeddurationoftreatmentdidnotreveal

anyadverseeffects.Insomeindividuals,administrationoffivetimestherecommendedtherapeuticdosefor

twicetherecommendeddurationoftreatmentledtoanincreaseinwaterconsumption,adecreaseinfeed

intakeandwateryfaeces.

Incompatibilities

Contactofpenicillincontainingsolutionswithmetalsandtheuseofmetalsystemsfortheiradministrationis

knowntoadverselyinfluencepenicillinstability.Thereforesuchsystemsshouldbeavoidedandtheyshould

notbeusedforthestorageofsolutions.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSORWASTE

MATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinalproduct

shouldbedisposedofinaccordancewithlocalrequirements.

Askyourveterinarysurgeontodisposeofmedicinalproductsnolongerrequired.Thesemeasuresshould

helptoprotecttheenvironment.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

15. OTHERINFORMATION

Listofpacksizes:

250gram,1kg.

Notallpacksizesmaybemarketed.

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