AMOXIVET 100 Premix for pigs

Main information

  • Trade name:
  • AMOXIVET 100 Premix for pigs
  • Pharmaceutical form:
  • Premix for medicated feed
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • AMOXIVET 100 Premix for pigs
    Spain
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • amoxicillin
  • Therapeutic area:
  • Pigs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0194/001
  • Authorization date:
  • 22-12-2009
  • EU code:
  • FR/V/0194/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Dokument1

VETERINARYMEDICINALPRODUCT

PERLIUMAMOXIVAL100MG/GPREMIXFOR

PIGS

PARTI-B

SUMMARYOFPRODUCTCHARACTERISTICS

(ENGLISHVERSION)

PHARMACEUTICALFORM

Premixformedicatedfeedingstuff

Dokument1

1.NAMEOFTHEVETERINARYMEDICINALPRODUCT

PERLIUMAMOXIVAL100MG/GPREMIXFORPIGS

BELGIUM/NETHERLANDS Dokamox100mg/gPremixforpigs

FRANCE Amoxivet100Premixforpigs

GERMANY PerliumAmoxival100mg/gPremixforpigs

HUNGARY PerliumAmoxival100mg/gPremixforpigs

ITALY PerliumAmoxival100mg/gPremixforpigs

POLAND PerliumAmoxival100mg/gPremixforpigs

PORTUGAL PerliumAmoxival100mg/gPremixforpigs

SPAIN PerliumAmoxival100mg/gPremixforpigs

UNITEDKINGDOM PerliumAmoxival100mg/gPremixforpigs

2.QUALITATIVEANDQUANTITATIVECOMPOSITION

1gofpremixcontains:

Activesubstance

Amoxicillin(asAmoxicillintrihydrate) 100mg

Excipients:

Forafulllistofexcipients, seesection6.1.

3.PHARMACEUTICALFORM

Premixformedicatedfeedingstuff.

Beigegranulatedpowder

4.CLINICALPARTICULARS

4.1Targetspecies

Pigs.

4.2Indicationsforusespecifyingthetargetspecies

Inpigs:PreventivetreatmentofrespiratorydiseasesduetoStreptococcussuis, limitedtoreducing

mortality.Thepresenceofthediseaseintheherdshouldbeestablishedbeforethepreventive

treatment

4.3Contraindications

Donotuseinanimalswithseriouskidney(accompaniedbyanuriaandoliguria)and/orliverfailure.

Donotusedinanimalswithknownhypersensitivitytobetalactamins.

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Theuseoftheproductiscontraindicatedwhenaresistancetoamoxicillinisknown.

Donotuseinthepresenceofβ-lactamaseproducingbacteria.

Donotadministertorabbits,guinea-pigs,hamstersorgerbils.

4.4Specialwarnings

Animalswithreducedfeedintakeand/ordisturbedgeneralconditionhavetobetreatedparenterally

4.5Specialprecautionsforuse

i)Specialprecautionsforuseinanimals

Animalswithdistinctiveclinicalsignsofstreptococcosisrequireindividualtreatment.

Useoftheveterinarymedicinalproductshouldbebasedonsusceptibilitytestingandtakeinto

accountofficialandlocalantimicrobialpolicies.

Inappropriateuseoftheveterinarymedicinalproductmayincreasetheprevalenceofbacteria

resistanttoamoxicillin.

Thisdrugpremixisintendedforthepreparationofsoliddrugfeedandcannotbeusedasis;the

concentrationofincorporationofthedrugpremixinsolidfeedmustnotbelowerthan5kg/ton.

ii)Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproductto

animals

Whenfeedisbeingprepared,avoidskincontact.

Whilsthandlingtheproduct,wearamask,coveralls,protectivegogglesandglovesatalltimes.

Avoidinhalationofdust..Weareitheradisposablehalf-maskrespiratorconformingtoEuropean

StandardEN149oranon-disposablerespiratortoEuropeanStandardEN140withafiltertoEN143.

Toruleoutanyriskofingestionitisrecommendednottoeat,ordrinkwhileusingtheproductandto

washthehandsafteruse.

Penicillinsandcephalosporinsmaycausehypersensitivity(allergy)followinginjection,inhalation,

ingestionorskincontact.Hypersensitivitytopenicillinsmayleadtocross-reactionsto

cephalosporinsandviceversa.Allergicreactiontothesesubstancesmayoccasionallybeserious.

1.Donothandlethisproductifyouknowyouaresensitised,orifyouhavebeenadvisednottowork

withsuchpreparations.

2.Handlethisproductwithgreatcaretoavoidexposuretakingallrecommendedprecautions.

3.Ifyoudevelopsymptomsfollowingexposure,suchasaskinrash,youshouldseekmedicaladvice

andshowthedoctorthiswarning.Swellingoftheface, lipsoreyesordifficultyinbreathingare

moreserioussymptomsandrequireurgentmedicalattention.

4.6Adversereactions(frequencyandseriousness)

Gastrointestinalsignsmaysometimesbeobserved(diarrhea).

Penicillinsmaycauseallergicreactionsaftertheadministrationoftheproduct.Allergicreactionsto

thesesubstancesmaysometimesbesevere(anaphylaxis).

4.7Useduringpregnancy,lactationorlay

Laboratorystudieshavenotproducedanyevidenceofteratogenic,embryotoxicormaternotoxic

effectsofamoxicillin.Nevertheless,nostudywasperformedinthetargetspeciesduringpregnancy

orlactation.Therefore,useonlyaccordinglytothebenefit/riskassessmentbytheresponsible

veterinarian.

Dokument1

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Donotadministertogetherwithbacteriostaticanti-infectiousagents(tetracyclines,sulphonamids…).

Donotusesimultaneouslywithneomycinasitpreventstheabsorptionoforalpenicillins

4.9Amountstobeadministeredandadministrationroute

Premixformedicatedfeedingstuff

20mgofamoxicillin/kgbodyweightbydayfor5consecutivedays,byoralrouteinfeed.

Forafeedintakeof40g/kg,thisdoseregimencorrespondsto500ppminmedicatedfeed. Inorderto

respectthedoseregimenandtotakeintoaccounttherealfoodintake,theincorporationratecanbe

increased,whichleadstoahigherconcentrationinfood

Theproductcanbeincorporatedinpelletedfeedpreconditionedwithsteamforupto15minutesata

temperaturenotexceeding78°C

Donotuseinliquidfeed

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Apartfromallergicreactions,penicillinshaveminimaldirecttoxicity.

Thereisnoantidote,incaseofaccidentaloverdosage,thetreatmentissymptomatic.

4.11Withdrawalperiod(s)

Meatandoffal:5days

5.PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antibacterialforsystemicuse

ATCvetcode:QJ01CA04

5.1 Pharmacodynamicproperties

Amoxicillinisasemi-syntheticpenicillin,derivedfrom6APA(6-penicillinicacid).Itisaslightly

acidcompound,slightlyfat-soluble,stableinacidmediumandcanbeadministeredbyenteralor

parenteralroute.

Amoxicillinisabroadspectrumantibioticwithabactericideeffectprimarilytowardssensitive

microorganisms.Itcausesdeteriorationstothebacterialcellwall,leadingtoosmoticlysisofthecell.

.

Streptococcussuisareusuallysusceptibletoamoxicillin(MIC< 0.5µg/ml).

forStreptococcussuis

2007-2008–France:0.015µg/ml

2004-2005–Germany:0.06µg/ml

1999-2001-Spain:

0.25µg/ml

5.2 Pharmacokineticparticulars

Formatiert:Englisch(Großbritannien)

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Afteroraladministrationinfeed,amoxicillinbioavailabilityisapproximately30%.Thefraction

reachingthebloodstreamismetabolizedtoaslightextent. Themetaboliteidentifiedinlaboratory

speciesispenicilloicacidthatisrapidlyeliminatedintheurine.Amoxicillinisweaklyboundto

plasmaproteins(about20%)andiswidelydistributedindifferentorgans.

Aftersingleoraladministrationoftheproductatdoselevelof20mg/kginpigs,meanCmax

correspondedto2.93µg/mL,thereforealmost6timesthecriticalbreakpointforamoxicillinresistance

inS. suis.ThemeanTmaxcorrespondedto1.8hour.Thetimewhenamoxicillinmeanplasma

concentrationswereabovethecriticalMIC(0.5µg/mL)was6hours,i.e.,25%ofthedosinginterval.

Twelvehoursaftertreatment,meanamoxicillinconcentrationwas0.159µg/mL,i.e.,stillabovethe

MIC90valuesagainstS.suis(0.015µg/mL)observedin2007-2008.

6.PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Soya-beanoil,refined

Corncobgranules

6.2Incompatibilities

Noneknown.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:1year

Shelflifeafterfirstopening:useimmediatelyafterfirstopening

Shelflifeafterincorporationintomealandpelletedfeed:3months

6.4Specialprecautionsforstorage

Donotstoreabove25°C

Storeinadryplace

Keepthebagtightlyclosedinordertoprotectfrommoisture

6.5Natureandcompositionofimmediatepackaging

Lowdensitypolyethylene/paper/paperbag

Bagof10kg

Bagof25kg

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwastematerials

derivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.

7.MARKETINGAUTHORISATIONHOLDER

LaboratoiresSOGEVAL

Dokument1

200AvenuedeMayenne

BP2227

53022LAVALCedex–France

Tel:(33)02-43-49-51-51

Fax:(33)02-43-53-97-00

e-mail:sogeval@sogeval.fr

8.MARKETINGAUTHORISATIONNUMBER(S)

9.DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10.DATEOFREVISIONOFTHETEXT

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable.

OTHERINFORMATION

Tobesuppliedonlyonveterinaryprescription

Dokument1

VETERINARYMEDICINALPRODUCT

PERLIUMAMOXIVAL100MG/GPREMIXFOR

PIGS

ANNEXOFPARTI-B

LABELLINGPROJECT

Bag10kgand25kg

(Englishversion)

PharmaceuticalForm

Premixformedicatedfeedingstuff

Dokument1

LABEL

PERLIUMAMOXIVAL100MG/GPREMIXFORPIGS

1.NAMEANDADRESSOFTHEMARKETINGAUTHORISATIONHOLDERANDOF

THEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFORBATCH

RELEASE,IFDIFFERENT

LaboratoiresSOGEVAL

200RoutedeMayenne–BP227

53022LAVALCedex9

France

2.NAMEOFTHEVETERINARYMEDICINALPRODUCT

PERLIUMAMOXIVAL100MG/GPREMIXFORPIGS

Amoxicillin(asAmoxicillintrihydrate)

Premixformedicatedfeedingstuff.

Beigegranulatedpowder

BELGIUM/NETHERLANDS Dokamox100mg/gPremixforpigs

FRANCE Amoxivet100Premixforpigs

GERMANY PerliumAmoxival100mg/gPremixforpigs

HUNGARY PerliumAmoxival100mg/gPremixforpigs

ITALY PerliumAmoxival100mg/gPremixforpigs

POLAND PerliumAmoxival100mg/gPremixforpigs

PORTUGAL PerliumAmoxival100mg/gPremixforpigs

SPAIN PerliumAmoxival100mg/gPremixforpigs

UNITEDKINGDOM PerliumAmoxival100mg/gPremixforpigs

3.STATEMENTOFACTIVEANDOTHERSUBSTANCES

1gPremixcontains:

Activesubstance:

Amoxicillin(asAmoxicillintrihydrate)............................. 100mg

Beigegranulatedpowder

4.INDICATION(S)

Inpigs:PreventivetreatmentofrespiratorydiseasesduetoStreptococcussuis, limitedtoreducing

mortality.Thepresenceofthediseaseintheherdshouldbeestablishedbeforethepreventive

treatment.

5.CONTRADINDICATIONS

Donotuseinanimalswithseriouskidney(accompaniedbyanuriaandoliguria)and/orliverfailure.

Donotusedinanimalswithknownhypersensitivitytobetalactamins.

Theuseoftheproductiscontraindicatedwhenaresistancetoamoxicillinisknown.

Donotuseinthepresenceofβ-lactamaseproducingbacteria.

Dokument1

Donotadministertorabbits,guinea-pigs,hamstersorgerbils.

6. ADVERSEREACTIONS

Gastrointestinalsignsmaysometimesbeobserved(diarrhea).

Penicillinsmaycauseallergicreactionsaftertheadministrationoftheproduct.Allergicreactionsto

thesesubstancesmaysometimesbesevere(anaphylaxis).

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthislabelling, pleaseinformyour

veterinarysurgeon.

7.TARGETSPECIES

Pigs.

8.METHODANDROUTE(S)OFADMINISTRATION

Premixformedicatedfeedingstuff

20mgofamoxicillin/kgbodyweightbydayfor5consecutivedays,byoralrouteinfeed.

9. ADVICEONCORRECTADMINISTRATION

Forafeedintakeof40g/kg,thisdoseregimencorrespondsto500ppminmedicatedfeed. Inorderto

respectthedoseregimenandtotakeintoaccounttherealfoodintake, theincorporationratecanbe

increased, whichleadstoahigherconcentrationinfood

Theproductcanbeincorporatedinpelletedfeedpreconditionedwithsteamforupto15minutesata

temperaturenotexceeding78°C

Donotuseinliquidfeed

10.WITHDRAWALPERIOD

Meatandoffal:5days.

11.SPECIALSTORAGECONDITIONS

Keepoutofthereachandsightofchildren.

Storeinadryplace.Storebelow25

C

Keepthebagtightlyclosedinordertoprotectfrommoisture

Donotuseaftertheexpirydatestatedonthebag

Shelflifeafterfirstopening:useimmediatelyafterfirstopening

Shelflifeafterincorporationintomealandpelletedfeed:3months

12.SPECIALWARNING(S)

Animalswithreducedfeedintakeand/ordisturbedgeneralconditionhavetobetreatedparenterally

SPECIALPRECAUTIONSFORUSEINANIMALS

Animalswithdistinctiveclinicalsignsofstreptococcosisrequireindividualtreatment.

Useoftheveterinarymedicinalproductshouldbebasedonsusceptibilitytestingandtakeinto

accountofficialandlocalantimicrobialpolicies.

Inappropriateuseoftheveterinarymedicinalproductmayincreasetheprevalenceofbacteria

resistanttoamoxicillin.

Thisdrugpremixisintendedforthepreparationofsoliddrugfeedandcannotbeusedasis;the

concentrationofincorporationofthedrugpremixinsolidfeedmustnotbelowerthan5kg/ton.

Dokument1

SPECIALPRECAUTIONSTOBETAKENBYTHEPERSONADMINISTERINGTHE

PRODUCTTOANIMALS

Whenfeedisbeingprepared,avoidskincontact.

Whilsthandlingtheproduct,wearamask,coveralls, protectivegogglesandglovesatalltimes.

Avoidinhalationofdust.Weareitheradisposablehalf-maskrespiratorconformingtoEuropean

StandardEN149oranon-disposablerespiratortoEuropeanStandardEN140withafiltertoEN143.

Toruleoutanyriskofingestionitisrecommendednottoeat,ordrinkwhileusingtheproductand to

washthehandsafteruse.

Penicillinsandcephalosporinsmaycausehypersensitivity(allergy)followinginjection, inhalation,

ingestionorskincontact.Hypersensitivitytopenicillinsmayleadtocross-reactionsto

cephalosporinsandviceversa. Allergicreactiontothesesubstancesmayoccasionallybeserious.

1.Donothandlethisproductifyouknowyouaresensitised,orifyouhavebeenadvisednottowork

withsuchpreparations.

2.Handlethisproductwithgreatcaretoavoidexposuretakingallrecommendedprecautions.

3.Ifyoudevelopsymptomsfollowingexposure,suchasaskinrash, youshouldseekmedicaladvice

andshowthedoctorthiswarning.Swellingoftheface,lipsoreyesordifficultyinbreathingare

moreserioussymptomsandrequireurgentmedicalattention.

DRUGINTERACTIONSANDOTHERFORMSOFINTERACTION

Donotadministertogetherwithbacteriostaticanti-infectiousagents(tetracyclines,sulphonamids…).

Donotusesimultaneouslywithneomycinasitpreventstheabsorptionoforalpenicillins

OVERDOSE(SYMPTOMES,EMERGENCYPROCEDURES,ANTIDOTES)

Apartfromallergicreactions,penicillinshaveminimaldirecttoxicity.

Thereisnoantidote,incaseofaccidentaloverdosage,thetreatmentissymptomatic.

USEDURINGPREGANCY,LACTATIONorLAYING

Laboratorystudieshavenotproducedanyevidenceofteratogenic,embryotoxicormaternotoxic

effectsofamoxicillin.Nevertheless,nostudywasperformedinthetargetspeciesduringpregnancy

orlactation.Therefore,useonlyaccordinglytothebenefit/riskassessmentbytheresponsible

veterinarian.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSORWASTE

MATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.

14. DATEONWHICHTHEPACKAGELEAFLETWASAPPROVED

15. OTHERINFORMATION

ORALROUTE

FORANIMALTREATMENTONLY–TOBESUPPLIEDONLYONVETERINARY

PRESCRIPTION

PACKAGESIZE

Bagof10kg

Bagof25kg

BATCHNUMBER

Dokument1

EXPIRYDATE

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