Suispirin, 1000 mg/ g, oral powder for pigs

Main information

  • Trade name:
  • Suispirin, 1000 mg/ g, oral powder for pigs
  • Pharmaceutical form:
  • Oral powder
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Suispirin, 1000 mg/g, oral powder for pigs
    Italy
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • acetylsalicylic acid
  • Therapeutic area:
  • Pigs

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0364/001
  • Authorization date:
  • 28-09-2011
  • EU code:
  • UK/V/0364/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Issued:October2011

AN:00512/2010

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Suispirin,1000mg/g,oralpowderforpigs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

1.0gpowdercontains:

Activesubstance:

Acetylsalicylicacid 1000mg

3. PHARMACEUTICALFORM

Oralpowder.

Whitetoalmostwhitepowder.

4. CLINICALPARTICULARS

4.1Targetspecies

Pigs

4.2Indicationsforuse,specifyingthetargetspecies

Pig:

Supportivetreatmentforreductionofpyrexiaincombinationwith,appropriateanti-

infectivetherapy,ifnecessary.

4.3Contraindications

Donotuseincaseofhypersensitivitytotheactivesubstanceorincasesof

gastrointestinal

irritationandulcers,chronicgastro-intestinaldisorders,bronchospasm,liverfunction

impairmentornephropathies.

Donotuseinpregnantorlactatingsows.

Donotuseinpigletslessthan4weeksofage.

4.4Specialwarnings

Incombinedtreatmentwithtetracyclines,atreatmentintervalofatleastonehour

betweenthetwoactiveagentsisrecommended.

4.5Specialprecautionsforuse

Specialprecautionsforuseinanimals

Itmustbeensuredthattheanimalsconsumesufficientwaterduringtreatment.

GiventhatSuispirinmayinhibitclottingofblood,itisrecommendedthatelectivesurgery

shouldnotbeperformedonanimalswithin7daysaftertheendoftreatment.

Issued:October2011

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Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Donoteat,drinkorsmokewhilstusingthisproduct.Contactviatheskinormucous

membranesoftheusermustbeavoidedduetotheriskofsensitisation.Ifyouknowthat

youareallergictoaspirin,avoidcontactwiththisproduct.Usesuitableprotective

clothingwhenusingthisproduct,suchasglovesandafacemask.Washhandsandall

exposedskinafteruse.

4.6Adversereactions(frequencyandseriousness)

Gastrointestinalirritationmayoccurespeciallyinanimalswithpre-existing

gastrointestinaldisease.Suchirritationmayclinicallybemanifestedbyproductionof

blackmanureduetobloodlossinthegastrointestinaltract.

Inhibitionofnormalbloodclottingmayoccurincidentally.Ifthiseffectoccursitwillbe

reversibleandeffectswilldiminishwithinapproximately7days.

4.7Useduringpregnancy,lactationorlay

Donotuseduringthewholeofpregnancyandlactation.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Penicillins,sulphonamides

Asaresultofitshighplasmaproteinbinding,acetylsalicylicacidmaysuppressstrongly

bindingsubstancessuchaspenicillinsandsulphonamides,thereforepotentiatingtheir

effect.

Furosemide

Thediureticeffectoffurosemideisdecreased.Thismaycausesymptomsoftoxicityin

animalsreceivinghighaspirindoses.

Tetracyclines

Combinedadministrationofbufferedacetylsalicylicacidwithtetracyclinesmayleadto

chelateformation.

Aminoglycosideantibiotics

Acombinationofacetylsalicylicacidandaminoglycosideantibioticsleadstoincreased

nephrotoxicpotential.

Ascorbicacid,methionine,ammoniumchloride

Urinaryacidificationcausedbyascorbicacid,methionineorammoniumchlorideleads

todeceleratedrenalsalicylicacidsecretionwithheightenedriskoftoxicreactions.

Medicinesleadingtourinaryalkalinisation(sodiumhydrogencarbonate)

Therenalsecretionofsalicylicacidisacceleratedbythealkalinisationoftheurine

(sodiumhydrogencarbonate).

Non-steroidalanti-inflammatories

CombinationwithotherNSAIDsleadstoincreasedorintensifiedoccurrenceofside

effects,particularlywithinthegastro-intestinaltract.

Glucocorticoids

Simultaneousadministrationofglucocorticoidsincreasestheriskofgastro-intestinal

bleeding.

Issued:October2011

AN:00512/2010

4.9Amountstobeadministeredandadministrationroute

Oralpowderfortopdressinguse.

Foruseinindividualpigsonfarmswhereonlyasmallnumberofpigsaretoreceivethe

veterinarymedicinalproduct.

Pig:

30mgacetylsalicylicacid(correspondingto30mgoftheproduct)perkgBWtwice

daily.

Thetreatmentperiodis3consecutivedays.

Minimumbodyweightofpigstobetreated:11kg.

Treatmentisachievedbymixingtheproductwithapproximately50gor200g

(accordingtobodyweight)ofthenormaldietperpig.Formeasuringthecorrectamount

oftheveterinarymedicinalproductpleaseusetheenclosedscoopsaccordingtothe

dosagetablebelow.Non-medicatedfeedshouldonlybeofferedaftercomplete

consumptionofallthemedicatedfeed.Animalsshouldbeisolatedfromotheranimals

fortreatment.

Medicatedfeedshouldbefreshlypreparedbeforeeachadministration.

PigType Bodyweigh

t(kg) Gramsoftheproduct

peranimal(Twice

daily) Equalamountin

ml

(formeasuringthe

dosewith

scoops)

Weanerpig

(small) 11 0.33 0.4

Weanerpig(big) 25 0.75 1.0

Fatteningpig

(small) 50 1.50 2.0

Fatteningpig

(big) 100 3.00 4.0

Sow 250 7.50 10.0

Scoops –twoscoopsmeasuring0.4ml(=0.33goftheproduct)and3ml(=2.25gof

theproduct)aresupplied.

Part-consumedfeedmustbedisposedofwithotherwastefeedandnotgiventoother

animals.

Toavoidoverdosingthepigstobetreatedshouldbeweighedorbodyweightaccurately

estimatedbyanexperiencedperson.

Feedconsumptionmaybereducedinclinicallysickanimalsandalsoinolderpigs

thereforefeedintakemayneedtobeadjustedtoachievetargetdosageintake.The

correctquantityoftheproductshouldbethoroughlymixedwiththefeedinabucketor

similarreceptacle.Toachievegoodmixtureandhomogeneityapre-mixturecanbe

used.

Theproductshouldonlybeaddedtodrynon-pelletedfeed.Donotinuseinadryhopper

orasemiliquidfeeder.

Issued:October2011

AN:00512/2010

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Pigstoleratedosagesupto90mg/kgforupto6dayswithoutanysignificantadverse

effects.

Treatmentincaseofoverdose:discontinuetreatmentwithacetylsalicylicacid

immediatelyandinitiatesymptomatictreatment.Thealkalinisationoftheurinewith

sodiumhydrogencarbonatemayleadtoacceleratedsecretionofacetylsalicylicacidor

salicylicacid.

4.11Withdrawalperiod

Pig:

Meatandoffal:1day

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Otheranalgesicsandantipyretics,Salicylicacidand

derivatives

ATCvetcode:QN02BA01

5.1Pharmacodynamicproperties

Acetylsalicylicacidisawell-known,non-steroidalanti-inflammatoryandoneoftheweak

analgesics.Acetylsalicylicacidhasananti-inflammatoryeffect,aperipheralanalgesic

andantipyreticeffectanditinhibitsthrombocyteaggregation.

Theeffectivenessofacetylsalicylicacidisdueprimarilytotheinhibitionoftheenzyme

cyclooxygenase,responsiblefortheformationofprostaglandinsandthromboxanefrom

arachidonicacid.Prostaglandinsaresignificantcausesofinflammations,painand

fever.

5.2Pharmacokineticparticulars

Followingoraladministration,acetylsalicylicacidisabsorbedinthestomachandupper

smallintestinedependingonthestomachcontents,itspHvalueandevacuationtimeas

wellasthegalenicformulation.Itishydrolysedtoitsmainmetabolitesalicylicacidwithin

onlyafewminutes.Deacetylationbeginswiththeabsorbtionintothemucosaandtakes

placetoalargeextentduringfirstpassmetabolism.Particularlyhighconcentrationsof

themainmetabolite,salicylicacid,canbefoundinthestomachwall,liver,heart,lungs,

renalcortex,bloodplasma,bonemarrowandinflamedtissue.Relativelylow

concentrationsareobservedinnon-inflamedmuscle,fatandconnectivetissue.

Followingadministrationofacetylsalicylicacidtopigs,maximumplasmaconcentrations

ofsalicylicacidarereachedapproximately2to3hourspostadministrationviathefeed.

24hoursafterthefinalapplication,onlytracesofsalicylicacidcanbedetectedinthe

plasmaandtissue.

Thedistributionvolumeofsalicylicacidislow.Upto75%ofsalicylicacidisboundto

plasmaproteinsinpigs.Salicylatemayovercometheplacentalbarrier.

Theeliminationhalflifeincreaseswithincreasingacetylsalicylicaciddoses.Themean

terminalhalflifeforsalicylicacidaftertreatmentwiththeproductviathefeedwasfound

tobebetween1.8and3.7hours.

Followingconjugationintheliver,salicylicacidissecretedviathekidneys.Secretionis

acceleratedwithurinepHvaluesbetween5and8.

Issued:October2011

AN:00512/2010

6. PHARMACEUTICALPARTICULARS

6.1LISTOFEXCIPIENTS

None.

6.2Incompatibilities

Inabsenceofcompatibilitystudythisproductcannotbemixedwithotherveterinary

products.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:5years

Shelf-lifeafterfirstopeningtheimmediatepackaging: 6months

Shelf-lifeafteradditiontothefeedaccordingtodirections: 15hours

6.4.Specialprecautionsforstorage

Securelyreclosepart-usedcontainersorsachetsafteruse.

6.5Natureandcompositionofimmediatepackaging

1x100gpowderand10x100gpowderarefilledinsachetswithpaper/polyethylene/

aluminium/polyethylenefoil.

Polystyrenescoopsof0.4mland3mlareattached.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.

Issued:October2011

AN:00512/2010

7. MARKETINGAUTHORISATIONHOLDER

aniMedicaGmbH

ImSüdfeld9

48308Senden-Bösensell

Germany

8. MARKETINGAUTHORISATIONNUMBER

Vm24745/4013

9. DATEOFFIRSTAUTHORISATION

18October2011

10 DATEOFREVISIONOFTHETEXT

October2011

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable.