KetoProPig 100mg/ ml Oral Solution for Pigs

Main information

  • Trade name:
  • KetoProPig 100mg/ ml Oral Solution for Pigs
  • Pharmaceutical form:
  • Oral solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • KetoProPig 100mg/ml Oral Solution for Pigs
    Italy
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • ketoprofen
  • Therapeutic area:
  • Pigs

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0239/001
  • Authorization date:
  • 10-07-2011
  • EU code:
  • UK/V/0239/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Revised:November2011

AN:01317/2011

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SUMMARYOFTHEPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

KetoProPig100mg/mlOralSolutionforuseindrinkingwaterforPigs

KeProPig100mg/mlOralSolutionforuseindrinkingwaterforPigs(ESand

PO)

2. QUALITATIVEANDQUANITIATIVECOMPOSITION

Eachmlcontains:

Activesubstance

Ketoprofen: 100mg

Excipients

BenzylAlcohol: 20mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Oralsolution

Transparentandcolourlessliquid.

4. CLINICALPARTICULARS

4.1 Targetspecies

FatteningPigs

4.2 IndicationsforUse

Symptomatictreatmentforreductionofpyrexiaincasesofacuteinfectious

respiratorydiseaseinfatteningpigsincombinationwithanappropriateanti-

infectivetherapy.

4.3 Contra-Indications

Donotuseincaseofhypersensitivitytoketoprofen.

Donotuseinanimalsknowntobeallergictoaspirin.

Donotuseinpregnantanimals.

Donotuseinpigsalreadysufferingfromgastriculcers,inordernottoaggravate

theirsituation.

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4.4 Specialwarningsforeachtargetspecies

Avoiduseindehydrated,hypovolaemicorhypotensivepigsasthereisa

potentialriskofincreasedrenaltoxicity.

Useinveryyounganimalsmayinvolveadditionalrisk:however,ifused,

animalsrequirecarefulclinicalmanagement.

Asketoprofenisulcerogenic,theuseisnotrecommendedincaseofPMWS

(Post-weaningmultisystemicwastingsyndrome)becauseulcersarealready

frequentlyassociatedwiththispathology.

Donotexceedtherecommendeddosetoreducetheriskofadversereactions.

Tolimittheappearanceofulcers,administrationovera24hourperiodis

recommended.

Forsafetyreasonstheadministrationoftheproductmustnotexceeda

maximumtreatmentperiodofthreedays.

4.5 SpecialPrecautionsforUse

i. Specialprecautionsforuseinanimals

Donotuseinpigssufferingfromcardiac,hepaticorrenaldiseaseor

gastrointestinalproblems,wherethereisthepossibilityofgastro-

intestinalulcerationorbleedingorwherethereisevidenceofablood

dyscrasia.

Donotuseincaseofhypersensitivitytoketoprofenortoanyofthe

excipients.

Donotuseinanimalsknowntobeallergictoaspirin.

Ifseriousadverseeventssuchassignsofulcersorgastrointestinal

haemorrhageoccur,useoftheproductshouldbestoppedandthe

adviceofaveterinarianshouldbesought.

ii. Specialprecautionstobetakenbythepersonadministeringthe

veterinarymedicinalproducttotheanimals

-Personalprotectiveequipmentconsistingofrubberglovesand

safetyglassesshouldbewornwhenmixingtheveterinarymedicinal

product.

-Inthecaseofaccidentalspillageontoskin,theaffectedareashould

bewashedimmediatelywithsoapandwater.

-Incaseofaccidentaleyecontact,irrigatetheeyesthoroughlywith

cleanrunningwaterimmediately.Seekmedicaladviceifirritation

persists.

-Contaminatedclothingshouldberemovedandanysplashesonto

theskinshouldbewashedoffimmediately.Washhandsafteruse.

-Hypersensitivityreactions(skinrash,urticaria)couldoccur.People

withknownhypersensitivitytotheactivesubstanceshouldavoid

contactwiththeveterinarymedicinalproduct.

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4.6 Adversereactions

Feedintakemaydecreaseduetothetreatmentandthegastriculcersinduced

bythetreatment.

Intolerancestudiesulcershavebeenobservedinupto70%ofthetreated

animals.

Whereadministrationisperformedovera24hourperiod,nosevereulcerswere

identified.Inapunctuatedadministrationoftheproduct(maximal3hoursfor

administration),atleast12%ofsevereulcerswereidentified.Threedaysafter

thecessationofdosing,gastriculcersgenerallyrecover(withsomeresidual

scarring)orareintheprocessofrecovery/cicatrisation.

4.7 Useduringpregnancyandlactation

Gestation:Donotuseinpregnantanimals.

Lactation:Notapplicable.

4.8 Interactionswithothermedicamentsandotherformsofinteractions

InteractionsbetweenKetoprofenandthemostcommonlyusedantibioticshave

notbeeninvestigated.

Pre-treatmentwithotheranti-inflammatorysubstancesmayresultinadditionalor

increasedadverseeffects.DonotadministercorticosteroidsorotherNSAIDs

concurrentlyorwithin24hoursofeachother.Thetreatment-freeperiod,

however,shouldtakeintoaccountthepharmacologicalpropertiesofthe

productsusedpreviously.Ketopropig100mg/mlmustnotbeadministeredin

conjunctionwithotherNSAIDsorglucocorticosteroids.Gastrointestinaltract

ulcerationmaybeexacerbatedbycorticosteroidsinanimalsgivennon-steroidal

anti-inflammatorydrugs.Theconcomitantadministrationofactivesubstances

thatarehighlyplasmaproteinboundmaydemonstrateacompetitiveeffectwith

theketoprofenwiththepossibilityofconsequenttoxiceffectsduetotheunbound

fractionofthedrug.

Avoidcombiningwithanticoagulantdrugs,particularlycoumarinderivativessuch

aswarfarin.

4.9 Amounttobeadministeredandadministrationroute

Theveterinarymedicinalproductisadministeredbyoralroute,dilutedin

drinkingwater.Administrationovera24hourperiodisrecommended.

Medicatedwatershouldbetheonlywatersupplyduringtheperiodoftreatment.

Medicatedwatershouldberefreshedevery24hours.Theproductmaybeput

directlyintotheheadertankorintroducedviaawaterproportionerpump.Once

thetreatmentperiodhasfinished,thepigsshouldbegivenunmedicatedwater.

Therecommendeddailydoseis3mgofketoprofen/kgbodyweightequivalentto

0.03mlofKetoProPig10%OralSolutionperkgbodyweight.

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Durationoftreatment:1day.Basedontherisk-benefitassessmentofthe

veterinarianadditionaladministrationforanother1-2daysatthemostcanbe

considered;seealso4.4and4.6.

Thewaterintakeofthepigstobetreatedshouldbemeasuredbefore

calculatingthetotalamountofproducttobeadministeredeachday.

Thefollowingcalculationshouldbemadetodeterminethequantityof

KetoProPig100mg/mlOralSolutioninmltobeaddedtothedailyconsumption

ofdrinkingwater:

0.03mlKetoProPig100mg/ml/ Averagebodyweight

(kg)

kgbodyweight/day xoftheanimalstobe

treated =mlKetoProPig100mg/ml/

Averageamountofdrinkingwater/animal(l) lofdrinkingwater

Topreventoverdosing,pigsshouldbegroupedaccordingtobodyweightandan

averagebodyweightestimatedasaccuratelyaspossible.

4.10Overdose(symptoms,emergencyprocedure,antidotesifnecessary)

Overdoseupto3xtherecommendeddosecancauseGIulcers,proteinloss,

andkidneyandliverdamage.Earlysignsoftoxicityincludelossofappetiteand

depression.Incaseofoverdosage,symptomatictreatmentshouldbeinitiated.

4.11Withdrawalperiod

Meatandoffal:2days.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antiinflammatoryandantirheumaticproducts,

non-steroids

ATCvetcode:QM01AE03

5.1PharmacodynamicProperties

Ketoprofen,2-(phenyl3benzoyl)propionicacid,isanonsteroidalanti-

inflammatorydrugbelongingtothearylpropionicacidgroup.Ketoprofeninhibits

thebiosynthesisofPGE2andPGF2alphawithoutaffectingtheratioof

PGE2/PGF2alphaandthromboxanes.Althoughitisacyclooxygenaseinhibitor,

ketoprofenissaidtostabilizelysosomalmembranesandantagonizesthe

actionsofbradykinin.Ketoprofenpossessesanti-inflammatory,analgesicand

antipyreticactivity.

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Theanti-inflammatoryactivityisincreasedbyanenantiomerconversionfromthe

(R)tothe(S)form.Indeed,the(S)formisknowntosupportthemajoranti-

inflammatoryactivityofketoprofen.

5.2 PharmacokineticProperties

Afterasingleoraladministration,themeanC

observedwas10.1µg.mL -1 at

ameanTmaxof0.8h.

Themean±SDtotalAUCwas30.5µg.h.mL -1

.Themean

SDbioavailability

was93%.

Afterrepeatedoraladministrationofthesamedoseindrinkingwater,thekinetic

profilepresentsprincipally2differentphasesperadministrationday,clearly

relatedtotheday- nightcycle,whichinfluencedtheanimal’swaterconsumption.

Thefirstphase(first8hoursafterofferingtreatment)correspondedtothe

absorptionphaseoftheproduct.Consideringtherapidabsorptionphaseforthe

singleadministration,thelongerphaseobservedforrepeatedadministrationsis

duetotheadministrationroute:ketoprofenadministeredviadrinkingwateris

consumedbytheanimalssparselyduringtheday.Theeliminationphase

observedinthefollowinghoursisdirectlyrelatedtothelowdrinkingwater

consumptionbytheanimalsduringthenighttime.

Themean

SDobservedC

was1.9µg.mL -1

.TheT

fluctuatebetween5

and32hoursafterthebeginningofadministrations.

Afterabsorption,ketoprofenbindsextensivelytoplasmaproteins,mainly

albumina,provingthatthisunionisenantioselective.Meandistributionvolume

was223.2mL/kg.

Thepredominantmetabolicrouteisbyglucoconjugation,formingthe

correspondingketoprofenmetabolites(50-80%oftheparentdrug),whichare

rapidlyexcretedthroughurine.Liveristhemainorganinvolvedintheelimination

ofthedrug.Meaneliminationlifetimevaluewas2.1hoursandMRT3.1hours.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Benzylalcohol

Argininebase

CitricAcidMonohydrate

PurifiedWater

6.2 Incompatibilities

Noneknown.

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6.3 Shelf-life

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:36months

Shelf-lifeafterfirstopeningtheimmediatepackaging:4months

Shelf-lifeafterdilution:24hours

6.4 Specialprecautionsforstorage

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorage

conditions

6.5 Natureandcompositionofimmediatepackaging

1litrewhiteHDPEcontainerscoatedwithfluorinatedpolymers,providedwith

whitepolypropylenecapswithscrewtopandsealedwithathreelayer-seal.

Eachcontainerisprovidedwithapolypropylenecupmeasuringdevice

graduatedfrom10upto75ml.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

7. MARKETINGAUTHORISATIONHOLDER

LabianaLifeSciencesS.A.U.

C/Venus26

CanParelladaIndustrial

Terrassa

08228Barcelona

Spain

8. MARKETINGAUTHORISATIONNUMBER

Vm 32112/4000

9. DATEOFTHEFIRSTAUTHORISATION/RENEWALOFTHE

AUTHORISATION

Date:16July2008

10.DATEOFREVISIONOFTHETEXT

Date:November2011

Revised:November2011

AN:01317/2011

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