Carprogesic 20mg Tablets

Main information

  • Trade name:
  • Paracarp 20mg
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Paracarp 20mg
    Germany
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • carprofen
  • Therapeutic area:
  • Dogs

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0236/001
  • Authorization date:
  • 03-09-2011
  • EU code:
  • UK/V/0236/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Revised:April2011

AN:00689/2010

SUMMARYOFPRODUCTCHARACTERISTICS

1. NameoftheVeterinaryMedicinalProduct

Carprogesic20mgTabletsforDogs(UK,France)

Paracarp20mgTabletsforDogs(Germany)

Norocarp20mgTabletsforDogs(Belgium,Luxembourg)

2. QualitativeandQuantitativeComposition

Eachtabletcontains:

ActiveIngredient:

Carprofen 20mg

Excipients:

ForafulllistofexcipientsseeSection6.1

3. PharmaceuticalForm

Tablet

Awhite/offwhitecirculartabletof8mmdiameter,20embossedononesideanda

singlebreaklineontheotherside.

4. ClinicalParticulars

4.1 TargetSpecies:

Dogs

4.2 IndicationsforUse,SpecifyingtheTargetSpecies:

Inthedog:

Reductionofinflammationandpaincausedbymusculo-skeletaldisordersand

degenerativejointdisease.Asafollowuptoparenteralanalgesiainthe

managementofpost-operativepain.

4.3 Contraindications:

Donotuseincats.

Donotuseinpuppieslessthan4monthsofage.

Donotuseincaseofhypersensitivitytoactivesubstanceortoanyofthe

excipients.

Donotuseindogssufferingfromcardiac,hepaticorrenaldisease,wherethereisa

possibilityofgastrointestinalulcerationorbleeding,orwherethereisevidenceofa

blooddyscrasia.

Refertosection4.7

4.4 SpecialWarningsforEachTargetSpecies:

RefertoSections4.3and4.5.

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4.5 SpecialPrecautionsforUse:

Specialprecautionsforuseinanimals

Useinageddogsmayinvolveadditionalrisk.

Ifsuchausecannotbeavoided,dogsmayrequirecarefulclinicalmanagement.

Avoiduseinanydehydrated,hypovolaemicorhypotensivedog,asthereisa

potentialriskofincreasedrenaltoxicity.

NSAIDscancauseinhibitionofphagocytosisandhenceinthetreatmentof

inflammatoryconditionsassociatedwithbacterialinfection,appropriateconcurrent

antimicrobialtherapyshouldbeinstigated.

SomeNSAIDsmaybehighlyboundtoplasmaproteinsandcompetewithother

highlybounddrugswhichcanleadtotoxiceffects.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals:

Intheeventofaccidentalingestionofthetablets,seekmedicaladviceandshow

thedoctorthepackageleaflet.Washhandsafterhandlingtheproduct.

4.6 AdverseReactions(FrequencyandSeriousness):

TypicalundesirableeffectsassociatedwithNSAIDssuchasvomiting,soft

faeces/diarrhea,faecaloccultblood,lossofappetiteandlethargyhavebeen

reported.Theseadversereactionsoccurgenerallywithinthefirsttreatmentweek

andareinmostcasestransientanddisappearfollowingterminationofthe

treatmentbutinveryrarecasesmaybeseriousorfatal.

Ifadversereactionsoccur,useoftheproductshouldbestoppedandtheadviceof

aveterinarianshouldbesought.

AswithotherNSAIDsthereisariskofrarerenaloridiosyncratichepaticadverse

events.

4.7 UseDuringPregnancy,LactationorLay:

Studiesinlaboratoryspecies(ratandrabbit)haveshownevidenceoffoetotoxic

effectsofcarprofenatdosesclosetothetherapeuticdose.Thesafetyofthe

veterinarymedicinalproducthasnotbeenestablishedduringpregnancyand

lactation.Donotuseinpregnantorlactatingbitches.

4.8 InteractionswithOtherMedicalProductsandOtherFormsofInteraction:

DonotadministerNSAIDsandglucocorticoidsconcurrentlyorwithin24hoursof

eachother.SomeNSAIDsmaybehighlyboundtoplasmaproteinsandcompete

withotherhighlybounddrugs,whichcanleadtotoxiceffects.

Concurrentadministrationofpotentialnephrotoxicdrugsshouldbeavoided.

Revised:April2011

AN:00689/2010

4.9 AmountstobeAdministeredandAdministrationRoute:

Fororaladministration.

4mgcarprofenperkgbodyweightperday.

Aninitialdoseof4mgcarprofenperkgbodyweightperdaygivenasasingledaily

doseorintwoequallydivideddoses.Thedailydosemaybereduced,subjectto

clinicalresponse.

Durationoftreatmentwillbedependentupontheresponseseen.Long-term

treatmentshouldbeunderregularveterinarysupervision.

Donotexceedthestateddose.

Toextendanalgesicandanti-inflammatorycoverpost-operativelyparenteralpre-

operativetreatmentwithaninjectableCarprofenproductmaybefollowedwith

CarprofenTabletsat4mg/kg/dayfor5days.

4.10Overdose(Symptoms,EmergencyProcedures,Antidotes),ifnecessary:

Dosesuptothreetimestherecommendeddosagearereportedtobewithout

adverseeffectindogs.Thereisnospecificantidotetocarprofenbutgeneral

supportivetherapyasappliedtoclinicaloverdosagewithNSAIDsshouldbe

applied.

4.11WithholdPeriod:

Notapplicable.

5. PharmacologicalProperties

Pharmacotherapeuticgroup:Anti-inflammatory

ATCvetcode:QM01AE91

5.1 PharmacodynamicProperties:

Carprofen(CPF),(

)-6-chloro- 

-methylcarbazole-2-aceticacid,isanonsteroidal

anti-inflammatorydrug(NSAID).Itisaderivativeofphenylpropionicacidanda

memberofthearylpropionicacidclassofNSAIDs.Asarepresentativeofthe2-

arylpropionicfamily,itcontainsachiralcenteratC

ofthepropionicmoietyand

therefore,existsin2sterioisomericforms,the(+)-Sand(-)-Renantiomers.

Carprofenpossessanti-inflammatory,analgesicandanti-pyreticactivity.Carprofen

likemostotherNSAIDsisaninhibitoroftheenzymecyclo-oxygenaseofthe

arachidonicacidcascade.Howevertheinhibitionofprostaglandinsynthesisby

carprofenisslightinrelationtoitsanti-inflammatoryandanalgesicpotency.The

precisemodeofactionofcarprofenisnotclear.

Revised:April2011

AN:00689/2010

5.2 PharmacokineticProperties:

Absorptionisrapidwith>90%absorptionafteroraladministration.Thevolumeof

distributionissmallandcarprofenishighlyboundtoplasmaproteins.

Biotransformationofcarprofenoccursinthelivertoformtheesterglucuronideand

two1-O-acyl- β-D-glucuronidediastereoisomers.Thesearesecretedinthebiliary

tractandexcretedinthefaeces.TheC

is28.51µg/mlandtheAUCis237.33

µg/ml.hour

6. PharmaceuticalParticulars

6.1 ListofExcipients:

MicrocrystallineCellulose

LactoseMonohydrate

CrosscarmelloseSodium

PovidoneK30

SodiumLaurilSulphate

MagnesiumStearate

6.2 Incompatibilities:

NotApplicable.

6.3 Shelf-Life:

Shelf-lifeoftheveterinarymedicinalproductaspackageforsale:

Tubs:3years

Blisterstrips:2years

6.4 SpecialPrecautionsforStorage:

Donotstoreabove25ºC.

Storeinadryplace.

6.5 NatureandCompositionofImmediatePackaging:

Polypropylenetubswithwhitepolyethylenesnapsecurecaps.

PVC/Aluminium/Orientatedpolyamideblisterswithaluminiumliddingfoil.

Packsizes:Blisters

Boxof10blisters,eachblistercontains10tablets.

Packsizes:Tubs

Tubcontaining100tablets.

Notallpacksizesmaybemarketed.

Revised:April2011

AN:00689/2010

6.6 SpecialPrecautionsfortheDisposalofUnusedVeterinaryMedicinalProduct

orWasteMaterialsDerivedFromtheUseofSuchProducts:

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements

7. MarketingAuthorisationHolder

NorbrookLaboratoriesLimited

StationWorks

Newry

Co.Down

BT356JP

NorthernIreland

8. MarketingAuthorisationNumber

Vm02000/4248

9. DateofFirstAuthorisation

12April2006

10. DateofRevisionoftheText

April2011