Carprogesic

Main information

  • Trade name:
  • Carprogesic 100mg Tablets for Dogs
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Carprogesic 100mg Tablets for Dogs
    Ireland
  • Language:
  • English

Therapeutic information

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

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0319/001
  • Authorization date:
  • 23-03-2009
  • EU code:
  • UK/V/0319/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

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SUMMARYOFPRODUCTCHARACTERISTICS

1. NameoftheVeterinaryMedicinalProduct

Carprogesic100mgTabletsforDogs.

2. QualitativeandQuantitativeComposition

Eachtabletcontains:

ActiveIngredient:

Carprofen 100 mg

Excipients:

Tartrazine(E102) 1.2 mg

ForafulllistofexcipientsseeSection6.1

3. PharmaceuticalForm

Tablet

Ayellowcirculartabletof8mmdiameter,100embossedononesideandasingle

breaklineontheotherside.

Thetabletscanbedividedintoequalhalves.

4. ClinicalParticulars

4.1 TargetSpecies:

Dogs

4.2 IndicationsforUse, Specifying theTargetSpecies:

Inthedog:

Reductionofinflammationandpaincausedbymusculoskeletaldisordersand

degenerativejointdisease.Asafollowuptoparenteralanalgesiainthemanagement

ofpostoperativepain.

4.3 Contraindications:

Donotuseincats.

Donotuseinpregnantorlactatingbitches.

Donotuseinpuppieslessthan4 monthsofage.

Donotuseincaseofhypersensitivityto activesubstanceortoanyoftheexcipients.

Donotuseindogssufferingfromcardiac,hepaticorrenaldisease,wherethereisa

possibilityofgastrointestinalulcerationorbleeding,orwherethereisevidenceofa

blooddyscrasia.

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4.4 SpecialWarningsforEachTargetSpecies:

Referto Sections4.3 and4.5.

4.5 SpecialPrecautionsforUse:

Specialprecautionsforuseinanimals

Useinageddogsmayinvolveadditionalrisk.

Ifsuchausecannotbeavoided,suchdogsmayrequireareduceddosageandcareful

clinicalmanagement.

Avoiduseinanydehydrated,hypovolaemicorhypotensivedog,asthereisapotential

riskofincreasedrenaltoxicity.

NSAIDscancauseinhibitionofphagocytosisandhenceinthetreatmentof

inflammatoryconditionsassociatedwithbacterialinfection,appropriateconcurrent

antimicrobialtherapyshouldbeinstigated.

Referto section4.8.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproductto animals:

Intheeventofaccidentalingestionofthetablets,seekmedicaladviceandshowthe

doctorthepackageleaflet.Washhandsafterhandlingtheproduct.

4.6 AdverseReactions(Frequencyand Seriousness):

TypicalundesirableeffectsassociatedwithNSAIDssuchasvomiting,soft

faeces/diarrhoea,faecaloccultblood,lossofappetiteandlethargyhavebeenreported.

Theseadversereactionsoccurgenerallywithinthefirsttreatmentweekandarein

mostcasestransientanddisappearfollowingterminationofthetreatmentbutinvery

rarecasesmaybeseriousorfatal.

Ifadversereactionsoccur,useoftheproductshouldbestoppedandtheadviceofa

veterinarianshouldbesought.

AswithotherNSAIDsthereisariskofrarerenaloridiosyncratichepaticadverse

events.

4.7 UseDuring Pregnancy,LactationorLay:

Studiesinlaboratoryspecies(ratandrabbit)haveshownevidenceoffoetotoxic

effectsofcarprofenatdosesclosetothetherapeuticdose.Thesafetyofthe

veterinarymedicinalproducthasnotbeenestablishedduringpregnancyandlactation.

Donotuseinpregnantorlactatingbitches.

4.8 InteractionswithOtherMedicalProductsand OtherFormsofInteraction:

DonotadministerNSAIDsandglucocorticoidsconcurrentlyorwithin24hoursof

eachother.SomeNSAIDsmaybehighlyboundtoplasmaproteinsandcompetewith

otherhighlybounddrugs,whichcanleadtotoxiceffects.

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Concurrentadministrationofpotentialnephrotoxicdrugsshouldbeavoided.

4.9 Amountsto beAdministered and AdministrationRoute:

Fororaladministration.

4mgcarprofenperkgbodyweightperday.

Aninitialdoseof4mgcarprofenperkgbodyweightperdaygivenasasingledaily

doseorintwoequallydivideddoses.Thedailydosemaybereduced,subjectto

clinicalresponse.

Durationoftreatmentwillbedependentupontheresponseseen.Long-termtreatment

shouldbeunderregularveterinarysupervision.

Donotexceedthestateddose.

Toextendanalgesicandanti-inflammatorycoverpost-operativelyparenteralpre-

operativetreatmentwithaninjectableCarprofenproductmaybefollowedwith

Carprogesic100 mgTabletsat4mg/kg/dayforupto 5 days.

Returnanyhalvedtabletstotheblisterpack andusewithin48 hours.

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

Donotexceedthestateddose.Thereisnospecificantidoteforcarprofenoverdosage

butgeneralsupportivetherapy,asappliedtoclinicaloverdosagewithNSAIDsshould

beapplied.

4.11 Withhold Period:

Notapplicable.

5. PharmacologicalProperties

Pharmacotherapeuticgroup:Non-steroidalanti-inflammatorydrug

ATCVetCode:QM01AE91

5.1 PharmacodynamicProperties:

Carprofen(CPF),(

)-6-chloro- 

-methylcarbazole-2-aceticacid,isanonsteroidal

anti-inflammatorydrug(NSAID).Itisaderivativeofphenylpropionicacidanda

memberofthearylpropionicacidclassofNSAIDs.Asarepresentativeofthe2-

arylpropionicfamily,itcontainsachiralcenteratC

ofthepropionicmoietyand

therefore,existsin2 sterioisomericforms,the(+)-Sand(-)-Renantiomers.

Carprofenpossessanti-inflammatory,anaglesicandanti-pyreticactivity.Carprofen

likemostotherNSAIDsisaninhibitoroftheenzymecyclo-oxygenaseofthe

arachidonicacidcascade.Howevertheinhibitionofprostaglandinsynthesisby

carprofenisslightinrelationtoitsanti-inflammatoryandanalgesicpotency.The

precisemodeofactionofcarprofenisnotclear.

5.2 PharmacokineticProperties:

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Absorptionisrapidwith>90%absorptionafteroraladministration.Thevolumeof

distribution is smallandcarprofenishighlyboundtoplasmaproteins.

Biotransformationofcarprofenoccursinthelivertoformtheesterglucuronideand

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

tractandexcretedinthefaeces.TheC

is28.51µg/mlandtheAUCis237.33

µg/ml.hour.

6. PharmaceuticalParticulars

6.1 ListofExcipients:

Tartrazine(E102)

MicrocrystallineCellulose

LactoseMonohydrate

Croscarmellosesodium

PovidoneK30

Sodiumlaurilsulphate

MagnesiumStearate

6.2 Incompatibilities:

NotApplicable.

6.3 Shelf-Life:

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:2 years

6.4 SpecialPrecautionsforStorage:

Donotstoreabove25ºC.

Storeinadryplace.

Protectfromlight.

6.5 NatureandCompositionofImmediatePackaging:

Carprogesic100mgTabletsaresuppliedineither:

PolypropyleneSnapSecureTubscontaining14,30or100tablets,sealedwithawhite

lowdensityPolyethyleneSnapSecureCap, or

Aluminium-Aluminiumblisterstripsof10tabletsincartonscontaining10,20,30,50,

60, 70, 100, 140, 180, 200, 250, 280, 300, 500 or1000tablets.

6.6 SpecialPrecautionsfortheDisposalofUnusedVeterinaryMedicinalProductor

WasteMaterialsDerivedFromtheUseofSuchProducts:

Anyunusedproductorwastematerialshouldbedisposedofinaccordancewith

nationalrequirements.

7. MarketingAuthorisationHolder

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Norbrook LaboratoriesLimited

StationWorks

CamloughRoad

NEWRY

Co. Down,BT356JP

NorthernIreland

8. MarketingAuthorisationNumber(s)

Vm02000/4281

9. DateofFirstAuthorisation/RenewaloftheAuthorisation

5 August2009

10. DateofRevisionoftheText