Carprieve 20 mg Flavoured Tablets for Dogs

Main information

  • Trade name:
  • Carprieve 20 mg Flavoured Tablets for Dogs
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Carprieve 20 mg Flavoured Tablets for Dogs
    Hungary
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0353/001
  • Authorization date:
  • 22-02-2012
  • EU code:
  • UK/V/0353/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Issued:March2011

AN:01523/2009

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Carprieve20mgFlavouredTabletsforDogs(UK,AT,BG,CY,CZ,ET,HU,IE,LV,LT,

RO,SK,SL)

Norocarp20mgFlavouredTabletsforDogs(BE,FR,EL,IT,LU,NL.PT,ES)

NorodylFlavour20mgTabletsforDogs(DK)

Carprieve20mgChewableTabletsforDogs(FI)

NorocarpF20mgTabletsforDogs(FR)

Paracarp20mgFlavouredTabletsforDogs(DE)

Scanodyl20mgFlavouredTabletsforDogs(PL)

Carprievevet20mgChewableTabletsforDogs(SE)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains:

ActiveSubstance:

Carprofen 20mg

Excipients:

Forafulllistofexcipientsseesection6.1

3. PHARMACEUTICALFORM

Tablet.

Lightbrown,round,flat,beveledgedtablet

Thetabletscanbedividedintoequalhalves.

4. CLINICALPARTICULARS

4.1 Targetspecies:

Dogs

4.2 Indicationsforuse,specifyingthetargetspecies:

Foranalgesiaandreductionofchronicinflammation,forexampleindegenerativejoint

diseaseinthedog.

Thetabletsalsocanbeusedinthemanagementofpostoperativepain.

Issued:March2011

AN:01523/2009

4.3 Contraindications:

Donotexceedthestateddose.

Donotuseincats.TheeliminationtimeofNSAIDs,includingcarprofen,inthecatis

longerthaninthedogandthetherapeuticindexisnarrower.Intheabsenceofspecific

datauseinthecatiscontra-indicated.

Donotuseindogssufferingfromcardiac,hepaticorrenaldisease,wherethereisa

possibilityofgastrointestinalulcerationorbleeding,orwherethereisevidenceof

blooddyscrasiaorhypersensitivitytotheproduct.AswithotherNSAIDsthereisarisk

ofrareidiosyncraticrenalorhepaticadverseeffects.

Donotuseinpuppieslessthan4months.

Donotuseincaseofhypersensitivitytoactivesubstanceortoanyoftheexcipients.

Refertosection4.7and4.8

4.4 SpecialWarningsforeachtargetspecies:

Seesections4.3and4.5.

4.5 Specialprecautionsforuse:

(i)Specialprecautionsforuseinanimals:

Useinageddogsmayinvolveadditionalrisk.Ifsuchausecannotbeavoided,such

dogsmayrequireareduceddosageandcarefulclinicalmanagement.

Avoiduseinanydehydrated,hypovolaemicorhypotensivedog,asthereisapotential

riseofincreasedrenaltoxicity.

NSAIDscancauseinhibitionofphagocytosisandhenceinthetreatmentof

inflammatoryconditionsassociatedwithbacterialinfection,appropriateconcurrent

antimicrobialtherapyshouldbeinstigated.

(ii)Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals:

Incaseofaccidentalingestionseekmedicaladviceandshowthepackageleafletor

thelabeltothephysician.Washhandsafterhandlingproduct.

Issued:March2011

AN:01523/2009

4.6 Adversereactions(frequencyandseriousness):

TypicalundesirableeffectsassociatedwithNSAIDs,suchasvomiting,soft

faeces/diarrhoea,faecaloccultblood,lossofappetiteandlethargyhavebeen

reported.Theseadversereactionsgenerallyoccurwithinthefirsttreatmentweekand

areinmostcasestransientanddisappearfollowingterminationofthetreatmentbutin

veryrarecasesmaybeseriousorfatal.

AswithotherNSAIDsthereisariskofrarerenaloridosyncratichepaticadverse

events.

4.7 Useduringpregnancy,lactationorlay:

Studiesinlaboratoryspecies(ratandrabbit)haveshownevidenceoffoetotoxic

effectsofcarprofenatdosesclosetothetherapeuticdose.Thesafetyofthe

veterinarymedicinalproducthasnotbeenestablishedduringpregnancyandlactation.

Donotuseinpregnantorlactatingbitches.Forbreedinganimals,donotuseduring

reproductionperiod.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction:

Carprofenishighlyboundtoplasmaproteinsandcompetewithotherhighlybound

drugs,whichcanincreasetheirrespectivetoxiceffects.Donotusethisveterinary

medicinalproductconcurrentlywithorwithin24hoursofotherNSAIDsorconcurrently

withglucocorticoids.

Concurrentadministrationofpotentiallynephrotoxicdrugsshouldbeavoided.Refer

alsotosection4.5.

Donotadministerconcurrentlywithanticoagulants.

4.9 Amountstobeadministeredandadministrationroute:

Fororaladministration.Thetabletsarepalatableandwillinglyconsumedbymostdogs

whenoffered.

2to4mgcarprofenperkgbodyweightperday.

Aninitialdoseof4mgcarprofenperkgbodyweightperdaygivenasasingledaily

doseorintwoequallydivideddosesmay,subjecttoclinicalresponse,bereduced

after7daysto2mgcarprofen/kgbodyweight/daygivenasasingledose.

Durationoftreatmentwillbedependentupontheresponseseen.Longtermtreatment

shouldbeunderregularveterinarysupervision.

Toextendanalgesicandanti-inflammatorycoverpost-operatively,parenteral

preoperativetreatmentmaybefollowedwithCarprofentabletsat4mg/kg/dayforupto

5days.

Donotexceedthestateddose.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary:

Thereisnospecificantidoteforcarprofenoverdosagebutgeneralsupportivetherapy

asappliedtoclinicaloverdosagewithNSAIDsshouldbeapplied.

Issued:March2011

AN:01523/2009

4.11Withdrawalperiod:

Notapplicable

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:

ATCVetCode:QM01AE91Anti-inflammatory

5.1 Pharmacodynamicproperties:

Carprofenisamemberofthe2 –arylpropionicacidgroupofnonsteroidalanti-

inflammatorydrugs(NSAIDs)andpossessesanti-inflammatory,analgesicand

antipyreticactivity.

CarprofenlikemostotherNSAIDsisaninhibitoroftheenzymecyclo-oxygenaseofthe

arachidonicacidcascade.Howevertheinhibitionofprostaglandinsynthesisby

carprofenisslightinrelationtoitsanti-inflammatoryandanalgesicpotency.At

therapeuticdosesinthedoginhibitionoftheproductsofcyclo-oxygenase

(prostaglandinsandthromboxanes)orlipoxygenase(leukotrienes)hasbeenabsentor

slight.Theprecisemodeofactionofcarprofenisnotclear.

5.2 PharmacokineticParticulars

Afterasingleoraladministrationof4mgofcarprofenperkgofbodyweightindogs,

thetimetoobtainamaximumplasmaticconcentrationof31

g/mlis2.5hours.The

oralbioavailabilityismorethan90%ofthetotaldose.Carprofenismorethan98%

boundtoplasmaproteinsanditsvolumeofdistributionislow.Carprofenisexcreted

inthebilewith70%ofanintra-venousdoseofcarprofenbeingeliminatedinthe

faeces,mainlyastheglucuronideconjugate.Carprofenundergoesan

enantioselectiveenterohepaticcycleindogs,withonlytheS(+)enantiomerbeing

significantlyrecycled.TheplasmaticclearanceoftheS(+)carprofenisabouttwice

thatoftheR(-)carprofen.ThebiliaryclearanceofS(+)carprofenseemstobesubject

tostereoselectivelytooasitisaboutthreetimeshigherthanthatofR(-)carprofen.

Carprofenismainlyexcretedinthebilewith70%ofanintra-venousdoseofcarprofen

beingeliminatedinthefaeces,mainlyastheglucuronideconjugate,and8-15%via

urine.

Issued:March2011

AN:01523/2009

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients:

LactoseMonohydrate

Sodiumlaurylsulphate

SpraydriedPigliverpowderEHT

Sucrose

Yeastextract(dried)

GroundWheatgerm

StarchPregelatinised

PovidoneK30

MicrocrystallineCellulose

GuarGum

MagnesiumStearate

PurifiedWater

6.2 Incompatibilities:

Notapplicable

6.3 Shelflife:

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:18months.

Shelf-lifeafterfirstopeningtheimmediatepackaging:24hours.

Anydividedtabletportionsremainingafter24hoursshouldbediscarded.

6.4 Specialprecautionsforstorage:

Storeinadryplace.

Protectfromlight.

Donotstoreabove25ºC

Dividedtabletsshouldbestoredintheblisterpack.

Duetothepalatablenatureofthetablets,storeinasecurelocation.Severeadverse

reactionsmayoccuriflargequantitiesareingested.Ifyoususpectyourdoghas

consumedCarprofenFlavoured/ChewableTablets(insertapprovednational

tradenameonapproval)abovethelabelleddose,pleasecontactyourveterinarian.

6.5 Natureandcompositionofimmediatepackaging:

Aluminium-Aluminiumpacksof10tabletsperstripincartonscontaining20,100,200,

or500tablets.

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductor

wastematerialsderivedfromtheuseofsuchproducts:

Issued:March2011

AN:01523/2009

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

Issued:March2011

AN:01523/2009

7. MARKETINGAUTHORISATIONHOLDER

NorbrookLaboratoriesLimited

StationWorks

Newry

Co.Down,BT356JP

NorthernIreland

8. MARKETINGAUTHORISATIONNUMBER

Vm02000/4303

9. DATEOFFIRSTAUTHORISATION

15March2011

10. DATEOFREVISIONOFTHETEXT

March2011

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