Carprodyl Flavour 50 mg

Main information

  • Trade name:
  • Carprodyl Flavour 50 mg
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Carprodyl Flavour 50 mg
    United Kingdom
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0175/002
  • Authorization date:
  • 13-02-2012
  • EU code:
  • FR/V/0175/002
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

1/5

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

CARPRODYLF50mg,tabletsfordogs[ATBECYCZDEDKELFRHUIEITLUNLPTPLSKUK]

CARPRODYL50mg,tabletsfordogs[ESSE]

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains:

Activeingredient:

Carprofen..................................................................................................50mg

Excipients

Yellowironoxide(E172)......................................................... 4.68750.09375 mg

Forafulllistofexcipients,seesection6.1

3. PHARMACEUTICALFORM

Tablet.

Circular,beige,scoredtablets.

Thetabletscanbedividedintoequalhalves.

4. CLINICALPARTICULARS

4.1Targetspecies

Dogs.

4.2Indicationsforuse,specifyingthetargetspecies

Reductionofinflammationandpaincausedbymusculo-skeletaldisordersanddegenerativejointdisease.

Asafollowuptoparenteralanalgesiainthemanagementofpost-operativepain.

4.3Contraindications

Donotuseincats.

Donotuseinpregnantorlactatingbitches.

Donotuseincasesofknownhypersensitivitytotheactivesubstanceortoanyoftheexcipientsofthe

product.

Donotuseindogssufferingfromcardiac,hepaticorrenaldisease,wherethereisapossibilityofgastro-

intestinalulcerationorbleeding,orwherethereisevidenceofablooddyscrasia.

Donotuseinpupslessthan4monthsofage.

4.4Specialwarningsforeachtargetspecies

RefertoSections4.3and4.5.

2/5

4.5Specialprecautionsforuse

Specialprecautionsforuseinanimals

Useinageddogsmayinvolveadditionalrisk.Ifsuchausecannotbeavoided,dogsmayrequirecareful

clinicalmanagement.

Avoiduseinanydehydrated,hypoproteinemic,hypovolaemicorhypotensivedog,asthereisapotentialrisk

ofincreasedrenaltoxicity.

NSAIDscancauseinhibitionofphagocytosisandhenceinthetreatmentofinflammatoryconditions

associatedwithbacterialinfection,appropriateconcurrentantimicrobialtherapyshouldbeinstigated.

Responsetolongtermtreatmentshouldbemonitoredatregularintervalsbyaveterinarysurgeon.

Asthetabletsareflavoured,theyshouldbestoredinasafeplaceoutofthereachofanimals.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproductto

animals

Intheeventofaccidentalingestionofthetablets,seekmedicaladviceandshowthedoctorthepackage

leaflet.

Washhandsafterhandlingtheproduct.

4.6Adversereactions(frequencyandseriousness)

TypicalundesirableeffectsassociatedwithNSAIDs,suchasvomiting,softfaeces/diarrhea,faecaloccult

blood,lossofappetiteandlethargyhavebeenreported.Theseadversereactionsoccurgenerallywithinthe

firsttreatmentweekandareinmostcasestransientanddisappearfollowingterminationofthetreatmentbut

inveryrarecasesmaybeseriousorfatal.

Rarecasesofgastrointestinalbleedingarereported.

Ifadversereactionsoccur,useoftheproductshouldbestoppedandtheadviceofaveterinarianshouldbe

sought.

AswithotherNSAIDsthereisarareriskofrenaloridiosyncratichepaticadverseevents.

4.7Useduringpregnancy,lactationorlay

Studiesinlaboratoryspecies(ratandrabbit)haveshownevidenceoffoetotoxiceffectsofcarprofenatdoses

closetothetherapeuticdose.

Indogs,thesafetyoftheveterinarymedicinalproducthasnotbeeninvestigatedduringpregnancyand

lactation.Donotuseinpregnantorlactatingbitches.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Carprofenmustnotbeadministeredwithglucocorticoids.

DonotadministerotherNSAIDsandglucocorticoidsconcurrentlyorwithin24hoursofadministrationof

theproduct.

DonotadministerotherNSAIDsconcurrentlyorwithin24hoursofeachother.SomeNSAIDsmaybe

highlyboundtoplasmaproteinsandcompetewithotherhighlybounddrugs,whichcanleadtotoxiceffects.

Concurrentadministrationofpotentialnephrotoxicdrugsshouldbeavoided.

4.9Amountstobeadministeredandadministrationroute

Fororaladministration.

4mgcarprofenperkgbodyweightperday

Tolimittheinflammationandrelievethepaincausedbymusculo-skeletaldisordersanddegenerativejoint

disease:

Aninitialdoseof4mgcarprofenperkgbodyweightperdaygivenasasingledailydoseorintwoequally

divideddoses.Thedailydosemaybereduced,subjecttoclinicalresponse.

3/5

Durationoftreatmentwillbedependantupontheresponseseen.Longtermtreatmentshouldbeunder

regularveterinarysupervision.

Toextendanalgesicandanti-inflammatorycoverpost-operatively,parenteralpreoperativetreatmentwith

carprofeninjectionmaybefollowedwithcarprofentabletsat4mg/kg/dayfor5days.

Donotexceedthestateddose.

Thetabletsareflavouredandconsequentlytakenbymostofdogsvoluntarily.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Nosignsoftoxicityappearedwhendogsweretreatedwithcarprofenatlevelsupto6mg/kgtwicedailyfor

7days(3timestherecommendeddoserateof4mg/kg)and6mg/kgoncedailyforafurther7days(1.5

timestherecommendeddoserateof4mg/kg).

Thereisnospecificantidoteforcarprofenoverdosagebutgeneralsupportivetherapy,asappliedtoclinical

overdosagewithNSAIDs,shouldbeapplied.

Severeadversereactionsmayoccuriflargequantitiesareingested.Ifyoususpectthatyourdoghas

consumedtabletsabovethelabelleddose,contactyourveterinarian.

4.11Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Non-steroidalanti-inflammatorydrug.

ATCvetcode:QM01AE91.

5.1Pharmacodynamicproperties

Carprofen,isanon-steroidalanti-inflammatorydrug(NSAID)ofthe2-arylpropionicacidclassand

possessesanti-inflammatory,analgesicandantipyreticactivities.

Themechanismofactionofcarprofen,likeotherNSAIDs,isbelievedtobeassociatedwiththeinhibitionof

cyclooxygenaseactivity.

Twouniquecyclooxygenaseshavebeendescribedinmammals.Theconstitutivecyclooxygenase,COX-1,

synthesizesprostaglandinsnecessaryfornormalgastrointestinalandrenalfunction.Theinducible

cyclooxygenase,COX-2,generatesprostaglandinsinvolvedininflammation.InhibitionofCOX-1isthought

tobeassociatedwithgastrointestinalandrenaltoxicitywhileinhibitionofCOX-2providesanti-

inflammatoryactivity.Inaninvitrostudy,usingcaninecellcultures,carprofendemonstratedselective

inhibitionofCOX-2versusCOX-1.Clinicalrelevanceofthesedatahasnotbeshown.

Carprofenhasalsobeenshowntoinhibitthereleaseofseveralprostaglandinsintwoinflammatorycell

systems:ratpolymorphonuclearleukocytes(PMN)andhumanrheumatoidsynovialcells,indicating

inhibitionofacute(PMNsystem)andchronic(synovialcellsystem)inflammatoryreactions.

Severalstudieshavedemonstratedthatcarprofenhasmodulatoryeffectsonbothhumoralandcellular

immuneresponses.Carprofen,alsoinhibitstheproductionofosteoclast-activatingfactor(OAF),PGE

and

byitsinhibitoryeffectonprostaglandinbiosynthesis.

5.2Pharmacokineticparticulars

Afteroraladministration,carprofeniswellabsorbedinthedogs.Followingtheadministrationoftheproduct

tabletsindogs,ameanCmax(maximumconcentrationinserum)of6.1mg/Land3.6mg/Lwasachievedat

approximately1hourforCarprofenR(-)andCarprofenS(+),respectively.Forbothenantiomers,themean

half-lifewasapproximately9hours.Theanalgesiceffectfromeachdosepersistsforatleast12hours.

4/5

Carprofenhasasmallvolumeofdistributionandalowsystemicclearance.Itishighlyboundtoplasma

protein.

Carprofenismetabolisedintheliverbyconjugationandoxidation.Theexcretionoftheglucuronide

conjugateismainlyfaecalafterbiliaryexcretion.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Porkaroma

Tabletgradeinactivatedyeast(inactivatedyeast,magnesiumstearateandtricalciumphosphate)

Low-substitutedhydroxypropylcellulose

Yellowironoxide(E172)

Silicacolloidalanhydrous

Tabletgradelactosemonohydrate(lactosemonohydrate,povidone,crospovidone)

Magnesiumstearate

6.2Incompatibilities

Notapplicable.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale: 3years.

Halvedtabletsshouldbeusedwithin7days.

6.4Specialprecautionsforstorage

Thismedicinalproductdoesnotrequireanyspecialtemperaturestorageconditions

Storetabletsandhalf-tabletsintheoriginalblisterinordertoprotectfromlight.

6.5Natureandcompositionofimmediatepackaging

Materialoftheprimarycontainer

Complex(polyamide/Aluminium/PVC)/Aluminiumblisters

Packsizes

Boxcontaining20tablets:4blistersof5tablets

Boxcontaining100tablets:20blistersof5tablets

Boxcontaining200tablets:40blistersof5tablets

Boxcontaining500tablets:100blistersof5tablets

Notallpacksizesmaybemarketed.

5/5

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproductsorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinalproduct

shouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFTHEFIRSTAUTHORISATIONORDATEOFRENEWALOFTHE

AUTHORISATION

10. DATEOFREVISIONOFTHETEXT

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FDA - U.S. Food and Drug Administration

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FDA - U.S. Food and Drug Administration

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FDA - U.S. Food and Drug Administration

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