Carprieve 100mg Tablets for Dogs

Main information

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

Documents

Localization

  • Available in:
  • Carprieve 100mg Tablets for Dogs
    United Kingdom
  • Language:
  • English

Therapeutic information

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

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0317/001
  • Authorization date:
  • 16-06-2011
  • EU code:
  • UK/V/0317/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Revised:June2011

AN:00149/2011

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SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Carprieve100mgTabletsforDogs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains:

ActiveIngredients:

Carprofen 100mg

Excipients:

Tartrazine(E102)1.2mg

Forafulllistofexcipients,seesection6.1

3. PHARMACEUTICALFORM

Tablet

Ayellowcirculartabletof8mmdiameter,100embossedononesideanda

singlebreaklineontheotherside.

Thetabletscanbedividedintoequalhalves.

4. CLINICALPARTICULARS

4.1 TargetSpecies

Dogs

4.2 Indicationsforuse,specifyingthetargetspecies

Inthedog:

Reductionofinflammationandpaincausedbymusculoskeletaldisordersand

degenerativejointdisease.Asafollowuptoparenteralanalgesiainthe

managementofpostoperativepain.

4.3 Contraindications

Donotuseincats.

Donotuseinpregnantorlactatingbitches.

Donotuseinpuppieslessthan4monthsofage.

Donotuseincaseofhypersensitivitytoactivesubstanceortoanyofthe

excipients.

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Donotuseindogssufferingfromcardiac,hepaticorrenaldisease,where

thereisapossibilityofgastrointestinalulcerationorbleeding,orwherethereis

evidenceofablooddyscrasia.

4.4 Specialwarningsforeachtargetspecies

RefertoSections4.3and4.5.

4.5 Specialprecautionsforuse

i. Specialprecautionsforuseinanimals

Useinageddogsmayinvolveadditionalrisk.

Ifsuchausecannotbeavoided,suchdogsmayrequireareduced

dosageandcarefulclinicalmanagement.

Avoiduseinanydehydrated,hypovolaemicorhypotensivedog,asthere

isapotentialriskofincreasedrenaltoxicity.

NSAIDscancauseinhibitionofphagocytosisandhenceinthetreatment

ofinflammatoryconditionsassociatedwithbacterialinfection,appropriate

concurrentantimicrobialtherapyshouldbeinstigated.

Refertosection4.8

ii.Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Intheeventofaccidentalingestionofthetablets,seekmedicaladviceand

showthedoctorthepackageleaflet.

Washhandsafterhandlingtheproduct.

4.6 Adversereactions(frequencyandseriousness)

TypicalundesirableeffectsassociatedwithNSAIDssuchasvomiting,soft

faeces/diarrhoea,faecaloccultblood,lossofappetiteandlethargyhavebeen

reported.Theseadversereactionsoccurgenerallywithinthefirsttreatment

weekandareinmostcasestransientanddisappearfollowingterminationof

thetreatmentbutinveryrarecasesmaybeseriousorfatal.

Ifadversereactionsoccur,useoftheproductshouldbestoppedandthe

adviceofaveterinarianshouldbesought.

AswithotherNSAIDsthereisariskofrarerenaloridiosyncratichepatic

adverseevents.

4.7 Useduringpregnancy,lactationorlay

Studiesinlaboratoryspecies(ratandrabbit)haveshownevidenceof

foetotoxiceffectsofcarprofenatdosesclosetothetherapeuticdose.The

safetyoftheveterinarymedicinalproducthasnotbeenestablishedduring

pregnancyandlactation.Donotuseinpregnantorlactatingbitches.

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4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

DonotadministerotherNSAIDsandglucocorticoidsconcurrentlyorwithin24

hoursofeachother.SomeNSAIDsmaybehighlyboundtoplasmaproteins

andcompetewithotherhighlybounddrugs,whichcanleadtotoxiceffects.

Concurrentadministrationofpotentialnephrotoxicdrugsshouldbeavoided.

4.9 Amountstobeadministeredandadministrationroute

Fororaladministration.

4mgcarprofenperkgbodyweightperday.

Aninitialdoseof4mgcarprofenperkgbodyweightperdaygivenasasingle

doseorintwoequallydivideddoses.Thedailydosemaybereduced,subject

toclinicalresponse.

Durationoftreatmentwillbedependentupontheresponseseen.Long-term

treatmentshouldbeunderregularveterinarysupervision.

Donotexceedthestateddose.

Toextendanalgesicandanti-inflammatorycoverpost-operativelyparenteral

pre-operativetreatmentwithaninjectableCarprofenproductmaybefollowed

withCarprofenTabletsat4mg/kg/dayforupto5days.

Returnanyhalvedtabletstotheblisterpackandusewithin48hours.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Donotexceedthestateddose.Thereisnospecificantidoteforcarprofen

overdosagebutgeneralsupportivetherapy,asappliedtoclinicaloverdosage

withNSAIDsshouldbeapplied.

4.11WithdrawalPeriod(s)

Notapplicable

5. PHARMACOLOGICALORIMMUNOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Non-steroidalanti-inflammatorydrug

ATCVetCode:QM01AE91

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5.1 Pharmacodynamicproperties

Carprofen,(

)-6-chloro- 

-methylcarbazole-2-aceticacid,isanon-steroidal

anti-inflammatorydrug(NSAID).Itisaderivativeofphenylpropionicacidand

amemberofthearylpropionicacidclassofNSAIDs.Asarepresentativeof

the2-arylpropionicfamily,itcontainsachiralcenteratC

ofthepropionic

moietyandtherefore,existsin2sterioisomericforms,the(+)-Sand(-)-R

enantiomers.

Carprofenpossessanti-inflammatory,anaglesicandanti-pyreticactivity.

CarprofenlikemostotherNSAIDsisaninhibitoroftheenzymecyclo-

oxygenaseofthearachidonicacidcascade.Howevertheinhibitionof

prostaglandinsynthesisbycarprofenisslightinrelationtoitsanti-

inflammatoryandanalgesicpotency.Theprecisemodeofactionofcarprofen

isnotclear.

5.2 Pharmacokineticproperties

Absorptionisrapidwith>90%absorptionafteroraladministration.The

volumeofdistributionissmallandcarprofenishighlyboundtoplasma

proteins.Biotransformationofcarprofenoccursinthelivertoformtheester

glucuronideandtwo1-O-acyl- β-D-glucuronidediastereoisomers.Theseare

secretedinthebiliarytractandexcretedinthefaeces.TheC

is28.51

µg/mlandtheAUCis237.33µg/ml.hour.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Tartrazine(E102)

Microcrystallinecellulose

Lactosemonohydrate

Croscarmellosesodium

PovidoneK30

Sodiumlaurilsulphate

Magnesiumstearate

6.2 Incompatibilities

Notapplicable.

6.3 Shelf-life

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:2years

6.4 Specialprecautionsforstorage

Donotstoreabove25ºC.

Storeinadryplace.

Protectfromlight.

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6.5 Natureandcompositionofimmediatepackaging

Carprieve100mgTabletsaresuppliedineither:

PolypropyleneSnapSecureTubscontaining14,30or100tablets,sealedwith

awhitelowdensityPolyethyleneSnapSecureCap,or

Aluminium-Aluminiumblisterstripsof10tabletsincartonscontaining10,20,

30,50,60,70,100,140,180,200,250,280,300,500or1000tablets.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinal

productsorwastematerials

Anyunusedproductorwastematerialshouldbedisposedofinaccordance

withnationalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

NorbrookLaboratoriesLimited

StationWorks

CamloughRoad

Newry

Co.Down,BT356JP

NorthernIreland

8. MARKETINGAUTHORISATIONNUMBER

Vm 02000/4283

9. DATEOFFIRSTAUTHORISATION

21July2009

10. DATEOFREVISIONOFTEXT

June2011