DOLAGIS dogs tablet 120 mg

Main information

  • Trade name:
  • DOLAGIS dogs tablet 120 mg
  • Pharmaceutical form:
  • Chewable tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DOLAGIS dogs tablet 120 mg
    Spain
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0172/002
  • Authorization date:
  • 24-08-2011
  • EU code:
  • FR/V/0172/002
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

DOLAGIS120mgchewabletabletsfordogs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Activesubstance:

Onetabletcontains:

Carprofen.....................................................................120mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Chewabletablet.

Clover-shapedscoredbeigetablet

Thetabletcanbedividedintofourequalparts.

4. CLINICALPARTICULARS

4.1 Targetspecies

Dogs.

4.2 Indicationsforuse,specifyingthetargetspecies

Inthedog:

Reductionofinflammationandpaincausedbymusculo-skeletaldisordersanddegenerativejoint

disease.

Asafollow-uptoparenteralanalgesiainthemanagementofpost-operativepain.

4.3 Contraindications

Donotuseinpregnantandlactatingbitches.

Donotuseindogsagedlessthan4monthsintheabsenceofspecificdata.

Donotuseincats.

Donotuseindogs,sufferingfromcardiac,hepaticorrenaldisease,whenthereisapossibilityof

gastrointestinalulcerationorbleedingorwherethereisevidenceofblooddyscrasia.

Donotuseincaseofhypersensitivitytotheactivesubstance,tootherNSAIDandtoanyoftheexcipients.

4.4 Specialwarningsforeachtargetspecies

Seesections4.3and4.5.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Useinageddogs,mayinvolveadditionalrisk.Ifsuchausecannotbeavoided,dogsmayrequireareduced

dosageandcarefulclinicalmanagement.

Avoiduseinanydehydrated,hypovolaemicorhypotensivedog,asthereisapotentialriskofincreasedrenal

toxicity.

Concurrentadministrationofpotentialnephrotoxicdrugsshouldbeavoided.

NSAIDcancauseinhibitionofphagocytosisandhenceinthetreatmentofinflammatoryconditions

associatedwithbacterialinfection,appropriateconcurrentantimicrobialtherapyshouldbe

instigated.

AswithotherNSAID,photodermatitisduringtreatmentwithcarprofenhasbeenobservedin

laboratoryanimalsandinhumans.Theseskinreactionshaveneverbeenobservedindogs.

DonotadministerotherNSAIDconcurrentlyorwithin24hoursofeachother.SomeNSAIDmaybehighly

boundtoplasmaproteinsandcompetewithotherhighlybounddrugs,whichcanleadtotoxiceffects.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproductto

animals

.

Incaseofaccidentalingestion,seekmedicaladviceimmediatelyandshowthepackageleaflettothe

physician.

Washhandsafterhandlingtheproduct.

4.6 Adversereactions(frequencyandseriousness)

TypicalundesirableeffectsassociatedwithNSAID,suchasvomiting,softfaeces/diarrhea,faecaloccultblood,

lossofappetiteandlethargyhavebeenreported.Theseadversereactionsgenerallyoccurwithinthefirst

treatmentweekandareinmostcasestransientanddisappearfollowingterminationofthetreatmentbutinvery

rarecasesmaybeseriousorfatal.

Ifadversereactionsoccur,useoftheproductshouldbestoppedandtheadviceofaveterinarianshouldbe

sought.

AswithotherNSAIDthereisariskofrarerenaloridiosyncratichepaticadverseevents.

4.7 Useduringpregnancyandlactation

Studiesinlaboratoryspecies(ratandrabbit)haveshownevidenceoffoetotoxiceffectsofcarprofenatdoses

closetothetherapeuticdose.Thesafetyoftheveterinarymedicinalproducthasnotbeenestablishedduring

pregnancyandlactation.Donotuseinpregnantorlactatingbitches.

Forbreedinganimals,donotuseduringreproductionperiod.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Carprofenishighlyboundtoplasmaproteinsandcompetewithotherhighlybounddrugs,whichcanincrease

theirrespectivetoxiceffects.

DonotusethisveterinarymedicinaldrugconcurrentlywithotherNSAIDorwithglucocorticoids.

Concurrentadministrationofpotentiallynephrotoxicdrugs(e.g.aminogylcosideantibiotics)shouldbeavoided.

Refersalsotosection4.5

4.9 Amountstobeadministeredandadministrationroute

Fororaladministration.

4mgcarprofenperkgbodyweightperday.

Aninitialdoseof4mgcarprofenperkgbodyweightperdaygivenasasingledailydose.Theanalgesiceffect

fromeachdosepersistsforatleast12hours.

Thedailydosemaybereduced,subjecttoclinicalresponse.

Durationoftreatmentwillbedependantupontheresponseseen.Longtermtreatmentshouldbeunderregular

veterinarysupervision.

Toextendanalgesicandanti-inflammatorycoverpost-operativelyparenteralpre-operativetreatmentwithan

injectablecarprofenmaybefollowedwithcarprofentabletsat4mg/kg/dayfor5days.

Donotexceedthestateddose.

Thebreakabilitymethodisthefollowing:Putthetabletonaflatsurface,withitsscoredsidefacingthesurface

(convexfaceup).

Withthetipofforefinger,exertaslightverticalpressureonthemiddleofthetablettobreakitintohalves.In

ordertoobtainquarters,thenexertaslightpressureonthemiddleofonehalfwithforefinger.

Eachchewabletabletcanbequarteredforaccuratedosingaccordingtotheindividualbodyweightofthe

animal.

Numberoftabletsperday Dogweight(kg)

¼

7.5 <14.4

½

14.5 <20.9

¾ 21 <29.9

1

30 <37.4

1¼ 37.5 <44.9

45 <52.4

52.5 <59.9

2

60 <70

Thechewabletabletsareflavouredandare well acceptedbydogs.Thechewabletabletscanbeadministered

withorwithoutfood.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Bibliographicdatareportthatcarprofeniswelltoleratedindogsattwicetherecommendeddosagefor42days.

4.11 Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

ATCvetcode:QM01AE91

Pharmacotherapeuticgroup:anti-inflammatory,NSAID,arylproprionicacids

5.1 Pharmacodynamicproperties

Carprofenisanon-steroidalanti-inflammatorydrug(NSAID),ofthe2-arylpropionicacidclassandpossesses

anti-inflammatory,analgesicandantipyreticactivities.

Themechanismofactionofcarprofen,isnotwellknown.However,itwasshownthattheinhibitionofthecyclo-

oxygenaseenzymebycarprofenisrelativelyweakattherecommandeddosage.Moreover,itwasshownthat

carprofendoesn’tinhibitthegenerationofthromboxane(TX)B2indogclottingbloodandneitherprostaglandin

(PG)E2nor12-hydroxyeicosatetraenoicacid(HETE)ininflammatoryexudateareinhibited.Thissuggeststhe

mechanismofactionofcarprofenisnottheinhibitionoftheeicosanoids.Someauthorssuggestedanactivityof

carprofenononeornumerousinflammatoymediatorsnotyetidentifiedbutnoclinicalevidencecouldbeshown.

Carprofenexistsintwoenantiomericforms,R(-)-carprofenandS(+)-carprofenandtheracemicformistheone

marketed.LaboratoryanimalstudiessuggestthattheS(+)enantiomerpossessesgreateranti-inflammatory

potency.

Ulcerogenicpotentialofcarprofenhasbeenshownintherodentsbutnotinthedogs.

5.2 Pharmacokineticparticulars

Afterasingleoraladministrationof4mgofcarprofenperkgofbodyweightindog,thetimetoobtaina

maximumplasmaticconcentrationof23µg/mlisabout2hours.Theoralbioavailabilityismorethan90%ofthe

totaldose.Carprofenismorethan98%boundtoplasmaproteinsanditsvolumeofdistributionislow.

Carprofenisexcretedinthebilewith70%ofanintra-venousdoseofcarprofenbeingeliminatedinthefaeces,

mainlyastheglucuronideconjugate.Carprofenundergoesanenantioselectiveenterohepaticcycleindog,with

onlytheS(+)enantiomerbeingsignificantlyrecycled.TheplasmaticclearanceoftheS(+)carprofenisabout

twicethatoftheR(-)carprofen.ThebiliaryclearanceofS(+)carprofenseemstobesubjecttostereoselectivity

tooasitisaboutthreetimeshigherthanthatofR(-)carprofen.

Environmentalproperties

Nostudieshavebeenperformed.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Pigliverflavour

Yeast,

Croscarmellosesodium,

Copovidone,

Magnesiumstearate,

Anhydrouscolloidalsilica,

Microcrystallinecellulose,

Lactosemonohydrate.

6.2 Incompatibilities

None

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:36months

Shelf-lifeafterfirstopeningtheimmediatepackaging:72hours

6.4. Specialprecautionsforstorage

Donotstoreabove30°C

Protectfromlight.

Dividedtabletsshouldbestoredintheblisterpack.Anydividedtabletportionsremainingafter72hoursshould

bediscarded.

6.5 Natureandcompositionofimmediatepackaging

Blistercomplex:PVDC-PVC/Aluminiumheatsealedblisterswith6tablets/blister.

Cardboardboxwith2blistersof6tablets.

Cardboardboxwith20blistersof6tablets.

Cardboardboxwith40blistersof6tablets.

Cardboardboxwith80blistersof6tablets.

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinalproducts

shouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

LaboratoiresSOGEVAL

200AvenuedeMayenne –BP2227

53022LAVALCedex9

France

Tel:33243495151

Fax:33243539700

E-mail:sogeval@sogeval.fr

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

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