Reproval 5% Small Animal Injection for Dogs and Cats

Main information

  • Trade name:
  • NOROCARP 50 MD/ ML SOLUCIÓN INYECTABLE PARA PERROS Y GATOS
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • NOROCARP 50 MD/ML SOLUCIÓN INYECTABLE PARA PERROS Y GATOS
    Spain
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • carprofen
  • Therapeutic area:
  • Cats, Dogs

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0328/001
  • Authorization date:
  • 29-10-2008
  • EU code:
  • UK/V/0328/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Revised:November2012

AN:00800/2012

Page1of6

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Reproval50mg/mlSolutionforInjectionforDogsandCats(RMS)

Norocarp50mg/mlSolutionforInjectionforDogsandCats(allCMSexcept

France,Germany,SwedenandDenmark)

Carprieve50mg/mlSolutionforInjectionforDogsandCats(Franceand

Germany)

Norocarpvet.50mg/mlSolutionforInjectionforDogsandCats(Sweden)

Norodylvet.50mg/mlSolutionforInjectionforDogsandCats(Denmark)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontains:

Activesubstance:

Carprofen 50mg

Excipients:

BenzylAlcohol 10mg

SodiumFormaldehydeSulphoxylate 2.5mg

Forafulllistofexcipients,seesection6.1

3. PHARMACEUTICALFORM

SolutionforInjection

Aclearcolourlesstopaleyellowsolution.

4. CLINICALPARTICULARS

4.1 TargetSpecies

DogsandCats

4.2 IndicationsforUse,SpecifyingtheTargetSpecies

Dogs:Forthecontrolofpost-operativepainandinflammationfollowing

orthopaedicandsofttissue(includingintra-ocular)surgery.

Cats:Forthecontrolofpostoperativepainfollowingovariohysterectomy

andsofttissuesurgery.

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4.3 Contraindications

Donotuseinanimalssufferingfromcardiac,hepaticorrenaldiseaseor

gastrointestinalproblems,wherethereisapossibilityofgastrointestinal

ulcerationorbleeding,orhypersensitivitytocarprofenoranyotherNSAIDs

oranyexcipientsofthisproduct.AswithotherNSAIDsthereisariskof

rarerenaloridiosyncratichepaticadverseevents.

Donotuseaftersurgerywhichwasassociatedwithconsiderablebloodloss.

Donotuseincatsonrepeatedoccasions.

Donotuseincatslessthan5monthsofage.

Donotuseindogslessthan10weeksofage.

SeealsoSection4.7andSection4.8

4.4 SpecialWarningsforEachTargetSpecies

Inthecat,duetothelongerhalf-life,andnarrowertherapeuticindex,

particularcareshouldbetakennottoexceedtherecommendeddoseand

theuseofagraduated1mlsyringeisrecommendedtomeasurethedose

accurately.

4.5 SpecialPrecautionsforUse

i. SpecialPrecautionsforUseinAnimals

Donotexceedtherecommendeddoseordurationoftreatment

especiallyinthecat.

Useinageddogsandcats,mayinvolveadditionalrisk.Ifsuchuse

cannotbeavoided,suchanimalsmayrequireareduceddosageand

carefulclinicalmanagement.

Avoiduseinanydehydrated,hypovolaemicorhypotensiveanimal,

asthereisapotentialriskofincreasedrenaltoxicity.

NSAIDscancauseinhibitionofphagocytosisandhenceinthe

treatmentofinflammatoryconditionsassociatedwithbacterial

infection,appropriateconcurrentantimicrobialtherapyshouldbe

instigated.

ii. Specialprecautionstobetakenbythepersonadministeringthe

veterinarymedicinalproducttoanimals

Careshouldbetakenwhenhandlingtheproducttoavoidaccidental

self-injectionandskincontact.Ifskincontactoccurswashany

productfromtheskinimmediately.Washhandsafteruse.

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4.6 AdverseReactions(FrequencyandSeriousness)

TypicalundesirableeffectsassociatedwithNSAIDssuchasvomiting,soft

faeces/diarrhea,faecaloccultblood,lossofappetiteandlethargyhavebeen

reported.Theseadversereactionsoccurgenerallywithinthefirsttreatment

weekandareinmostcasestransientanddisappearfollowingterminationof

thetreatmentbutinveryrarecasesmaybeseriousorfatal.

Ifadversereactionsoccur,useoftheproductshouldbestoppedandthe

adviceofaveterinarianshouldbesought.

AswithotherNSAIDsthereisariskofrarerenaloridiosyncratichepatic

adverseevents.

Occasionallyreactionsattheinjectionsitemaybeobservedfollowing

subcutaneousinjection.

4.7 UseDuringPregnancy,LactationorLay

Laboratorystudiesinlaboratoryanimals(rat,rabbit)haveshownevidence

offoetotoxiceffectsofcarprofenatdosesclosetothetherapeuticdose.

Thesafetyoftheveterinarymedicinalproducthasnotbeenestablishedduring

pregnancyandlactation.Donotuseindogsorcatsduringpregnancyor

lactation.

4.8 InteractionwithotherMedicinalProductsandOtherFormsofInteraction

DonotadministerotherNSAIDsandglucocorticoidsconcurrentlyorwithin

24hoursoftheadministrationoftheproduct.Carprofenishighlyboundto

plasmaproteinsandmaycompetewithotherhighlybounddrugs,whichcan

leadtotoxiceffects.

Concurrentadministrationofpotentialnephrotoxicdrugsshouldbeavoided.

4.9 AmountstobeAdministeredandAdministration

Dogs:Inthedog,therecommendeddosageis4mg/kg(1ml/12.5kg)

bodyweight,byintravenousorsubcutaneousinjection,bestgiven

pre-operatively,eitheratthetimeofpremedicationorinductionof

anaesthesia.

Clinicaltrialevidenceindogssuggeststhatonlyasingledoseof

carprofenisrequiredinthefirst24hoursoftheinitialdose,however

iffurtheranalgesiaisrequiredpostsurgerywithinthis24hourperiod,

asinglehalf-dose(2mg/kg)ofcarprofenmaybegiventodogsas

necessary.

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Toextendanalgesicandanti-inflammatorycoverpost-operatively,

parenteraltherapymaybefollowedwithCarprofenTabletsat4

mg/kg/dayforupto5days.

Cats:Inthecat,therecommendeddosageis4mg/kg(0.24ml/3kg)

bodyweightasasingledosebyintravenousinjection,bestgivenpre-

operativelyatthetimeofanaesthesia.SeealsoSection4.4.

Forperi-operativeuseitisrecommendedtoadministertheproductat

least30minutesbeforeanaesthesia.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Thereisnospecificantidoteforcarprofenoverdosagebutgeneral

supportivetherapyasappliedtoclinicaloverdosagewithNSAIDsshouldbe

applied.

4.11WithdrawalPeriod(s)

Notapplicable

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antiflammatoryandantirheumaticproducts,

nonsteroids

ATCVetCode:QM01AE91

5.1 Pharmacodynamicproperties

Carprofen(CPF),(

)-6-chloro- 

-methylcarbazole-2-aceticacid,isa

nonsteroidalanti-inflammatorydrug(NSAID)withanalgesicandanti-pyretic

properties.Itisaderivativeofphenylpropionicacidandamemberofthe

arylpropionicacidclassofNSAIDs.Asarepresentativeofthe2-

arylpropionicfamily,itcontainsachiralcenteratC

ofthepropionicmoiety

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

enantiomers.

Themechanismofactionofcarprofenisunclear,therearetwoprincipal

theories.Oneproposesthatcarprofenisaselectiveinhibitorofthecyclo-

oxygenaseisoenzyme,COX-2.Thesecondhypothesisthatcarprofenisa

weakinhibitorofbothcyclo-oxygenaseisoforms,COX-1andCOX-2,and

thatitacts,atleastpartially,bysomeotherunknownmechanism.However

theS(+)enantiomerseemstoberesponsiblefortheselectiveCOX2

inhibitionofcarprofen.TheR(-)andS(+)enantiomersundergo

glucuronidationandtheS(+)enantiomerissubjectedtoenterohepatic

recycling.

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5.2 Pharmacokineticproperties

Followingsubcutaneousadministrationof4mgcarprofen/kg,peakplasma

concentrationsof12.6 μg/mlwereachievedinapproximately3hoursin

dogs.Bioavailabilityfollowingsubcutaneousadministrationisintherange

90-100%.Thevolumeofdistributionissmallwiththehighestdrug

concentrationsoccurringinplasma.Ratiosoftissuetoplasma

concentrationarelessthanonewhichisconsistentwithahighlevelof

bindingofcarprofentoplasmaproteins.Carprofenisprimarilyeliminatedby

biotransformationintheliverintoglucuronidemetabolites.70to80%of

metabolitesareeliminatedinfaecesand10-20%inurine.

Followingsinglesubcutaneousadministrationofcarprofenatadoserateof

4µg/kgbodyweighttodogs,thefollowingparameterswereobservedforthe

individualenantiomers(R-)and(S+)andtotalcarprofen:Cmax(R-)=6.51

µg/ml,Tmax(R-)=3.0hours,AUC(R-)=88.01µg/ml.hours,t

(R-)=9.098

hours;Cmax(S+)=6.15µg/ml,Tmax(S+)=3.125hours,AUC(S+)=80.01

µg/ml.hours,t

(S+)=8.139hours;Cmax(total)=12.6µg/ml,Tmax(total)=

3.031hours,AUC(total)=168.31µg/ml.hours,t

(total)=9.0hours.

Followingintravenousadministrationofcarprofentocatsahalf-life(t1/2)of

20.1±16.6hourswasobserved.Theeliminationhalf-lifeofcarprofenranged

from9to49hours.

6. PHARMACEUTICALPARTICULARS

6.1 ListofExcipient(s)

BenzylAlcohol

SodiumFormaldehydeSulphoxylate

L-Arginine

PoloxamerType188(LutrolF68)

WaterforInjections

6.2 Incompatibilities

Intheabsenceofcompatibilitystudiesthisveterinaryproductcannotbe

mixedwithotherproducts.

6.3 Shelf-Life

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years

Shelf-lifeafterfirstopeningtheimmediatepackaging:28days

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6.4 SpecialPrecautionsforStorage

Donotstoreabove25°C.

6.5 NatureandCompositionofImmediatePackaging

1x20ml,5x20ml,6x20ml,10x20mland12x20mlmultidoseamber

glass(Type1)vials,sealedwith20mmbromobutylbungsand20mm

aluminiumseals.

Notallpacksizesmaybemarketed.

6.6 SpecialPrecautionsfortheDisposalofUnusedVeterinaryMedicinal

ProductsorWasteMaterialsDerivedFromtheUseofSuchProducts,if

appropriate

Anyunusedveterinarymedicinalproductsorwastematerialsderivedfrom

suchveterinarymedicinalproductshouldbedisposedofinaccordancewith

localrequirements.

7. Nameorcorporatenameandaddressorregisteredplaceofbusinessof

theMarketingAuthorisationHolder

NorbrookLaboratoriesLimited

StationWorks

CamloughRoad

Newry

Co.Down

BT356JP

NorthernIreland

8. MARKETINGAUTHORISATIONNUMBER

Vm 02000/4268

9.DATEOFFIRSTAUTHORISATION

Date:02August2007

10.DATEOFREVISIONOFTEXT

Date:November2012

Approvedby: 15/11/2012