Norodyl 5% Small Animal Injection for Dogs and Cats

Main information

  • Trade name:
  • Norodyl 5% Small Animal Injection for Dogs and Cats
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Norodyl 5% Small Animal Injection for Dogs and Cats
    Spain
  • Language:
  • English

Therapeutic information

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

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0327/001
  • Authorization date:
  • 20-08-2009
  • EU code:
  • UK/V/0327/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Revised:February2013

AN:01741/2011

Page1of6

SUMMARYOFPRODUCTCHARACTERISTICS

1. NameoftheVeterinaryMedicinalProduct

Carprogesic50mg/mlSmallAnimalSolutionforInjectionforCatsandDogs

(RMS-UK)

Carprogesic50mg/mlSolutionforInjection(Carprofen)forDogsandCats(all

CMSexceptSweden)

Carprogesicvet.50mg/mlSolutionforInjection(Carprofen)forDogsandCats

(Sweden)

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(includingintraocular)surgery.

Cats:Forthecontrolofpost-operativepainfollowingovariohysterectomyand

softtissuesurgery.

Revised:February2013

AN:01741/2011

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4.3 Contraindications:

Donotuseinanimalssufferingfromcardiac,hepaticorrenaldiseaseor

gastrointestinalproblems,wherethereisapossibilityofgastrointestinal

ulcerationorbleeding,orhypersensitivitytocarprofenoranyotherNSAIDsor

anyexcipientsofthisproduct.AswithotherNSAIDsthereisariskofrare

renaloridiosyncratichepaticadverseevents.

Donotuseaftersurgerywhichwasassociatedwithconsiderablebloodloss.

Donotuseincatsonrepeatedoccasions.

Donotuseincatslessthan5monthsofage.

Donotuseindogslessthan10weeksofage.

Seealsosection4.7.

4.4 SpecialWarningsforEachTargetSpecies:

Inthecat,duetothelongerhalf-life,andnarrowertherapeuticindex,particular

careshouldbetakennottoexceedtherecommendeddoseandtheuseofa

graduated1mlsyringeisrecommendedtomeasurethedoseaccurately.

4.5 SpecialPrecautionsforUse:

(i)Specialprecautionsforuseinanimals

Donotexceedtherecommendeddoseordurationoftreatmentespeciallyin

thecat.

Useinageddogsandcats,mayinvolveadditionalrisk.Ifsuchusecannotbe

avoided,suchanimalsmayrequireareduceddosageandcarefulclinical

management.

Avoiduseinanydehydrated,hypovolaemicorhypotensiveanimal,asthereis

apotentialriskofincreasedrenaltoxicity.

NSAIDscancauseinhibitionofphagocytosisandhenceinthetreatmentof

inflammatoryconditionsassociatedwithbacterialinfection,appropriate

concurrentantimicrobialtherapyshouldbeinstigated.

(ii)Specialprecautionstobetakenbythepersonadministeringthe

veterinarymedicinalproducttoanimals

Careshouldbetakenwhenhandlingtheproducttoavoidaccidentalself-

injectionandskincontact.Ifskincontactoccurswashanyproductfromthe

skinimmediately.Washhandsafteruse.

Revised:February2013

AN:01741/2011

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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)haveshownevidenceof

foetotoxiceffectsofcarprofenatdosesclosetothetherapeuticdose.

Thesafetyoftheveterinarymedicinalproducthasnotbeenestablishedduring

pregnancyandlactation.Donotuseindogsorcatsduringpregnancyor

lactation.

4.8 InteractionwithotherMedicinalProductsandOtherFormsofInteraction:

DonotadministerNSAIDsandglucocorticoidsconcurrentlyorwithin24hours

ofadministrationoftheproduct.Carprofenishighlyboundtoplasmaproteins

andmaycompetewithotherhighlybounddrugs,whichcanleadtotoxic

effects.

Concurrentadministrationofpotentialnephrotoxicdrugsshouldbeavoided.

4.9 AmountstobeAdministeredandAdministration:

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

bodyweight,byintravenousorsubcutaneousinjection,bestgivenpre-

operatively,eitheratthetimeofpremedicationorinductionof

anaesthesia.

Clinicaltrialevidenceindogssuggeststhatonlyasingledoseof

carprofenisrequiredinthefirst24hoursoftheinitialdose,howeverif

furtheranalgesiaisrequiredpostsurgerywithinthis24hourperiod,a

singlehalf-dose(2mg/kg)ofcarprofenmaybegiventodogsas

necessary.

Revised:February2013

AN:01741/2011

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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:

Thereisnospecificantidoteforcarprofenoverdosagebutgeneralsupportive

therapyasappliedtoclinicaloverdosagewithNSAIDsshouldbeapplied .

4.11WithdrawalPeriod(s):

Notapplicable

5. PharmacologicalProperties

Pharmacotherapeuticgroup:Anti-inflammatoryandantirheumaticproducts,

nonsteroids

ATCVetCode:QM01AE91

5.1 Pharmacodynamicproperties:

Carprofen (CPF), (

)-6-chloro- 

-methylcarbazole-2-acetic acid, is a

nonsteroidalanti-inflammatorydrug(NSAID)withanalgesicandanti-pyretic

properties.Itisaderivativeofphenylpropionicacidandamemberofthe

arylpropionicacidclassofNSAIDs.Asarepresentativeofthe2-arylpropionic

family,itcontainsachiralcenteratC

ofthepropionicmoietyandtherefore,

existsin2sterioisomericforms,the(+)-Sand(-)-Renantiomers.

Themechanismofactionofcarprofenisunclear,therearetwoprincipal

theories.Oneproposesthatcarprofenisaselectiveinhibitorofthecyclo-

oxygenaseisoenzyme,COX-2.Thesecondhypothesisthatcarprofenisa

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

itacts,atleastpartially,bysomeotherunknownmechanism.Howeverthe

S(+)enantiomerseemstoberesponsiblefortheselectiveCOX2inhibitionof

carprofen.TheR(-)andS(+)enantiomersundergoglucuronidationandthe

S(+)enantiomerissubjectedtoenterohepaticrecycling.

Revised:February2013

AN:01741/2011

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5.2 Pharmacokineticproperties:

Followingsubcutaneousadministrationof4mgcarprofen/kg,peakplasma

concentrationsof12.6μg/mlwereachievedinapproximately3hoursindogs.

Bioavailabilityfollowingsubcutaneousadministrationisintherange90-100%.

Thevolumeofdistributionissmallwiththehighestdrugconcentrations

occurringinplasma.Ratiosoftissuetoplasmaconcentrationarelessthan

onewhichisconsistentwithahighlevelofbindingofcarprofentoplasma

proteins.Carprofenisprimarilyeliminatedbybiotransformationintheliverinto

glucuronidemetabolites.70to80%ofmetabolitesareeliminatedinfaecesand

10-20%inurine.

Followingsinglesubcutaneousadministrationofcarprofenatadoserateof4

µg/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)

WaterforInjection

6.2 Incompatibilities:

Inabsenceofcompatibilitystudiesthisproductcannotbemixedwithother

veterinaryproducts.

6.3 Shelf-Life:

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years

Shelf-lifeafterfirstopeningtheimmediatepackaging:28days

Revised:February2013

AN:01741/2011

Page6of6

6.4 SpecialPrecautionsforStorage:

Donotstoreabove25°C.

6.5 NatureandCompositionofImmediatePackaging:

Theproductispresentedin1x20ml,5x20ml,6x20ml,10x20mland12x

20mlmultidoseamberglass(Type1)vialssealedwith20mmbromobutyl

bungsand20mmaluminiumseals.

Notallpacksizesmaybemarketed

6.6 SpecialPrecautionsfortheDisposalofUnusedVeterinaryMedicinal

ProductsorWasteMaterialsDerivedFromtheUseofSuchProducts,if

appropriate:

Anyunusedveterinarymedicinalproductorwastematerialderivedfromsuch

veterinarymedicinalproductshouldbedisposedofinaccordancewithlocal

requirements.

7. NameorCorporateNameandAddressorRegisteredPlaceofBusinessof

theMarketingAuthorisationHolder

NorbrookLaboratoriesLimited

StationWorks

CamloughRoad

Newry

Co.Down

BT356JP

NorthernIreland

8. MarketingAuthorisationNumber

Vm02000/4267

9. DateofFirstAuthorisation

02August2007

10. DateofRevisionoftheText

February2013

Approved: 21/02/2013