Norodyl 50mg Tablets for Dogs

Main information

  • Trade name:
  • NOROCARP comprimés 50 mg
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • NOROCARP comprimés 50 mg
    France
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0242/002
  • Authorization date:
  • 12-09-2011
  • EU code:
  • UK/V/0242/002
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:February2012

AN.01970/2010

Page1of5

SUMMARYOFPRODUCTCHARACTERISTICS

1. NameoftheVeterinaryMedicinalProduct

Norodyl50mgTabletsforDogs(UK)

Norocarp50mgTabletsforDogs(France)

Carprogesic50mgTabletsforDogs(Germany,Belgium,Luxembourg)

2. QualitativeandQuantitativeComposition

Eachtabletcontains:

ActiveIngredient:

Carprofen 50mg

Excipients:

Forafulllistofexcipients,seesection6.1

3. PharmaceuticalForm

Tablet

Awhite/offwhitecirculartabletof8mmdiameter,50embossedonone

sideandasinglebreaklineontheotherside.

4. ClinicalParticulars

4.1 TargetSpecies:

Dogs

4.2 IndicationsforUse,SpecifyingtheTargetSpecies:

Inthedog:Reductionofinflammationandpaincausedbymusculo-

skeletaldisordersanddegenerativejointdisease.Asafollowupto

parenteralanalgesiainthemanagementofpost-operativepain.

4.3 Contraindications:

Donotuseincats.

Donotuseinpuppieslessthan4monthsofage.

Donotuseincaseofhypersensitivitytoactivesubstancesortoanyof

theexcipients.

Donotuseindogssufferingfromcardiac,hepaticorrenaldisease,

wherethereisapossibilityofgastrointestinalulcerationorbleeding,or

wherethereisevidenceofablooddyscrasia.

Refertosection4.7

Revised:February2012

AN.01970/2010

Page2of5

4.4 SpecialWarningsforEachTargetSpecies:

RefertoSections4.3and4.5.

4.5 SpecialPrecautionsforUse:

(i)Specialprecautionsforuseinanimals

Useinageddogsmayinvolveadditionalrisk.Ifsuchusecannotbe

avoided,suchdogsmayrequirecarefulclinicalmanagement.

Avoiduseinanydehydrated,hypovolaemicorhypotensivedog,as

thereisapotentialriskofincreasedrenaltoxicity.

NSAIDscancauseinhibitionofphagocytosisandhenceinthe

treatmentofinflammatoryconditionsassociatedwithbacterialinfection,

appropriateconcurrentantimicrobialtherapyshouldbeinstigated.

Refertosection4.8

SomeNSAIDsmaybehighlyboundtoplasmaproteinsandcompete

withotherhighlybounddrugs,whichcanleadtotoxiceffects.

(ii)Specialprecautionstobetakenbythepersonadministeringthe

veterinarymedicinalproducttoanimals

Intheeventofaccidentalingestionofthetablets,seekmedicaladvice

andshowthedoctorthepackageleaflet.Washhandsafterhandling

theproduct.

4.6 UndesirableEffects(FrequencyandSeriousness):

TypicalundesirableeffectsassociatedwithNSAIDssuchasvomiting,

softfaeces/diarrhea,faecaloccultblood,lossofappetiteandlethargy

havebeenreported.Theseadversereactionsoccurgenerallywithin

thefirsttreatmentweekandareinmostcasestransientanddisappear

followingterminationofthetreatmentbutinveryrarecasesmaybe

seriousorfatal.

Ifadversereactionsoccur,useoftheproductshouldbestoppedand

theadviceofaveterinarianshouldbesought.

AswithotherNSAIDsthereisariskofrarerenaloridiosyncratic

hepaticadverseevents.

4.7 UseDuringPregnancy,LactationorLay:

Studiesinlaboratoryspecies(ratandrabbit)haveshownevidenceof

foetotoxiceffectsofcarprofenatdosesclosetothetherapeuticdose.

Thesafetyoftheveterinarymedicinalproducthasnotbeen

establishedduringpregnancyandlactation.Donotuseinpregnantor

lactatingbitches.

Revised:February2012

AN.01970/2010

Page3of5

4.8 InteractionwithotherMedicinalProductsandOtherFormsof

Interaction:

DonotadministerNSAIDsandglucocorticoidsconcurrentlyorwithin

24hoursofeachother.SomeNSAIDsmaybehighlyboundtoplasma

proteinsandcompetewithotherhighlybounddrugs,whichcanleadto

toxiceffects.

Concurrentadministrationofpotentialnephrotoxicdrugsshouldbe

avoided.

4.9 AmountstobeAdministeredandAdministration:

Fororaladministration.

4mgcarprofenperkgbodyweightperday.

Aninitialdoseof4mgcarprofen/kgbodyweight/daygivenasasingle

dailydoseorin2equallydivideddoses.Thedosemaybereduced

subjecttoclinicalresponse.

Durationoftreatmentwillbedependentupontheresponseseen.

Long-termtreatmentshouldbeunderregularveterinarysupervision.

Donotexceedstateddose.

Toextendanalgesicandanti-inflammatorycoverpost-operatively

parenteralpre-operativetreatmentwithaninjectablecarprofenproduct

maybefollowedwithCarprofenTabletsat4mg/kg/dayfor5days.

4.10Overdose(symptoms,emergencyprocedures,antidotes),if

necessary:

Dosesuptothreetimestherecommendeddosagearereportedtobe

withoutadverseeffectindogs.Thereisnospecificantidoteto

carprofenbutgeneralsupportivetherapyasappliedtoclinical

overdosagewithNSAID’sshouldbeapplied.

4.11WithdrawalPeriod(s):

Notapplicable

5. PharmacologicalProperties

Pharmacotherapeuticgroup:Non-steroidalanti-inflammatorydrug

ATCVetCode:QM01AE91

5.1 Pharmacodynamicproperties:

Carprofen,(

)-6-chloro- 

-methylcarbazole-2-aceticacid,isanon-

steroidalanti-inflammatorydrug(NSAID).Itisaderivativeof

phenylpropionicacidandamemberofthearylpropionicacidclassof

NSAIDs.Asarepresentativeofthe2-arylpropionicfamily,itcontainsa

Revised:February2012

AN.01970/2010

Page4of5

chiralcenteratC

ofthepropionicmoietyandtherefore,existsin2

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

Carprofenpossessesanti-inflammatory,analgesicandanti-pyretic

activity.CarprofenlikemostotherNSAIDsisaninhibitorofthe

enzymecyclo-oxygenaseofthearachidonicacidcascade.However

theinhibitionofprostaglandinsynthesisbycarprofenisslightinrelation

toitsanti-inflammatoryandanalgesicpotency.Theprecisemodeof

actionofcarprofenisnotclear.

5.2 Pharmacokineticproperties:

Absorptionisrapidwith>90%absorptionafteroraladministration.The

volumeofdistributionissmallandcarprofenishighlyboundtoplasma

proteins.Biotransformationofcarprofenoccursinthelivertoformthe

esterglucuronideandtwo1-0-acyl- β-D-glucuronidediastereoisomers.

Thesearesecretedinthebiliarytractandexcretedinthefaeces.The

Cmaxis28.51µg/mlandtheAUCis237.33µg/ml.hour.

6. PharmaceuticalParticulars

6.1 ListofExcipient(s):

Microcrystallinecellulose

Lactosemonohydrate

Croscarmellosesodium

PovidoneK30

Sodiumlaurilsulfate

Magnesiumstearate

6.2 Incompatibilities:

None.

6.3 Shelf-Life:

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale

Tubs:3years

Blisterstrips:2years

6.4 SpecialPrecautionsforStorage:

Donotstoreabove25ºC.

Storeinadryplace.

6.5 NatureandCompositionofImmediatePackaging:

Polypropylenetubswithwhitepolyethylenesnapsecurecaps.

Revised:February2012

AN.01970/2010

Page5of5

PVC/Aluminium/Orientatedpolyamideblisterswithaluminiumlidding

foil.

Packsizes:Blisters

Boxof10blisters,eachblistercontains10tablets.

Boxof50blisters,eachblistercontains10tablets.

Packsizes:Tubs

Tubcontaining100tablets.

Tubcontaining500tablets.

Notallpacksizesmaybemarketed.

6.6 SpecialPrecautionsfortheDisposalofUnusedVeterinary

MedicinalProductsorWasteMaterialsDerivedFromtheUseof

SuchProducts:

Anyunusedveterinarymedicinalproductorwastematerialsderived

fromsuchveterinarymedicinalproductsshouldbedisposedofin

accordancewithlocalrequirements.

7. MarketingAuthorisationHolder

NorbrookLaboratoriesLimited

StationWorks

CamloughRoad

Newry

Co.Down

BT356JP

NorthernIreland

8. MarketingAuthorisationNumber

Vm02000/4266

9. DateofFirstAuthorisation

October2006.

10. DateofRevisionoftheText

February2012

ProhibitionofSale,Supplyand/orUse

UKauthorisedveterinarymedicinalproduct-UKrequirement

POM-V

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