Norodyl 100mg Tablets for Dogs

Main information

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

Documents

Localization

  • Available in:
  • Norodyl 100mg Tablets for Dogs
    Spain
  • Language:
  • English

Therapeutic information

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

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0318/001
  • Authorization date:
  • 23-03-2009
  • EU code:
  • UK/V/0318/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Issued21/07/2009–AN02479/2007

SUMMARYOFPRODUCTCHARACTERISTICS

1. NameoftheVeterinary MedicinalProduct

Norodyl100mgTabletsforDogs(UK&DK)

Paracarp100mgTabletsforDogs(Germany)

Norocarp 100mgTabletsforDogs(allotherCMS)

2. QualitativeandQuantitativeComposition

Eachtabletcontains:

ActiveIngredients

Carprofen 100 mg

Excipients

Tartrazine(E102) 1.2 mg

Forafulllistofexcipients,seesection6.1

3. PharmaceuticalForm

Tablet

Ayellowcirculartabletof8mmdiameter,100embossedononesideanda

singlebreaklineontheotherside.

Thetabletscanbedividedintoequalhalves.

4. ClinicalParticulars

4.1 TargetSpecies:

Dogs

4.2 IndicationsforUse, Specifying theTargetSpecies:

Inthedog:

Reductionofinflammationandpaincausedbymusculoskeletaldisordersand

degenerativejointdisease.

Asafollowuptoparenteralanalgesiainthemanagementofpostoperative

pain.

4.3 Contraindications:

Donotuseincats.

Donotuseinpregnantorlactatingbitches.

Donotuseinpuppieslessthan4 monthsofage.

Donotuseincaseofhypersensitivitytoactivesubstanceortoanyofthe

excipients.

Issued21/07/2009–AN02479/2007

Donotuseindogssufferingfromcardiac,hepaticorrenaldisease,where

thereisapossibilityofgastrointestinalulcerationorbleeding,orwherethere

isevidenceofablooddyscrasia.

4.4 SpecialWarningsforEachTargetSpecies:

Referto Sections4.3 and4.5.

4.5 SpecialPrecautionsforUse:

(i)SpecialPrecautionsforUseinAnimals

Useinageddogsmayinvolveadditionalrisk.

Ifsuchausecannotbeavoided,suchdogsmayrequireareduceddosageand

carefulclinicalmanagement.

Avoiduseinanydehydrated,hypovolaemicorhypotensivedog,asthereisa

potentialriskofincreasedrenaltoxicity.

NSAIDscancauseinhibitionofphagocytosisandhenceinthetreatmentof

inflammatoryconditionsassociatedwithbacterialinfection,appropriate

concurrentantimicrobialtherapyshouldbeinstigated.

Referto section4.8.

(ii)Specialprecautionstobetakenbythepersonadministeringthe

veterinary medicinalproductto animals

Intheeventofaccidentalingestionofthetablets,seekmedicaladviceand

showthedoctorthepackageleaflet.

Washhandsafterhandlingtheproduct.

4.6 AdverseReactions(Frequencyand Seriousness):

TypicalundesirableeffectsassociatedwithNSAIDssuchasvomiting,soft

faeces/diarrhoea,faecaloccultblood,lossofappetiteandlethargyhavebeen

reported.Theseadversereactionsoccurgenerallywithinthefirsttreatment

weekandareinmostcasestransientanddisappearfollowingterminationof

thetreatmentbutinveryrarecasesmaybeseriousorfatal.

Ifadversereactionsoccur,useoftheproductshouldbestoppedandtheadvice

ofaveterinarianshouldbesought.

AswithotherNSAIDsthereisariskofrarerenaloridiosyncratichepatic

adverseevents.

4.7 UseDuring Pregnancy, LactationorLay:

Studiesinlaboratoryspecies(ratandrabbit)haveshownevidenceof

foetotoxiceffectsofcarprofenatdosesclosetothetherapeuticdose.The

safetyoftheveterinarymedicinalproducthasnotbeenestablishedduring

pregnancyandlactation.Do notuseinpregnantorlactatingbitches.

Issued21/07/2009–AN02479/2007

4.8 InteractionwithotherMedicinalProductsand OtherFormsofInteraction:

DonotadministerotherNSAIDsandglucocorticoidsconcurrentlyorwithin

24hoursofeachother.SomeNSAIDsmaybehighlyboundtoplasma

proteinsandcompetewithotherhighlybounddrugswhichcanleadtotoxic

effects

Concurrentadministrationofpotentialnephrotoxicdrugsshouldbeavoided.

4.9 Amountsto beAdministered and Administration:

Fororaladministration.

4mgcarprofenperkgbodyweightperday.

Aninitialdoseof4mgcarprofenperkgbodyweightperdaygivenasasingle

doseorintwoequallydivideddoses.Thedailydosemaybereduced,subject

to clinicalresponse.

Durationoftreatmentwillbedependentupontheresponseseen.Long-term

treatmentshouldbeunderregularveterinarysupervision.

Donotexceedthestateddose.

Toextendanalgesicandanti-inflammatorycoverpost-operativelyparenteral

pre-operativetreatmentwithaninjectableCarprofenproductmaybefollowed

withNorodylTabletsat4mg/kg/dayforupto 5 days.

Returnanyhalvedtabletstotheblisterpack andusewithin48 hours.

4.10 Overdose(symptoms, emergencyprocedures, antidotes), ifnecessary:

Donotexceedthestateddose.Thereisnospecificantidoteforcarprofen

overdosagebutgeneralsupportivetherapy,asappliedtoclinicaloverdosage

withNSAIDsshouldbeapplied.

4.11 WithdrawalPeriod(s):

Notapplicable

5. PharmacologicalProperties

Pharmacotherapeuticgroup:Non-steroidalanti-inflammatorydrug

ATCVetCode:QM01AE91

5.1 Pharmacodynamicproperties:

Carprofen,(

)-6-chloro- 

-methylcarbazole-2-aceticacid,isanon-steroidal

anti-inflammatorydrug(NSAID).Itisaderivativeofphenylpropionicacid

andamemberofthearylpropionicacidclassofNSAIDs.Asarepresentative

ofthe2-arylpropionicfamily,itcontainsachiralcenteratC

ofthepropionic

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

enantiomers.Carprofenpossessanti-inflammatory,analgesicandanti-pyretic

activity.CarprofenlikemostotherNSAIDsisaninhibitoroftheenzyme

cyclo-oxygenaseofthearachidonicacidcascade.Howevertheinhibitionof

Issued21/07/2009–AN02479/2007

prostaglandinsynthesisbycarprofenisslightinrelationtoitsanti-

inflammatoryandanalgesicpotency.Theprecisemodeofactionofcarprofen

isnotclear.

5.2 Pharmacokineticproperties:

Absorptionisrapidwith>90%absorptionafteroraladministration.The

volumeofdistributionissmallandcarprofenishighlyboundtoplasma

proteins.Biotransformationofcarprofenoccursinthelivertoformtheester

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

secretedinthebiliarytractandexcretedinthefaeces.TheCmaxis28.51

µg/mlandtheAUCis237.33 µg/ml.hour.

6. PharmaceuticalParticulars

6.1 ListofExcipient(s):

Tartrazine(E102)

MicrocrystallineCellulose

LactoseMonohydrate

CroscarmelloseSodium

PovidoneK30

Sodiumlaurilsulphate

MagnesiumStearate

6.2 Incompatibilities:

Notapplicable.

6.3 Shelf-Life:

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:2 years

6.4 SpecialPrecautionsforStorage:

Donotstoreabove25ºC.

Storeinadryplace.

Protectfromlight.

6.5 Natureand CompositionofImmediatePackaging:

NorodylTabletsaresuppliedineither:

PolypropyleneSnapSecureTubscontaining14,30or100tablets,sealedwith

alowdensitywhitePolyethyleneSnapSecureCap, or

Aluminium-Aluminiumblisterstripswithstripsof10tabletsincartons

containing10,20,30,50,60,70,100,140,180,200,250,280,300,500or

1000 tablets.

Issued21/07/2009–AN02479/2007

6.6 SpecialPrecautionsfortheDisposalofUnusedVeterinaryMedicinalProducts

orWasteMaterialsDerived FromtheUseofSuchProducts, ifappropriate:

Anyunusedproductorwastematerialshouldbedisposedofinaccordance

withnationalrequirements.

7. NameorCorporateNameandAddressorRegisteredPlaceofBusinessof

theMarketing AuthorisationHolder

Norbrook LaboratoriesLimited

StationWorks

CamloughRoad

Newry

Co. Down

BT35 6JP

NorthernIreland

8. FinalInformation

MarketingAuthorisationNumber: Vm02000/4282

DateofApprovalofSPC: 21 July2009

DateofRevisionofSPC: 21 July2009