Carprodolor 50 mg/ ml Solution for Injection for Cattle

Main information

  • Trade name:
  • Carprodolor 50 mg/ ml Solution for Injection for Cattle
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Carprodolor 50 mg/ml Solution for Injection for Cattle
    Portugal
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • carprofen
  • Therapeutic area:
  • Cattle

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0429/001
  • Authorization date:
  • 23-01-2013
  • EU code:
  • UK/V/0429/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Issued:May2013

AN:01920/2011

Page1of6

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Carprodolor50mg/mlsolutionforinjectionforcattle

Carprodolorvet.50mg/mlsolutionforinjectionforcattle(FI)

Carprosan50mg/mlsolutionforinjectionforcattle(ES,PT)

Carprosanvet.50mg/mlsolutionforinjectionforcattle(NO,SE,DK,IS)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Perml:

Activesubstance:

Carprofen 50mg

Excipient(s):

Ethanol96% 0.1ml

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

SolutionforInjection

Clearpalestrawcolouredliquid

4. CLINICALPARTICULARS

4.1Targetspecies

Cattle

4.2Indicationsforuse,specifyingthetargetspecies

Theproductisindicatedasanadjuncttoantimicrobialtherapytoreduceclinical

signsinacuteinfectiousrespiratorydiseaseandacutemastitisincattle.

4.3Contraindications

Donotuseinanimalssufferingfromcardiac,hepaticorrenalimpairment.

Donotuseinanimalssufferingfromgastro-intestinalulcerationorbleeding.

Donotusewherethereisevidenceofablooddyscrasia.

Donotuseincasesofhypersensitivitytotheactivesubstanceortoanyofthe

excipients.

Issued:May2013

AN:01920/2011

Page2of6

4.4Specialwarnings

None

4.5Specialprecautionsforuse

i. Specialprecautionsforuseinanimals

Avoiduseinanydehydrated,hypovolaemicorhypotensiveanimal,asthere

isapotentialriskofincreasedrenaltoxicity.Concurrentadministrationof

potentiallynephrotoxicdrugsshouldbeavoided.

Donotexceedthestateddoseorthedurationoftreatment.

DonotadministerotherNSAID’sconcurrentlyorwithin24hoursofeach

other.

AsNSAIDtherapycanbeaccompaniedbyGIorrenalimpairment,

adjunctivefluidtherapyshouldbeconsideredespeciallyinthecaseofacute

mastitistreatment.

ii. Specialprecautionstobetakenbythepersonadministeringthe

veterinarymedicinalproducttoanimals

Carprofen,incommonwithotherNSAIDs,hasbeenshowntoexhibit

photosensitisingpotentialinlaboratorystudies.Avoidskincontactwiththe

veterinarymedicinalproduct.Shouldthisoccur,washtheaffectedareas

immediately.

Takecaretoavoidaccidentalself-injection.Intheeventofaccidentalself-

injectionseekmedicaladviceimmediately.

4.6Adversereactions(frequencyandseriousness)

Studiesincattlehaveshownthatatransientlocalreactionmayformatthesiteof

theinjection.

4.7Useduringpregnancy,lactationorlay

Intheabsenceofanyspecificstudiesinpregnantcattle,useonlyaftera

risk/benefitassessmenthasbeenperformedbytheattendingveterinarysurgeon.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Nospecificsignificantdruginteractionshavebeenreportedforcarprofen.During

clinicalstudiesincattlefourdifferentantibioticclasseswereused,macrolides,

tetracyclines,cephalosporinsandpotentiatedpenicllinswithoutknown

interactions.However,incommonwithotherNSAIDs,carprofenshouldnotbe

administeredsimultaneouslywithanotherveterinarymedicinalproductofthe

Issued:May2013

AN:01920/2011

Page3of6

NSAIDorglucocorticoidclass.Animalsshouldbecarefullymonitoredifcarprofen

isadministeredsimultaneouslywithananticoagulant.

NSAID’sarehighlyboundtoplasmaproteinsandmaycompetewithotherhighly

bounddrugs,suchthatconcomitantadministrationmayresultintoxiceffects.

4.9Amountstobeadministeredandadministrationroute

Singlesubcutaneousorintravenousinjectionatadosageof1.4mgcarprofen/kg

bodyweight(1ml/35kg)incombinationwithantibiotictherapy,asappropriate.

Thestoppershouldnotbepuncturedmorethan20times.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Inclinicalstudies,noadversesignswerereportedafterintravenousand

subcutaneousadministrationofupto5timestherecommendeddose.

Thereisnospecificantidoteforcarprofenoverdosagebutgeneralsupportive

therapy,asappliedtoclinicaloverdosagewithNSAID’s,shouldbeapplied.

4.11Withdrawalperiod(s)

Meatandoffal:21days

Milk: Zerohours

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Anti-inflammatoryandAnti-rheumaticproducts,

non-steroids

ATCvetcode:QM01AE91

5.1Pharmacodynamicproperties

Carprofenisamemberofthe2-arylpropionicacidgroupofnon-steroidalanti-

inflammatorydrugs(NSAID’s),andpossessesanti-inflammatory,analgesicand

antipyreticactivity.

Carprofen,likemostotherNSAID’sisaninhibitoroftheenzymecyclo-oxygenase

ofthearachidonicacidcascade.However,theinhibitionofprostaglandin

synthesisbycarprofenisslightinrelationtoitsanti-inflammatoryandanalgesic

potency.Theprecisemodeofactionisunclear.

Studieshaveshownthatcarprofenhaspotentantipyreticactivityandsignificantly

reducestheinflammatoryresponseinlungtissueincasesofacute,pyrexic

infectiousrespiratorydiseaseincattle.Studiesincattlewithexperimentally

inducedacutemastitishaveshownthatcarprofenadministeredintravenouslyhas

potentantipyreticactivityandimprovesheartrateandrumenfunction.

Issued:May2013

AN:01920/2011

Page4of6

5.2Pharmacokineticparticulars

Absorption:Followingasinglesubcutaneousdoseof1.4mgcarprofen/kgthe

maximumplasmaconcentration(C

)of15.4μg/mlwasreachedafter(T

)7-19

hours.

Distribution:Thehighestcarprofenconcentrationsarefoundinbileandplasma

andmorethan98%ofcarprofenisboundtoplasmaproteins.Carprofenwaswell

distributedinthetissueswiththehighestconcentrationsfoundinkidneyandliver

followedbyfatandmuscle.

Metabolism:Carprofen(parent)isthemaincomponentinalltissues.Carprofen

(parentcompound)isslowlymetabolisedprimarilybyringhydroxylation,

hydroxylationattheα-carbonandbyconjugationofthecarboxylicacidgroupwith

glucuronicacid.The8-hydroxylatedmetaboliteandunmetabolizedcarprofen

predominateinthefaeces.Bilesamplesarecomprisedofconjugatedcarprofen.

Elimination:Carprofenhasaplasmaeliminationhalf-lifeof70hours.Carprofenis

primarilyexcretedinthefaeces,indicatingthatthebiliarysecretionplaysan

importantrole.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Ethanol96%

Macrogol400

Poloxamer188

Ethanolamine

Waterforinjection

6.2Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnot

bemixedwithotherveterinarymedicinalproducts.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years

Shelf-lifeafterfirstopeningtheimmediatepackaging:28days

6.4.Specialprecautionsforstorage

Donotrefrigerateorfreeze

Keepthevialintheoutercartoninordertoprotectfromlight.

6.5Natureandcompositionofimmediatepackaging

Issued:May2013

AN:01920/2011

Page5of6

50mlamberglass(TypeI)vialscappedwithchlorbutylrubberstopperretainedby

analuminiumcrimpedsealinacardboardbox.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements

7. MARKETINGAUTHORISATIONHOLDER

LeVetBeheerB.V.

Wilgenweg7

3421TVOudewater

TheNetherlands

8. MARKETINGAUTHORISATIONNUMBER

Vm41821/4002

9. DATEOFFIRSTAUTHORISATION

May2013

10.DATEOFREVISIONOFTHETEXT

May2013

Issued:May2013

AN:01920/2011

Page6of6

APPROVED 7/05/13