Anarthron

Main information

  • Trade name:
  • Anarthron
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Anarthron
    Austria
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Pentosan polysulfate
  • Therapeutic area:
  • Dogs Non Food

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0223/001
  • Authorization date:
  • 20-10-2011
  • EU code:
  • UK/V/0223/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Revised:May2013

AN:00194/2012

Page1of6

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Anarthron100mg/mLsolutionforinjectionfordogs(AT,BE,FR,NL,UK)

CartrophenVet100mg/mLsolutionforinjectionfordogs(IS,NO,PL)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

PentosanPolysulfateSodium 100mg/ml

BenzylAlcohol 0.01ml/ml

3. PHARMACEUTICALFORM

Solutionforinjection

Aclear,colourlesspaleyellowsolution.

4. CLINICALPARTICULARS

4.1TargetSpecies

Dog

4.2Indicationsforuse,specifyingthetargetspecies

Forthetreatmentoflamenessandpainofdegenerativejoint

disease/osteoarthrosis(non-infectiousarthrosis)intheskeletallymature

dog.

4.3Contraindications

Donotuseinthetreatmentofsepticarthritis.Inthiscase,appropriate

antimicrobialtherapyshouldbeinstigated.

Donotuseindogswithadvancedliverorkidneyimpairment,orevidence

ofinfection.

Donotuseindogswithblooddisorders,coagulationdisorders,bleeding

ormalignancy(especiallyhaemangiosarcoma).Pentosanpolysulfatehas

ananticoagulanteffect.

Donotuseduringtheperi-operativeperiod.

Donotuseintheskeletallyimmaturedog(i.e.dogswhoselongbone

growthplateshavenotclosed).

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4.4Specialwarnings

Aclinicaleffectmaynotbeobserveduntilafterthesecondinjectionofthe

courseoftreatment.

4.5Specialprecautionsforuse

i. Specialprecautionsforuseinanimals:

Dogsshouldbeweighedpriortoadministrationtoensureaccurate

dosing.

Usewithcautionindogswithhistoryofpulmonarylacerations.

Cautionisalsorecommendedincasesofhepaticimpairment.

Donotexceedthestandarddose.Increasingtherecommendeddose

mayresultinexacerbationofstiffnessanddiscomfort.

Nomorethan3coursesof4injectionsshouldbeadministeredina

12monthperiod.

ii.Specialprecautionstobetakenbythepersonadministeringthe

medicinalproducttoanimals:

Careshouldbetakentoavoidaccidentalself-injection.Wash

splashesfromeyesandskinimmediatelywithwater.Washhands

afteruse.

4.6Adversereactions(frequencyandseriousness)

Emesis,diarrhoea,lethargyandanorexiahavebeenreportedfollowingthe

useofpentosanpolysulfate.Thesesignsmaybetheresultofa

hypersensitivityreactionandmayrequireappropriatesymptomatic

treatmentincludingantihistamineadministration.

Administrationoftheproductatrecommendeddoseratesresultsin

increasesofactivatedpartialthromboplastintime(aPTT)andthrombin

time(TT)whichmaypersistforupto24hoursafteradministrationin

healthydogs.Thisveryrarelyresultsinclinicaleffects,butbecauseofthe

fibrinolyticactionofpentosanpolysulfatesodium,thepossibilityofinternal

bleedingfromatumourorvascularabnormalityshouldbeconsideredif

signsdevelop.Itisrecommendedthattheanimalshouldbemonitoredfor

signsofbloodlossandtreatedappropriately

Bleedingdisorderssuchasnasalbleeding,haemorrhagicdiarrhoeaand

haematomashavebeenreported.

Localreactionssuchasatransientswellinghavebeenobservedpost

injection.

Revised:May2013

AN:00194/2012

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4.7Useduringpregnancy,lactationorlay

Laboratorystudiesinrabbitsshowedembryotoxiceffectsassociatedwith

aprimaryeffectontheparentatrepeateddailydoses2.5timesthe

recommendeddose.

Thesafetyoftheproductinthepregnantbitchhasnotbeenstudied,

thereforeuseisnotrecommendedinthesecircumstances.

Theproductshouldnotbeusedatthetimeofparturitionduetoits

anticoagulanteffects.

4.8Interactionwithothermedicinalproductsandotherformsof

interaction

NSAIDsandinparticularaspirinshouldnotbeusedincombinationwith

pentosanpolysulfatesodiumastheymayaffectthrombocyteadhesionand

potentiatetheanticoagulantactivityoftheproduct.Corticosteroidshave

beenshowntobeantagonistictoanumberofactionsofpentosan

polysulfatesodium.Furthermore,useofanti-inflammatorydrugsmayresult

inaprematureincreaseinthedog’sactivity,whichmayinterferewiththe

therapeuticactivityoftheproduct.

Donotuseconcurrentlywithsteroidsornon-steroidalanti-inflammatory

drugs,includingaspirinandphenylbutazone.

Donotuseconcurrentlywithheparin,warfarinorotheranti-coagulants.

4.9Amountstobeadministeredandadministrationroute

Dosage:3mgpentosanpolysulfatesodium/kgbodyweight(equivalentto

0.3ml/10kgbodyweight)onfouroccasions,withanintervalof5-7days

betweeneachadministration.

Administration:Byasepticsubcutaneousinjectiononlyof0.3ml/10kgof

bodyweight.Anappropriatelygraduatedsyringemustbeusedtoallow

accurateadministrationoftherequireddosevolume.Thisisparticularly

importantwheninjectingsmallvolumes.

Eachcaseshouldbeassessedindividuallybytheveterinarianandan

appropriatetreatmentprogramdetermined.

4.10Overdose(symptoms,emergencyprocedures,antidotes)(if

necessary)

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Repeateddailyoverdosesoffivetimestherecommendeddoseormore

resultsinanorexiaanddepression,whicharereversibleuponwithdrawalof

thedrug.

Atoverdosetheremaybehepatocellulardamageandanassociated,

dose-dependent,elevationinALT.

IncreasesinaPTTandTTaredose-dependent.Atrepeateddoses

greaterthanfivetimesthatrecommended,theseincreasesmaypersist

beyond1weekafteradministrationinhealthydogs.Signsassociatedwith

thesedefectsmayincludebleedingintothegastro-intestinaltract,body

cavitiesandecchymoses.Atrepeateddosesgreaterthantentimesthat

recommendedtheremaybefatalityasaresultofgastro-intestinal

haemorrhage.

Ifoverdoseoccursdogsshouldbehospitalisedandobservedand

supportivetherapyprovidedasdeemednecessarybytheveterinarian.

4.11Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Anti-inflammatoryandanti-rheumatic

products,non-steroids

ATCvetcode:QM01AX90

5.1Pharmacodynamicproperties

TheproductcontainsPentosanPolysulfateSodium(NaPPS),asemi-

syntheticpolymerwithameanmolecularweightof4000Daltons.

Inamodelofosteoarthritisindogs,whenNaPPSwasadministeredat

similartotherapeuticdoses,levelsofmetalloproteinasesincartilagewere

reducedandlevelsoftissueinhibitorofmetalloproteinase(TIMP)

increased,therebypreservingproteoglycancontentandprotecting

cartilagematrixfromdegradation.

IndogswithosteoarthritisadministrationofNaPPScausedfibrinolysis,

lipolysisanddecreasedplateletaggregability.

Ininvitrostudiesandinvivostudiesinlaboratoryspeciesusingdoses

abovethoseproposedfortherapeuticuse,NaPPSsuppressedlevelsof

anti-inflammatorymediatorsandstimulatedhyaluronsynthesisfrom

fibroblasts.

5.2Pharmacokineticparticulars

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Absorption:Inthedog,apeakplasmaconcentrationof7.40

g-eq

pentosanpolysulfatesodium/mLisachieved15minutesafter

subcutaneousadministration.

Distribution:Pentosanpolysulfatesodiumbindsmanyplasmaproteinswith

avariablestrengthofassociationanddissociationresultinginacomplex

equilibriumbetweenboundandunbounddrug.Pentosanpolysulfate

sodiumisconcentratedintheliverandkidneysandreticuloendothelial

system.Lowlevelsoccurinconnectivetissueandmuscle.Instudies

carriedoutwithrabbits,ithasbeenshownthattherapeuticconcentrations

oftheactiveingredientremaininthejointcartilagefor4-5daysafter

administration.Thevolumeofdistributionindogsis0.43L.

Biotransformation:Desulfationofpentosanpolysulfatesodiumoccursin

thehepato-reticulo-endothelialsystem,theliverbeingthemainsiteof

activity.Depolymerisationmayalsooccurinthekidney.

Elimination:Theproductiseliminatedwithahalflifeofapproximately3

hoursinthedog.Fortyeighthoursafterinjectionapproximately70%ofthe

doseadministerediseliminatedviaurine.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Benzylalcohol

Disodiumphosphatedodecahydrate

Sodiumdihydrogenphosphatedihydrate

Sodiumhydroxide

Hydrochloricacid

Waterforinjection

6.2Incompatibilities

Theproductshouldnotbeadministeredinthesamesyringewithother

substances.

6.3Shelf-life

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:3years.

Shelf-lifeafterfirstopeningtheimmediatepackaging:3months.

6.4Specialprecautionsforstorage

Donotstoreabove25 o

C.Keepcontainerintheoutercartoninorderto

protectfromlight.

6.5Natureandcompositionofimmediatepackaging

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AN:00194/2012

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A10mlPh.Eur.Type1clearglassvialfittedwitha20mmrubberstopper

Ph.Eurandclosedbyaplasticflipoffsealattachedtoanaluminiumseal.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productsorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfrom

suchveterinarymedicinalproductsshouldbedisposedofinaccordance

withlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

ArthropharmEuropeLimited

50BedfordStreet

Belfast

BT27FW

NorthernIreland

8. MARKETINGAUTHORISATIONNUMBER

Vm 15519/4002

9. DATEOFFIRSTAUTHORISATION

Date:01May2007

10.DATEOFREVISIONOFTHETEXT

Date:May2013

Approved: 17/05/2013