Atopica 100 mg/ml Oral Solution for Cats

Main information

  • Trade name:
  • Atopica 100 mg/ml Oral Solution for Cats
  • Pharmaceutical form:
  • Oral solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Atopica 100 mg/ml Oral Solution for Cats
    Hungary
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Ciclosporin
  • Therapeutic area:
  • Cats

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0226/001
  • Authorization date:
  • 23-06-2011
  • EU code:
  • FR/V/0226/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Atopica100mg/mloralsolutionforcats

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontains:

Activesubstance:

Ciclosporin 100mg

Excipient(s):

all-rac- 

-tocopherol(E-307)1.05mg

Ethanol,anhydrous(E-1510) 94.70mg

Propyleneglycol(E-1520) 94.70mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Oralsolution

Clear,yellowtobrownishliquid

4. CLINICALPARTICULARS

4.1 Targetspecies

Cat

4.2 Indicationsforuse,specifyingthetargetspecies

Symptomatictreatmentofchronicallergicdermatitisincats.

4.3 Contraindications

Donotuseincasesofhypersensitivitytotheactivesubstanceortoanyoftheexcipients.

DonotuseincatsinfectedwithFeLVorFIV.

Donotuseincatswithahistoryofmalignantdisordersorprogressivemalignantdisorders.

Donotvaccinatewithalivevaccineduringtreatmentorwithinatwo-weekintervalbeforeorafter

treatment(seealsosections4.5“Specialprecautionsforuse”and4.8“Interactionwithothermedicinal

products”).

4.4 Specialwarnings

None.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Allergicdermatitisincatscanhavevariousmanifestations,includingeosinophilicplaques,headand

neckexcoriation,symmetricalalopeciaand/ormiliarydermatitis.Clinicalsignsofallergicdermatitis

suchaspruritusandskininflammationarenotspecificforthisdisease.Othercausesofdermatitissuch

asectoparasiticinfestationsorfoodallergyshouldbeevaluatedandeliminatedwherepossible.Itis

goodpracticetotreatfleainfestationsbeforeandduringtreatmentofallergicdermatitis.Acomplete

clinicalexaminationshouldbeperformedpriortotreatment.TheimmunestatusofthecatstoFeLV

andFIVinfectionsshouldbeassessedbeforetreatment.

Anyinfectionsshouldbeproperlytreatedbeforeinitiationoftreatment.Infectionsoccurringduring

treatmentarenotnecessarilyareasonfordrugwithdrawal,unlesstheinfectionissevere.

Whileciclosporindoesnotinducetumours,itdoesinhibitT-lymphocytesandthereforetreatmentwith

ciclosporinmayleadtoanincreasedincidenceofclinicallyapparentmalignancyduetothedecreasein

antitumourimmuneresponse.Thepotentiallyincreasedriskoftumourprogressionmustbeweighed

againsttheclinicalbenefit.Iflymphadenopathyisobservedincatsbeingtreatedwithciclosporin,

furtherclinicalinvestigationsarerecommendedandtreatmentdiscontinuedifnecessary.

Inlaboratoryanimals,ciclosporinisliabletoaffectthecirculatinglevelsofinsulinandtocausean

increaseinglycaemia.Inthepresenceofsuggestivesignsofdiabetesmellitus,theeffectoftreatment

onglycaemiamustbemonitored.Theuseofciclosporinisnotrecommendedindiabeticcats.

CatsthatareseronegativeforT.gondiimaybeatriskofdevelopingclinicaltoxoplasmosisifthey

becomeinfectedwhileundertreatment.Inrarecasesthiscanbefatal.Potentialexposureof

seronegativecatsorcatssuspectedtobeseronegativetoToxoplasmashouldthereforebeminimised

(e.g.keepindoors,avoidrawmeatorscavenging).CiclosporinwasshowntonotincreaseT.gondii

oocytesheddinginacontrolledlaboratorystudy.Incasesofclinicaltoxoplasmosisorotherserious

systemicillness,stoptreatmentwithciclosporinandinitiateappropriatetherapy.

Treatmentwiththeproductmayresultindecreasedimmuneresponsetovaccination.Itis

recommendednottovaccinatewithinactivatedvaccinesduringtreatmentorwithinatwo-week

intervalbeforeorafteradministrationoftheproduct.Forlivevaccinesseealsosection4.3

“Contraindications”.

Clinicalstudiesincatshaveshownthatdecreasedappetiteandweightlossmayoccurduring

ciclosporintreatment.Monitoringofbodyweightisrecommended.Significantreductioninbodyweight

mayresultinhepaticlipidosis.Ifpersistent,progressiveweightlossoccursduringtreatmentitis

recommendedtodiscontinuetreatmentuntilthecausehasbeenidentified..

Theefficacyandsafetyofciclosporinhasneitherbeenassessedincatslessthan6monthsofagenor

weighinglessthan2.3kg.

Itisnotrecommendedtouseimmunosuppressiveagentsconcomitantly.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Washhandsafteradministration.Incaseofaccidentalingestion,seekmedicaladviceimmediatelyand

showthepackageleafletorthelabeltothephysician.Peoplewithknownhypersensitivitytociclosporin

shouldavoidcontactwiththeproduct.

4.6 Adversereactions(frequencyandseriousness)

In2clinicalstudieswith98catstreatedwithciclosporinthefollowingundesirableeffectswere

observed:

Verycommon:gastrointestinaldisturbancessuchasvomitinganddiarrhoea.Thesearegenerallymild

andtransientanddonotrequirethecessationofthetreatment.

Common:lethargy,anorexia,hypersalivation,weightlossandlymphopenia.Theseeffectsgenerally

resolvespontaneouslyaftertreatmentisstoppedorfollowingadecreaseinthedosingfrequency.

Asforthesubjectofmalignancy,pleaseseesections4.3“Contraindications”and4.5“Special

precautionsforuse”.

Sideeffectsmaybesevereinindividualanimals.

4.7 Useduringpregnancy,lactationorlay

Thesafetyofthedrughasneitherbeenstudiedinmalecatsusedforbreedingnorinpregnantor

lactatingfemalecats.Intheabsenceofsuchstudiesinthecat,itisrecommendedtousethedrugin

breedingcatsonlyuponapositiverisk/benefitassessmentbytheveterinarysurgeon.

Inlaboratoryanimals,atdoseswhichinducematernaltoxicity(ratsat30mg/kgBWandrabbitsat100

mg/kgBW)ciclosporinwasembryo-andfoetotoxic,asindicatedbyincreasedpre-andpostnatal

mortalityandreducedfoetalweighttogetherwithskeletalretardations.Inthewell-tolerateddoserange

(ratsatupto17mg/kgBWandrabbitsatupto30mg/kgBW)ciclosporinwaswithoutembryolethalor

teratogeniceffects.Inlaboratoryanimalsciclosporincrossestheplacentabarrierandisexcretedvia

milk.Thereforethetreatmentoflactatingcatsisnotrecommended.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Varioussubstancesareknowntocompetitivelyinhibitorinducetheenzymesinvolvedinthe

metabolismofciclosporin,inparticularcytochromeP450(CYP3A4).Thecompoundclassofazoles

(e.g.ketoconazole)isknowntoincreasethebloodconcentrationofciclosporinincats,whichis

consideredtobeclinicallyrelevant.Macrolidessuchaserythromycinmayincreasetheplasmalevelsof

ciclosporinuptotwofold.CertaininducersofcytochromeP450,anticonvulsantsandantibiotics(e.g.

trimethoprim/sulfadimidine)maylowertheplasmaconcentrationofciclosporin.

CiclosporinisasubstrateandaninhibitoroftheMDR1P-glycoproteintransporter.Therefore,theco-

administrationofciclosporinwithP-glycoproteinsubstratessuchasmacrocycliclactonescould

decreasetheeffluxofsuchdrugsfromblood-brainbarriercells,potentiallyresultinginsignsofCNS

toxicity.Inclinicalstudieswithcatstreatedwithciclosporinandselamectinormilbemycin,theredid

notappeartobeanassociationbetweenthesedrugs’concomitantuseandneurotoxicity.

Ciclosporincanincreasethenephrotoxicityofaminoglycosideantibioticsandtrimethoprim.The

concomitantuseofciclosporinisnotrecommendedwiththeseactiveingredients.

Particularattentionmustbepaidtovaccination(seesection4.3“Contraindications”and4.5“Special

precautionsforuse”).Concomitantuseofimmunosuppressiveagents:seesection4.5“Special

precautionsforuse”

4.9 Amountstobeadministeredandadministrationroute

Fororaluse.

Therecommended initialdaily doseofciclosporinis7mg/kgbodyweight(0.07mloforalsolutionper

andshouldinitiallybeadministereddaily .Thefrequencyofadministrationshouldsubsequentlybe

reduceddependingontheresponse.

Before commencingstarting treatment, anevaluationof all possiblealternative treatmentoptionsshould

be consideredmade .Theproductshouldinitiallybegivendailyuntilasatisfactoryclinicalimprovement

isseen(assessedbyintensityofpruritusandlesionseverity-excoriations,miliarydermatitis,

eosinophilicplaquesand/orself-inducedalopecia).Thiswillgenerallybethecasewithin4-8weeks.

Oncetheclinicalsignsofallergicdermatitisaresatisfactorilycontrolled,theproductcanthenbegiven

everysecondday.Insomecaseswheretheclinicalsignsarecontrolledwitheveryseconddaydosing,

theveterinarysurgeoncandecidetogivetheproductevery3to4days.Thelowesteffective

frequencyofdosingshouldbeusedtomaintaintheremissionofclinicalsigns.

Patientsshouldberegularlyre-evaluatedandalternativetreatmentoptionsreviewed.Thedurationof

treatmentshouldbeadjustedaccordingtotreatmentresponse.Treatmentmaybestoppedwhenthe

clinicalsignsarecontrolled.Uponrecurrenceofclinicalsigns,treatmentshouldberesumedatdaily

dosing,andincertaincasesrepeatedtreatmentcoursesmayberequired.

Theproductcanbegiveneithermixedwithfoodordirectlyintothemouth.Ifgivenwithfood,the

solutionshouldbemixedwithasmallamountoffood,preferablyafterasufficientperiodoffastingto

ensurecompleteconsumptionbythecat.Shouldthecatnotaccepttheproductmixedwithfood,it

shouldbegivenbyinsertingthesyringedirectlyintothecat’smouthanddeliveringtheentiredose.In

casethecatonlypartiallyconsumestheproductmixedwithfood,administrationoftheproductwiththe

syringeshouldberesumedonlythenextday.

Theefficacyandtolerabilityofthisproductwasdemonstratedinclinicalstudieswithadurationof4.5

months.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Thefollowingadverseeventswereseeninthecaseofrepeatedadministrationfor56daysat24mg/kg

(morethan3xtherecommendeddose)orfor6monthsatupto40mg/kg(morethan5xthe

recommendeddose):loose/softfaeces,vomiting,mildtomoderateincreasesinabsolutelymphocyte

counts,fibrinogen,activatedpartialthromboplastintime(APTT),slightincreasesinbloodglucoseand

reversiblegingivalhypertrophy.Thefrequencyandseverityofthesesignsweregenerallydoseand

timedependent.At3xtherecommendeddoseadministereddailyfornearly6months,changesinECG

(conductiondisturbances)mayoccurinveryrarecases.Theyaretransientandnotassociatedwith

clinicalsigns.Anorexia,recumbency,lossofskinelasticity,feworabsentfaeces,thinandclosedeye

lidsmaybeobservedinsporadiccasesat5xtherecommendeddose.Thereisnospecificantidoteand

incaseofsignsofoverdosethecatshouldbetreatedsymptomatically.

4.11Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antineoplasticandimmunomodulatingagents,immunosuppressants,

calcineurininhibitors,ciclosporin.

ATCvetcode:QL04AD01.

5.1 Pharmacodynamicproperties

Ciclosporin(alsoknownascyclosporin,cyclosporine,cyclosporineA,CsA)isaselective

immunosuppressor.Itisacyclicpolypeptideconsistingof11aminoacids,hasamolecularweightof

1203daltonsandactsspecificallyandreversiblyonTlymphocytes.

Ciclosporinexertsanti-inflammatoryandantipruriticeffectsinthetreatmentofallergicdermatitis.

CiclosporinhasbeenshowntopreferentiallyinhibittheactivationofT-lymphocytesonantigenic

stimulationbyimpairingtheproductionofIL-2andotherT-cellderivedcytokines.Ciclosporinalsohas

thecapacitytoinhibittheantigen-presentingfunctionoftheskinimmunesystem.Itlikewiseblocksthe

recruitmentandactivationofeosinophils,theproductionofcytokinesbykeratinocytes,thefunctionsof

Langerhanscells,thedegranulationofmastcellsandthereforethereleaseofhistamineandpro-

inflammatorycytokines.

Ciclosporindoesnotdepresshaematopoiesisandhasnoeffectonthefunctionofphagocyticcells.

5.2 Pharmacokineticparticulars

Absorption

Thebioavailabilityofciclosporinadministeredtocatsfastedfor24hours(eitherdirectlyintothemouth

ormixedwithasmallamountoffood)orjustafterfeedingwas29%and2 34 %respectively.Thepeak

plasmaconcentrationisgenerallyreachedwithin1to2hourswhengiventofastedcatsormixedwith

food.Theabsorptioncanbedelayedbyseveralhourswhengivenafterfeeding.Inspiteofdifferences

inthepharmacokineticsofthedruggivenmixedwithfoodordirectlyintothemouthoffedcats,ithas

beenshownthatthesameclinicalresponseisobtained.

Distribution

Incats,thevolumeofdistributionatsteadystateisabout3.3l/kg.Ciclosporiniswidelydistributedtoall

tissues,includingtheskin.

Metabolism

CiclosporinismetabolisedmainlyintheliverbycytochromeP450(CYP3A4),butalsointheintestine.

Metabolismtakesplaceessentiallyintheformofhydroxylationanddemethylation,leadingto

metaboliteswithlittleornoactivity.

Elimination

Eliminationismainlyviathefaeces.Asmallproportionoftheadministereddoseisexcretedthrough

urineasinactivemetabolites.

Aslightbioaccumulationrelatedtothelonghalflifeofthedrug(approximately24h)isobservedwith

repeateddosing.Thesteadystateisreachedwithin 75 days,withabioaccumulationfactorintherange

of1.0to1.72(typically1-2).

Inthecat,therearelargeinter-individualvariationsinplasmaconcentrations.Attherecommended

dosage,ciclosporinplasmaconcentrationsarenotpredictiveoftheclinicalresponse,therefore

monitoringofbloodlevelsisnotrecommended.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Cornoil-mono-di-triglycerides

Ethanol,anhydrous(E-1510)

Macrogolglycerolhydroxystearate

Propyleneglycol(E-1520)

all-rac- 

-Tocopherol(E-307)

6.2 Incompatibilities

Notapplicable.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:36months.

Shelf-lifeafterfirstopeningtheimmediatepackaging:70days.

6.4.Specialprecautionsforstorage

Donotstoreabove30°C.Donotstorebelow20°C.Storageintherefrigeratorshouldbeavoided.

Keepthebottleintheoutercarton.

Theproductcontainsfatcomponentsfromnaturaloriginwhichcanbecomesolidatlower

temperatures.Ajelly-likeformationmayoccurbelow20°Cwhichishoweverreversibleat

temperaturesupto30°C.Minorflakesoraslightsedimentmaystillbeobserved.However,thisdoes

neitheraffectthedosingnortheefficacyandsafetyoftheproduct.

6.5 Natureandcompositionofimmediatepackaging

Multi-doseamberglassbottlecontaining5mlor17mloralsolution,closedwitharubberstopperand

sealedwithascrewcap.Onebottleandadispenserset(consistingofaPEdiptubeanda1mlPE

syringe)packedinacardboardbox.

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

NovartisSantéAnimaleS.A.S.

14,bdRichelieu

F-92500Rueil-Malmaison

France

8. MARKETINGAUTHORISATIONNUMBER(S)

xyzxyz

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

DD/MM/YYYY}/{DDmonthYYYY}>

10 DATEOFREVISIONOFTHETEXT

monthYYYY

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable.

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