Strumafeline

Main information

  • Trade name:
  • Strumafeline 2.5mg Coated Tablets for Cats
  • Pharmaceutical form:
  • Coated tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Strumafeline 2.5mg Coated Tablets for Cats
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • thiamazole
  • Therapeutic area:
  • Cats Non Food

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0466/002
  • Authorization date:
  • 29-05-2013
  • EU code:
  • UK/V/0466/002
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Issued:August2013

AN:00232/2012

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SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Thiafeline5mgFilm-coatedTabletsforCats(AT,BE,CZ,DE,EE,EL,ES,FR,HU,

IE,IS,IT,LT,LU,LV,PL,PT,RO,SE,SK,UK)

Thiafelinevet5mgFilm-coatedTabletsforcats(FI)

ThiafelineVet(DK,NO)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains:

Activesubstance:

Thiamazole 5 mg

Excipient(s):

Titaniumdioxide(E171) 0.15mg

SunsetYellowFCF(E110) 0.09mg

QuinolineYellowWS(E104) 0.075mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Film-coatedtablet.

Orangebiconvextablets5.5mmdiameter.

4. CLINICALPARTICULARS

4.1Targetspecies

Cats.

4.2Indicationsforuse,specifyingthetargetspecies

Forthestabilisationofhyperthyroidismincatspriortosurgicalthyroidectomy.

Forthelong-termtreatmentoffelinehyperthyroidism.

4.3Contraindications

Donotuseincatssufferingfromsystemicdiseasesuchasprimaryliverdiseaseor

diabetesmellitus.

Donotuseincatsshowingsignsofautoimmunedisease.

Donotuseinanimalswithdisordersofwhitebloodcells,suchasneutropeniaand

lymphopenia.

Donotuseinanimalswithplateletdisordersandcoagulopathies(particularly

thrombocytopenia).

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Donotuseinpregnantorlactatingfemales.Refertosection4.7.

Donotuseincatswithhypersensitivitytothiamazoleortheexcipient,polyethylene

glycol.

4.4Specialwarningsforeachtargetspecies

Asthiamazolecancausehaemoconcentration,catsshouldalwayshaveaccessto

drinkingwater.

4.5Specialprecautionsforuse

Specialprecautionsforuseinanimals

Ifmorethan10mgperdayisrequiredanimalsshouldbemonitoredparticularly

carefully.

Useoftheproductincatswithrenaldysfunctionshouldbesubjecttocarefulrisk:

benefitassessmentbytheclinician.Duetotheeffectthiamazolecanhaveon

reducingtheglomerularfiltrationrate,theeffectoftherapyonrenalfunctionshould

bemonitoredcloselyasdeteriorationofanunderlyingconditionmayoccur.

Haematologymustbemonitoredduetoriskofleucopeniaorhaemolyticanaemia.

Anyanimalthatsuddenlyappearsunwellduringtherapy,particularlyiftheyare

febrile,shouldhaveabloodsampletakenforroutinehaematologyandbiochemistry.

Neutropenicanimals(neutrophilcounts<2.5x10 9

/l)shouldbetreatedwith

prophylacticbactericidalantibacterialdrugsandsupportivetherapy.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Washhandsafteruse.

Inthecaseofaccidentalingestion,seekmedicaladviceimmediatelyandshowthe

packageleafletorthelabeltothephysician.

Thiamazolemaycausevomiting,epigastricdistress,headache,fever,arthralgia,

pruritusandpancytopaenia.Treatmentissymptomatic.

Washhandswithsoapandwaterafterhandlinglitterusedbytreatedanimals.

Donoteat,drinkorsmokewhilehandlingthetabletorusedlitter.

Donothandlethisproductifyouareallergictoanti-thyroidproducts.Ifallergic

symptomsdevelop,suchasaskinrash,swellingoftheface,lipsoreyesordifficulty

inbreathing,youshouldseekmedicalattentionimmediatelyandshowthepackage

leafletorlabeltothedoctor.

Donotbreakorcrushtablets.

Asthiamazoleisasuspectedhumanteratogen,womenofchild-bearingageand

pregnantwomenshouldweargloveswhenhandlinglitteroftreatedcats.

Pregnantwomenshouldweargloveswhenhandlingthisproduct.

4.6Adversereactions(frequencyandseriousness)

Adversereactionshavebeenreportedfollowinglongtermcontrolofhyperthyroidism.

Inmanycasessignsmaybemildandtransitoryandnotareasonforwithdrawalof

treatment.Themoreseriouseffectsaremainlyreversiblewhenmedicationis

stopped.Adversereactionsareuncommon.Themostcommonclinicalsideeffects

reportedincludevomiting,inappetance/anorexia,lethargy,severepruritusand

excoriationsoftheheadandneck,bleedingdiathesisandicterusassociatedwith

hepatopathy, andhaematologicalabnormalities(eosinophilia,lymphocytosis,

neutropenia,lymphopenia,slightleucopenia,agranulocytosis,thrombocytopeniaor

haemolyticanaemia).Thesesideeffectsresolvedwithin7-45daysaftercessationof

thiamazoletherapy.

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Possibleimmunologicalsideeffectsincludeanaemiawithraresideeffectsincluding

thrombocytopenia and serum anti-nuclear antibodies, and, very rarely,

lymphadenopathycanoccur.Treatmentshouldbestoppedimmediatelyand

alternativetherapyconsideredfollowingasuitableperiodforrecovery.

Followinglong-termtreatmentwiththiamazoleinrodents,anincreasedriskof

neoplasiainthethyroidglandhasbeenshowntooccur,butnoevidenceisavailable

incats.

4.7Useduringpregnancy,lactationorlay

Laboratorystudiesinratsandmicehaveshownevidenceofteratogenicand

embryotoxiceffectsofthiamazole.Thesafetyoftheproductwasnotassessedin

pregnantorlactatingcats.Donotuseinpregnantorlactatingfemales.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Concurrenttreatmentwithphenobarbitalmayreducetheclinicalefficacyof

thiamazole.

Thiamazoleisknowntoreducethehepaticoxidationofbenzimidazolewormersand

mayleadtoincreasesintheirplasmaconcentrationswhengivenconcurrently.

Thiamazoleisimmunomodulatory,thereforethisshouldbetakenintoaccountwhen

consideringvaccinationprogrammes.

4.9Amountstobeadministeredandadministrationroute

Fororaladministrationonly.

Forthestabilisationoffelinehyperthyroidismpriortosurgicalthyroidectomyandfor

thelongtermtreatmentoffelinehyperthyroidism,therecommendedstartingdoseis

5mgperday.

Whereverpossible,thetotaldailydoseshouldbedividedintotwoandadministered

morningandevening.Tabletsshouldnotbesplit.

If,forreasonsofcompliance,oncedailydosingwitha5mgtabletispreferable,then

thisisacceptablealthoughthe2.5mgtabletgiventwicedailymaybemore

efficaciousintheshortterm.The5mgtabletisalsosuitableforcatsrequiringhigher

doserates.

Haematology,biochemistryandserumtotalT4shouldbeassessedbeforeinitiating

treatmentandafter3weeks,6weeks,10weeks,20weeks,andthereafterevery3

months.Ateachoftherecommendedmonitoringintervals,thedoseshouldbe

titratedtoeffectaccordingtothetotalT4andtoclinicalresponsetotreatment.Dose

adjustmentsshouldbemadeinincrementsof2.5mgandtheaimshouldbeto

achievethelowestpossibledoserate.

Ifmorethan10mgperdayisrequiredanimalsshouldbemonitoredparticularly

carefully.

Thedoseadministeredshouldnotexceed20mg/day.

Forlongtermtreatmentofhyperthyroidismtheanimalshouldbetreatedforlife.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Intolerancestudiesinyounghealthycats,thefollowingdose-relatedclinicalsigns

occurredatdosesofupto30mg/animal/day:anorexia,vomiting,lethargy,pruritus

and haematologicalandbiochemicalabnormalitiessuchas neutropenia,

lymphopenia,reducedserumpotassiumandphosphoruslevels,increased

magnesiumandcreatininelevelsandtheoccurrenceofanti-nuclearantibodies.Ata

doseof30mg/daysomecatsshowedsignsofhaemolyticanaemiaandsevere

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clinicaldeterioration.Someofthesesignsmayalsooccurinhyperthyroidcatstreated

atdosesofupto20mgperday.

Excessivedosesinhyperthyroidcatsmayresultinsignsofhypothyroidism.Thisis

howeverunlikely,ashypothyroidismisusuallycorrectedbynegativefeedback

mechanisms.PleaserefertoSection4.6:Adversereactions.

Ifoverdosageoccurs,stoptreatmentandgivesymptomaticandsupportivecare.

4.11Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:antithyroidpreparations,sulphur-containingimidazole

derivates.

ATCVetCode:QH03BB02.

5.1Pharmacodynamicproperties

Thiamazoleactsbyblockingthebiosynthesisofthyroidhormoneinvivo.Theprimary

actionistoinhibitbindingofiodidetotheenzymethyroidperoxidase,thereby

preventingthecatalysediodinationofthyroglobulinandT

andT

synthesis.

5.2Pharmacokineticparticulars

Absorption

Followingoraldosinginhealthycats,thiamazoleisrapidlyandcompletelyabsorbed

withabioavailabilityof>75%.However,thereisaconsiderablevariationbetween

animals.

Peakplasmalevelsoccurapproximately0.5-1hourafterdosing(t

=0.69h).C

isbetween1.1and2.7µg/ml(1.78µg/ml)andhalf-lifeis3.3h.

Distribution

Frommanandratsitisknownthatthedrugcancrosstheplacentaandconcentrates

inthefoetalthyroidgland.Thereisalsoahighrateoftransferintobreastmilk.

Thedrugresidencetimeinthethyroidglandisassumedtobelongerthaninthe

plasma.

Metabolismandelimination

Themetabolismofthiamazoleincatshasnotbeeninvestigated,however,inrats

thiamazoleisrapidlymetabolisedinthethyroidgland.About64%ofthe

administereddosebeingeliminatedintheurineandonly7.8%excretedinfaeces.

Thisisincontrastwithmanwheretheliverisimportantforthemetabolicdegradation

ofthecompound.

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6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Tabletcore:

Lactosemonohydrate

Povidone

SodiumstarchglycolateTypeA

Silica,colloidalanhydrous

Magnesiumstearate

Coating:

Hypromellose

Cellulose,microcrystalline

Lactosemonohydrate

Macrogol

Titaniumdioxide(E171)

SunsetYellowFCF(E110)

QuinolineYellowWS(E104)

6.2Incompatibilities

Notapplicable.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:30months.

6.4.Specialprecautionsforstorage

Keeptheblisterintheouterpackageinordertoprotectfromlight.

6.5Natureandcompositionofimmediatepackaging

30tabletsinacardboardcartoncontaining1aluminium/pvcstripseachstripwith30

tablets.

60tabletsinacardboardcartoncontaining2aluminium/pvcstripseachstripwith30

tablets.

120tabletsinacardboardcartoncontaining4aluminium/pvcstripseachstripwith30

tablets.

150tabletsinacardboardcartoncontaining5aluminium/pvcstripseachstripwith30

tablets.

300tabletsinacardboardcartoncontaining10aluminium/pvcstripseachstripwith30

tablets.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

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7. MARKETINGAUTHORISATIONHOLDER

LeVetBeheerB.V.

Wilgenweg7

3421TVOudewater

TheNetherlands

8. MARKETINGAUTHORISATIONNUMBER

Vm41821/4006

9. DATEOFFIRSTAUTHORISATION

22August2013

10 DATEOFREVISIONOFTHETEXT

August2013

Approved: 22/08/2013