Forthyron

Main information

  • Trade name:
  • Thyforon flavoured 400 microgram tablets for dogs
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Thyforon flavoured 400 microgram tablets for dogs
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • levothyroxine sodium
  • Therapeutic area:
  • Dogs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0388/002
  • Authorization date:
  • 26-10-2011
  • EU code:
  • UK/V/0388/002
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

RevisedDecember2011

AN:01148/2010

Page1of6

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Forthyronflavoured400microgramtabletsfordogs

UK:Thyforonflavoured400microgramtabletsfordogs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Onetabletcontains:

400microgramlevothyroxinesodiumpertabletequivalentto389microgram

levothyroxine

Forafulllistofexcipients,seesection6.1

3. PHARMACEUTICALFORM

Tablet

Offwhiteroundtabletwithbrownspots,quadrisectwithsidescores

Thetabletscanbedividedintohalvesorquarters

4. CLINICALPARTICULARS

4.1. Targetspecies

Dogs.

4.2. Indicationsforuse,specifyingthetargetspecies

Forthetreatmentofhypothyroidismindogs.

4.3. Contra-indications

Donotuseindogssufferingfromuncorrectedadrenalinsufficiency.

Donotuseincasesofknownhypersensitivitytolevothyroxinesodium.

4.4. Specialwarningsforeachtargetspecies

Thediagnosishypothyroidismshouldbeconfirmedwithappropriatetests.

4.5. Specialprecautionsforuse

Specialprecautionsforuseinanimals

Asuddenincreaseindemandforoxygendeliverytoperipheraltissues,plusthe

chronotropiceffectsoflevothyroxinesodium,mayplaceunduestressonapoorly

functioningheart,causingdecompensationandsignsofcongestiveheartfailure.

Hypothyroiddogssufferingfromhypoadrenocorticismhaveadecreasedabilityto

metaboliselevothyroxinesodiumandthereforeanincreasedriskofthyrotoxicosis.

Dogswithconcurrenthypoadrenocorticismandhypothyroidismshouldbestabilised

withglucocorticoidandmineralocorticoidtreatmentpriortotreatmentwithlevothyroxine

sodiumtoavoidprecipitatingahypoadrenocorticalcrisis.Afterthis,thyroidtests

shouldberepeated,thengradualintroductionoflevothyroxinetherapy,startingwith25%

ofthenormaldose,increasingby25%incrementseveryfortnightuntiloptimal

RevisedDecember2011

AN:01148/2010

Page2of6

stabilisationisachievedisrecommended.Gradualintroductionoftherapyisalso

recommendedfordogswithotherconcurrentillnesses;particularlyindogswithcardiac

disease,diabetesmellitusandrenalorhepaticdysfunction.

Specialprecautionstobetakenbythepersonadministeringthemedicinal

producttoanimals

Washhandsafteradministeringthetablets.Pregnantwomenshouldhandletheproduct

withcaution.Inthecaseofaccidentalingestion,seekmedicaladviceimmediatelyand

showthepackageleafletorthelabeltothephysician.Note:thisproductcontainsahigh

concentrationofL-thyroxinesodiumandmaypresentarisktohumans,inparticular

children,ifingested.

4.6. Adversereactions(frequencyandseriousness)

Restorationofphysicalactivitymayunmaskorintensifyotherproblems,suchas

osteoarthrosis.Adversereactionsofthyroidhormonesaregenerallyassociatedwith

excessivedosageandcorrespondtothesymptomsofhyperthyroidism.Seealso

section4.10.

4.7. Useduringpregnancy,lactationorlay

Thesafetyoftheveterinarymedicinalproducthasnotbeenestablishedinpregnantor

lactatingbitches.However,levothyroxineisanendogenoussubstanceandthyroid

hormonesareessentialforthedevelopingfoetus,especiallyduringthefirstperiodof

gestation.Hypothyroidismduringpregnancymayresultinmajorcomplicationssuchas

foetaldeathandapoorperinataloutcome.Maintenancedoseoflevothyroxinesodium

mayneedadjustmentduringpregnancy.Pregnantbitchesshouldthereforebe

monitoredonaregularbasefromconceptionuntilseveralweeksafterdelivery.

4.8.Interactionswithothermedicinalproductsandotherformsofinteraction

Avarietyofdrugsmayimpairplasmaortissuebindingofthethyroidhormonesoralter

thyroidhormonemetabolism(eg.barbiturates,antacids,anabolicsteroids,diazepam,

furosemide,mitotane,phenylbutazone,phenytoin,propranolol,largedosesof

salicylates,andsulphonamides.).Whentreatingdogsthatarereceivingconcurrent

medicationthepropertiesofthesedrugsshouldbetakenintoconsideration.

Estrogensmayincreasethyroidrequirements.

Ketaminemaycausetachycardiaandhypertensionwhenusedinpatientsreceiving

thyroidhormones.Theeffectofcatecholaminesandsympaticomimeticsisincreasedby

levothyroxine.

Anincreaseinthedosageofdigitalismaybenecessaryinapatientthathadpreviously

compensatedcongestiveheartfailureandthatisplacedonthyroidhormone

supplementation.Followingtreatmentofhypothyroidismindogswithconcurrent

diabetes,carefulmonitoringofdiabeticcontrolisrecommended.

Mostdogsonchronichigh-dose,dailyglucocorticoidtherapywillhaveverylowor

undetectableserumT

concentrations,aswellassubnormalT

values.

RevisedDecember2011

AN:01148/2010

Page3of6

4.9 Amountstobeadministeredandadministrationroute

Therecommendedstartingdosageoflevothyroxinesodiumis10µg/kgbodyweight

orallyevery12hour.Becauseofvariabilityinabsorptionandmetabolism,thedosage

mayrequirealterationsbeforeacompleteclinicalresponseisobserved.Theinitial

dosageandfrequencyofadministrationaremerelyastartingpoint.Therapyhastobe

highlyindividualisedandtailoredtotherequirementsoftheindividualdog.When

initiatingdosingofdogsweighinglessthan5kgbodyweight,aquarterofone200μg

tabletshouldbeadministeredoncedaily.Suchcases

shouldbemonitoredcarefully.Inthedog,absorptionoflevothyroxinesodiummaybe

affectedbythepresenceoffood.Thetimingoftreatmentanditsrelationtofeeding

shouldthereforebekeptconsistentfromdaytoday.Toadequatelymonitortherapy,

troughvalues(justpriortotreatment)andpeakvalues(aboutthreehoursafterdosing)

ofplasmaT

canbemeasured.Inadequatelydoseddogspeakplasmaconcentration

ofT

shouldbeinthehigh-normalrange(approximately30to47nmol/l)andtrough

valuesshouldbeaboveapproximately19nmol/l.IfT

levelsareoutsidethisrangethe

levothyroxinedosecanbeadjustedin50to200µgincrementsuntilthepatientis

clinicallyeuthyroidandserumT

iswithinthereferencerange.PlasmaT

levelscanbe

retestedtwoweeksafterchangeofdosage,butclinicalimprovementisanequally

importantfactorindeterminingindividualdosageandthiswilltakefourtoeightweeks.

Whentheoptimumreplacementdosehasbeenattained,clinicalandbiochemical

monitoringmaybeperformedevery6 –12months.

Tobreakatabletaccuratelyandeasily,placethetabletscoreside

upandapplypressurewithyourthumb.

Tobreakthetabletintwoparts;holdonehalfofthetabletdownandpressdownthe

otherhalf.

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

Followingadministrationofoverdosesthyrotoxicosiscouldoccur.Thyrotoxicosisasa

sideeffectofmildoversupplementationisuncommonindogs,owingtothecanine

abilitytocatabolizeandexcretethyroidhormones.Incaseofaccidentalintakeoflarge

amountsoftheveterinarymedicinalproductabsorptioncanbedecreasedbyinduction

ofvomitingandoraladministrationofbothactivatedcharcoalandmagnesiumsulphate

once.

Overdosesofthreeuptosixtimeslabelrecommendedstartingdosefor4consecutive

weeksinhealthy,euthyroiddogsresultedinnosignificantclinicalsignsthatcouldbe

attributedtotreatment.Singleoverdoseupto3-6xtherecommendeddosedoesnot

poseathreattothedog,andnoactionsarenecessary.However,followingchronic

over-supplementation,clinicalsignsofhyperthyroidismsuchaspolydipsia,polyuria,

panting,weightlosswithoutanorexia,andeitherorbothtachycardiaandnervousness

RevisedDecember2011

AN:01148/2010

Page4of6

maytheoreticallyoccur.ThepresenceofthesesignsshouldresultinevaluationofT

serumconcentrationstoconfirmthediagnosis,andimmediatediscontinuanceofthe

supplementation.Oncethesignshaveabated(daystoweeks),thethyroiddosagehas

beenreviewed,andtheanimalhasfullyrecovered,alowerdosagemaybeinstituted,

withtheanimalbeingmonitoredclosely.

4.11.Withdrawalperiods

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:syntheticthyroidhormones

ATCvetcode:QH03AA01.

5.1. Pharmacodynamicproperties

Pharmacologicallylevothyroxineisclassifiedasahormonalpreparationthatreplaces

deficientendogenoushormones.

LevothyroxineT

isconvertedtotriiodothyronineT

actsoncellularprocessesvia

specificligand-receptorinteractionswiththenucleus,themitochondria,andtheplasma

membrane.InteractionofT

withbindingsitesleadstoaugmentedtranscriptionofDNA

ormodulationofRNA,thusinfluencingproteinsynthesisandenzymeaction.

Thyroidhormonesactonmanydifferentcellularprocesses.Indevelopinganimalsand

humanbeings,theyarecrucialdeterminantsofnormaldevelopment,especiallyinthe

centralnervoussystem.Thyroidsupplementationincreasesbasalcellularmetabolism

andoxygenconsumptiontherebyaffectingthefunctionofvirtuallyallorgansystems.

5.2. Pharmacokineticparticulars

SomedogsappearedtoconsistentlyeitherabsorbL-thyroxinebetterand/oreliminateit

moreslowlythandootherdogs.Furthermoreabsorptionandeliminationrateis

influencedbydailyintakeoflevothyroxinesodium(highabsorption/loweliminationin

caseoflowintakeandviceversaincaseofhighintake).Thevariabilityin

pharmacokineticparametersbetweenindividualdogsisconsiderableand,althoughthe

presenceoffoodmayaffectabsorption,itisconsideredtohaveaminoreffectonthe

parametersoverall.Absorptionisrelativelyslowandincomplete:InmostcasesT

occursbetween1to5hoursafteroraladministration,meanC

variesmorethan3

foldbetweendogsonthesamedoses.Inadequatelydoseddogstheplasmapeak

approachesorslightlyexceedstheupperlimitofnormalplasmaT

levels,andbythe

endof12hoursafteroraladministration,plasmaT

usuallydeclinestothelowerhalfof

thenormalrange.TheratesofdisappearanceofT

fromtheplasmaareslowedin

hypothyroidism.Alargepartofthethyroxineistakenupbytheliver.L-thyroxineisbound

toplasma-proteinsandplasmalipoproteins.Partofadoseofthyroxineismetabolised

tothemorepotenttriiodothyronine(T

)bydeiodination.Theprocessofdeiodination

continues.Thesefurtherdeiodinatedmetabolicproducts(otherthanT

andT

)donot

RevisedDecember2011

AN:01148/2010

Page5of6

havethyromimeticactivity.Otherpathwaysofthyroidhormonemetabolisminclude

conjugationtoformsolubleglucuronidesandsulphatesforbiliaryorurinaryexcretionas

wellascleavageoftheetherlinkageoftheiodothyroninemolecule.Inthedog,over

50%oftheT

producedeachdayarelostinthefaeces.Theextrathyroidalbodystores

ofT

areeliminatedandreplacedinabout1day.

6. PHARMACEUTICALPARTICULARS

6.1. Listofexcipients

Calciumhydrogenphosphatedihydrate,

Cellulose,Microrcrystalline,

SodiumStarchGlycolate(typeA),

Magnesiumstearate.

Naturalmeatflavour

6.2. Incompatibilities

Notapplicable

6.3. Shelf-life

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years

Shelf-lifeofremainingtabletparts:4days.

6.4. Specialprecautionsforstorage

Donotstoreabove25°C.

Returnanydividedtablettotheopenedblisterandusewithin4days.

6.5. Natureandcontentsofimmediatepackaging

Theproductispackagedinablister[Aluminium(20µm)-PVC/PE/PVDC(250/30/90)

white].

10Tabletsperblister,5or25blisterspercarton,50or250tabletspercarton.

Notallpacksizesmaybemarketed.

6.6. Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerials,derivedfromtheuseofsuchproductsif

appropriate.

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductshouldbedisposedofinaccordancewithlocal

requirements.

RevisedDecember2011

AN:01148/2010

Page6of6

7. MARKETINGAUTHORISATIONHOLDER

EurovetAnimalHealthB.V.

Handelsweg25,5531AEBladel

TheNetherlands

8. MARKETINGAUTHORIZATIONNUMBER

Vm16849/4035

9. DATEOFFIRSTAUTHORISATION

22November2011

10. DATEOFREVISIONOFTHETEXT

December2011

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Sodium oxybate

Sodium oxybate

Sodium oxybate (Active substance: Sodium oxybate) - Centralised - Art 28 - (PSUR - Commission Decision (2018)5381 of Fri, 03 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10612/201710

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2043 (Dr Ulrich Granzer)

EU/3/18/2043 (Dr Ulrich Granzer)

EU/3/18/2043 (Active substance: Combination of carboplatin and sodium valproate) - Orphan designation - Commission Decision (2018)5275 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/036/18

Europe -DG Health and Food Safety

25-7-2018

#FDA issues updated safety communication for Zoll LifeVest 4000 regarding “Message Code 102,” and updated patient checklist.  https://go.usa.gov/xUEPn  #MedicalDevices

#FDA issues updated safety communication for Zoll LifeVest 4000 regarding “Message Code 102,” and updated patient checklist. https://go.usa.gov/xUEPn  #MedicalDevices

#FDA issues updated safety communication for Zoll LifeVest 4000 regarding “Message Code 102,” and updated patient checklist. https://go.usa.gov/xUEPn  #MedicalDevices

FDA - U.S. Food and Drug Administration

11-7-2018

Fosavance (Merck Sharp and Dohme B.V.)

Fosavance (Merck Sharp and Dohme B.V.)

Fosavance (Active substance: Alendronate Sodium / Colecalciferol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4518 of Wed, 11 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/619/T/42

Europe -DG Health and Food Safety

10-7-2018

Adrovance (Merck Sharp and Dohme B.V.)

Adrovance (Merck Sharp and Dohme B.V.)

Adrovance (Active substance: Alendronate sodium / Colecalciferol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4477 of Tue, 10 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/759/T/39

Europe -DG Health and Food Safety

10-7-2018

Ammonaps (Swedish Orphan Biovitrum International AB)

Ammonaps (Swedish Orphan Biovitrum International AB)

Ammonaps (Active substance: Sodium phenylbutyrate) - Centralised - Yearly update - Commission Decision (2018)4483 of Tue, 10 Jul 2018

Europe -DG Health and Food Safety

5-7-2018

Withdrawn application:  Prohippur, sodium benzoate, Initial authorisation

Withdrawn application: Prohippur, sodium benzoate, Initial authorisation

Europe - EMA - European Medicines Agency

19-6-2018

Xyrem (UCB Pharma S.A.)

Xyrem (UCB Pharma S.A.)

Xyrem (Active substance: Sodium oxybate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3912 of Tue, 19 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/593/T/74

Europe -DG Health and Food Safety

1-6-2018

Valproate

Valproate

Valproate (Active substance: medicinal products containing substances related to valproate (sodium valproate, valproic acid, valproate semisodium, valpromide, valproate magnesium)) - Community Referrals - Art 31 - Commission Decision (2018)3623 of Fri, 01 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/A-31/1454

Europe -DG Health and Food Safety

29-5-2018

EU/3/14/1400 (Orphan Europe S.A.R.L.)

EU/3/14/1400 (Orphan Europe S.A.R.L.)

EU/3/14/1400 (Active substance: (1S,4R,5R,7S)-3,4-dibenzyl-2-oxo-6,8-dioxa-3-azabyciclo[3.2.1]octane-7-carboxylic acid-L-lysine) - Transfer of orphan designation - Commission Decision (2018)3402 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/185/14/T/01

Europe -DG Health and Food Safety

28-3-2018

EU/3/17/1876 (FGK Representative Service GmbH)

EU/3/17/1876 (FGK Representative Service GmbH)

EU/3/17/1876 (Active substance: Sodium (1R,3R,4R,5S)-3-({2-N-acetylamino-2-deoxy-3-O-[(1S)-1-carboxylato-2-cyclohexylethyl]-beta-D-galactopyranosyl}oxy)-4-({6-deoxy-alpha-L-galactopyranosyl}oxy)-5-ethyl-cyclohexan-1-yl-(38-oxo-2,5,8,11,14,17,20,23,26,29,32,35-dodecaoxa-39-azahentetracontan-41-yl)carboxamide) - Transfer of orphan designation - Commission Decision (2018)2011 of Wed, 28 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/010/17/T/01

Europe -DG Health and Food Safety

21-3-2018

EU/3/16/1711 (Akcea Therapeutics UK Ltd)

EU/3/16/1711 (Akcea Therapeutics UK Ltd)

EU/3/16/1711 (Active substance: Volanesorsen sodium) - Transfer of orphan designation - Commission Decision (2018)1822 of Wed, 21 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/082/16/T/01

Europe -DG Health and Food Safety