Forthyron 200 Microgram Flavoured Tablet

Main information

  • Trade name:
  • Forthyron 200 Microgram Flavoured Tablet
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Forthyron 200 Microgram Flavoured Tablet
    Slovenia
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0388/001
  • Authorization date:
  • 26-10-2011
  • EU code:
  • UK/V/0388/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised: December2011

AN:01146/2010

Page1of6

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Forthyronflavoured200microgramtabletsfordogs

UK:Thyforonflavoured200microgramtabletsfordogs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Onetabletcontains:

200microgramlevothyroxinesodiumpertabletequivalentto194microgram

levothyroxine

Forafulllistofexcipients,seesection6.1

3. PHARMACEUTICALFORM

Tablet

Offwhiteroundtabletwithbrownspots,quadrisectwithsidescores

Thetabletsmaybedividedintohalvesorquarters

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%

Revised: December2011

AN:01146/2010

Page2of6

ofthenormaldose,increasingby25%incrementseveryfortnightuntiloptimal

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

Revised: December2011

AN:01146/2010

Page3of6

undetectableserumT

concentrations,aswellassubnormalT

values.

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

Revised: December2011

AN:01146/2010

Page4of6

over-supplementation,clinicalsignsofhyperthyroidismsuchaspolydipsia,polyuria,

panting,weightlosswithoutanorexia,andeitherorbothtachycardiaandnervousness

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

Revised: December2011

AN:01146/2010

Page5of6

continues.Thesefurtherdeiodinatedmetabolicproducts(otherthanT

andT

)donot

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.

7. MARKETINGAUTHORISATIONHOLDER

EurovetAnimalHealthB.V.

Handelsweg25,5531AEBladel

Revised: December2011

AN:01146/2010

Page6of6

TheNetherlands

8. MARKETINGAUTHORIZATIONNUMBER

Vm16849/4034

9. DATEOFFIRSTAUTHORISATION

22November2011

10. DATEOFREVISIONOFTHETEXT

December2011

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Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Slovakia and EFSA – Final report

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Slovakia and EFSA – Final report

Published on: Tue, 07 Aug 2018 00:00:00 +0200 Presented document is the final report of the project GA/EFSA/DATA/2017/01: “Strategic Partnership with Slovakia on Data Quality (Pilot project)”. The report describes national processes and tools in order to implement internal validation and quality control of collected data according to EFSA requirements. A description of the data transmission processes from the National Databases to the EFSA databases, terminology, data mapping and data transformations fo...

Europe - EFSA - European Food Safety Authority Publications

10-8-2018

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Westminster Pharmaceuticals, LLC is voluntarily recalling all lots, within expiry, of Levothyroxine and Liothyronine (Thyroid Tablets, USP) 15 mg, 30 mg, 60 mg, 90 mg, & 120 mg to the wholesale level. These products are being recalled as a precaution because they were manufactured using active pharmaceutical ingredients that were sourced prior to the FDA’s Import Alert of Sichuan Friendly Pharmaceutical Co., Ltd., which as a result of a 2017 inspection were found to have deficiencies with Current Good Ma...

FDA - U.S. Food and Drug Administration

17-7-2018

Blokhuis kondigt grootschalige extra vaccinatie aan: Ruim half miljoen kinderen krijgen oproep

Blokhuis kondigt grootschalige extra vaccinatie aan: Ruim half miljoen kinderen krijgen oproep

Volgend jaar worden zo’n 650.000 kinderen extra opgeroepen om zich te laten inenten tegen de zeer ernstige infectieziekte meningokokken. Het gaat om kinderen die zijn geboren na 1 januari 2001 en voor mei 2004. Dat laat staatssecretaris Paul Blokhuis (VWS) weten in een brief aan de Tweede Kamer. Reden voor deze maatregel is dat in de afgelopen jaren een stijging te zien is van het aantal mensen dat de infectie meningokokken type W oploopt. Met deze extra vaccinatieronde moet die groei worden ingedamd. He...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

29-3-2007

New reimbursement status of lipid lowering medicinal products enters into force on 23 April 2007

New reimbursement status of lipid lowering medicinal products enters into force on 23 April 2007

As of 23 April 2007, the reimbursement status of lipid lowering medicinal products will be changed. The decision includes all lipid lowering medicinal products with marketing authorisations in Denmark on 15 March 2007.

Danish Medicines Agency

26-11-2018

Today’s statement highlights increased expectations for information required in 510(k) submissions; each averages 1,185 pages, compared to 475 pages in 2009. Reviewers spend more time reviewing applications, but time to decision has become more efficient

Today’s statement highlights increased expectations for information required in 510(k) submissions; each averages 1,185 pages, compared to 475 pages in 2009. Reviewers spend more time reviewing applications, but time to decision has become more efficient

Today’s statement highlights increased expectations for information required in 510(k) submissions; each averages 1,185 pages, compared to 475 pages in 2009. Reviewers spend more time reviewing applications, but time to decision has become more efficient https://go.usa.gov/xPHdE 

FDA - U.S. Food and Drug Administration

26-11-2018

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009.  https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https://go.usa.gov/xPHdn 

FDA - U.S. Food and Drug Administration

17-9-2018

Scientific guideline:  Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1, draft: consultation open

Scientific guideline: Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1, draft: consultation open

The Guideline on the investigation of medicinal products in the term and preterm neonates was prepared during the period from 2007 to 2009 and came into effect in 2010 (EMEA/536810/2008). Considerable experience of assessing PIP applications covering neonatal age subset has been gained since then and it has become apparent that some essential questions arise repeatedly during the assessment of Paediatric Investigation Plans (PIP) applications for products intended to be investigated and used in neonates....

Europe - EMA - European Medicines Agency

18-4-2018

EU/3/18/2009 (SOTIO a.s)

EU/3/18/2009 (SOTIO a.s)

EU/3/18/2009 (Active substance: Autologous dendritic cells pulsed with killed ovarian cancer cells and matured by TLR3 ligand ex vivo) - Orphan designation - Commission Decision (2018)2405 of Wed, 18 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/246/17

Europe -DG Health and Food Safety

18-4-2018

EU/3/18/2008 (StolmAr and Partner PatentanwAlte PartG mbB)

EU/3/18/2008 (StolmAr and Partner PatentanwAlte PartG mbB)

EU/3/18/2008 (Active substance: Adeno-associated viral vector serotype 9 encoding miRNA against human superoxide dismutase 1) - Orphan designation - Commission Decision (2018)2404 of Wed, 18 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/254/17

Europe -DG Health and Food Safety

18-4-2018

EU/3/18/2007 (Dr Philippe Moullier)

EU/3/18/2007 (Dr Philippe Moullier)

EU/3/18/2007 (Active substance: Adeno-associated viral vector serotype 8 containing the human acid alpha-glucosidase gene) - Orphan designation - Commission Decision (2018)2403 of Wed, 18 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/255/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2005 (IQVIA RDS Ireland Limited)

EU/3/18/2005 (IQVIA RDS Ireland Limited)

EU/3/18/2005 (Active substance: Tazemetostat) - Orphan designation - Commission Decision (2018)1893 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/222/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2004 (IQVIA RDS Ireland Limited)

EU/3/18/2004 (IQVIA RDS Ireland Limited)

EU/3/18/2004 (Active substance: Tazemetostat) - Orphan designation - Commission Decision (2018)1892 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/217/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2003 (Pharmadev Healthcare Ltd)

EU/3/18/2003 (Pharmadev Healthcare Ltd)

EU/3/18/2003 (Active substance: Ribavirin) - Orphan designation - Commission Decision (2018)1891 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/225/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2002 (Pharmadev Healthcare Ltd)

EU/3/18/2002 (Pharmadev Healthcare Ltd)

EU/3/18/2002 (Active substance: Ribavirin) - Orphan designation - Commission Decision (2018)1890 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/224/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2001 (Soligenix UK Ltd)

EU/3/18/2001 (Soligenix UK Ltd)

EU/3/18/2001 (Active substance: Recombinant modified ricin toxin A-chain subunit) - Orphan designation - Commission Decision (2018)1889 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/242/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2006 (IQVIA RDS Ireland Limited)

EU/3/18/2006 (IQVIA RDS Ireland Limited)

EU/3/18/2006 (Active substance: Tazemetostat) - Orphan designation - Commission Decision (2018)1894 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/234/17

Europe -DG Health and Food Safety