Dilaterol 25 microgr/ ml oral syrup for horses

Main information

  • Trade name:
  • Dilaterol 25 microgr/ ml oral syrup for horses
  • Pharmaceutical form:
  • Oral liquid
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Dilaterol 25 microgr/ml oral syrup for horses
    Italy
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Clenbuterol
  • Therapeutic area:
  • Horses

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0423/001
  • Authorization date:
  • 26-09-2012
  • EU code:
  • UK/V/0423/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

AN:01218/2011

Issued:March2013

Page1of5

SUMMARYOFPRODUCTCHARACTERISTICS

1.NAMEOFTHEVETERINARYMEDICINALPRODUCT

Dilaterol25micrograms/mlsyrupforhorses.(AT,BE,CZ,ES,HU,IE,IT,LU,PL,PT,

RO,SK,UK)

Dilaterolvet.25micrograms/mlsyrupforhorses.(FI,IS,NO,SE)

Dilaterolvet.(DK)

Dilaterol22micrograms/mlsyrupforhorses(FR)

2.QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontains:

Activesubstance

Clenbuterolhydrochloride25micrograms

(correspondingto22microgramsclenbuterol)

Preservatives:

Methylparahydroxybenzoate(E218)2.02mg

Propylparahydroxybenzoate0.26mg

Forafulllistofexcipients,seesection6.1

3.PHARMACEUTICALFORM

Syrup

Clearcolourlesssyrup

4.CLINICALPARTICULARS

4.1Targetspecies

Horses

4.2Indicationsforuse,specifyingthetargetspecies

Treatmentofrespiratorydiseaseinhorseswhereitisconsideredthatairwayobstruction

duetobronchospasmand/oraccumulationofmucusisacontributingfactor,and

improvedmucociliaryclearanceisdesirable.Tobeusedaloneorasadjuvanttherapy.

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4.3Contraindications

Donotuseincasesofknownhypersensitivitytotheactivesubstanceoranyofthe

excipients.

Donotuseinhorseswithknowncardiacdisease.

Foruseduringpregnancyorlactationseesection4.7.

4.4Specialwarningsforeachtargetspecies

None

4.5Specialprecautionsforuse

Specialprecautionsforuseinanimals

Incasesaccompaniedbybacterialinfectiontheadministrationofantimicrobialagentsis

recommended.

Incaseofglaucomatheproductmustonlybeusedafteracarefulrisk-benefit

assessment.

Specialprecautionsshouldbetakenincaseofhalothaneanaesthesia,sincetheheart

functioncanshowincreasedsensitivitytocatecholamines.

Specialprecautionstobetakenbythepersonadministeringthemedicinal

producttoanimals

Thisproductcontainsclenbuterolhydrochloride,abeta-agonist.

Wearglovestoavoidskincontact.Incaseofaccidentalskincontact,washaffectedarea

thoroughly.Ifirritationoccurs/persistsseekmedicaladvice.Washhandsthoroughlyafter

usingtheproduct.

Takecaretoavoideyecontact.Inthecaseofaccidentaleyecontact,flushthoroughly

withcleanwaterandseekmedicaladvice.

Donoteat,drinkorsmokewhenusingthisproduct.Incaseofaccidentalingestion,seek

medicaladviceimmediatelyandshowthepackageleaflettothehealthcareprofessional.

Peoplewithknownhypersensitivitytoclenbuterolshouldavoidcontactwiththe

veterinarymedicinalproduct.

4.6Adversereactions(frequencyandseriousness)

Clenbuterolmaycausesideeffectssuchassweating(mainlyneckregion),muscle

tremor,tachycardia,slighthypotensionorrestlessness.Thesearetypicalfor  -agonists

andoccurrarely.

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4.7Useduringpregnancyorlactation

Ifusedduringpregnancy,treatmentmustbediscontinuedaminimumof4daysbefore

theexpectedtimeofdelivery,sinceuterinecontractionsmaybeabolishedorlabourmay

beprolongedunderitsinfluence.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

TheproductantagonisestheeffectsofprostaglandinF2-alphaandoxytocin.

Theproductisantagonisedby  -adrenergicblockingagents.

Donotadministerconcurrentlywithotherbeta-adrenergicagents.

Duringtheuseofbothlocalandgeneralanaestheticsonecannotexcludeafurther

vasculardilatationandfallofbloodpressure,particularlyifusedincombinationwith

atropine.

4.9Amountstobeadministeredandadministrationroute

Fororaluse.

Eachdepressionofthepumpdelivers4mlofproduct(0.100mgofclenbuterol

hydrochloride,equivalentto0.088mgclenbuterol).

Thepumpneedstobeprimedbeforethefirstuseonly.Primethepumpbypressing

twiceanddiscardtheretrievedsyrup.

Itisnotpossibletoextractallthecontentsusingthepumpprovided.

Administer4mloftheproductper125kgbodyweighttwicedaily.

Thisisequivalenttotwicedailyadministrationof0.8microgramsclenbuterol

hydrochlorideperkgbodyweight.

Thesyrupshouldbeaddedtothefeed.

Treatmentshouldcontinueforaslongasnecessary

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Dosagesofclenbuterolhydrochlorideupto4timesthetherapeuticdose(administered

orally)foraperiodof90dayscausedtransientsideeffectstypicalforbeta2-

adrenoceptoragonists(sweating,tachycardia,muscletremor),whichrequiredno

treatment.

Incaseofaccidentaloverdose,a  -blocker(suchaspropranolol)maybeusedas

antidote.

4.11Withdrawalperiod(s)

Meatandoffal –28days

Notauthorisedforuseinlactatinganimalsproducingmilkforhumanconsumption.

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5.PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:selectivebeta-2-adrenoreceptoragonists

ATCVetcode:QR03CC13

5.1Pharmacodynamicproperties

Theproductcontainsclenbuterolhydrochloride,whichisasympathomimeticamine

whichpreferentiallybindsto 

2adrenoreceptorsoncellmembranesofthebronchi.This

subsequentlyactivatestheenzymeadenylatecyclaseinsmoothmusclecells,thus

providingintensebronchodilatingpropertiesanddecreasingairwayresistancewith

minimumeffectonthecardiovascularsystem.Theproducthasbeenshowntoinhibit

histaminereleasefrommastcellsinthelungs,andenhancemucociliaryclearancein

horses

5.2Pharmacokineticparticulars

Afteroraladministrationinhorses,clenbuterolisreadilyabsorbedandmaximumplasma

concentrationsreachedwithin2hoursofdosing.Steadystateconcentrationsinplasma

arereachedafter3-5daystreatmentandrangefrom1.0 –2.2ng/ml.

Thesubstanceisrapidlydistributedintissuesandmetabolisedprimarilybytheliver.

Clenbuterolisthemainexcretoryproductandapproximately45%ofthedoseis

eliminatedunchangedintheurine.Thekidneysexcrete70 –91%ofthetotaldose,and

theremainderiseliminatedinthefaeces(6 –15%).

6.PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Methylparahydroxybenzoate(E218)

Propylparahydroxybenzoate

Carbomer974P

Sucrose

Macrogol400

Glycerol(85%)

Ethanol(96%)

Sodiumhydroxide

Water,purified

6.2Incompatibilities

Notknown.

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6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years

Shelflifeafterfirstopeningtheimmediatepackaging:3months

6.4.Specialprecautionsforstorage

Donotstoreabove25°C.Protectfromlight.

6.5Natureandcompositionofimmediatepackaging

355mlHDPEbottlesealedwithanaluminium/PEheatsealandatransparentHDPE

cap.Theproductissuppliedinacartonboxwithamulti-componentmechanicalpump

dispensercapableofdelivering4mloftheproduct.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproductor

wastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

7.MARKETINGAUTHORISATIONHOLDER

LeVetBeheerB.V.

Wilgenweg7

3421TVOudewater

TheNetherlands

8.MARKETINGAUTHORISATIONNUMBER

Vm41821/4001

9.DATEOFFIRSTAUTHORISATION

March2013

10.DATEOFREVISIONOFTHETEXT

March2013

Approved 7/03/13