HIPPOTWIN

Main information

  • Trade name:
  • HIPPOTWIN
  • Pharmaceutical form:
  • Oral paste
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • HIPPOTWIN
    Germany
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • AGENTS AGAINST NEMATODOSIS
  • Therapeutic area:
  • Horses Food

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • NL/V/0111/001
  • Authorization date:
  • 07-02-2010
  • EU code:
  • NL/V/0111/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

ANNEXI

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Hippotwin439mg/goralpasteforhorses.

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Compositionpergram

Activesubstance:

Pyrantelembonate(equivalentto152.2mgofpyrantel)439mg

Excipient(s):

Methylparahydroxybenzoate(E218) 1mg

Propylparahydroxybenzoate(E216). 0.3mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Oralpaste

Yellow,viscous,oilypaste

4. CLINICALPARTICULARS

4.1 Targetspecies

Horses,poniesandfoals(ofover8weeksofage).

4.2 Indicationsforuse,specifyingthetargetspecies

Infestationswithadultstagesofroundworm,particularlyascarids(Parascarisequorum),small

strongyles(Cyathostomumspp.,Triodontophorusspp.)andlargestrongyles(Strongylusedentatus,

Strongylusequinus,Strongylusvulgaris),seatworm/pinworm(Oxyurisequi)andtapeworm

(Anoplocephalaperfoliata)inhorses,poniesandfoals.

TheefficacytowardsAnoplocephalaperfoliataisvariable.

4.3 Contraindications

Donotuseinanimalsknowntobehypersensitivetotheactivesubstance.

4.4 Specialwarnings

Treatmentagainsttapewormsshouldonlybeundertakenwhentapewormshavebeendiagnosed.

Resistancetopyrantelembonatehasbeenreportedincyathostominsinhorses.Thereforetheuseof

thisproductshouldbebasedonlocal(regional,farm)epidemiologicalinformationaboutsusceptibilityof

cyathostominsandrecommendationsonhowtolimitfurtherselectionforresistancetoanthelmintics.

Careshouldbetakentoavoidthefollowingpracticesbecausetheyincreasetheriskofdevelopmentof

resistanceandcouldultimatelyresultinineffectivetherapy:

-Toofrequentandrepeateduseofanthelminticsfromthesameclass,overanextendedperiodoftime.

-Underdosing,whichmaybeduetounderestimationofbodyweight,misadministrationoftheproduct,

orlackofcalibrationofthedosingdevice(ifany).

Suspectedclinicalcasesofresistancetoanthelminticsshouldbefurtherinvestigatedusingappropriate

tests(e.g.FaecalEggCountReductionTest).Wheretheresultsofthetest(s)stronglysuggest

resistancetoaparticularanthelmintic,ananthelminticbelongingtoanotherpharmacologicalclassand

havingadifferentmodeofactionshouldbeused.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

None.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Occurrenceofsensitisationandcontactdermatitiscannotbecompletelyexcluded,sodirectcontact

withtheskinshouldbeavoided.

Wearsuitablegloves.

4..6Adversereactions(frequencyandseriousness)

Noneknown.

4.7 Useduringpregnancyandlactation

Useduringpregnancyandlactationispermitted.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Theproductshouldnotbeusedconcurrentlywithanthelminticproductscontaininglevamisole,

piperazineorcholinesteraseinitiators(e.g.organophosphates).

4.9 Amountstobeadministeredandadministrationroute

Posology

Forsingleoraladministrationtohorses.

(a)Fortreatmentoflargeandsmallstrongyles,largeroundwormsandseatworm/pinwormsthe

recommendeddoseis19mgpyrantelembonateperkgofbodyweight.Onesyringeisintendedfor

1200kgbodyweightandeachsyringeissubdividedinto24markings.Theequivalentofone

markingissufficienttotreat50kgofbodyweight.

(b)Fortreatmentoftapewormstherecommendeddoseis38mgpyrantelembonateperkgof

bodyweight.Onesyringeisintendedfor600kgbodyweightandeachsyringeissubdividedinto24

markings.Theequivalentoftwomarkingsissufficienttotreat50kgofbodyweight.

Toensureadministrationofacorrectdose,bodyweightshouldbedeterminedasaccuratelyas

possible;accuracyofthedosingdeviceshouldbechecked.

Positionthelocking-ringovertheappropriatemarkontheplungerofthesyringeandremovethecap

fromthenozzle,openthemouthofthehorse,depositthepasteasfaraspossibleonthebackofthe

tongueandmakethehorseswallow.Theamountofpasterequestedcanbesetandlockedusingthe

screw-ringnutontheinjector.Swallowingcanbestimulatedbyputtingahandunderthechinand

raisingtheheadofthehorse.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Hippotwiniswelltoleratedupto5timestherecommendedtherapeuticdosefortreatmentof

nematodes.Ifoverdosingcausessignssuchassalivation,musclefibrillations,tachypnoea,dyspnoea,

ataxia,tremorsorconvulsionsatropinecanbeusedasantidote.

4.11Withdrawalperiod(s)

Meatandoffal:Zerodays.

Notpermittedforuseinmaresproducingmilkforhumanconsumption.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:anthelmintics,tetrahydropyrimidines.

ATCvetcode:QP52AF02.

5.1 Pharmacodynamicproperties

Pyrantelembonate,thepamoicacidsaltof1,4,5,6-tetrahydro-1-methyl-2-[(trans-2-2-thienyl)-vinyl]-

pyrimidine,isananthelminticbelongingtothetetrahydropyrimidinegroup.

Pyrantelembonateactsasacholinergicagonistthatleadstoadepolarizingneuromuscularblocking

withspasticparalysisofthenematodeandsubsequentremovalfromthehostbyperistalticexpulsion.

Inhorsespyrantelembonateiseffectivetowardsadultstagesoflargeandsmallstrongyles,theascarid

(Parascarisequorum)andtheseatworm/pinworm(Oxyurisequi).Theefficacytowardsadultstages

ofthetapewormAnoplocephalaperfoliataisvariable.

Lesspyrantelsusceptiblemutantshavebeendescribedwithpartialcross-resistanceagainstmorantel

andlevamisole.Resistancetopyrantelhasbeenreportedinsmallandlargestrongyles.

5.2 Pharmacokineticparticulars

Pyrantelembonateisaninsolublesaltanditisnotwellabsorbedfromthegastro-intestinaltract.The

absorbedfractionisquicklyandalmostcompletelybrokendownintheliverintoanumberof

anthelminticinactivemetabolites.

Excretionoftheunabsorbedfractionofpyrantel(embonate)mainlyoccursviathefaeces.After

administrationofHippotwinatadoseof19mgpyrantelembonateperkgbodyweightamaximum

pyrantelconcentrationof733mg/kgfaecesisdetectedwithin24hours;threedaysafteradministration

nopyrantelcouldbedetectedinthefaecesanymore.AfteradministrationofHippotwinof38mg

pyrantelembonate/kgbodyweight,pyrantelwasstilldetectedinthefaecesafter3days.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Methylparahydroxybenzoate(E218)

Propylparahydroxybenzoate(E216)

Polysorbate80(E433)

Colloidalanhydroussilica(E551)

Maizeoil

6.2 Incompatibilities

Noneknown.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductpackagedforsale:2years.

Shelf-lifeafterfirstopeningtheimmediatepackaging:1month.

6.4.Specialprecautionsforstorage

Donotstoreabove25

C.

Donotrefrigerateorfreeze.

6.5 Natureandcompositionofimmediatepackaging

Pre-filledmulti-dosepolyethylenesyringewithadjustablescrewringclosedwithapolyethylenecap.

Eachsyringecontains52gpaste.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

Name: CaballoB.V.

Address: Leysendwarsstraat26

4901PGOosterhout

TheNetherlands

tel: +31(0)162460443

fax: +31(0)162430122

e-mail: contact_us@hippotwin.nl

8. MARKETINGAUTHORISATIONNUMBER(S)

Netherlands-REGNL09693

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

12June2002.

10 DATEOFREVISIONOFTHETEXT

16October2008.

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable.

ANNEXIII

LABELLINGANDPACKAGELEAFLET

A.LABELLING

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

(OUTERCARTON/CARDBOARDBOX)

Readthepackageleafletbeforeuse

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Hippotwin439mg/goralpasteforhorses

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Compositionpergram:

Activesubstance

Pyrantelembonate(equivalentto152.2mgofpyrantel)439mg

Excipients

Methylparahydroxybenzoate(E218) 1mg

Propylparahydroxybenzoate(E216). 0.3mg

3. PHARMACEUTICALFORM

Oralpaste.

4. PACKAGESIZE

Multi-dosesyringewith52grampaste.

5. TARGETSPECIES

Horses,poniesandfoals(ofover8weeksofage).

6. INDICATION(S)

-

7. METHODANDROUTE(S)OFADMINISTRATION

Fororaladministration.

8. WITHDRAWALPERIOD

Withdrawalperiod:

Meatandoffal: 0days

Notpermittedforuseinmaresproducingmilkforhumanconsumption.

9. SPECIALWARNING(S),IFNECESSARY

Readthepackageleafletbeforeuse.

10. EXPIRYDATE

EXPmonth/year

Shelf-lifeafterfirstopeningtheimmediatepackaging:1month.

11. SPECIALSTORAGECONDITIONS

Donotstoreabove25

C.

Donotrefrigerateorfreeze.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly.

Tobesuppliedonlyonveterinaryprescription.

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

Name: CaballoB.V.

Address: Leysendwarsstraat26

4901PGOosterhout

TheNetherlands

16. MARKETINGAUTHORISATIONNUMBER(S)

………..

17. MANUFACTURER’SBATCHNUMBER

Batchnumber………..

MINIMUMPARTICULARSTOAPPEARONLARGEIMMEDIATEPACKAGING

UNITS

(Pre-filledmultidosisPESYRINGEwithadjustablescrewringclosedwithaPEcap)

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Hippotwin439mg/goralpasteforhorses

2. QUANTITYOFTHEACTIVESUBSTANCE(S)

1gramcontains

Pyrantelembonate(equivalentto152.2mgofpyrantel)439mg

Methylparahydroxybenzoate(E218) 1mg

Propylparahydroxybenzoate(E216). 0.3mg

3. CONTENTSBYWEIGHT,BYVOLUMEORBYNUMBEROFDOSES

Syringecontaining52grampaste.

4. ROUTE(S)OFADMINISTRATION

Fororaladministration.

5. WITHDRAWALPERIOD

Withdrawalperiod:

Meatandoffal:0days.

Notpermittedforuseinmaresproducingmilkforhumanconsumption.

6. BATCHNUMBER

Batchnumber

7. EXPIRYDATE

EXPmonth/year

8. THEWORDS“FORANIMALTREATMENTONLY”

Foranimaltreatmentonly.

B.PACKAGELEAFLET

PACKAGELEAFLET

Hippotwin439mg/goralpasteforhorses

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERAND

OFTHEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFOR

BATCHRELEASE,IFDIFFERENT

Marketingauthorisationholder

Name: CaballoB.V.

Address: Leysendwarsstraat26

4901PGOosterhout

TheNetherlands

Manufacturerforthebatchrelease

Name: DutchFarmVeterinaryPharmaceuticalsB.V.

Address: Veemweg1

2771MTBarneveld

TheNetherlands

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Hippotwin439mg/goralpasteforhorses

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

Compositionpergram:

Activesubstance

Pyrantelembonate(equivalentto152.2mgofpyrantel)439mg

Excipients

Methylparahydroxybenzoate(E218)1mg,propylparahydroxybenzoate(E216)0.3mg,polysorbate80

(E433),colloidalanhydroussilica(E551)andmaizeoil.

Description

Yellow,viscous,oilypaste.

4. INDICATION(S)

Infestationswithadultstagesofroundworm,particularlyascarids(Parascarisequorum),small

strongyles(Cyathostomumspp.,Triodontophorusspp.)andlargestrongyles(Strongylusedentatus,

Strongylusequinus,Strongylusvulgaris),seatworm/pinworm(Oxyurisequi)andtapeworm

(Anoplocephalaperfoliata)inhorses,poniesandfoals.

TheefficacytowardsAnoplocephalaperfoliataisvariable.

5. CONTRAINDICATIONS

Donotuseinanimalsknowntobehypersensitivetotheactivesubstance.

6. ADVERSEREACTIONS

Noneknown.

7. TARGETSPECIES

Horses,poniesandfoals(ofover8weeksofage).

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOF

ADMINISTRATION

Posology

Forsingleoraladministrationtohorses.

(a)Fortreatmentoflargeandsmallstrongyles,largeroundwormsandseatworm/pinwormsthe

recommendeddoseis19mgpyrantelembonateperkgofbodyweight.Onesyringeisintendedfor

1200kgbodyweightandeachsyringeissubdividedinto24markings.Theequivalentofone

markingissufficienttotreat50kgofbodyweight.

(b)Fortreatmentoftapewormstherecommendeddoseis38mgpyrantelembonateperkgof

bodyweight.Onesyringeisintendedfor600kgbodyweightandeachsyringeissubdividedinto24

markings.Theequivalentoftwomarkingsissufficienttotreat50kgofbodyweight.

9. ADVICEONCORRECTADMINISTRATION

Toensureadministrationofacorrectdose,bodyweightshouldbedeterminedasaccuratelyas

possible;accuracyofthedosingdeviceshouldbechecked.

Positionthelocking-ringovertheappropriatemarkontheplungerofthesyringeandremovethecap

fromthenozzle,openthemouthofthehorse,depositthepasteasfaraspossibleonthebackofthe

tongueandmakethehorseswallow.Theamountofpasterequestedcanbesetandlockedusingthe

screw-ringnutontheinjector.Swallowingcanbestimulatedbyputtingahandunderthechinand

raisingtheheadofthehorse.

10. WITHDRAWALPERIOD

Meatandoffal:Zerodays.

Notpermittedforuseinmaresproducingmilkforhumanconsumption.

11. SPECIALSTORAGEPRECAUTIONS

Keepoutofthereachandsightofchildren.

Donotstoreabove25

C.

Donotrefrigerateorfreeze.

Shelf-lifeafterfirstopeningtheimmediatepackaging:1month.

Donotuseaftertheexpirydatestatedonthelabel/carton.

12. SPECIALWARNING(S)

Specialprecautionsforuseinanimals

Treatmentagainsttapewormsshouldonlybeundertakenwhentapewormshavebeendiagnosed.

Treatmentagainsttapewormsshouldonlybeundertakenwhentapewormshavebeendiagnosed.

Resistancetopyrantelembonatehasbeenreportedincyathostominsinhorses.Thereforetheuseof

thisproductshouldbebasedonlocal(regional,farm)epidemiologicalinformationaboutsusceptibilityof

cyathostominsandrecommendationsonhowtolimitfurtherselectionforresistancetoanthelmintics.

Careshouldbetakentoavoidthefollowingpracticesbecausetheyincreasetheriskofdevelopmentof

resistanceandcouldultimatelyresultinineffectivetherapy:

-Toofrequentandrepeateduseofanthelminticsfromthesameclass,overanextendedperiodoftime.

-Underdosing,whichmaybeduetounderestimationofbodyweight,misadministrationoftheproduct,

orlackofcalibrationofthedosingdevice(ifany).

Suspectedclinicalcasesofresistancetoanthelminticsshouldbefurtherinvestigatedusingappropriate

tests(e.g.FaecalEggCountReductionTest).Wheretheresultsofthetest(s)stronglysuggest

resistancetoaparticularanthelmintic,ananthelminticbelongingtoanotherpharmacologicalclassand

havingadifferentmodeofactionshouldbeused.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Occurrenceofsensitisationandcontactdermatitiscannotbecompletelyexcluded,sodirectcontact

withtheskinshouldbeavoided.

Wearsuitablegloves.

Adversereactions

Noneknown.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinformyour

veterinarysurgeon.

Useduringpregnancyandlactation

Useduringpregnancyandlactationispermitted.

Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Hippotwiniswelltoleratedupto5timestherecommendedtherapeuticdosefortreatmentof

nematodes.Ifoverdosingcausessignssuchassalivation,musclefibrillations,tachypnoea,dyspnoea,

ataxia,tremorsorconvulsionsatropinecanbeusedasantidote.

Interactionwithothermedicinalproductsandotherformsofinteraction

Thisproductshouldnotbeusedconcurrentlywithanthelminticproductscontaininglevamisole,

piperazineorcholinesteraseinitiators(e.g.organophosphates).

Incompatibilities

Notknown.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIALS,IFANY

Medicinesshouldnotbedisposedofviawastewaterorhouseholdwaste.

Askyourveterinarysurgeonhowtodisposeofmedicinesnolongerrequired.Thesemeasuresshouldhelp

toprotecttheenvironment.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

14November2008.

15. OTHERINFORMATION

Package(size)

Pre-filledmulti-dosepolyethylenesyringewithadjustablescrewringclosedwithapolyethylenecap,

packedinacardboardbox.

Eachsyringecontains52gpaste.

Foranyinformationaboutthisveterinarymedicinalproduct,pleasecontactthelocalrepresentativeof

themarketingauthorisationholder.

There are no safety alerts related to this product.

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