Droncit Horse Paste 9%

Main information

  • Trade name:
  • Droncit Horse Paste 9%
  • Pharmaceutical form:
  • Oral paste
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Droncit Horse Paste 9%
    Germany
  • Language:
  • English

Therapeutic information

  • Therapeutic area:

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0125/001
  • Authorization date:
  • 22-04-2011
  • EU code:
  • FR/V/0125/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

FinalSPCDRONCITRENEWAL

February2006

SUMMARYOFPRODUCTCHARACTERISTICS

1. Nameoftheveterinarymedicinalproduct

Droncit9%OralGelforHorses

2. Qualitativeandquantitativecomposition

Activesubstance

Praziquantel…………………...........................90.0mg

Excipients

PropylP arahydroxybenzoate(E216)…………0.2mg

MethylParahydroxybenzoate(E218)…………1.4mg

Excipientsad………………………………………………1.0g

Forafulllistofexcipients,seesection6.1

3. Pharmaceuticalform

Gelfororaluseinhorse

Whitesoftgel

4. Clinicalparticulars

4.1.Targetspecies

Horse

4.2.Indicationsforuse,specifyingthetargetspecies

TreatmentofinfectionswithcestodesofthespeciesAnoplocephalaperfoliata,sensitiveto

praziquantel.

4.3.Contraindications

Noneknown

Milk:see section4.11

(Donotuseinmaresfromwhichmilkistakenforhumanconsumption)

4.4.Specialwarningsforeachtargetspecies

Astapeworminfestationisunlikelytooccurinhorsesbeforetwomonthsofage,treatmentoffoals

belowthisageisnotconsiderednecessary.

Inordertolimitexcretionoftheproductanditsmetabolitesonthepasturehorsesshouldremain

stabledfor2daysaftertreatment.

Parasiteresistancetoaparticularclassofanthelminticmaydevelopfollowingfrequent,repeateduse

ofananthelminticofthatclass.

MRLsformilkhavenotbeenestablished

Seesection4.11Withdrawalperiods

FinalSPCDRONCITRENEWAL

February2006

4.5.Specialprecautionsforuse

i)Specialprecautionsforuseinanimals

None.

ii)Specialprecautionstobetakenbythepersonadministeringthemedicinalproductsto

animals

Washhandsthoroughlyaftertreatinganimals.

Anyspillageoftheproductontohumanskinshouldberemovedbywashingwithsoapandwater.

Donoteat,drinkorsmokeduringapplication

iii)Otherprecautions

4.6.Adversereactions(frequencyandseriousness)

Incaseofveryhighinfestationlevels,destructionofthetapewormsmaycauseamildtransientcolic

andloosefaecesinthetreatedhorse.

4.7.Useduringpregnancy,lactationorlay

Thestudiesconductedinlaboratoryanimals(rat,rabbit)haverevealednoevidenceofteratogenic,

embryotoxicormaternotoxiceffectsfollowingadministrationofpraziquantelattherapeuticdoses.The

safetyoftheveterinarymedicinalproductfollowingadministrationtomaresduringgestationand

lactationhasnotbeenstudied.Theproductshouldonlybeusedinmaresduringpregnancyand

lactationafterassessmentofthebenefit/riskbalancebytheveterinarian.

4.8.Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

Intheabsenceofcompatibilitystudiesthisveterinaryproductmustnotbemixedwithothermedicinal

products.

4.9.Amount(s)tobeadministeredandadministrationroute

Dosage

Therecommendeddoserateis1mgPraziquantel/kgbodyweight.Thiscorrespondsto6.67ggelper

600kgbw.

Administrationanddurationoftreatment

Oraluse.

Thegelisadministeredusingameasureddoseapplicator,eachgraduationofwhichismarkedoutto

deliverthedoserequiredtotreat50kgbodyweight

Singletreatmentonly.

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

FinalSPCDRONCITRENEWAL

February2006

Noadverseeffectswerereportedaftertheadministrationoftheproductfor3consecutivedaysupto

5timestherecommendeddose.

4.11.Withdrawalperiod(s)

Edibletissues:Zerodays

Milk:Donotuseinmaresfromwhichmilkistakenforhumanconsumption

5. Pharmacologicalproperties

Pharmacotherapeuticgroup:Anthelmintics

ATCVetCode:QP52AA01

5.1.Pharmacodynamicproperties

Praziquantel,apyrazinoisoquinolinederivative,isusedasananthelminticinvariousanimalspecies.

Praziquantelisveryrapidlyabsorbedviathesurfaceoftheparasitesandevenlydistributedinthe

parasite.Severedamagetotheparasiteintegumentoccursveryrapidlyinvitroandinvivo,resultingin

contractionandparalysisoftheparasites.Thebasisforthisrapidonsetofactionis,inparticular,the

changeinCa++permeabilityoftheparasitemembranestriggeredbypraziquantelandtheresulting

disruptionoftheparasitemetabolism .

5.2.Pharmacokineticparticulars

Praziquantelisabsorbedveryrapidlyandalmostcompletelyinthestomachandsmallintestine

followingoraladministrationinhorses.Maximumserumlevelsarealreadyreachedwithinthefirsthour

postapplication.Praziquantelisveryrapidlydistributedintoallorgans.Theeliminationhalf-liveof

14C-praziquantelanditsmetabolitesis5hoursinhorses.Praziquantelisrapidlymetabolisedinthe

liver.Themainmetaboliteoccurringisthe4-hydroxycyclohexylderivativeofpraziquantel.Inhorses,

24hafteradministration,approximately31%oftheadministereddosewaseliminatedviaurineand

approximately24%ofthedosewaseliminatedviafaeces.

Environmentalproperties

6. Pharmaceuticalparticulars

6.1.Listofexcipients

PropylParahydroxybenzoate(E216)

MethylParahydroxybenzoate(E218)

Glycerol

Carbomer

Sodiumhydroxide

Purifiedwater

6.2.Incompatibilities

Intheabsenceofcompatibilitystudiesthisveterinarymedicinalproductmustnotbemixedwithother

veterinarymedicinalproducts.

6.3.Shelf-life

2years

Shelflifeafterfirstopeningthecontainer:discardafterfirstopening.

6.4.Specialprecautionsforstorage

FinalSPCDRONCITRENEWAL

February2006

Nospecialprecautionsforstorage

6.5.Natureandcompositionofimmediatepackaging

6.67gof9%gel

Highdensitypolyethylenesyringewithcapmadeofhighdensitypolyethyleneandplasticplunger

madeofpolystyrolwitharretingring.

Presentationstobemarketed

Boxwithonegraduatedapplicatorcontaining6.67ggel

6.6.Specialprecautionsforthedisposalofunusedveterinarymedicinalproductor

wastematerialsderivedfromtheuseofsuchproducts,ifappropriate

Anyunusedproductorwastematerialshouldbedisposedofinaccordancewiththenational

requirements.

7. Marketingauthorisationholder

BayerAG

BusinessGroupAnimalHealth

D-51368Leverkusen

NationalBayersubsidiariesrespectively

8. Marketingauthorisationnumber(s)

6-12-2018

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