ZERMEX 2% LA Solution injectable for sheep

Main information

  • Trade name:
  • Zermex 2% LA solution for Injection for sheep
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Zermex 2% LA solution for Injection for sheep
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • moxidectin
  • Therapeutic area:
  • Sheep

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0209/001
  • Authorization date:
  • 11-04-2011
  • EU code:
  • FR/V/0209/001
  • Last update:
  • 09-08-2016

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

PACKAGELEAFLET

PACKAGELEAFLET

ZERMEX2%w/vLASolutionforInjectionforSheep

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERAND

OFTHEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFOR

BATCHRELEASE,IFDIFFERENT

Marketingauthorisationholder:

<Pfizer/FortDodgesubsidiariesineachMemberState>

Manufacturerforthebatchrelease:

PfizerOlot,S.L.U.

CarreteraCamprodons/n–LaRiba

17813–ValldeBianya

Gerona,Spain

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

ZERMEX2%w/vLASolutionforInjectionforSheep

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

Eachmlcontains:

Activesubstances

Moxidectin 20mg

Excipients

Benzylalcohol

Forafulllistofexcipients,seesection6.1

70mg

4. INDICATION(S)

Treatmentand preventionofmixed infectionsofgastro-intestinalnematodes, respiratorynematodes

and certainanthropod parasitesinsheep.

Moxidectinisindicatedfortreatmentofinfectionscausedbymoxidectinsensitivestrainsof:

-Gastro-intestinalnematodes:

Haemonchuscontortus(adultsandL3)

Ostertagia(Teladorsagia)circumcincta(adultsandL3,includinginhibitedlarvae)

Trichostrongylusaxei(adults)

Trichostrongyluscolubriformis(adultsandL3)

Nematodirusspathiger(adults)

Cooperiacurticei(macmasteri)(adults)

Cooperiapunctata(adults)

Oesophagostomumcolumbianum(L3)

Chabertiaovina(adults)

-Respiratorytractnematodes

Dictyocaulusfilaria(adults)

- LarvaeofDiptera

Oestrusovis:L1,L2,L3

- Mangemites

Psoroptesovis

TrialshaveshownthatmoxidectiniseffectiveagainstcertainstrainsofHaemonchuscontortus,

TeladorsagiacircumcinctaandTrichostrongylusspp.resistantto benzimidazoles.

Theproducthasapersistentactionand protectssheep againstinfectionorre-infectionwiththe

followingparasitesfortheperiod indicated:

Species Days

Ostertagia(Teladorsagia)circumcincta 97

Haemonchuscontortus 111

Trichostrongyluscolubriformis 44

Psoroptesovis 60

Persistentefficacyperiodshavenotbeenestablishedforparasitespeciesotherthanthoseincludedin

thelistabove.Therefore,re-infectionofanimalsonpasturecontaminatedbyparasitesotherthanthese

remainspossiblebeforethe44dayminimumpersistencyperioddemonstratedforspecificspecies.

5. CONTRAINDICATIONS

Donotuseindairysheep,atanystageoflife.

Donotuseinsheeplessthan15kgbodyweight.

Donotuseincasesofhypersensitivitytotheactivesubstanceortoanyexcipients.

6. ADVERSEREACTIONS

Swellingand inflammationmaybefound attheinjectionsiteinsomeanimalsfollowingtreatment.

Theswellinggenerallydisappearswithin7 daysoftreatmentand generallyresolveswithoutany

medicaltreatmentrequired.

Inrarecases, adversereactionssuchastransitorysalivation, depression, drowsinessand ataxia

mightoccur. No particulartreatmentisrequired;thesesymptomsusuallydisappearwithin24 to 48

hours. Thereisno specificantidote.

7. TARGETSPECIES

Sheep

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOF

ADMINISTRATION

Dosageis0.5ml/10kgbodyweighttogive1mgmoxidectin/kgbodyweight.The50mlvialstoppers

mustnotbebroachedmorethan10times.Useautomaticsyringeequipmentforthe200mland500ml

vials.

Toensureadministrationofacorrectdose,bodyweightshouldbedeterminedasaccuratelyaspossible;

accuracyofthedosingdeviceshouldbechecked.Ifanimalsaretobetreatedcollectivelyratherthan

individually,theyshouldbegroupedaccordingtotheirbodyweightanddosedaccordingly,inorderto

avoidunder-oroverdosing.

Theinjectionshouldbeadministeredasasinglesubcutaneousinjectionatthebaseoftheearusingan

18gauge,25–40mm hypodermicneedle.Withtheanimal'sheadundercontrol,theformulationshould

beadministeredabout2cmcaudalfromtheanterior(rostral)edgeofthepinnaatthebaseoftheear.

Theskinatthebaseoftheselectedearshouldbepinchedandtheproductinjectedintothe

subcutaneoustissue.Followingsubcutaneousadministration,theneedleshouldbewithdrawnfromthe

skinaspressureisappliedwiththethumbatthepointofinsertionforseveralseconds.Ifleakage

occursthenpressureshouldbeappliedforseveraladditionalseconds.

Diagram:Earinjectionprocedure

9. ADVICEONCORRECTADMINISTRATION

Thisproducthasbeenformulatedspecificallyforsubcutaneousinjectioninthebaseoftheearofsheep

andmustnotbegivenbyanyotherrouteofadministrationortoanyotherspecies.

10. WITHDRAWALPERIOD

Meatandoffal:104days.

Milk:Notpermittedforuseindairysheep,atanystageoflife.

Thewithdrawalperiodisbasedsolelyonasingleinjectionatthebaseoftheear.

11. SPECIALSTORAGEPRECAUTIONS

Keepoutofthereachandsightofchildren.

Donotstoreabove25°C.

Keepthecontainerintheoutercartoninordertoprotectfromlight.

Shelflifeafterfirstopeningtheimmediatepackaging:28days.

12. SPECIALWARNING(S)

Avoiddirectcontactwithskinandeyes.

Washhandsafteruse.

Donotsmoke,drinkoreatwhilehandlingtheproduct.

Takecareto avoid self-injection. Ifthisoccurs, itisunlikelythatanyproductrelated symptomswill

beobserved. Incaseofaccidentalselfinjection, seek medicaladviceimmediatelyand showthe

packageleafletorthelabelto thephysician. Adviceto MedicalPractitionersincaseofaccidental

selfinjection: Treatsymptomatically.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIAL,IFANY

Extremelydangerousforfishandaquaticorganisms.Donotcontaminateponds,waterwaysorditches

withtheproductoremptycontainer.

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

15. OTHERINFORMATION

Pharmacodynamicproperties

Moxidectinisanendectocideactiveagainstawiderangeofinternalandexternalparasitesandisa

secondgenerationmacrocycliclactoneofthemilbemycinfamily.

MoxidectininteractswithGABAreceptorsandchloridechannels.Theneteffectistoopenthe

chloridechannelsonthepostsynapticjunctiontoallowtheinflowofchlorideionsandinducean

irreversiblerestingstate.Thisresultsinflaccidparalysisandeventualdeathofparasitesexposedto

thedrug.

TheproducthasapersistentactivityagainstthesecondinstarlarvaeofOestrusOvis(L2Larvaeonly)

upto80daysaftertreatment.

However,re-infestationwith1stinstarlarvaeisnotpreventedandclinicalsignsarisingfromsuchre-

infestationmaybeobservedduringthisperiod.

Packaging

Natureoftheprimarycontainer:HDPEvial

Chlorinatedbutylrubberstopper.Aluminiumflip-offseal(50ml).Aluminiumseal(200mland500ml).

Presentationstobesoldandidentificationnumbers:

Boxcontaining1vialof50mlsize(60mlvialfilledto50ml)

Boxcontaining1vialof200mlsize

Boxcontaining1vialof500mlsize

Notallpacksizesmaybemarketed.

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