Otimectin vet. 1 mg/g ear gel for cats

Main information

  • Trade name:
  • Otimectin vet. 1 mg/g ear gel for cats
  • Pharmaceutical form:
  • Ear gel
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Otimectin vet. 1 mg/g ear gel for cats
    Austria
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • ivermectin
  • Therapeutic area:
  • Cats Non Food

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • NL/V/0112/001
  • Authorization date:
  • 16-01-2012
  • EU code:
  • NL/V/0112/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

[Version7.1,10/2006]

ANNEXI

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Otimectinvet.1mg/geargelforcats(AT,BE,CZ,DE,EL,IE,FI,FR,IS,LT,NL,NO,PL,PT,SE,

UK)

Otimectin1mg/geargelforcats(ES,IT)

OtimectinVet.(DK)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Activesubstanceperg:

Ivermectin 1mg

Excipients:

Forafulllistofexcipientsseesection6.1.

3. PHARMACEUTICALFORM

Eargel.

Colourlesstoslightlyyellow,slightlyopalescentandviscousgel

4. CLINICALPARTICULARS

4.1 Targetspecies

Cats.

4.2 Indicationsforuse,specifyingthetargetspecies

Treatmentofearmite(Otodectescynotis)infestationincats.

4.3 Contraindications

Donotuseincaseofhypersensitivitytotheactivesubstanceortoanyoftheexcipients.

Donotuseifthetympanicmembraneisperforated.

Donotuseifthetympanicmembranecannotbefullyvisualized.

Donotuseincatswithobstructedexternalearcanalsduetochronicinflammation.

Donotuseincatssufferingfromsystemicdisorders.

4.4 Specialwarningsforthetargetspecies

AllthecatshousedtogethershouldbetreatedsimultaneouslyagainstOtodectescynotisinfestation.

Otherreceptivecompanionanimals(dogs,ferrets)inthehouseholdshouldbetreatedaswellwith

anothersuitableproductwhenthepresenceofearmiteisdetectedandconfirmed.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Intheabsenceofavailableinformationonsafetytheproductshouldnotbeusedoncatsunder16weeks

ofage.

Careshouldbetakentoavoidthattheproductcomesintocontactwiththeeyesormouthafter

administration.

Careshouldbetakentoensurethatcatsdonotingesttheproductbymutualorselfgroomingatthesite

ofapplication.

Avermectinsmaynotbewelltoleratedinallnontargetspecies.Casesofintolerancearereportedin

dogs,especiallyCollies,OldEnglishSheepdogsandrelatedbreedsorcrosses,andalsointurtlesand

tortoises.

Dogsandcatsshouldnotbeallowedtoingestspilledgelorhaveaccesstousedpackagingduetothe

potentialforadverseeffectsrelatedtoivermectintoxicity.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Thisproductmaycausesensitisationbycontact,thereforeavoiddirectcontactwithskinandeyes

duringandafterapplication.

Washhandsandanyexposedareaafteruse.

Precautionsshouldbetakentoavoidsplashestothefaceand/oreyesshouldtheanimalshakeitshead

followinginstillationoftheproduct.

4.6 Adversereactions(frequencyandseriousness)

Accidentaluseinkittensandcatswithperforatedeardrumsorobstructedexternalearcanalmaylead

tosideeffectscharacterizedbydepressionofthecentralnervoussystemassociatedwithapathy,

anorexia,mydriasis,ataxia,tremorsandsalivation.

4.7 Useduringpregnancyandlactation

Studiesinlaboratoryanimalshavenotproducedanyevidenceofteratogenicorfoetotoxiceffectsat

concentrationsusedintheproduct.Thesafetyoftheproductwasnotassessedinpregnantorlactating

queens.Theproductshouldbeusedaccordinglytothebenefit/riskassessmentbytheresponsible

veterinarianinpregnantandlactatinganimals.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

ConcomitanttreatmentwithanydruginteractingwithP-glycoproteinsshouldbeavoided(e.g.selamectin

andpiperazine).

4.9 Amountstobeadministeredandadministrationroute

Posology

Forlocaladministrationintheexternalearcanal.

Filltheexternalearcanalwiththeproduct.Thisprovidesadoseofapproximately1gramofthe

veterinarymedicinalproduct(equivalentto1mgivermectin)perear.Massagegentlyforeven

distributionbypressingfromtheoutsideontheauricle.

Repeatadministrationafter7daysand14days.

Afurtherveterinaryexaminationaftertreatmentisrecommendedasitmaybenecessarytorepeator

reconsiderthetreatment.Directionsforuse

Rinseorcleantheearsbeforeusingtheproduct.

Bothearsshouldbetreated.

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

Nosignsofoverdosehavebeenobservedfollowingauraladministrationoftwotreatmentssevendays

apartatfivetimestherecommendeddoseofivermectin.

Incomatoseanimalsneostigminemethylsulfatehasbeenusedasantidote.

4.11Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticalgroup:otologicals,antiparasitics.

ATCvetcode:QS02QA03.

5.1 Pharmacodynamicproperties

Ivermectinbelongstothegroupofavermectins,afamilyofcloselyrelatedmacrocycliclactones.

Ivermectinhasabroadantiparasiticactivityagainstnematodesandarthropods.Itactsbyinhibiting

nerveimpulses.Compoundsofthemacrocycliclactoneclassbindselectivelyandwithhighaffinityto

glutamate-gatedchlorideionchannelswhichoccurininvertebratenerveandmusclecells.Thisleadsto

anincreaseinthepermeabilityofthecellmembranetochlorideionswithhyperpolarizationofthenerve

ormusclecell,resultinginparalysisanddeathoftherelevantparasites.Compoundsofthisclassmay

alsointeractwithotherligand-gatedchloridechannels,suchasthosegatedbytheneurotransmitter

gamma-aminobutyricacid(GABA).

ResistancehasnotbeenobservedinOtodectescynotis.

Theeffectivenessoftheproductmightbepartlyrelatedtoaphysicaleffectoftheexcipients.

5.2 Pharmacokineticparticulars

Pharmacokineticdataoniveremectinafterlocaladministrationintheearofcatsindicateabsorptionand

sloweliminationofivermectin,resultinginmeanresidualplasmaconcentrationsofabout20ng/ml6.5

daysafterthethirdtreatment.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Hydroxyethylcellulose

Propyleneglycol(E490).

6.2 Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixedwithother

veterinarymedicinalproducts.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:30months.

Shelflifeafterfirstopeningtheimmediatepackaging:4weeks.

6.4.Specialprecautionsforstorage

Donotstoreabove25°C.

Donotrefrigerateorfreeze.

6.5 Natureandcompositionofimmediatepackaging

Tubeconsistingofaluminiumwithanexternalcoatingofwhitepolyurethaneandaninternalcoatingof

epoxyresinandascrewcapofpolyethylenecontaining10gramgel.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Donotcontaminatesurfacewatersorditcheswithproductorusedcontainersinceivermectinis

extremelydangeroustofishandaquaticlife.

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

Name: LeVetB.V.

Address: Wilgenweg7

3421TVOudewater

TheNetherlands

tel: +31(0)348565858

fax: +31(0)348565454

e-mail: info@levetpharma.com

8. MARKETINGAUTHORISATIONNUMBER(S)

REGNL09990.

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

17April2003.

10 DATEOFREVISIONOFTHETEXT

21May2012.

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable.

ANNEXIII

LABELLINGANDPACKAGELEAFLET

A.LABELLING

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

OUTERCARTON

Readthepackageleafletbeforeuse

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

OTIMECTINvet.1mg/geargelforcats

(Ivermectin)

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Eachggelcontains

Ivermectin 1mg

3. PHARMACEUTICALFORM

Eargel.

4. PACKAGESIZE

10g.

5. TARGETSPECIES

Cats.

6. INDICATION(S)

Treatmentofearmite(Otodectescynotis)infestationincats.

7. METHODANDROUTEOFADMINISTRATION

Forauricularuse.

8. WITHDRAWALPERIOD

Notapplicable.

9. SPECIALWARNING(S),IFNECESSARY

Readthepackageleafletbeforeuse.

10. EXPIRYDATE

EXP(month/year)

Onceopened,useby4weeks.

11. SPECIALSTORAGECONDITIONS

Donotstoreabove25

C.

Donotrefrigerateorfreeze.

Donotuseafterexpirydatestatedonthetubeandthecarton.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly.

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

Name: LeVetB.V.

Address: Wilgenweg7

3421TVOudewater

TheNetherlands

16. MARKETINGAUTHORISATIONNUMBER(S)

REGNL09990.

17. MANUFACTURER’SBATCHNUMBER

Batchnumber..............

MINIMUMPARTICULARSTOAPPEARONSMALLIMMEDIATEPACKAGING

UNITS

ALUMINIUMTUBE

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

OTIMECTINvet.1mg/geargelforcats

2. QUANTITYOFTHEACTIVESUBSTANCE(S)

Ivermectin 1mg/g

3. CONTENTSBYWEIGHT,BYVOLUMEORBYNUMBEROFDOSES

10g.

4. ROUTE(S)OFADMINISTRATION

Forauricularuse.

5. WITHDRAWALPERIOD

-

6. BATCHNUMBER

Batchnumber..........

7. EXPIRYDATE

EXP(month/year)

Onceopened,useby4weeks.

8. THEWORDS“FORANIMALTREATMENTONLY”

Foranimaltreatmentonly.

B.PACKAGELEAFLET

PACKAGELEAFLET

OTIMECTINvet.1mg/geargelforcats

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERAND

OFTHEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFOR

BATCHRELEASE,IFDIFFERENT

Marketingauthorisationholder:

Name: LeVetB.V.

Address: Wilgenweg7

3421TVOudewater

TheNetherlands

Manufacturerforthebatchrelease:

Name: ProdulabPharmaB.V.

Address: Forellenweg16

4941SJRaamsdonksveer

TheNetherlands

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

OTIMECTINvet.1mg/geargelforcats

(Ivermectin)

3. STATEMENTOFTHEACTIVESUBSTANCEANDOTHERINGREDIENTS

Description

Colourlesstoslightlyyellow,slightlyopalescentandviscousgel.

Activesubstanceperg:

Ivermectin 1mg

4. INDICATION(S)

Treatmentofearmite(Otodectescynotis)infestationincats.

5. CONTRAINDICATIONS

Donotuseincaseofhypersensitivitytotheactivesubstanceortoanyoftheexcipients.

Donotuseifthetympanicmembraneisperforated.

Donotuseifthetympanicmembranecannotbefullyvisualized.

Donotuseincatswithobstructedexternalearcanalsduetochronicinflammation.

Donotuseincatssufferingfromsystemicdisorders.

6. ADVERSEREACTIONS

Accidentaluseinkittensandcatswithperforatedeardrumsorobstructedexternalearcanalmaylead

tosideeffectscharacterizedbydepressionofthecentralnervoussystemassociatedwithapathy,

anorexia,mydriasis,ataxia,tremorsandsalivation.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinformyour

veterinarysurgeon.

7. TARGETSPECIES

Cats.

8. DOSAGEFOREACHSPECIES,ROUTEANDMETHODOFADMINISTRATION

Posology

Forlocaladministrationintheexternalearcanal.

Filltheexternalearcanalwiththeproduct.Thisprovidesadoseofapproximately1gramofthe

veterinarymedicinalproduct(equivalentto1mgivermectin)perear.Massagegentlyforeven

distributionbypressingfromtheoutsideontheauricle.

Repeatadministrationafter7daysand14days.

Afurtherveterinaryexaminationaftertreatmentisrecommendedasitmaybenecessarytorepeator

reconsiderthetreatment

Directionsforuse

RinseorcleantheearsbeforeusingOTIMECTIN.

Bothearsshouldbetreated.

9. ADVICEONCORRECTADMINISTRATION

Notapplicable.

10. WITHDRAWALPERIOD

Notapplicable.

11. SPECIALSTORAGEPRECAUTIONS

Keepoutofthereachandsightofchildren.

Donotstoreabove25

C.

Donotrefrigerateorfreeze.

Donotuseafterexpirydatestatedonthetubeandthecarton.

Onceopened,useby4weeks.

12. SPECIALWARNING(S)

Specialwarningsforthetargetspecies

AllthecatshousedtogethershouldbetreatedsimultaneouslyagainstOtodectescynotisinfestation.

Otherreceptivecompanionanimals(dogs,ferrets)inthehouseholdshouldbetreatedaswellwith

anothersuitableproductwhenthepresenceofearmiteisdetectedandconfirmed.

Specialprecautionsforuseinanimals

Intheabsenceofavailableinformationonsafetytheproductshouldnotbeusedoncatsunder16weeks

ofage.

Careshouldbetakentoavoidthattheproductcomesintocontactwiththeeyesormouthafter

administration.

Careshouldbetakentoensurethatcatsdonotingesttheproductbymutualorselfgroomingatthesite

ofapplication.

Avermectinsmaynotbewelltoleratedinallnontargetspecies.Casesofintolerancearereportedin

dogs,especiallyCollies,OldEnglishSheepdogsandrelatedbreedsorcrosses,andalsointurtlesand

tortoises.

Dogsandcatsshouldnotbeallowedtoingestspilledgelorhaveaccesstousedpackagingduetothe

potentialforadverseeffectsrelatedtoivermectintoxicity.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Thisproductmaycausesensitisationbycontact,thereforeavoiddirectcontactwithskinandeyes

duringandafterapplication.

Washhandsandanyexposedareaafteruse.

Precautionsshouldbetakentoavoidsplashestothefaceand/oreyesshouldtheanimalshakeitshead

followinginstillationoftheproduct.

Useduringpregnancyandlactation

Studiesinlaboratoryanimalshavenotproducedanyevidenceofteratogenicorfoetotoxiceffectsat

concentrationsusedinthisproduct.Thesafetyoftheproductwasnotassessedinpregnantorlactating

queens.Theproductshouldbeusedaccordinglytotheebenefit/riskassessmentbytheresponsible

veterinarianinpregnantandlactatinganimals.

Overdose(symptoms,emergencyprocedures,antidotes)(ifnecessary)

Nosignsofoverdosehavebeenobservedfollowingauraladministrationoftwotreatmentssevendays

apartatfivetimestherecommendeddoseofivermectin.

Incomatoseanimalsneostigminemethylsulfatehasbeenusedasantidote.

Interactionwithothermedicinalproductsandotherformsofinteraction

ConcomitanttreatmentwithanydruginteractingwithP-glycoproteinsshouldbeavoided(e.g.selamectin

andpiperazine).

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIALS,IFANY

Medicinesshouldnotbedisposedofviawastewaterorhouseholdwaste.

Askyourveterinarysurgeonhowtodisposeofmedicinesnolongerrequired.Thesemeasuresshouldhelp

toprotecttheenvironment.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

Willfollow.

15. OTHERINFORMATION

Pharmacodynamicproperties

Ivermectinbelongstothegroupofavermectins,afamilyofcloselyrelatedmacrocycliclactones.

Ivermectinhasabroadantiparasiticactivityagainstnematodesandarthropods.Itactsbyinhibiting

nerveimpulses.Compoundsofthemacrocycliclactoneclassbindselectivelyandwithhighaffinityto

glutamate-gatedchlorideionchannelswhichoccurininvertebratenerveandmusclecells.Thisleadsto

anincreaseinthepermeabilityofthecellmembranetochlorideionswithhyperpolarizationofthenerve

ormusclecell,resultinginparalysisanddeathoftherelevantparasites.Compoundsofthisclassmay

alsointeractwithotherligand-gatedchloridechannels,suchasthosegatedbytheneurotransmitter

gamma-aminobutyricacid(GABA).

ResistancehasnotbeenobservedinOtodectescynotis.

Theeffectivenessoftheproductmightbepartlyrelated to aphysicaleffectoftheexcipients.

Pharmacokineticparticulars

Pharmacokineticdataoniveremectinafterlocaladministrationintheearofcatsindicateabsorptionand

sloweliminationofivermectin,resultinginmeanresidualplasmaconcentrationsofabout20ng/ml6.5

daysafterthethirdtreatment.

Package(size)

Tubeconsistingofaluminiumwithanexternalcoatingofwhitepolyurethaneandaninternalcoatingof

epoxyresinandascrewcapofpolyethylenecontaining10gramgel.

Foranyinformationaboutthisveterinarymedicinalproduct,pleasecontactthelocalrepresentativeof

themarketingauthorisationholder.