EXETEC 2 small dogs

Main information

  • Trade name:
  • EXETEC 2 small dogs
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • EXETEC 2 small dogs
    France
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • praziquantel, combinations
  • Therapeutic area:
  • Dogs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0232/001
  • Authorization date:
  • 30-09-2011
  • EU code:
  • FR/V/0232/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

September2011

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

France EXETEC2

United-Kingdom TheBlueCross –DogWormerforsmalldogs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains:

Activesubstances

Oxantel 40.06mg(equivalentto111.8mgofoxantelembonate)

Pyrantel 9.99mg(equivalentto28.8mgofpyrantelembonate)

Praziquantel 10.00mg

Excipienttoone190mgdivisibletablet

Excipients

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Tablet

Paleyellowtoyellow,oblongtabletwithbreakingline.

4. CLINICALPARTICULARS

4.1 Targetspecies

Dogs

4.2 Indicationsforuse,specifyingthetargetspecies

Forcurativetreatmentofdogsharbouringmixedparasiticinfestationswiththefollowingadultstages

ofnematodeandcestodespecies:

Nematodes:

Toxocaracanis

Toxascarisleonina

Ancylostomacaninum

Uncinariastenocephala

Trichurisvulpis

Cestodes:

Dipylidiumcaninum

Taeniaspp

Echinococcusmultilocularis

Echinococcusgranulosus

4.3 Contraindications

Seesection4.8.

4.4 Specialwarningsforeachtargetspecies

Parasiteresistancetoanyparticularclassofanthelminticmaydevelopfollowingfrequent,repeated

useofananthelminticofthatclass.

Fleasserveasintermediatehostsforoneofthecommontapeworms –Dipylidiumcaninum.

Tapeworminfestationmayreoccurunlesscontrolofintermediatehosts(fleas)isundertaken.

September2011

4.5 Specialprecautionsforuse

i)Specialprecautionsforuseinanimals

RoundwormandHookworminfection:

Insomeanimals,AncylostomacaninumandToxocaracanismaynotbetotallyeradicatedbythe

treatment,resultinginacontinuedriskofeggsheddingintotheenvironment.Follow-upexaminations

ofthefaecesareadvisableandaccordingtotheresultsoftheseexaminations,treatmentwitha

nematodicidalproductmaybecarriedoutifnecessary.

Theproductisnotrecommendedforuseinpupsyoungerthantwomonthsoldorweighinglessthan

1kg.

Indebilitatedorheavilyinfestedanimals,theproductshouldbeusedonlyaccordingtoabenefit/risk

assessmentbytheresponsibleveterinarian

Donotuseinanimalswithknownhypersensitivitytoanyofthecomponentsoftheproduct.

ii)Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Someconstituentsofthisproductmaycauseallergicreactionsorskinirritation.

Avoidcontactwiththeskin.

Peoplewithknownhypersensitivitytoanyoftheingredientsshouldavoidcontactwiththisproduct.

Washhandsafteruse.

Incaseofaccidentalingestion,seekmedicaladviceandshowthepackageleaflettothephysician.

4.6 Adversereactions(frequencyandseriousness)

Vomitinganddiarrhoeamaybeobservedfollowingthetreatment.

Despitenotbeingobservedinstudiesperformedwiththeproduct,anorexiacanoccurasitisa

commonadverseeffectofproductscontainingpraziquantel.

4.7 Useduringpregnancy,lactationorlay

Thesafetyoftheveterinarymedicinalproducthasnotbeenestablishedduringpregnancyand

lactation.Theuseisnotrecommendedduringpregnancyandlactation.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Donotusesimultaneouslywithlevamisole,piperazineorcholineesteraseinhibitors

4.9 Amountstobeadministeredandadministrationroute

Therecommendeddoserateis20mgoxantel/5mgpyrantel/5mgpraziquantelperkgbodyweight,

ieonetabletper2kgbodyweightinasingleintake,byoralroute.

Administertherequirednumberoftablets,accordingtobodyweight,orally,inasingleadministration.

Preferably,dogsshouldbefastedpriortotreatment.Foodmaybegivenonehourormoreafter

treatment.

Weightofdog Numberoftablets

1kg ½

From1.1to2kg 1

From2.1to4kg 2

From4.1to6kg 3

Thetabletcanbedividedintohalves.

Dogskepttogetherorinkennelsshouldbetreatedatthesametime.

4.10 Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Administrationoftheproducttohealthydogsat5timestherecommendeddosagefor6consecutive

weekshadnoadverseconsequences.

4.11 Withdrawalperiod(s)

Notapplicable.

September2011

5. PHARMACOLOGICALPROPERTIES

ATCvetCode:QP52AA51Praziquantel,combinations

5.1 Pharmacodynamicproperties

Theproductcontainsthreeactiveingredients,pyrantelembonate,oxantelembonateand

praziquantel.Thespectrumofactivityoftheproductiswide,directedtowardsgastro-intestinal

roundworms(ascaris,whipwormandhookworms)andtapeworms.

Pyrantelhasaparalysingeffectonroundwormmuscles,byactivatingacetylcholinereceptors.Its

activityismoreparticularlydirectedagainstToxocaracanis,Toxascarisleonina,Uncinaria

stenocephalaandAncylostomacaninum.ItsactivityagainstTrichurisvulpisisnegligible.

Oxantelisanm-oxyphenolicderivateofpyrantel,thathasbeendevelopedforitsactivityagainst

whipworms.

Praziquantelleadstomuscularcontractions,paralysisandalteredparasitetegumentintegrity.Itis

activeagainstadultsandlarvalstagesofdogtapeworms,Echinococcus,TaeniaandDipylidium.

5.2 Pharmacokineticparticulars

Afteroraladministration,theabsorptionofoxantelembonateisnegligible.Pyrantelisquickly

absorbedbutinsmallquantities(T

max =1.38h,C

=0.048µg/ml)andisveryquicklyeliminated.

Praziquantelisquicklyabsorbed(T

max =1.28h,C

=0.4µg/ml)andeliminated(eliminationhalf-life

1.5h).

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Dextrates

PovidoneK30

SodiumLaurylsulphate

Baconflavour

Crospovidone

Sodiumstearylfumarate

6.2 Incompatibilities

Notapplicable

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:threeyears

Discardanyunusedhalftablet

6.4. Specialprecautionsforstorage

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

6.5 Natureandcompositionofimmediatepackaging

Polyamide-aluminium-PVC/aluminiumblisterorpolychlorotrifluoroethylene-PVC/aluminiumblister

stripof10tablets.

Cardboxwith1stripof10tablets

Cardboxwith6stripsof10tablets

Cardboxwith10stripsof10tablets

Notallpacksizesmaybemarketed

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.

September2011

7. MARKETINGAUTHORISATIONHOLDER

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10 DATEOFREVISIONOFTHETEXT

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

September2011

OUTERPACKAGE

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

France EXETEC2

United-Kingdom TheBlueCross –DogWormerforsmalldogs

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Activesubstances

Oxantel 40.06mg(equivalentto111.8mgofoxantelembonate)

Pyrantel 9.99mg(equivalentto28.8mgofpyrantelembonate)

Praziquantel 10.00mg

Excipienttoone190mgdivisibletablet

3. PHARMACEUTICALFORM

Tablet

4. PACKAGESIZE

Cardboardboxwith1stripof10tablets

Cardboardboxwith6stripsof10tablets

Cardboardboxwith10stripsof10tablets

5. TARGETSPECIES

Dogs

6. INDICATIONS

Notincluded

7. METHODANDROUTEOFADMINISTRATION

Oralroute.

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Notapplicable.

9. SPECIALWARNINGS,IFNECESSARY

Readthepackageleafletbeforeuse

10. EXPIRYDATE

EXP:

Discardanyunusedhalftablet.

11. SPECIALSTORAGEPRECAUTIONS

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSORWASTE

MATERIALS,IFANY

Askyourveterinarysurgeonhowtodisposeofmedicinesnolongerrequired.Thesemeasuresshould

helptoprotecttheenvironment.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSORRESTRICTIONS

REGARDINGSUPPLYANDUSE,ifapplicable

FORANIMALTREATMENTONLY

September2011

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

16. MARKETINGAUTHORISATIONNUMBER(S)

17. MANUFACTURER’SBATCHNUMBER

Lot:

September2011

PACKAGELEAFLET

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERANDOFTHE

MANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFORBATCHRELEASE,IF

DIFFERENT

MarketingAuthorisationholder

Manufacturerforthebatchrelease:

VETOQUINOL

MAGNYVERNOIS

F-70200LURE

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

France EXETEC2

United-Kingdom TheBlueCross –DogWormerforsmalldogs

3. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Activesubstances

Oxantel 40.06mg(equivalentto111.8mgofoxantelembonate)

Pyrantel 9.99mg(equivalentto28.8mgofpyrantelembonate)

Praziquantel 10.00mg

Excipienttoone190mgdivisibletablet

4. INDICATIONS

Forcurativetreatmentofdogsharbouringmixedparasiticinfestationswiththefollowingadultstages

ofnematodeandcestodespecies:

Nematodes:

Toxocaracanis

Toxascarisleonina

Ancylostomacaninum

Uncinariastenocephala

Trichurisvulpis

Cestodes:

Dipylidiumcaninum

Taeniaspp

Echinococcusmultilocularis

Echinococcusgranulosus

5. CONTRAINDICATIONS

Seeparagraph“Specialwarnings”

6. ADVERSEREACTIONS

Vomitinganddiarrhoeamaybeobservedfollowingthetreatment.

Despitenotbeingobservedinstudiesperformedwiththeproduct,anorexiacanoccurasitisa

commonadverseeffectofproductscontainingpraziquantel.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinformyour

veterinarysurgeon.

September2011

7. TARGETSPECIES

Dogs.

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOFADMINISTRATION

Therecommendeddoserateis20mgoxantel/5mgpyrantel/5mgpraziquantelperkgbodyweight,

ieonetabletper2kgbodyweightinasingleintake,byoralroute.

Administertherequirednumberoftablets,accordingtobodyweight,orally,inasingleadministration.

Preferably,dogsshouldbefastedpriortotreatment.Foodmaybegivenonehourormoreafter

treatment.

Weightofdog Numberoftablets

1kg ½

From1.1to2kg 1

From2.1to4kg 2

From4.1to6kg 3

Thetabletcanbedividedintohalves.

Dogskepttogetherorinkennelsshouldbetreatedatthesametime.

9. ADVICEONCORRECTADMINISTRATION

None.

10. WITHDRAWALPERIOD

Notapplicable.

11. SPECIALSTORAGEPRECAUTIONS

Keepoutofthereachandsightofchildren.

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

DonotuseaftertheexpirydatewhichisstatedonthecartonafterEXP

Discardanyunusedhalftablet.

12. SPECIALWARNINGS

Specialwarningsforeachtargetspecies

Parasiteresistancetoanyparticularclassofanthelminticmaydevelopfollowingfrequent,repeated

useofananthelminticofthatclass.

Fleasserveasintermediatehostsforoneofthecommontapeworms –Dipylidiumcaninum.

Tapeworminfestationmayreoccurunlesscontrolofintermediatehosts(fleas)isundertaken.

Specialprecautionsforuseinanimals

RoundwormandHookworminfection:

Insomeanimals,AncylostomacaninumandToxocaracanismaynotbetotallyeradicatedbythe

treatment,resultinginacontinuedriskofeggsheddingintotheenvironment.Follow-upexaminations

ofthefaecesareadvisableandaccordingtotheresultsoftheseexaminations,treatmentwitha

nematodicidalproductmaybecarriedoutifnecessary.

Theproductisnotrecommendedforuseinpupsyoungerthantwomonthsoldorweighinglessthan

1kg.

Indebilitatedorheavilyinfestedanimals,theproductshouldbeusedonlyaccordingtoabenefit/risk

assessmentbytheresponsibleveterinarian.

Donotuseinanimalswithknownhypersensitivitytoanyofthecomponentsoftheproduct.

September2011

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproduct

toanimals

Someconstituentsofthisproductmaycauseallergicreactionsorskinirritation.

Avoidcontactwiththeskin.

Peoplewithknownhypersensitivitytoanyoftheingredientsshouldavoidcontactwiththisproduct.

Washhandsafteruse.

Incaseofaccidentalingestion,seekmedicaladviceandshowthepackageleaflettothephysician.

Useduringpregnancy,lactationorlay

Thesafetyoftheveterinarymedicinalproducthasnotbeenestablishedduringpregnancyand

lactation.Theuseisnotrecommendedduringpregnancyandlactation.

Interactionwithothermedicinalproductsandotherformsofinteraction

Donotusesimultaneouslywithlevamisole,piperazineorcholineesteraseinhibitors

Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Administrationoftheproducttohealthydogsat5timestherecommendeddosagefor6consecutive

weekshadnoadverseconsequences.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTORWASTE

MATERIALS,IFANY

Askyourveterinarysurgeonhowtodisposeofmedicinesnolongerrequired.Thesemeasuresshould

helptoprotecttheenvironment.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

15. OTHERINFORMATION

Cardboxwith1stripof10tablets

Cardboxwith6stripsof10tablets

Cardboxwith10stripsof10tablets

Notallpacksizesmaybemarketed.

September2011

BLISTER

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

France EXETEC2

United-Kingdom TheBlueCross –DogWormerforsmalldogs

2. NAMEOFTHEMARKETINGAUTHORISATIONHOLDER

3. EXPIRYDATE

EXP:

4. BATCHNUMBER

Lot:

5. THEWORDS“FORANIMALTREATMENTONLY”

Foranimaltreatmentonly.

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