EXETEC 25 large dogs

Main information

  • Trade name:
  • The Blue Cross Dog Wormer for Large Dogs, Tablets
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • The Blue Cross Dog Wormer for Large Dogs, Tablets
    United Kingdom
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0232/003
  • Authorization date:
  • 30-09-2011
  • EU code:
  • FR/V/0232/003
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

September2011

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

France EXETEC25

United-Kingdom TheBlueCross –DogWormerforlargedogs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains

Activesubstances

Oxantel 500.70mg(equivalentto1397.5mgofoxantelembonate)

Pyrantel 124.85mg(equivalentto360mgofpyrantelembonate)

Praziquantel 125.00mg

Excipienttoone2375mgdivisibletablet

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

September2011

4.4 Specialwarningsforeachtargetspecies

Parasiteresistancetoanyparticularclassofanthelminticmaydevelopfollowingfrequent,repeated

useofananthelminticofthatclass

Fleasserveasintermediatehostsforoneofthecommontapeworms –Dipylidiumcaninum.

Tapeworminfestationmayreoccurunlesscontrolofintermediatehosts(fleas)isundertaken.

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,

ieonetabletper25kgbodyweightinasingleintake,byoralroute.

Administertherequirednumberoftablets,accordingtobodyweight,orally,inasingleadministration.

Preferably,dogsshouldbefastedpriortotreatment.Foodmaybegivenonehourormoreafter

treatment.

Weightofdog Numberoftablets

From10.1to12.5kg ½

From12.6to25kg 1

From25.1to50kg 2

From50.1to75kg 3

Thetabletcanbedividedintohalves.

Dogskepttogetherorinkennelsshouldbetreatedatthesametime.

September2011

4.10 Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Administrationoftheproducttohealthydogsat5timestherecommendeddosagefor

6consecutiveweekshadnoadverseconsequences.

4.11 Withdrawalperiod(s)

Notapplicable.

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

Noneapplicable

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:threeyears

Discardanyunusedhalftablet

6.4. Specialprecautionsforstorage

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

6.5 Natureandcompositionofimmediatepackaging

Polyamide-aluminium-PVC/aluminiumblisterorpolychlorotrifluoroethylene-PVC/aluminiumblister

stripof3tablets.

Cardboardboxwith1stripof3tablets

Cardboardboxwith6stripsof3tablets

Cardboardboxwith10stripsof3tablets

Cardboardboxwith20stripsof3tablets

Notallpacksizesmaybemarketed

September2011

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10 DATEOFREVISIONOFTHETEXT

PROHIBITIONOFSALE,SUPPLYAND/ORUSE-

March2011

OUTERPACKAGE

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

France EXETEC25

United-Kingdom TheBlueCross –DogWormerforlargedogs

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Oxantel 500.70mg(equivalentto1397.5mgofoxantelembonate)

Pyrantel 124.85mg(equivalentto360mgofpyrantelembonate)

Praziquantel 125.000mg

Excipienttoone2375mgdivisibletablet

3. PHARMACEUTICALFORM

Tablet.

4. PACKAGESIZE

Cardboardboxwith1stripof3tablets

Cardboardboxwith6stripsof3tablets

Cardboardboxwith10stripsof3tablets

Cardboardboxwith20stripsof3tablets

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

March2011

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

16. MARKETINGAUTHORISATIONNUMBER(S)

17. MANUFACTURER’SBATCHNUMBER

March2011

PACKAGELEAFLET

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERANDOFTHE

MANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFORBATCHRELEASE,IF

DIFFERENT

MarketingAuthorisationholder

Manufacturerforthebatchrelease:

VETOQUINOL

MAGNYVERNOIS

F-70200LURE

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

France EXETEC25

United-Kingdom TheBlueCross –DogWormerforlargedogs

3. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Activesubstances

Oxantel 500.70mg(equivalentto1397.5mgofoxantelembonate)

Pyrantel 124.85mg(equivalentto360mgofpyrantelembonate)

Praziquantel 125.000mg

Excipienttoone2375mgdivisibletablet

4. INDICATIONS

Forcurativetreatmentofdogsharbouringmixedparasiticinfestationswiththefollowingadultstages

ofnematodeandcestodespecies:

Nematodes:

Toxocaracanis

Toxascarisleonina

Ancylostomacaninum

Uncinariastenocephala

Trichurisvulpis

Cestodes:

Dipylidiumcaninum

Taeniaspp

Echinococcusmultilocularis

Echinococcusgranulosus

5. CONTRAINDICATIONS

Seeparagraph“Specialwarnings”.

March2011

6. ADVERSEREACTIONS

Vomitinganddiarrhoeamaybeobservedfollowingthetreatment.

Despitenotbeingobservedinstudiesperformedwiththeproduct,anorexiacanoccurasitisa

commonadverseeffectofproductscontainingpraziquantel.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinformyour

veterinarysurgeon.

7. TARGETSPECIES

Dogs.

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOFADMINISTRATION

Therecommendeddoserateis20mgoxantel/5mgpyrantel/5mgpraziquantelperkgbodyweight,

ieonetabletper25kgbodyweightinasingleintake,byoralroute.

Administertherequirednumberoftablets,accordingtobodyweight,orally,inasingleadministration.

Preferably,dogsshouldbefastedpriortotreatment.Foodmaybegivenonehourormoreafter

treatment.

Weightofdog Numberoftablets

From10.1to12.5kg ½

From12.6to25kg 1

From25.1to50kg 2

From50.1to75kg 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.

March2011

Specialprecautionsforuseinanimals

RoundwormandHookworminfection:

Insomeanimals,AncylostomacaninumandToxocaracanismaynotbetotallyeradicatedbythe

treatment,resultinginacontinuedriskofeggsheddingintotheenvironment.Follow-upexaminations

ofthefaecesareadvisableandaccordingtotheresultsoftheseexaminations,treatmentwitha

nematodicidalproductmaybecarriedoutifnecessary.

Theproductisnotrecommendedforuseinpupsyoungerthantwomonthsoldorweighinglessthan

1kg.

Indebilitatedorheavilyinfestedanimals,theproductshouldbeusedonlyaccordingtoabenefit/risk

assessmentbytheresponsibleveterinarian.

Donotuseinanimalswithknownhypersensitivitytoanyofthecomponentsoftheproduct.

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

Foranimaltreatmentonly.

Cardboardboxwith1stripof3tablets

Cardboardboxwith6stripsof3tablets

Cardboardboxwith10stripsof3tablets

Cardboardboxwith20stripsof3tablets

Notallpacksizesmaybemarketed.

March2011

BLISTER

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

France EXETEC25

United-Kingdom TheBlueCross –DogWormerforlargedogs

2. NAMEOFTHEMARKETINGAUTHORISATIONHOLDER

3. EXPIRYDATE

EXP:

4. BATCHNUMBER

Lot:

5. THEWORDS“FORANIMALTREATMENTONLY”

Foranimaltreatmentonly.