FLIMABO 100 mg/g suspension for use in drinking water for chickens and pigs

Main information

  • Trade name:
  • FLIMABO 100 mg/g suspension for use in drinking water for chickens and pigs
  • Pharmaceutical form:
  • Oral suspension
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FLIMABO 100 mg/g suspension for use in drinking water for chickens and pigs
    Netherlands
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • AGENTS AGAINST NEMATODOSIS
  • Therapeutic area:
  • Chicken, Pigs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0243/001
  • Authorization date:
  • 19-12-2012
  • EU code:
  • FR/V/0243/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

1.3.1 Flubendazole

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SUMMARYOFPRODUCTCHARACTERISTICS

1.3.1 Flubendazole

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1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

FLIMABO100mg/gsuspensionforuseindrinkingwaterforchickensandpigs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachgofsuspensionforuseindrinkingwatercontains:

Activesubstance:

Flubendazole 100mg

Excipients:

Methylparahydroxybenzoate(E218) 2.0mg

Sodiumbenzoate(E211) 5.0mg

Disodiumedetate 0.1mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Suspensionforuseindrinkingwater.

Whitetobrownishwhitesuspension.

4. CLINICALPARTICULARS

4.1 Targetspecies

Pigs(piglets,pigsforfattening,pregnantsows)andchickens(layerhens,chickensfor

reproduction,pullets,broilers).

4.2 Indicationsforuse,specifyingthetargetspecies

Inhens/chickens:

- TreatmentofhelminthiasiscausedbyAscaridiagalli(adultstages),Heterakisgallinarum

(adultstages),Capillariaspp.(adultstages).

Inpigs:

- TreatmentofhelminthiasiscausedbyAscarissuum(adultandintestinallarvalstages)in

piglets,fatteningpigsandpregnantsows.

4.3 Contraindications

Donotuseincasesofknownhypersensitivitytotheactivesubstanceortoanyofthe

excipients.

4.4 Specialwarningsforeachtargetspecies

Inchickens,optimalresultscanonlybeachievedifstrictrulesofhygienearerespectedinthe

maintenanceofthecages.

1.3.1 Flubendazole

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Inbothspecies:

Careshouldbetakentoavoidthefollowingpracticesbecausetheyincreasetheriskof

developmentofresistanceandcouldultimatelyresultinineffectivetherapy:

Toofrequentandrepeateduseofanthelminticsfromthesameclass,overanextendedperiod

oftime.

Underdosing,whichmaybeduetounderestimationofbodyweight,misadministrationofthe

product,orlackofcalibrationofthedosingdevice(ifany).

Suspectedclinicalcasesofresistancetoanthelminticsshouldbefurtherinvestigatedusing

appropriatetests(e.g.FaecalEggCountReductionTest).Wheretheresultsofthetest(s)

stronglysuggestresistancetoaparticularanthelmintic,ananthelminticbelongingtoanother

pharmacologicalclassandhavingadifferentmodeofactionshouldbeused.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

i)Specialprecautionsforuseinanimals

Developmentdisordersofthefeatherscannotbefullyexcludedaftertheadministrationof

flubendazole.

ii)Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Directcontactwithproductshouldbeavoided. Wearprotectivegloveswhileusingthe

product.Washhandsafteruse.

Peoplewithknownhypersensitivitytoflubendazoleshouldavoidcontactwiththeveterinary

medicinalproduct.Intheeventofeyecontact,rinsethoroughlywithwater.Incaseof

appearanceandpersistenceofconjunctivalredness,seekmedicaladviceandshowthe

packageleaflettothephysician.

4.6 Adversereactions(frequencyandseriousness)

Noundesirableeffectshavebeendemonstratedwithflubendazoleafteradministrationofthe

therapeuticdoseinpigsorinchickens.

4.7 Useduringpregnancy,lactationorlay

Thesafetyoftheproducthasbeendemonstratedinlayinghens.Theproductcanbe

administeredtotheseanimals.

Laboratorystudiesinrabbitsandratshavenotproducedanyevidenceofembryotoxicity,

teratogenicityattherapeuticdoses.Highdosagesgaveequivocalresults.Thesafetyofthe

producthasnotbeendemonstratedinpregnantsows.Inlaboratorystudiesinrats,therewere

noeffectsonpupsduringlactation.Thesafetyoftheproducthasnotbeenassessedin

pregnantandlactatingsows.Theuseoftheproductduringpregnancyandlactationshouldbe

subjecttobenefit/riskrationassessmentbytheresponsibleveterinarian.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9 Amountstobeadministeredandadministrationroute

1.3.1 Flubendazole

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Hens/chickens:

1.43mgflubendazole(=14.3mgproduct)perkgbodyweightdailyviaoraladministration

during7daysi.e.1goftheproductper70kgbodyweightdailyfor7days.

Pigs:

a) TreatmentofhelminthiasiscausedbyAscarissuum(adultstagesandintestinallarval

stages)inpiglets,pigsforfatteningandpregnantsows:

1mgflubendazole(=10mgproduct)perkgbodyweightdailyviaoraladministration

during5days,i.e.1goftheproductper100kgbodyweightdailyfor5days.

b) TreatmentofhelminthiasiscausedbyAscarissuum(adultstages)inpigletsandpigs

forfattening.

2.5mgflubendazole(=25mgproduct)perkgbodyweightdailyviaoral

administrationduring2days,i.e.2.5goftheproductper100kgbodyweightdailyfor2days.

Pigsshouldbegroupedaccordingtotheirbodyweightanddosedaccordingly,inorderto

preventunderoroverdosing.

Calculatethedosageaccuratelywiththefollowingformula:

…mg[product]

perkgbw/day XAveragebw(kg)ofthe

treatedanimals

=

.... mg [product]

perlitredrinkingwater averagequantityofdrinkingwater(litre/animal)consumed

in4h

Thiswillresultinaconcentrationofflubendazolebetween20and200mgperlitre.

Methodofadministration:

Administrationindrinkingwater

1)Therequiredquantityoftheproductisinfunctionoftheestimatedbodyweightofthe

totalgroupanimals(seetablebelowforguidance).

Hens/chickens,7daysoftreatment

Totalweightof

chickens Amountofmedicationtobeused

(g/day) Totalamountofmedicationused

(g/7days)

1400kg

7000kg

35000kg 20g

100g

500g 7x20g

7x100g

7x500g

Pigs,5daysoftreatment

Totalweightofpigs Amountofmedicationtobe

used(g/day) Totalamountofmedicationused

(g/5days)

2000kg

10000kg

50000kg 20g

100g

500g 5x20g

5x100g

5x500g

Pigs,2daysoftreatment

Totalweightofpigs Amountofmedicationtobe Totalamountofmedicationused

1.3.1 Flubendazole

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used(g/day) (g/2days)

2000kg

4000kg

40000kg 50g

100g

1000g 2x50g

2x100g

2x1000g

2)Eachdayapredilutionispreparedcontainingthedailyrequireddoseoftheproduct

admixedin10to100timesitsweightinwaterdependingonthedistributionsystem.For

example:for500goftheproduct,add5litresto50litresofwater.

3)Squeezethesachetgentlybeforeuseandthenemptythecontentsintothepredilution

recipient.

4)Iflessthanentiresachetisrequired,therequireddoseshouldbemeasuredbysuitably

calibratedweighingequipment.

5)Stirthepredilutionvigorouslywithamanualmixer(whisk)for2minutestoobtaina

whitemilkyhomogenousmixture.

6)Thispredilutionmustbedistributedviathegeneralwatersupplysystem:

Tanks:addthepredilutiontothequantityofwaterusuallyconsumedbytheanimalsover

aperiodofupto4hours.

Dosingpumps:adjusttheflowrateofthepumptodistributethepredilutionoveraperiod

ofupto4hours.

Inordertoensureadministrationofthecorrectdose,asubstantialwaterflowmustbe

presentinthedrinkingwatersystem.Administrationoftheproductoveraperiodofupto

4hoursoneachtreatmentday,attimeswhenwaterconsumptionislikelytobehighest

preventsprecipitationofflubendazoleinthewaterdeliverysystemandallowswashing

outofthedrinkingwatersystemwithina24hourperiodaftertheperiodofdrug

administrationisfinished.

7)Priortoandaftertheperiodoftreatmentmakesurethewaterdistributionsystemis

cleaned.

8)Makesurethatallanimalsinthegroupreceiveenoughdrinkingwaterwiththeproduct.

Withholddrinkingwaterfor2hoursbeforetreatmenttostimulatethirst.

9)Thecorrespondingdosemustalwaysbedistributedwhenthewaterconsumptionofthe

animalsishighest.

4.10 Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Flubendazolehasalowacuteoraltoxicity.

Inhens,noundesirableeffectshavebeenobservedafteradministrationofupto15mg/kg

b.w./dayflubendazole.

Inporcine,noadverseeffectshavebeenobservedafteradministrationofupto50mg/kg

b.w./dayflubendazole.

Insituationwhenaccidentaloverdoseissuspectedofhavingoccurred,thereisnoantidoteand

treatmentshouldbesymptomatic.

4.11Withdrawalperiod(s)

Meatandoffal:

chickens:2days

1.3.1 Flubendazole

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pigs:

- dose1mg/kgbodyweightfor5days:3days

- dose2.5mg/kgbodyweightfor2days:4days

Eggs:zerodays.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Anthelmintics,Benzimidazolesandrelatedsubstances

ATCvetcode:QP52AC12

5.1 Pharmacodynamicproperties

Flubendazoleisabenzimidazoleanthelmintic.Itactsbybindingtotubulinoftheparasite,the

dimericsubunitproteinofthemicrotubules.Itinhibitsmicrotubularassemblyinabsorptive

cells:i.e.inintestinalcellsofnematodesorthetegumentalcellsofcestodes.Thisisshownby

disappearanceofcytoplasmicmicrotubules,accumulationofsecretorygranulesinthe

cytoplasmduetoablockintheirtransport,leadingtoanimpairedcoatingofthecellular

membraneandadecreaseddigestionandabsorptionofnutrients.Irreversiblelytic

degenerationofthecells,duetotheaccumulationofsecretorysubstances(hydrolyticand

proteolyticenzymes)resultsinthedeathoftheparasite.Thesechangesarerelativelyfastand

areprimarilyseeninthoseorganellesdirectlyinvolvedinthesecretoryandabsorptive

functionsofthecells.Incontrastthechangesarenotseenincellsofthehost.Anothertubulin-

relatedeffectisthestronginhibitionofegghatchbyinhibitionofmicrotubule-depended

processesinthedevelopingwormegg(celldivision).

5.2 Pharmacokineticparticulars

Flubendazoleispoorlysolubleinaqueoussystems,suchasthegastrointestinaltract,which

resultsinalowdistributionrateandalowabsorption.Thisisreflectedbythehighfaecal

excretionofunchangedparentdrug.Thesmallfractionabsorbedisextensivelymetabolised

byfirst-passmetabolismintheliver,involvingcarbamatehydrolysisandketonereduction.

Thebiotransformationproductsareconjugatedtoglucuronidesorsulphateconjugatesand

excretedwiththebileandtheurine.Theexcretionwithurineisrelativelylowandconsists

almostexclusivelyofmetaboliteswithonlysmallamountsofunchangedcompound.Inpigs

andchickens,thehalf-lifeofflubendazoleanditsmetabolitesinplasmais12hoursto2days.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Sodiumbenzoate(E211)

Methylparahydroxybenzoate(E218)

Disodiumedetate

Carmellosesodium

Xanthangum

Citricacidmonohydrate

Carbomers

Propyleneglycol

Water,purified

1.3.1 Flubendazole

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6.2 Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixed

withotherveterinarymedicinalproducts.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years.

Shelflifeafterdilutionorreconstitutionaccordingtodirections:24hours.

Anysuspensionremaininginthesachetafterfirstopeningshouldbediscarded.

6.4 Specialprecautionsforstorage

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

6.5 Natureandcompositionofimmediatepackaging

Boxcontaining2sachets(sachetPE/PET/aluminium/PET)of20gsuspensionforusein

drinkingwater.

Boxcontaining24sachets(sachetPE/PET/aluminium/PET)of20gsuspensionforusein

drinkingwater.

Boxcontaining2sachets(sachetPE/PET/aluminium/PET)of50gsuspensionforusein

drinkingwater.

Boxcontaining24sachets(sachetPE/PET/aluminium/PET)of50gsuspensionforusein

drinkingwater.

Boxcontaining1sachet(sachetPE/PET/aluminium/PET)of100gsuspensionforusein

drinkingwater.

Boxcontaining5sachets(sachetPE/PET/aluminium/PET)of100gsuspensionforusein

drinkingwater.

Boxcontaining25sachets(sachetPE/PET/aluminium/PET)of100gsuspensionforusein

drinkingwater.

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

KRKAd.d.,Novomesto,Šmarješkacesta6,8501Novomesto,Slovenia

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10. DATEOFREVISIONOFTHETEXT

1.3.1 Flubendazole

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PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable.

Tobesuppliedonlyonveterinaryprescription.

Administrationbyaveterinarysurgeonorundertheirdirectresponsibility.

1.3.1 Flubendazole

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LABELLINGANDPACKAGELEAFLET

1.3.1 Flubendazole

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A.LABELLING

1.3.1 Flubendazole

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PARTICULARSTOAPPEARONTHEOUTERPACKAGE

BOX

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

FLIMABO100mg/gsuspensionforuseindrinkingwaterforchickensandpigs

Flubendazole

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

1gofwhitetobrownishwhitesuspensioncontains100mgofflubendazolewith2mgofmethyl

parahydroxybenzoate(E218),5mgofsodiumbenzoate(E211)and0,1mgof disodiumedetate .

3. PHARMACEUTICALFORM

Suspensionforuseindrinkingwater.

4. PACKAGESIZE

2x20g

24x20g

2x50g

24x50g

1x100g

5x100g

25x100g

5. TARGETSPECIES

Pigs(piglets,pigsforfattening,pregnantsows)andchickens(layerhens, chickensforreproduction

pullets,broilers).

6. INDICATION(S)

7. METHODANDROUTE(S)OFADMINISTRATION

Readthepackageleafletbeforeuse.

Indrinkingwateruse.

8. WITHDRAWALPERIOD

Withdrawalperiod:

Meatandoffal:

chickens:2days

pigs:

-dose1mg/kgbodyweightfor5days:3days

1.3.1 Flubendazole

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-dose2.5mg/kgbodyweightfor2days:4days

Eggs:zerodays

9. SPECIALWARNING(S),IFNECESSARY

Readthepackageleafletbeforeuse.

10. EXPIRYDATE

EXP:

Shelflifeafterdilutionorreconstitutionaccordingtodirections:24hours.

11. SPECIALSTORAGECONDITIONS

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Disposal:readpackageleaflet.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly-tobesuppliedonlyonveterinaryprescription.

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

KRKAd.d.,Novomesto,Šmarješkacesta6,8501Novomesto,Slovenia

16. MARKETINGAUTHORISATIONNUMBER(S)

17. MANUFACTURER’SBATCHNUMBER

Lot:

1.3.1 Flubendazole

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PARTICULARSTOAPPEARONTHEIMMEDIATEPACKAGE

Label

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

FLIMABO100mg/gsuspensionforuseindrinkingwaterforchickensandpigs

Flubendazole

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

1gofwhitetobrownishwhitesuspensioncontains100mgofflubendazolewith2mgofmethyl

parahydroxybenzoate(E218),5mgofsodiumbenzoate(E211)and0,1mgof disodiumedetate .

3. PHARMACEUTICALFORM

Suspensionforuseindrinkingwater.

4. PACKAGESIZE

20g

50g

100g

5. TARGETSPECIES

Pigs(piglets,pigsforfattening,pregnantsows)andchickens(layerhens, chickensforreproduction ,

pullets,broilers).

6. INDICATION(S)

7. METHODANDROUTE(S)OFADMINISTRATION

Readthepackageleafletbeforeuse.

Indrinkingwateruse.

8. WITHDRAWALPERIOD

Withdrawalperiod:

Meatandoffal:

chickens:2days

pigs:

-dose1mg/kgbodyweightfor5days:3days

-dose2.5mg/kgbodyweightfor2days:4days

Eggs:zerodays

9. SPECIALWARNING(S),IFNECESSARY

1.3.1 Flubendazole

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Readthepackageleafletbeforeuse.

10. EXPIRYDATE

EXP:

Shelflifeafterdilutionorreconstitutionaccordingtodirections:24hours.

Informationaboutthebatchnumberanddateofexpirationareshownonthesealededgeofthebag.

11. SPECIALSTORAGECONDITIONS

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly-tobesuppliedonlyonveterinaryprescription.

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

KRKAd.d.,Novomesto,Šmarješkacesta6,8501Novomesto,Slovenia

16. MARKETINGAUTHORISATIONNUMBER(S)

17. MANUFACTURER’SBATCHNUMBER

Lot:

1.3.1 Flubendazole

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B.PACKAGELEAFLET

1.3.1 Flubendazole

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PACKAGELEAFLET

FLIMABO100mg/gsuspensionforuseindrinkingwaterforchickensandpigs

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERAND

OFTHEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFOR

BATCHRELEASE,IFDIFFERENT

KRKAd.d.,Novomesto,Šmarješkacesta6,8501Novomesto,Slovenia

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

FLIMABO100mg/gsuspensionforuseindrinkingwaterforchickensandpigs

Flubendazole

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

1gofwhitetobrownishwhitesuspensioncontains100mgofflubendazolewith2mgof

methylparahydroxybenzoate(E218),5mgofsodiumbenzoate(E211)and0,1mgof

disodiumedetate .

4. INDICATION(S)

Inhens/chickens:

- TreatmentofhelminthiasiscausedbyAscaridiagalli(adultstages),Heterakisgallinarum

(adultstages),Capillariaspp.(adultstages).

Inpigs:

- TreatmentofhelminthiasiscausedbyAscarissuum(adultandintestinallarvalstages)in

piglets,fatteningpigsandpregnantsows.

5. CONTRAINDICATIONS

Donotuseincasesofknownhypersensitivitytotheactivesubstanceortoanyofthe

excipients.

6. ADVERSEREACTIONS

Noundesirableeffectshavebeendemonstratedwithflubendazoleafteradministrationofthe

therapeuticdoseinpigsorinchickens.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinform

yourveterinarysurgeon.

7. TARGETSPECIES

1.3.1 Flubendazole

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Pigs(piglets,pigsforfattening,pregnantsows)andchickens(layerhens, chickensfor

reproduction ,pullets,broilers).

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOFADMINISTRATION

Hens/chickens:

1.43mgflubendazole(=14.3mgproduct)perkgbodyweightdailyviaoraladministrationduring

7daysi.e.1goftheproductper70kgbodyweightdailyfor7days.

Pigs:

a)TreatmentofhelminthiasiscausedbyAscarissuum(adultstagesandintestinallarval

stages)inpiglets,pigsforfatteningandpregnantsows:

1mgflubendazole(=10mgproduct)perkgbodyweightdailyviaoraladministrationduring

5days,i.e.1goftheproductper100kgbodyweightdailyfor5days.

b)TreatmentofhelminthiasiscausedbyAscarissuum(adultstages)inpigletsandpigsfor

fattening:

2.5mgflubendazole(=25mgproduct)perkgbodyweightdailyviaoraladministration

during2days,i.e.2.5goftheproductper100kgbodyweightdailyfor2days.

Pigsshouldbegroupedaccordingtotheirbodyweightanddosedaccordingly,inorderto

preventunderoroverdosing.

Calculatethedosageaccuratelywiththefollowingformula:

…mg[product]

perkgbw/day XAveragebw(kg)ofthe

treatedanimals

=

.... mg [product]

perlitredrinkingwater averagequantityofdrinkingwater(litre/animal)consumed

in4h

Thiswillresultinaconcentrationofflubendazolebetween20and200mmgperlitre.

9. ADVICEONCORRECTADMINISTRATION

Administrationindrinkingwater

1)Therequiredquantityoftheproductisinfunctionoftheestimatedbodyweightofthe

totalgroupanimals(seetablebelowforguidance).

Hens/chickens,7daysoftreatment

Totalweightof

chickens Amountofmedicationtobeused

(g/day) Totalamountofmedicationused

(g/7days)

1400kg

7000kg

35000kg 20g

100g

500g 7x20g

7x100g

7x500g

Pigs,5daysoftreatment

Totalweightofpigs Amountofmedicationtobe

used(g/day) Totalamountofmedicationused

(g/5days)

1.3.1 Flubendazole

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2000kg

10000kg

50000kg 20g

100g

500g 5x20g

5x100g

5x500g

Pigs,2daysoftreatment

Totalweightofpigs Amountofmedicationtobe

used(g/day) Totalamountofmedicationused

(g/2days)

2000kg

4000kg

40000kg 50g

100g

1000g 2x50g

2x100g

2x1000g

2)Eachdayapredilutionispreparedcontainingthedailyrequireddoseoftheproduct

admixedin10to100timesitsweightinwaterdependingonthedistributionsystem.For

example:for500goftheproduct,add5litresto50litresofwater.

3)Squeezethesachetgentlybeforeuseandthenemptythecontentsintothepredilution

recipient.

4)Iflessthanentiresachetisrequired,therequireddoseshouldbemeasuredbysuitable

calibratedweighingequipment.

5)Stirthepredilutionvigorouslywithamanualmixer(whisk)for2minutestoobtaina

whitemilkyhomogenousmixture.

6)Thispredilutionmustbedistributedviathegeneralwatersupplysystem:

Tanks:addthepredilutiontothequantityofwaterusuallyconsumedbytheanimalsover

aperiodofupto4hours.

Dosingpumps:adjusttheflowrateofthepumptodistributethepredilutionoveraperiod

ofupto4hours.

Inordertoensureadministrationofthecorrectdose,asubstantialwaterflowmustbe

presentinthedrinkingwatersystem.Administrationoftheproductoveraperiodofupto

4hoursoneachtreatmentday,attimeswhenwaterconsumptionislikelytobehighest,

preventsprecipitationofflubendazoleinthewaterdeliverysystemandallowswashing

outofthedrinkingwatersystemwithina24hourperiodaftertheperiodofdrug

administrationisfinished.

7)Priortoandaftertheperiodoftreatmentmakesurethewaterdistributionsystemis

cleaned.

8)Makesurethatallanimalsinthegroupreceiveenoughdrinkingwaterwiththeproduct.

Withholddrinkingwaterfor2hoursbeforetreatmenttostimulatethirst.

9)Thecorrespondingdosemustalwaysbedistributedwhenthewaterconsumptionofthe

animalsishighest.

10. WITHDRAWALPERIOD

Meatandoffal:

chickens:2days

pigs:

1.3.1 Flubendazole

SPC,LabelingandPackageLeaflet FR

SmPCPIL034187/7 12.11.2012–Updated:02.01.2013 Page19of20

- dose1mg/kgbodyweightfor5days:3days

- dose2.5mg/kgbodyweightfor2days:4days

Eggs:zerodays

11. SPECIALSTORAGEPRECAUTIONS

Keepoutofthereachandsightofchildren.

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

DonotuseaftertheexpirydatewhichisstatedonthepackagingafterEXP.

Shelflifeafterincorporationintodrinkingwater:24hours.

12. SPECIALWARNING(S)

Specialwarningsforeachtargetspecies

Inchickens,optimalresultscanonlybeachievedifstrictrulesofhygienearerespectedinthe

maintenanceofthecages.

Inbothspecies:

Careshouldbetakentoavoidthefollowingpracticesbecausetheyincreasetheriskof

developmentofresistanceandcouldultimatelyresultinineffectivetherapy:

Toofrequentandrepeateduseofanthelminticsfromthesameclass,overanextendedperiod

oftime.

Underdosing,whichmaybeduetounderestimationofbodyweight,misadministrationofthe

product,orlackofcalibrationofthedosingdevice(ifany).

Suspectedclinicalcasesofresistancetoanthelminticsshouldbefurtherinvestigatedusing

appropriatetests(e.g.FaecalEggCountReductionTest).Wheretheresultsofthetest(s)

stronglysuggestresistancetoaparticularanthelmintic,ananthelminticbelongingtoanother

pharmacologicalclassandhavingadifferentmodeofactionshouldbeused.

Specialprecautionsforuseinanimals

Developmentdisordersofthefeatherscannotbefullyexcludedaftertheadministrationof

flubendazole.

Useduringpregnancy,lactationorlay

Thesafetyoftheproducthasbeendemonstratedinlayerhens.Theproductcanbe

administeredtotheseanimals.

Laboratorystudiesinrabbitsandratshavenotproducedanyevidenceofembryotoxicity,

teratogenicityattherapeuticdoses.Highdosagesgaveequivocalresults.Thesafetyofthe

producthasnotbeendemonstratedinpregnantsows.Inlaboratorystudiesinrats,therewere

noeffectsonpupsduringlactation.Thesafetyoftheproducthasnotbeenassessedin

pregnantandlactatingsows.Theuseoftheproductduringpregnancyandlactationshouldbe

subjecttobenefit/riskrationassessmentbytheresponsibleveterinarian.

Interactionandincompatibilities

Noneknown.

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixed

withotherveterinarymedicinalproducts.

Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Flubendazolehasalowacuteoraltoxicity.

1.3.1 Flubendazole

SPC,LabelingandPackageLeaflet FR

SmPCPIL034187/7 12.11.2012–Updated:02.01.2013 Page20of20

Inhens,noundesirableeffectshavebeenobservedafteradministrationofupto15mg/kg

b.w./dayflubendazole.

Inporcine,noadverseeffectshavebeenobservedafteradministrationofupto50mg/kg

b.w./dayflubendazole.

Insituationwhenaccidentaloverdoseissuspectedofhavingoccurred,thereisnoantidoteand

treatmentshouldbesymptomatic.

Userwarnings

Directcontactwithproductshouldbeavoided.Wearprotectivegloveswhileusingthe

product.Washhandsafteruse.

Peoplewithknownhypersensitivitytoflubendazoleshouldavoidcontactwiththeveterinary

medicinalproduct.Intheeventofeyecontact,rinsethoroughlywithwater.Incaseof

appearanceandpersistenceofconjunctivalredness,seekmedicaladviceandshowthe

packageleaflettothephysician.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements.Askyour

veterinarysurgeonhowtodisposeofmedicinesnolongerrequired.Thesemeasuresshouldhelp

toprotecttheenvironment.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVE

15. OTHERINFORMATION

Boxcontaining2sachets(sachetPE/PET/aluminium/PET)of20gsuspensionforusein

drinkingwater.

Boxcontaining24sachets(sachetPE/PET/aluminium/PET)of20gsuspensionforusein

drinkingwater.

Boxcontaining2sachets(sachetPE/PET/aluminium/PET)of50gsuspensionforusein

drinkingwater.

Boxcontaining24sachets(sachetPE/PET/aluminium/PET)of50gsuspensionforusein

drinkingwater.

Boxcontaining1sachet(sachetPE/PET/aluminium/PET)of100gsuspensionforusein

drinkingwater.

Boxcontaining5sachets(sachetPE/PET/aluminium/PET)of100gsuspensionforusein

drinkingwater.

Boxcontaining25sachets(sachetPE/PET/aluminium/PET)of100gsuspensionforusein

drinkingwater.

Notallpacksizesmaybemarketed.

Foranyinformationaboutthisveterinarymedicinalproduct,pleasecontactthelocal

representativeofthemarketingauthorisationholder.

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