Solubenol 100 mg/g oral emulsion

Main information

  • Trade name:
  • Solubenol
  • Pharmaceutical form:
  • Oral emulsion
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Solubenol
    Germany
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • flubendazole
  • Therapeutic area:
  • Chicken, Pigs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0160/001
  • Authorization date:
  • 15-11-2011
  • EU code:
  • FR/V/0160/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

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APPENDIXI

SUMMARYOFPRODUCTCHARACTERISTICS

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1.NAMEOFTHEVETERINARYMEDICINALPRODUCT

Solubenol100mg/goralemulsionforpigsandchickens.

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachgramcontains:

Activesubstance:

Flubendazole 100,0mg

Excipients:

Propylparahydroxybenzoate(E216) 4,0mg

Methylparahydroxybenzoate(E218) 4,0mg

Butylhydroxytoluene(E321) 0,2mg

Propyleneglycol(E1520) 50,0mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Oralemulsion.

Whitehomogeneousviscousfluid.

4. CLINICALPARTICULARS

4.1 Targetspecies

Pigs(piglets,pigsforfatteningandpregnantsows)andchickens(layerhens,chickensforreproductionand

pullets).

4.2 Indicationsforuse,specifyingthetargetspecies

Inchickens:

Treatmentofhelminthiasiscausedby:

-Ascaridiagalli(maturestages)

-Heterakisgallinarum(maturestages)

-Capillariaspp.(maturestages)

Inpigs:

TreatmentofinfectionbymaturestagesandintestinallarvalstagesofAscarissuuminpiglets,pigs

forfatteningandpregnantsows

4.3 Contraindications

Donotuseinthecaseofhypersensitivitytotheactivesubstanceortoanyoftheexcipients.

4.4 Specialwarningsforeachtargetspecies

Chickens:

Inchickens,optimalresultscanonlybeachievedifstrictrulesofhygienearerespectedinthemaintenanceof

thecages.

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Pigs:

None.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Developmentdisordersofthefeatherscannotbefullyexcludedaftertheadministrationofflubendazole.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproductto

animals

Directcontactwithproductshouldbeavoided.Itisadvisabletoweargloveswhenhandlingtheproduct.

Washhandsafteruse.

Peoplewithknownhypersensitivitytoflubendazoleshouldavoidcontactwiththeveterinarymedicinal

product.

Intheeventofeyecontact,rinsethoroughlywithwaterandifconjunctivalrednesspersists,seekmedical

advice.

Otherspecialprecautions

Duetoconcernsfortheenvironmentwhentheproductisusedinfreerangepoultryorpigs,animalsmustbe

keptindoorsduringthetreatmentperiodandfor1dayafterlasttreatment.

4.6 Adversereactions(frequencyandseriousness)

Noundesirableeffectshavebeendemonstratedafteradministrationofthetherapeuticdoseinpigsorin

chickens.

4.7 Useduringpregnancy,lactationorlay

Thesafetyoftheproducthasbeendemonstratedinlayerhens.Theproductcanbeadministeredtothese

animals.

Atthedoseregimenof1mgflubendazole/kg/dayfor5days,theproductcanbeusedinpregnantsows.

Thesafetyoftheproducthasnotbeendemonstratedatthedoseregimenof2.5mgflubendazole/kg/dayfor2

days.Donotuseinpregnantsowsatthisdoseregimen.

Thesafetyoftheproducthasnotbeenassessedinlactatingsows.Theuseoftheproductduringthelactation

shouldbesubjecttobenefit/riskratioassessmentbytheresponsibleveterinarian.

4.8 Interactionswithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9 Amountstobeadministeredandadministrationroute

Posology:

Chickens:

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1.43mgflubendazole(=14.3mgproduct)perkgbodyweightdailyviaoraladministrationduring7days,i.e.1

goftheproductper70kgbodyweightdailyfor7days.

Pigs:

a.TreatmentofmaturestagesandintestinallarvalstagesofAscarissuuminpiglets,pigsforfattening

andpregnantsows

1mgflubendazole(=10mgproduct)perkgbodyweightdailyviaoraladministrationduring5days,

i.e.1goftheproductper100kgbodyweightdailyfor5days

b.TreatmentofmaturestagesofAscarissuuminpigletsandpigsforfattening

2,5mgflubendazole(=25mgproduct)perkgbodyweightdailyviaoraladministrationduring2days,

i.e.2,5goftheproductper100kgbodyweightdailyfor2days.

Pigsshouldbegroupedaccordingtotheirbodyweightanddosedaccordingly,inordertopreventunderor

overdosing.

Calculatethedosageaccuratelywiththefollowingformula:

…mg[product]

perkgbw/day XAveragebw(kg)ofthe

treatedanimals

=

....mg[product]

perlitredrinkingwater averagequantityofdrinkingwater(litre/animal)consumedin

4h

Thiswillresultinaconcentrationofflubendazolebetween20and200mgperlitre.

Methodofadministration

Administrationindrinkingwater:

1)Therequiredquantityoftheproductisinfunctionoftheestimatedbodyweightofthetotalgroup

animals(seetablebelowforapproximateamountsneeded).

7daytreatmentforchickens:

TotalweightofchickensAmountofmedicationtobe

used(g/day) Totalamountofmedication

used(g/7days)

1400kg

7000kg

35000kg 20g

100g

500g 7x20g

7x100g

7x500g

5daytreatmentforpigs:

Totalweightofpigs Amountofmedicationtobe

used(g/day) Totalamountofmedication

used(g/5days)

2000kg

10000kg

50000kg 20g

100g

500g 5x20g

5x100g

5x500g

2daytreatmentforpigs:

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Totalweightofpigs Amountofmedicationtobe

used(g/day) Totalamountofmedication

used(g/2days)

2000kg

10000kg

50000kg 50g

250g

1250g 2x50g

2x250g

2x1250g

2)Eachdayapredilutionispreparedcontainingthedailyrequireddoseoftheproductadmixedin10to

100timesitsweightinwaterdependingonthedistributionsystem.Forexample:for500gofthe

product,add5litresto50litresofwater.

3)Squeezethesachetgentlybeforeuseandthenemptythecontentsintothepredilutionrecipient.

4)Stirthepredilutionvigorouslywithamanualmixer(whisk)foratleast3minutestoobtainawhite

milkyhomogenousmixture.

5)Thispredilutionmustbedistributedviathegeneralwatersupplysystem:

Tanks:addthepredilutiontothequantityofwaterusuallyconsumedbytheanimalsoveraperiodof

upto4hours,homogenizethecontentsofthereservoiratleastevery30minuteswithanelectricor

manualmixer.

Dosingpumps:adjusttheflowrateofthepumptodistributethepredilutionoveraperiodofupto4

hours.Homogenizethepredilutionevery30minuteswithanautomaticmixerormanually.

Inordertoensureadministrationofthecorrectdose,asubstantialwaterflowmustbepresentinthe

drinkingwatersystemandmixingofthesolutioninthedeliverysystem(tankordosingpump)isessential

duringapplication.Administrationoftheproductoveraperiodofupto4hoursoneachtreatmentday,at

timeswhenwaterconsumptionislikelytobehighest,preventsprecipitationofflubendazoleinthewater

deliverysystemandallowswashingoutofthedrinkingwatersystemwithina24hourperiodafterthe

periodofdrugadministrationisfinished.

6)Priortoandaftertheperiodoftreatmentmakesurethewaterdistributionsystemiscleaned.

7)Makesurethatallanimalsinthegroupreceiveenoughdrinkingwaterwiththeproduct.Withhold

drinkingwaterfor2hoursbeforetreatmenttostimulatethirst.

8)Thecorrespondingdosemustalwaysbedistributedwhenthewaterconsumptionoftheanimalsis

highest.

4.10Overdose(symptoms,emergencyprocedures,antidotes)

Inchickens,noundesirableeffectshavebeenobservedafteradministrationofupto4timesthe

recommendeddosefor14days.Evenatdoses4timestherecommendeddose,eggqualityisnotaltered.

Onlyareductionineggweightandaslightdecreaseineggproductioncanbeobservedwithdosesoftwice

therecommendeddoseandover.Eggweightreturnstonormalwhentreatmentisdiscontinued.

Inpigs,noundesirableeffectshavebeenobservedatthehighestdose;5x2,5mgperkgbodyweightduring

3x2consecutivedays(or12,5mgduring6consecutivedays).

Intheeventofamassiveoverdose,mildtransientdiarrhoeacanoccurbythe2 nd

dayoftreatment,possibly

lastingfor7to12dayswithoutaffectingthebehaviourorperformanceoftheanimals.

4.11Withdrawalperiods

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Meatandoffal:chickens:4days

pigs:4days

Eggs:zerodays.

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5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Anthelminthicagent

ATCVetCode:QP52AC12.

5.1 Pharmacodynamicproperties

Flubendazoleisabenzimidazoleanthelmintic.Itactsbybindingtotubulinoftheparasite,thedimericsubunit

proteinofthemicrotubules.Itinhibitsmicrotubularassemblyinabsorptivecells:i.e.inintestinalcellsof

nematodesorthetegumentalcellsofcestodes.Thisisshownbydisappearanceofcytoplasmicmicrotubules,

accumulationofsecretorygranulesinthecytoplasmduetoablockintheirtransport,leadingtoanimpaired

coatingofthecellularmembraneandadecreaseddigestionandabsorptionofnutrients.Irreversiblelytic

degenerationofthecell,duetotheaccumulationofsecretorysubstances(hydrolyticandproteolytic

enzymes),resultsinthedeathoftheparasite.Thesechangesarerelativelyfastandareprimarilyseenin

thoseorganellesdirectlyinvolvedinthesecretoryandabsorptivefunctionsofthecells.Incontrastthe

changesarenotseenincellsofthehost.

Anothertubulin-relatedeffectisthestronginhibitionofegghatchbyinhibitionofmicrotubule-dependent

processesinthedevelopingwormegg(celldivision).

5.2 Pharmacokineticparticulars

Flubendazoleispoorlysolubleinaqueoussystems,suchasthegastrointestinaltract,whichresultsinalow

dissolutionrateandalowabsorption.Thisisreflectedbythehighfaecalexcretionofunchangedparentdrug.

Thesmallfractionabsorbedisextensivelymetabolisedbyfirst-passmetabolismintheliver,involving

carbamatehydrolysisandketonereduction.Thebiotransformationproductsareconjugatedtoglucuronidesor

sulphateconjugatesandexcretedwiththebileandtheurine.

Theexcretionwithurineisrelativelylowandconsistsalmostexclusivelyofmetaboliteswithonlysmall

amountsofunchangedcompound.

Inpigsandchicken,thehalf-lifeofflubendazoleanditsmetabolitesinplasmais12hoursto2days.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Butylhydroxytoluene(E321)

Propylparahydroxybenzoate(E216)

Methylparahydroxybenzoate(E218)

Propyleneglycol(E1520)

Higholeicsunfloweroil

Acacia

Monoglyceridecitrate

Xanthangum

Citricacidmonohydrate

Disodiumedetate

Sodiumhydroxide

Purifiedwater

6.2 Incompatibilities

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Donotmixwithanyotherveterinarymedicinalproducts.

6.3 Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:3years

Shelflifeafterdilutionorreconstitutionaccordingtodirections:1day

6.4 Specialprecautionsforstorage

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

6.5 Natureandcompositionofimmediatepackaging

Sachetsconsistingoffourlayers(PE/PET/ALU/PET)inacarboardbox:

Boxcontaining2sachetsof20g

Boxcontaining24sachetsof20g

Boxcontaining1sachetof100g

Boxcontaining5sachetsof100g

Boxcontaining1sachetsof500g

Boxcontaining5sachetsof500g

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialderivedfromsuchveterinarymedicinalproduct

shouldbedisposedofinaccordancewithlocalrequirements.

7. NAMEOFTHEMARKETINGAUTHORISATIONHOLDER

(tobecompletedlocally)

8. MARKETINGAUTHORIZATIONNUMBER

(tobecompletedlocally)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORIZATION

(tobecompletedlocally)

10. DATEOFREVISIONOFTHETEXT

(tobecompletedlocally)

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