Soludox 500 mg/g powder for use in drinking water for pigs and chickens

Main information

  • Trade name:
  • Soludox 500 mg/g powder for use in drinking water for pigs and chickens
  • Pharmaceutical form:
  • Powder for oral solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Soludox 500 mg/g powder for use in drinking water for pigs and chickens
    Netherlands
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • doxycycline
  • Therapeutic area:
  • Chicken Food, Pigs Food

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • NL/V/0141/001
  • Authorization date:
  • 25-08-2011
  • EU code:
  • NL/V/0141/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Summaryofproductcharacteristics,

labellingandpackageleaflet

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Soludox500mg/gpowderforuseindrinkingwaterforpigsandchickens

Soludox433mg/gpowderforuseindrinkingwaterforpigsandchickens(Franceonly)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

1gramofpowdercontains:

Activesubstance:

Doxycyclinehyclate500mg,correspondingto433mgdoxycycline

France:Doxycycline433mg,correspondingto500mgdoxycyclinehyclate

Excipients:

Forafulllistofexcipients,seesection6.1

3 PHARMACEUTICALFORM

Powderforuseindrinkingwater

Yellowcrystallinepowder

4 CLINICALPARTICULARS

4.1 Targetspecies

Pigsandchickens(broiler,pullet,breeder).

4.2 Indicationsforuse,specifyingthetargetspecies

Pigs:Forthetreatmentoftheclinicalsignsassociatedwithporcinerespiratorydiseasecausedby

Actinobacilluspleuropneumoniae,Pasteurellamultocida,andMycoplasmahyopneumoniaesusceptibleto

doxycycline.

Chickens:Whereclinicaldiseaseispresentintheflock,toreducemortality,morbidity,andclinicalsigns

andtoreducelesionsduetoPasteurellosiscausedbyPasteurellamultocidaortoreducemorbidityand

lesionsinrespiratoryinfectionscausedbyOrnithobacteriumrhinotracheale(ORT).

4.3 Contra-indications

Donotuseincaseofhypersensitivitytotheactivesubstanceortoanyofexcipients.

Donotuseinanimalswithanimpairedliverfunction.

4.4 Specialwarningforeachtargetspecies.

None.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Duetolikelyvariability(time,geographical)insusceptibilityofbacteriafordoxycycline,especially

susceptibilityofA.pleuropneumoniaeandO.rhinotrachealemaydifferfromcountrytocountryandeven

farmtofarm,bacteriologicalsamplingandsusceptibilitytestingarerecommended.Useoftheproduct

shouldbebasedoncultureandsensitivityofmicro-organismsfromdiseasedcasesonfarm.Ifthisisnot

possible,therapyshouldbebasedonlocal(regional,farmlevel)epidemiologicalinformationabout

susceptibilityofthetargetbacteria.

Aseradicationofthetargetpathogensmaynotbeachieved,medicationshouldthereforebecombined

withgoodmanagementpractices,e.g.goodhygiene,properventilation,nooverstocking.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproductto

animals

Ifyouknowyouareallergictothetetracyclineclassofantibiotics,specialcareshouldbetakenwhen

handlingthisproductorthemedicatedsolution.

Duringpreparationandadministrationofthemedicateddrinkingwater,skincontactwiththeproductand

inhalationofdustparticlesshouldbeavoided.Wearimpermeablegloves(e.g.rubberorlatex)andan

appropriatedustmask(e.g.disposablehalf-maskrespiratorconformingtoEuropeanStandardEN149)

whenapplyingtheproduct.

Intheeventofeyeorskincontact,rinsetheaffectedareawithlargeamountsofcleanwaterandif

irritationoccurs,seekmedicalattention.Washhandsandcontaminatedskinimmediatelyafterhandling

theproduct.

Ifyoudevelopsymptomsfollowingexposuresuchasskinrash,youshouldseekmedicaladviceandshow

thiswarningtothephysician.Swellingoftheface,lipsoreyes,ordifficultywithbreathingaremore

serioussymptomsandrequireurgentmedicalattention.

Donotsmoke,eatordrinkwhilehandlingtheproduct.

Takemeasurestoavoidproducingdustwhenincorporatingtheproductintowater.Avoiddirectcontact

withskinandeyeswhenhandlingtheproducttopreventsensitisationandcontactdermatitis.

4.6 Adversereactions(frequencyandseriousness)

Tetracyclinesmay-inveryrarecases-inducephotosensitivityandallergicreactions.Ifsuspectedadverse

reactionsoccur,treatmentshouldbediscontinued.Informyourveterinarysurgeonifadversereactions

occurthatarenotstated.

4.7 Useduringpregnancy,lactationorlay

Doxycyclinehasalowaffinityforformingcomplexeswithcalciumandstudieshavedemonstratedthat

doxycyclinescarcelyaffectsskeletonformation.Nonegativeeffectswereobservedinpoultryafterthe

administrationoftherapeuticdosesofdoxycycline.

Intheabsenceofspecificstudiestheuseoftheproductisnotrecommendedduringpregnancyorlactation.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Donotcombinewithantibioticsthatarebacteriocidale.g.penicillinsorcephalosporins.

Absorptionofdoxycyclinecanbedecreasedinthepresenceofhighquantitiesofcalcium,iron,

magnesiumoraluminiuminthediet.Donotadministeredtogetherwithantacids,kaolinandiron

preparations.

Itisadvisedthattheintervalbetweentheadministrationofotherproductscontainingpolyvalentcations

shouldbe1-2hoursbecausetheylimittheabsorptionoftetracyclines.

Doxycyclineincreasestheactionofanticoagulants.

ThesolubilityoftheproductispHdependentandwillprecipitateifmixedinalkalinesolution.

Donotstorethedrinkingwaterinmetalliccontainers.

4.9 Amountstobeadministeredandadministrationroute

Administrationorallywiththedrinkingwater.

Therecommendeddoseinpigsis:

12.5mgdoxycyclinehyclate(25mgproduct)perkgbodyweightperdayfor4consecutivedays.Ifno

improvementinclinicalsignsisseenwithinthistime,thediagnosisshouldbereviewedandtreatment

changed.Incaseofsevereinfectionsthemedicationperiodmaybeprolongedforamaximumof8

consecutivedaysasdeterminedbytheattendingveterinarysurgeon.

Therecommendeddoseinchickensis:

10mgdoxycyclinehyclate(20mgproduct)perkgbodyweightperdayfor3-4consecutivedaysincase

ofinfectionscausedbyP.multocidaand

20mgdoxycyclinehyclate(40mgproduct)perkgbodyweightperdayfor3-4consecutivedaysincase

ofinfectionscausedbyO.rhinotracheale.

Basedonthedosetobeused,andthenumberandweightoftheanimalstobetreated,theexactdaily

amountofproductcanbecalculated.Thefollowingformulacanbeusedtocalculatetheconcentrationof

theproductindrinkingwater:

mgproduct/kgbodyweight/day x Meanbodyweight(kg)of

animalstobetreated

=....mgproductperl

drinkingwater

Meandailywaterconsumption(l)peranimal

Toensureacorrectdosagebodyweightshouldbedeterminedasaccuratelyaspossible.Theuptakeof

medicateddrinkingwaterdependsontheclinicalconditionofthepigs/chickens.Inordertoobtainthe

correctdosagetheconcentrationofdoxycyclinehastobeadjustedaccordingly.Theuseofsuitably

calibratedweighingequipmentisrecommendedifpartpacksareused.Thedailyamountistobeaddedto

thedrinkingwatersuchthatallmedicationwillbeconsumedin24hours.Medicateddrinkingwater

shouldberefreshedorreplacedevery24hours.Itisrecommendedtoprepareaconcentratedpre-solution-

approximately100gramsproductperlitredrinkingwater-andtodilutethisfurthertotherapeutic

concentrationsifrequired.Alternatively,theconcentratedsolutioncanbeusedinaproportionalwater

medicator.SolubilityoftheproductispHdependentanditmayprecipitateifitismixedinhardalkaline

drinkingwater.Useatminimumconcentrationsof200mgpowderperlitredrinkingwaterinareaswith

hardalkalinedrinkingwater(hardnessabove10.2°dandpHmorethan8.1).Duringthetreatmentperiod

animalsshouldnothaveaccesstootherwatersourcesthanthemedicatedwater.

4.10Overdose(symptoms,emergencyprocedures,antidotes)

Overdosesupto1.6timesthelabelrecommendeddoseresultedinnoclinicalsignsthatcouldbeattributed

totreatment.Poultrytoleratedoubleoverdosesofdoxycycline(40mg/kgbodyweight)withoutany

clinicaleffect.

4.11Withdrawalperiods

Pigs:

-Meatandoffal:4 days

Chickens:

-Meatandoffal:3days,followingadoserateof10mg/kgbodyweightfor4days.

-Meatandoffal:12days,followingadoserateof20mg/kgbodyweightfor4days.

-Eggs:Notauthorisedforuseinlayingbirdsproducingeggsforhumanconsumption.

Donotusewithin4weeksofonsetofthelayingperiod

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antibacterial-Tetracycline.ATCvetcode:QJ01AA02

5.1 Pharmacodynamicproperties

Doxycyclinebelongstothegroupofthetetracyclineantibiotics.Theseantibioticshaveabroadspectrum

ofantimicrobialactivity,sharingthesamebasicstructureofpolycyclicnaphthacenecarboxamide.

Doxycyclineisprimarilyabacteriostaticdrug.Itexertsitsactionbyinhibitingtheproteinsynthesisofthe

bacterialcell.Inhibitionofbacterialproteinsynthesisresultsindisturbanceofallfunctionsnecessaryfor

thelifeofbacteria.Especiallycell-divisionandtheformationofthecellwallareimpaired.

Doxycyclineisabroad-spectrumantibiotic,activeagainstalargenumberofGram-positiveandGram-

negative,aerobeandanaerobemicro-organisms,Mycoplasmata,ChlamydiaeandRickettsia.

ForOrnithobacteriumrhinotrachealeresultsdemonstrateagreatvariationfromhightolowsusceptibility,

dependingonthegeographicalregionwhereisolatescamefrom.

Inpigpathogensresistanceagainstdoxycyclinemayalsovary;especiallysusceptibilityfiguresof

A.pleuropneumoniaemaydifferfromcountrytocountryandevenfarmtofarm.

Fourresistancemechanismsacquiredbymicroorganismsagainsttetracyclinesingeneralhavebeen

reported:Decreasedaccumulationoftetracyclines(decreasedpermeabilityofthebacterialcellwalland

activeefflux),proteinprotectionofthebacterialribosome,enzymaticinactivationoftheantibioticand

rRNAmutations(preventingthetetracyclinebindingtoribosome).Tetracyclineresistanceisusually

acquiredbymeansofplasmidsorothermobileelements(e.g.conjugativetransposones).Crossresistance

betweentetracyclineshasalsobeendescribed.Duetothegreaterliposolubilityandgreaterfacilitytopass

throughcellmembranes(incomparisontotetracycline),doxycyclineretainsacertaindegreeofefficacy

againstmicroorganismswithacquiredresistancetotetracyclines.

5.2 Pharmacokineticproperties

Doxycyclineisabsorbedinthestomachandthefirstpartoftheduodenum.Comparedtotheolder

tetracyclinestheabsorptionofdoxycyclineislessaffectedbythepresenceofbivalentcationsinfood.

Bioavailabilityinnon-fastedpigsisapproximately21%.

Followingoraladministrationatadoseof12.8mg/kgbodyweight,steadystateconcentrationsduring

medicationrangebetweenaC

of0.40µg/mlintheearlymorningtoaC

of0.87µg/mlinthelate

afternooninpigs.

Followingadministrationofdoxycyclinehyclateatanactualdoseof21mg/kgbodyweighttochickens

meanplasmaconcentrationsabove1µg/mlwerereachedwithin6hoursandlastedfor6hoursafter

cessationofmedication.From24hupto96hafterstartoftreatmentthedoxycyclineplasma

concentrationsexceeded2µg/ml.Followingadministrationofdoxycyclinehyclateatanactualdoseof10

mg/kgbodyweightsteadystateplasmaconcentrationsrangedfrom0.75to0.93µg/gbetween12and96

hoursafterstartofmedication.

Becausedoxycyclineishighlylipidsoluble,ithasagoodtissuepenetration.Respiratorytracttissue:

plasmaratiosof1.3(healthylungs),1.9(pneumoniclungs)and2.3(nasalmucosa)havebeenreportedfor

doxycycline.Plasmaproteinbindingishigh(over90%).

Doxycyclineisscarcelymetabolised.Doxycyclineisprimarilyexcretedwiththefaeces.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Tartaricacid

6.2 Incompatibilities

SolubilityofdoxycyclineispHdependent.Precipitationwilloccurinanalkalinesolution.Intheabsence

ofcompatibilitystudies,thisproductmustnotbemixedwithotherveterinarymedicinalproducts.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:3years

Shelf-lifeafterfirstopeningtheimmediatepackaging:9months

Shelf-lifeafterdilutionorreconstitutionaccordingtodirections:Afterreconstitutionwithwater,any

productremainingafter24hoursshouldbediscarded.

6.4 Storageprecautions

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

Keepthebagtightlyclosedafterfirstopeninginordertoprotectfrommoisture.

6.5 Natureandcompositionofimmediatepackaging

Sachetsof100g,250g,500gand1kgand10x100ginacartonbox.

Formedfromapolyester/polyethylene/aluminium/polyethyleneorapolyester/

polyethylene/aluminium/ionomerlaminate.

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

EurovetAnimalHealthB.V.

Handelsweg25

5531AEBladel

TheNetherlands

8. MARKETINGAUTHORISATIONNUMBER

Tobecompletednationally.(NL/V/0141/001/DC)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Tobecompletednationally

10. DATEOFREVISIONOFTHETEXT

Tobecompletednationally

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Tobecompletednationally

LABELTEXT

SINGLESACHETS/BAGS

1x100g/250g/500g/1kg

Thefulltextwillbeprintedonthesinglesachet/bag

Formatusedisespeciallyforthistypeoflabelling

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

=

IMMEDIATEPACKAGE

=

LEAFLET

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Soludox500mg/gpowderforuseindrinkingwaterforpigsandchickens

Doxycyclinehyclate

Franceonly:Soludox433mg/gpowderforuseindrinkingwaterforpigsandchickens

Doxycycline

2. STATEMENTOFTHEACTIVESUBSTANCEANDOTHERINGREDIENT

Compositionpergramproduct

ActiveSubstance:

Doxycyclinehyclate

France:Doxycycline

Excipients

Tartaricacid

500mgcorrespondingto433mgdoxycycline

433mgcorrespondingto500mgdoxycyclinehyclate

500mg

3. PHARMACEUTICALFORM

Yellowpowderforuseindrinkingwater.

4. PACKAGESIZE

100g(250g,500g,1kg)

5. TARGETSPECIES

Pigsandchickens(broiler,pullet,breeder).

6. INDICATION(S)

Pigs:Forthetreatmentoftheclinicalsignsassociatedwithporcinerespiratorydiseasecausedby

Actinobacilluspleuropneumoniae,Pasteurellamultocida,andMycoplasmahyopneumoniaesusceptibleto

doxycycline.

Chickens:Whereclinicaldiseaseispresentintheflock,toreducemortality,morbidity,andclinicalsigns

andtoreducelesionsduetoPasteurellosiscausedbyPasteurellamultocidaortoreducemorbidityand

lesionsinrespiratoryinfectionscausedbyOrnithobacteriumrhinotracheale(ORT).

7. CONTRAINDICATIONS

Donotuseincaseofhypersensitivitytotheactivesubstanceortoanyofexcipients.

Donotuseinanimalswithanimpairedliverfunction.

8. ADVERSEREACTIONS

Tetracyclinesmay-inveryrarecases-inducephotosensitivityandallergicreactions.Ifsuspectedadverse

reactionsoccur,treatmentshouldbediscontinued.Ifyounoticeanyseriouseffectsorothereffectsnot

mentionedinthisproductinformation,pleaseinformyourveterinarysurgeonorpharmacist.

9. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOFADMINISTRATION

Administrationorallywiththedrinkingwater.

Therecommendeddoseinpigsis:

12.5mgdoxycyclinehyclate(25mgproduct)perkgbodyweightperdayfor4consecutivedays.Ifno

improvementinclinicalsignsisseenwithinthistime,thediagnosisshouldbereviewedandtreatment

changed.Incaseofsevereinfectionsthemedicationperiodmaybeprolongedforamaximumof8

consecutivedaysasdeterminedbytheattendingveterinarysurgeon.

Therecommendeddoseinchickensis:

10mgdoxycyclinehyclate(20mgproduct)perkgbodyweightperdayfor3-4consecutivedaysincase

ofinfectionscausedbyP.multocidaand

20mgdoxycyclinehyclate(40mgproduct)perkgbodyweightperdayfor3-4consecutivedaysincase

ofinfectionscausedbyO.rhinotracheale

Basedonthedosetobeused,andthenumberandweightoftheanimalstobetreated,theexactdaily

amountofproductcanbecalculated.Thefollowingformulacanbeusedtocalculatetheconcentrationof

theproductindrinkingwater:

mgproduct/kgbodyweight/day x Meanbodyweight(kg)of

animalstobetreated

=....mgproductperl

drinkingwater

Meandailywaterconsumption(l)peranimal

Toensureacorrectdosagebodyweightshouldbedeterminedasaccuratelyaspossible.Theuptakeof

medicateddrinkingwaterdependsontheclinicalconditionofthepigs/chickens.Inordertoobtainthe

correctdosagetheconcentrationofdoxycyclinehastobeadjustedaccordingly.Theuseofsuitably

calibratedweighingequipmentisrecommendedifpartpacksareused.Thedailyamountistobeaddedto

thedrinkingwatersuchthatallmedicationwillbeconsumedin24hours.Medicateddrinkingwater

shouldberefreshedorreplacedevery24hours.Itisrecommendedtoprepareaconcentratedpre-solution-

approximately100gramsproductperlitredrinkingwater-andtodilutethisfurthertotherapeutic

concentrationsifrequired.Alternatively,theconcentratedsolutioncanbeusedinaproportionalwater

medicator.SolubilityoftheproductispHdependentanditmayprecipitateifitismixedinhardalkaline

drinkingwater.Useatminimumconcentrationsof200mgpowderperlitredrinkingwaterinareaswith

hardalkalinedrinkingwater(hardnessabove10.2°dandpHmorethan8.1).Duringthetreatmentperiod

animalsshouldnothaveaccesstootherwatersourcesthanthemedicatedwater.

10. WITHDRAWALPERIODS

Pigs:

-Meatandoffal:4days

Chickens:

-Meatandoffal:3days,followingadoserateof10mg/kgbodyweightfor4days.

-Meatandoffal:12days,followingadoserateof20mg/kgbodyweightfor4days.

-Eggs:Notauthorisedforuseinlayingbirdsproducingeggsforhumanconsumption.

Donotusewithin4weeksofonsetofthelayingperiod.

11. SPECIALWARNINGS

Specialprecautionsforuseinanimals

Duetolikelyvariability(time,geographical)insusceptibilityofbacteriafordoxycycline,especially

susceptibilityofA.pleuropneumoniaeandO.rhinotrachealemaydifferfromcountrytocountryandeven

farmtofarm,bacteriologicalsamplingandsusceptibilitytestingarerecommended.Useoftheproduct

shouldbebasedoncultureandsensitivityofmicro-organismsfromdiseasedcasesonfarm.Ifthisisnot

possible,therapyshouldbebasedonlocal(regional,farmlevel)epidemiologicalinformationabout

susceptibilityofthetargetbacteria.

Aseradicationofthetargetpathogensmaynotbeachieved,medicationshouldthereforebecombined

withgoodmanagementpractices,e.g.goodhygiene,properventilation,nooverstocking.

Userwarnings

Ifyouknowyouareallergictothetetracyclineclassofantibiotics,specialcareshouldbetakenwhen

handlingthisproductorthemedicatedsolution.

Duringpreparationandadministrationofthemedicateddrinkingwater,skincontactwiththeproductand

inhalationofdustparticlesshouldbeavoided.Wearimpermeablegloves(e.g.rubberorlatex)andan

appropriatedustmask(e.g.disposablehalf-maskrespiratorconformingtoEuropeanStandardEN149)

whenapplyingtheproduct.

Intheeventofeyeorskincontact,rinsetheaffectedareawithlargeamountsofcleanwaterandif

irritationoccurs,seekmedicalattention.Washhandsandcontaminatedskinimmediatelyafterhandling

theproduct.

Ifyoudevelopsymptomsfollowingexposuresuchasskinrash,youshouldseekmedicaladviceandshow

thiswarningtothephysician.Swellingoftheface,lipsoreyes,ordifficultywithbreathingaremore

serioussymptomsandrequireurgentmedicalattention.

Donotsmoke,eatordrinkwhilehandlingtheproduct.

Takemeasurestoavoidproducingdustwhenincorporatingtheproductintowater.Avoiddirectcontact

withskinandeyeswhenhandlingtheproducttopreventsensitisationandcontactdermatitis.

Useduringpregnancyorlactation

Doxycyclinehasalowaffinityforformingcomplexeswithcalciumandstudieshavedemonstratedthat

doxycyclinescarcelyaffectsskeletonformation.Nonegativeeffectswereobservedinpoultryafterthe

administrationoftherapeuticdosesofdoxycycline.

Intheabsenceofspecificstudiestheuseoftheproductisnotrecommendedduringpregnancyorlactation.

Interactionswithothermedicinalproductsandotherformsofinteraction

Donotcombinewithantibioticsthatarebactericidallikepenicillinsorcephalosporins.

Absorptionofdoxycyclinecanbedecreasedinthepresenceofhighquantitiesofcalcium,iron,

magnesiumoraluminiuminthediet.Donotadministeredtogetherwithantacids,kaolinandiron

preparations.

Itisadvisedthattheintervalbetweentheadministrationofotherproductscontainingpolyvalentcations

shouldbe1-2hoursbecausetheylimittheabsorptionoftetracyclines.

Doxycyclineincreasestheactionofanticoagulants.

ThesolubilityoftheproductispHdependentandwillprecipitateifmixedinalkalinesolution.

Donotstorethedrinkingwaterinmetalliccontainers.

Intheabsenceofcompatibilitystudies,thisproductmustnotbemixedwithotherveterinarymedicinal

products.

12. EXPIRYDATE

EXP{month/year};DonotuseaftertheexpirydatestatedonthelabelafterEXP.

13. SPECIALSTORAGEPRECAUTIONS

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

Keepthebagtightlyclosedafterfirstopeninginordertoprotectfrommoisture.

Shelf-lifeafterfirstopeningthepackaging:9months.

Shelf-lifeafterdilutionorreconstitutionaccordingtodirections:Afterreconstitutionwithwaterany

productremainingafter24hoursshouldbediscarded.

14. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTORWASTE

MATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialderivedfromsuchveterinarymedicinal

productshouldbedisposedofinaccordancewithlocalrequirements.

15. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly.

Prescriptiononlymedicine-Tobecompletednationally.

16. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

17. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERANDOF

THEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFORBATCH

RELEASE,IFDIFFERENT

EurovetAnimalHealthB.V.

Handelsweg25,5531AEBladel,TheNetherlands

18. MARKETINGAUTHORISATIONNUMBER(S)

Tobecompletednationally

19. MANUFACTURER’SBATCHNUMBER

Lot{number}

20. DATEONWHICHTHETEXTWASLASTAPPROVED

Tobecompletednationally

21. OTHERINFORMATION

Packsizes:100g,10x100g,250g,500gand1kg

Notallpacksizesmaybemarketed.

LABELLING10x100g

Cartonboxforthe10x100gramsAlufoilsachets

withlabelfor100gramsachets

andleaflet

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

CARTON10X100GRAMonly

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Soludox500mg/gpowderforuseindrinkingwaterforpigsandchickens

Doxycyclinehyclate

Franceonly:Soludox433mg/gpowderforuseindrinkingwaterforpigsandchickens

Doxycycline

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Compositionpergramproduct:

ActiveSubstance:

Doxycyclinehyclate

France:Doxycycline

Excipients

Tartaricacid

500mgcorrespondingto433mgdoxycycline

433mgcorrespondingto500mgdoxycyclinehyclate

500mg

3. PHARMACEUTICALFORM

Yellowpowderforuseindrinkingwater.

4. PACKAGESIZE

10x100gram

5. TARGETSPECIES

Pigsandchickens(broiler,pullet,breeder).

6. INDICATION(S)

Pigs:Forthetreatmentoftheclinicalsignsassociatedwithporcinerespiratorydiseasecausedby

Actinobacilluspleuropneumoniae,Pasteurellamultocida,andMycoplasmahyopneumoniaesusceptibleto

doxycycline.

Chickens:Whereclinicaldiseaseispresentintheflock,toreducemortality,morbidity,andclinicalsigns

andtoreducelesionsduetoPasteurellosiscausedbyPasteurellamultocidaortoreducemorbidityand

lesionsinrespiratoryinfectionscausedbyOrnithobacteriumrhinotracheale(ORT).

7. METHODANDROUTE(S)OFADMINISTRATION

Tobeadministeredorallyinthedrinkingwater.

8. WITHDRAWALPERIOD

Pigs:

-Meatandoffal:4days

Chickens:

-Meatandoffal:3days,followingadoserateof10mg/kgbodyweightfor4days.

-Meatandoffal:12days,followingadoserateof20mg/kgbodyweightfor4days.

-Eggs:Notauthorisedforuseinlayingbirdsproducingeggsforhumanconsumption.

Donotusewithin4weeksofonsetofthelayingperiod.

9. SPECIALWARNING(S),IFNECESSARY

Specialprecautionsforuseinanimals

Readthepackageleafletbeforeuse.

UserWarnings

Readthepackageleafletbeforeuse.

10. EXPIRYDATE

EXP{month/year};DonotuseaftertheexpirydatestatedonthelabelafterEXP.

11. SPECIALSTORAGECONDITIONS

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSORWASTE

MATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialderivedfromsuchveterinarymedicinal

productshouldbedisposedofinaccordancewithlocalrequirements.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly.

Prescriptiononlymedicine(orsimilarwording,nationalissue)

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

EurovetAnimalHealthB.V.

Handelsweg25,5531AEBladel,TheNetherlands

16. MARKETINGAUTHORISATIONNUMBER(S)

Tobecompletednationally

17. MANUFACTURER’SBATCHNUMBER

Lot{number}

PARTICULARSTOAPPEARONTHEIMMEDIATEPACKAGE

AluminiumFoilSachet100g(packedper10)

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Soludox500mg/gpowderforuseindrinkingwaterforpigsandchickens

Doxycyclinehyclate

Franceonly:Soludox433mg/gpowderforuseindrinkingwaterforpigsandchickens

Doxycycline

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Compositionpergramproduct:

ActiveSubstance:

Doxycyclinehyclate

France:Doxycycline

Excipients

Tartaricacid

500mgcorrespondingto433mgdoxycycline

433mgcorrespondingto500mgdoxycyclinehyclate

500mg

3. PHARMACEUTICALFORM

Yellowcrystallinepowderforuseindrinkingwater.

4. PACKAGESIZE

100gram

5. TARGETSPECIES

Pigsandchickens(broiler,pullet,breeder).

6. INDICATION(S)

Pigs:Forthetreatmentoftheclinicalsignsassociatedwithporcinerespiratorydiseasecausedby

Actinobacilluspleuropneumoniae,Pasteurellamultocida,andMycoplasmahyopneumoniaesusceptibleto

doxycycline.

Chickens:Whereclinicaldiseaseispresentintheflock,toreducemortality,morbidity,andclinicalsigns

andtoreducelesionsduetoPasteurellosiscausedbyPasteurellamultocidaortoreducemorbidityand

lesionsinrespiratoryinfectionscausedbyOrnithobacteriumrhinotracheale(ORT).

7. METHODANDROUTE(S)OFADMINISTRATION

Tobeadministeredorallyinthedrinkingwater.

8. WITHDRAWALPERIOD

Pigs:

-Meatandoffal:4days

Chickens:

-Meatandoffal:3days,followingadoserateof10mg/kgbodyweightfor4days.

-Meatandoffal:12days,followingadoserateof20mg/kgbodyweightfor4days.

-Eggs:Notauthorisedforuseinlayingbirdsproducingeggsforhumanconsumption.

Donotusewithin4weeksofonsetofthelayingperiod.

9. SPECIALWARNING(S),IFNECESSARY

Specialprecautionsforuseinanimals

Readthepackageleafletbeforeuse.

UserWarnings

Readthepackageleafletbeforeuse.

10. EXPIRYDATE

EXP{month/year};DonotuseaftertheexpirydatestatedonthelabelafterEXP.

11. SPECIALSTORAGECONDITIONS

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSORWASTE

MATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialderivedfromsuchveterinarymedicinal

productshouldbedisposedofinaccordancewithlocalrequirements.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly.

Prescriptiononlymedicine(orsimilarwording,nationalissue)

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

EurovetAnimalHealthB.V.

Handelsweg25,5531AEBladel,TheNetherlands

16. MARKETINGAUTHORISATIONNUMBER(S)

Tobecompletednationally

17. MANUFACTURER’SBATCHNUMBER

Lot{number}

PACKAGELEAFLET

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERANDOF

THEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFORBATCH

RELEASE,IFDIFFERENT

EurovetAnimalHealthB.V.

Handelsweg25,5531AEBladel,TheNetherlands

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Soludox500mg/gpowderforuseindrinkingwaterforpigsandchickens

Doxycyclinehyclate.

Franceonly:Soludox433mg/gpowderforuseindrinkingwaterforpigsandchickens

Doxycycline.

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

Compositionpergramproduct:

ActiveSubstance:

Doxycyclinehyclate

France:Doxycycline

Excipients

Tartaricacid

500mgcorrespondingto433mgdoxycycline

433mgcorrespondingto500mgdoxycyclinehyclate

500mg

4. INDICATION(S)

Pigs:Forthetreatmentoftheclinicalsignsassociatedwithporcinerespiratorydiseasecausedby

Actinobacilluspleuropneumoniae,Pasteurellamultocida,andMycoplasmahyopneumoniaesusceptibleto

doxycycline.

Chickens:Whereclinicaldiseaseispresentintheflock,toreducemortality,morbidity,andclinicalsigns

andtoreducelesionsduetoPasteurellosiscausedbyPasteurellamultocidaortoreducemorbidityand

lesionsinrespiratoryinfectionscausedbyOrnithobacteriumrhinotracheale(ORT).

5. CONTRAINDICATIONS

Donotuseincaseofhypersensitivitytotheactivesubstanceortoanyofexcipients.

Donotuseinanimalswithanimpairedliverfunction.

6. ADVERSEREACTIONS

Tetracyclinesmay-inveryrarecases-inducephotosensitivityandallergicreactions.Ifsuspectedadverse

reactionsoccur,treatmentshouldbediscontinued.Ifyounoticeanyseriouseffectsorothereffectsnot

mentionedinthisproductinformation,pleaseinformyourveterinarysurgeonorpharmacist.

7. TARGETSPECIES

Pigsandchickens(broiler,pullet,breeder).

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOFADMINISTRATION

Administrationorallywiththedrinkingwater.

Therecommendeddoseinpigsis:

12.5mgdoxycyclinehyclate(25mgproduct)perkgbodyweightperdayfor4consecutivedays.Ifno

improvementinclinicalsignsisseenwithinthistime,thediagnosisshouldbereviewedandtreatment

changed.Incaseofsevereinfectionsthemedicationperiodmaybeprolongedforamaximumof8

consecutivedaysasdeterminedbytheattendingveterinarysurgeon.

Therecommendeddoseinchickensis:

10mgdoxycyclinehyclate(20mgproduct)perkgbodyweightperdayfor3-4consecutivedaysincase

ofinfectionscausedbyP.multocidaand

20mgdoxycyclinehyclate(40mgproduct)perkgbodyweightperdayfor3-4consecutivedaysincase

ofinfectionscausedbyO.rhinotracheale

9. ADVICEONCORRECTADMINISTRATION

Basedonthedosetobeused,andthenumberandweightoftheanimalstobetreated,theexactdaily

amountofproductcanbecalculated.Thefollowingformulacanbeusedtocalculatetheconcentrationof

theproductindrinkingwater:

mgproduct/kgbodyweight/day x Meanbodyweight(kg)of

animalstobetreated

=....mgproductperl

drinkingwater

Meandailywaterconsumption(l)peranimal

Toensureacorrectdosagebodyweightshouldbedeterminedasaccuratelyaspossible.Theuptakeof

medicateddrinkingwaterdependsontheclinicalconditionofthepigs/chickens.Inordertoobtainthe

correctdosagetheconcentrationofdoxycyclinehastobeadjustedaccordingly.Theuseofsuitably

calibratedweighingequipmentisrecommendedifpartpacksareused.Thedailyamountistobeaddedto

thedrinkingwatersuchthatallmedicationwillbeconsumedin24hours.Medicateddrinkingwater

shouldberefreshedorreplacedevery24hours.Itisrecommendedtoprepareaconcentratedpre-solution-

approximately100gramsproductperlitredrinkingwater-andtodilutethisfurthertotherapeutic

concentrationsifrequired.Alternatively,theconcentratedsolutioncanbeusedinaproportionalwater

medicator.SolubilityoftheproductispHdependentanditmayprecipitateifitismixedinhardalkaline

drinkingwater.Useatminimumconcentrationsof200mgpowderperlitredrinkingwaterinareaswith

hardalkalinedrinkingwater(hardnessabove10.2°dandpHmorethan8.1).Duringthetreatmentperiod

animalsshouldnothaveaccesstootherwatersourcesthanthemedicatedwater.

10. WITHDRAWALPERIOD

Pigs:

-Meatandoffal:4days

Chickens:

-Meatandoffal:3days,followingadoserateof10mg/kgbodyweightfor4days.

-Meatandoffal:12days,followingadoserateof20mg/kgbodyweightfor4days.

-Eggs:Notauthorisedforuseinlayingbirdsproducingeggsforhumanconsumption.

Donotusewithin4weeksofonsetofthelayingperiod.

11. SPECIALSTORAGEPRECAUTIONS

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

Keepthebagtightlyclosedafterfirstopeninginordertoprotectfrommoisture.

Shelf-lifeafterfirstopeningthepackaging:9months.

Shelf-lifeafterdilutionorreconstitutionaccordingtodirections:Afterreconstitutionwithwaterany

productremainingafter24hoursshouldbediscarded.

12. SPECIALWARNING(S)

Specialprecautionsforuse

Specialprecautionsforuseinanimals

Duetolikelyvariability(time,geographical)insusceptibilityofbacteriafordoxycycline,especially

susceptibilityofA.pleuropneumoniaeandO.rhinotrachealemaydifferfromcountrytocountryandeven

farmtofarm,bacteriologicalsamplingandsusceptibilitytestingarerecommended.Useoftheproduct

shouldbebasedoncultureandsensitivityofmicro-organismsfromdiseasedcasesonfarm.Ifthisisnot

possible,therapyshouldbebasedonlocal(regional,farmlevel)epidemiologicalinformationabout

susceptibilityofthetargetbacteria.

Aseradicationofthetargetpathogensmaynotbeachieved,medicationshouldthereforebecombined

withgoodmanagementpractices,e.g.goodhygiene,properventilation,nooverstocking.

Userwarnings:

Ifyouknowyouareallergictothetetracyclineclassofantibiotics,specialcareshouldbetakenwhen

handlingthisproductorthemedicatedsolution.

Duringpreparationandadministrationofthemedicateddrinkingwater,skincontactwiththeproductand

inhalationofdustparticlesshouldbeavoided.Wearimpermeablegloves(e.g.rubberorlatex)andan

appropriatedustmask(e.g.disposablehalf-maskrespiratorconformingtoEuropeanStandardEN149)

whenapplyingtheproduct.

Intheeventofeyeorskincontact,rinsetheaffectedareawithlargeamountsofcleanwaterandif

irritationoccurs,seekmedicalattention.Washhandsandcontaminatedskinimmediatelyafterhandling

theproduct.

Ifyoudevelopsymptomsfollowingexposuresuchasskinrash,youshouldseekmedicaladviceandshow

thiswarningtothephysician.Swellingoftheface,lipsoreyes,ordifficultywithbreathingaremore

serioussymptomsandrequireurgentmedicalattention.

Donotsmoke,eatordrinkwhilehandlingtheproduct.

Takemeasurestoavoidproducingdustwhenincorporatingtheproductintowater.Avoiddirectcontact

withskinandeyeswhenhandlingtheproducttopreventsensitisationandcontactdermatitis.

Useduringpregnancyorlactation

Doxycyclinehasalowaffinityforformingcomplexeswithcalciumandstudieshavedemonstratedthat

doxycyclinescarcelyaffectsskeletonformation.Nonegativeeffectswereobservedinpoultryafterthe

administrationoftherapeuticdosesofdoxycycline.

Intheabsenceofspecificstudiestheuseoftheproductisnotrecommendedduringpregnancyorlactation.

Interactionswithothermedicinalproductsandotherformsofinteraction

Donotcombinewithantibioticsthatarebactericidallikepenicillinsorcephalosporins.

Absorptionofdoxycyclinecanbedecreasedinthepresenceofhighquantitiesofcalcium,iron,

magnesiumoraluminiuminthediet.Donotadministeredtogetherwithantacids,kaolinandiron

preparations.

Itisadvisedthattheintervalbetweentheadministrationofotherproductscontainingpolyvalentcations

shouldbe1-2hoursbecausetheylimittheabsorptionoftetracyclines.

Doxycyclineincreasestheactionofanticoagulants.

ThesolubilityoftheproductispHdependentandwillprecipitateifmixedinalkalinesolution.

Donotstorethedrinkingwaterinmetalliccontainers.

Intheabsenceofcompatibilitystudies,thisproductmustnotbemixedwithotherveterinarymedicinal

products.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTORWASTE

MATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialderivedfromsuchveterinarymedicinal

productshouldbedisposedofinaccordancewithlocalrequirements.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

Tobecompletednationally

15. OTHERINFORMATION

Packsizes:100g,10x100g,250g,500gand1kg

Notallpacksizesmaybemarketed.

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