Doxivet 500 mg/g, powder for use in drinking water for broiler breeders

Main information

  • Trade name:
  • Doxivet 500 mg/g, powder for use in drinking water for broiler breeders
  • Pharmaceutical form:
  • Powder for oral solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Doxivet 500 mg/g, powder for use in drinking water for broiler breeders
    Romania
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • doxycycline
  • Therapeutic area:
  • Chicken

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • NL/V/0152/002
  • Authorization date:
  • 17-02-2012
  • EU code:
  • NL/V/0152/002
  • Last update:
  • 09-08-2016

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

PRODUCTLITERATURE

<PARTICULARSTOAPPEARONTHEOUTERPACKAGE>

CARTONBOX:10X100g–50X100g–250X100g

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

DOXIVET500mg/g,PowderforuseinDrinkingWaterforbroilerbreeders.

Doxycyclinehyclate

IT/CZ:DOXYCYCLINEDIVASA-FARMAVIC500mg/g,oralpowderforuseindrinkingwaterfor

broilerbreeders.

Doxycyclinehyclate

DK/SW:Doxivetvet,oralpowderforuseindrinkingwater.

Doxycyclinehyclate

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

1gofpowdercontains500mgofdoxycyclinehyclate(equivalentto433mgdoxycyclinebase).

3. PHARMACEUTICALFORM

Yellowtopaleyellowpowderforuseindrinkingwater.

4. PACKAGESIZE

10x100g

50x100g

250x100g

5. TARGETSPECIES

Broilerbreeders.

6. INDICATIONS

Whereclinicaldiseaseispresentintheflock,toreducemortality,morbidity,andclinicalsignsandto

reducelesionsduetoPasteurellosiscausedbyPasteurellamultocidaortoreducemorbidityand

lesionsinrespiratoryinfectionscausedbyOrnithobacteriumrhinotracheale(ORT).

7. METHODANDROUTEOFADMINISTRATION

Administrationroute:Indrinkingwateruse.

Pasteurellosis:10mgdoxycyclinehyclateperkgbw/dayfor3-4days.

ORT:20mgdoxycyclinehyclateperkgbw/dayfor3-4days.

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Meatandoffal:3daysincasesof10mg/kgbwforamaximumof4days.

Meatandoffal:12daysincasesof20mg/kgbwforamaximumof4days.

Eggs:Notauthorisedforuseinlayingbirdsproducingeggsforhumanconsumption.

9. SPECIALWARNINGS,IFNECESSARY

-------

10. EXPIRYDATE

EXP{month/year}

Shelf-lifeafterfirstopeningtheimmediatepackaging:12months.

Shelf-lifeafterdilutionindrinkingwater:24hours.

11. SPECIALSTORAGECONDITIONS

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productshouldbedisposedofinaccordancewithlocalrequirements.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly.Tobesuppliedonlyonveterinaryprescription.

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

DIVASA-FARMAVICS.A.

Ctra.SantHipòlit,km71

08503Gurb-Vic

Barcelona(Spain)

16. MARKETINGAUTHORISATIONNUMBER(S)

-------

17. MANUFACTURER’SBATCHNUMBER

Batch{number}

PARTICULARSTOAPPEARONTHEINMEDIATEPACKAGE

LABEL/LEAFLET:BAGof1kgAND2.5kg

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERAND

OFTHEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFOR

BATCHRELEASE,IFDIFFERENT

Marketingauthorisationholderandmanufacturerforthebatchrelease:

DIVASA-FARMAVICS.A.

Ctra.SantHipòlit,km71

08503Gurb-Vic

Barcelona(Spain)

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

DOXIVET500mg/g,PowderforuseinDrinkingWaterforbroilerbreeders.

Doxycyclinehyclate

IT/CZ:DOXYCYCLINEDIVASA-FARMAVIC500mg/g,oralpowderforuseindrinkingwaterfor

broilerbreeders.

Doxycyclinehyclate

DK/SW:Doxivetvet,oralpowderforuseindrinkingwater.

Doxycyclinehyclate

3. STATEMENTOFTHEACTIVESUBSTANCEANDOTHERINGREDIENTS

1gofpowdercontains500mgofdoxycyclinehyclate(equivalentto433mgdoxycyclinebase)

Yellowtopaleyellowpowderforuseindrinkingwater

4. INDICATIONS

Whereclinicaldiseaseispresentintheflock,toreducemortality,morbidity,andclinicalsignsandto

reducelesionsduetoPasteurellosiscausedbyPasteurellamultocidaortoreducemorbidityand

lesionsinrespiratoryinfectionscausedbyOrnithobacteriumrhinotracheale(ORT).

5. CONTRAINDICATIONS

Donotuseincaseofhypersensitivitytotheactivesubstanceortoanyofexcipients.

Donotuseinanimalswithanimpairedliverfunction.

6. ADVERSEREACTIONS

Tetracyclinesmay-inveryrarecases-inducephotosensitivityandallergicreactions.Ifsuspected

adversereactionsoccur,treatmentshouldbediscontinued.Ifyounoticeanyseriouseffectsorother

effectsnotmentionedinthisleaflet,pleaseinformyourveterinarysurgeon.

7. TARGETSPECIES

Broilerbreeders.

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOF

ADMINISTRATION

Administrationorallywiththedrinkingwater.

Therecommended dose is:10mgdoxycyclinehyclate(20mgproduct)perkgbodyweightperdayfor

3-4consecutivedaysincaseofinfectionscausedbyP.multocidaand20mgdoxycyclinehyclate(40

mgproduct)perkgbodyweightperdayfor3-4consecutivedaysincaseofinfectionscausedbyO.

rhinotracheale.

Basedonthedosetobeused,andthenumberandweightoftheanimalstobetreated,theexactdaily

amountofproductcanbecalculated.Thefollowingformulacanbeusedtocalculatetheconcentration

oftheproductindrinkingwater:

.....mgproduct/kgbody

weight/day x meanbodyweight(kg)ofanimals

tobetreated =....mgproductperl

drinkingwater

meandailywaterconsumption(l)peranimal

Toensureacorrectdosagebodyweightshouldbedeterminedasaccuratelyaspossible.Theuptakeof

medicateddrinkingwaterdependsontheclinicalconditionoftheanimals.Inordertoobtainthecorrect

dosagetheconcentrationofdoxycyclinehastobeadjustedaccordingly.Theuseofsuitablycalibrated

weighingequipmentisrecommendedifpartpacksareused.Thedailyamountistobeaddedtothe

drinkingwatersuchthatallmedicationwillbeconsumedin24hours.Medicateddrinkingwatershould

berefreshedorreplacedevery24hours.Itisrecommendedtoprepareaconcentratedpre-solution-

approximately100gramsproductperlitredrinkingwater-andtodilutethisfurthertotherapeutic

concentrationsifrequired.Alternatively,theconcentratedsolutioncanbeusedinaproportionalwater

medicator.SolubilityoftheproductispHdependentanditmayprecipitateifitismixedinhardalkaline

drinkingwater.Useatminimumconcentrationsof200mgpowderperlitredrinkingwaterinareaswith

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

periodanimalsshouldnothaveaccesstootherwatersourcesthanthemedicatedwater.

9. ADVICEONCORRECTADMINISTRATION

10. WITHDRAWALPERIODS

Meatandoffal:3daysincasesof10mg/kgbwforamaximumof4days.

Meatandoffal:12daysincasesof20mg/kgbwforamaximumof4days.

Eggs:Notauthorisedforuseinlayingbirdsproducingeggsforhumanconsumption.

11. SPECIALSTORAGEPRECAUTIONS

Keepoutofthereachandsightofchildren.

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

Donotuseaftertheexpirydatestatedonthelabel.

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years.

Shelf-lifeafterfirstopeningtheimmediatepackaging:12months.

Shelf-lifeafterdilutionorreconstitutionaccordingtodirections:24hoursafterdilutionindrinkingwater.

12. SPECIALWARNINGS

Specialprecautionsforuseinanimals

Duetolikelyvariability(time,geographical)insusceptibilityofbacteriafordoxycycline,especially

susceptibilityofO.rhinotrachealemaydifferfromcountrytocountryandevenfarmtofarm,

bacteriologicalsamplingandsusceptibilitytestingarerecommended.Useoftheproductshouldbe

basedoncultureandsensitivityofmicro-organismsfromdiseasedcasesonfarm.Ifthisisnotpossible,

therapyshouldbebasedonlocal(regional,farmlevel)epidemiologicalinformationaboutsusceptibility

ofthetargetbacteria.

Aseradicationofthetargetpathogensmaynotbeachieved,medicationshouldthereforebecombined

withgoodmanagementpractices,e.g.goodhygiene,properventilation,nooverstocking

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Ifyouknowyouareallergictothetetracyclineclassofantibiotics,specialcareshouldbetakenwhen

handlingthisproductorthemedicatedsolution.

Duringpreparationandadministrationofthemedicateddrinkingwater,skincontactwiththeproduct

andinhalationofdustparticlesshouldbeavoided.Wearimpermeablegloves(e.g.rubberorlatex)and

anappropriatedustmask(e.g.disposablehalf-maskrespiratorconformingtoEuropeanStandard

EN149)whenapplyingtheproduct.

Intheeventofeyeorskincontact,rinsetheaffectedareawithlargeamountsofcleanwaterandif

irritationoccurs,seekmedicalattention.Washhandsandcontaminatedskinimmediatelyafterhandling

theproduct.

Ifyoudevelopsymptomsfollowingexposuresuchasskinrash,youshouldseekmedicaladviceand

showthiswarningtothephysician.Swellingoftheface,lipsoreyes,ordifficultywithbreathingare

moreserioussymptomsandrequireurgentmedicalattention.

Donotsmoke,eatordrinkwhilehandlingtheproduct.

Takemeasurestoavoidproducingdustwhenincorporatingtheproductintowater.Avoiddirectcontact

withskinandeyeswhenhandlingtheproducttopreventsensitisationandcontactdermatitis.

Useduringpregnancy,lactationorlay

Doxycyclinehasalowaffinityforformingcomplexeswithcalciumandstudieshavedemonstratedthat

doxycyclinescarcelyaffectsskeletonformation.Nonegativeeffectswereobservedinpoultryafter

theadministrationoftherapeuticdosesofdoxycycline.

Interactionwithothermedicinalproductsandotherformsofinteractions

Donotcombinewithantibioticsthatarebacteriocidale.g.penicillinsorcephalosporins.

Absorptionofdoxycyclinecanbedecreasedinthepresenceofhighquantitiesofcalcium,iron,

magnesiumoraluminiuminthediet.Donotadministeredtogetherwithantacids,kaolinandiron

preparations.

Itisadvisedthattheintervalbetweentheadministrationofotherproductscontainingpolyvalentcations

shouldbe1-2hoursbecausetheylimittheabsorptionoftetracyclines.

Doxycyclineincreasestheactionofanticoagulants.

ThesolubilityoftheproductispHdependentandwillprecipitateifmixedinalkalinesolution.

Donotstorethedrinkingwaterinmetalliccontainers.

Overdose

Poultrytoleratedoubleoverdosesofdoxycycline(40mg/kgbodyweight)withoutanyclinicaleffect.

Incompatibilities

SolubilityofdoxycyclineispHdependent.Precipitationwilloccurinanalkalinesolution.Intheabsence

ofcompatibilitystudies,thisproductmustnotbemixedwithotherveterinarymedicinalproducts.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productshouldbedisposedofinaccordancewithlocalrequirements.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

17February2012

15. OTHERINFORMATION

Pharmaceuticalform

Yellowtopaleyellowpowderforuseindrinkingwater

Packsize

Box10x100g–50x100gand250x100g

Bag1000and2500g.

Notallpacksizesmaybemarketed.

Foranimaltreatmentonly–tobesuppliedonlyonveterinaryprescription.

Authorisationnumber:

EXP{month/year}

Batch{number}

Oncebroached,useby…

<PARTICULARSTOAPPEARONTHEIMMEDIATEPACKAGE>

LABELSACHET100g

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

DOXIVET500mg/g,PowderforuseinDrinkingWaterforbroilerbreeders.

Doxycyclinehyclate

IT/CZ:DOXYCYCLINEDIVASA-FARMAVIC500mg/g,oralpowderforuseindrinkingwaterfor

broilerbreeders.

Doxycyclinehyclate

DK/SW:Doxivetvet,oralpowderforuseindrinkingwater.

Doxycyclinehyclate

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

1gofpowdercontains500mgofdoxycyclinehyclate(equivalentto433mgdoxycyclinebase).

3. PHARMACEUTICALFORM

Yellowtopaleyellowpowderforuseindrinkingwater.

4. PACKAGESIZE

100g

5. TARGETSPECIE

Broilerbreeders.

6. INDICATION(S)

Whereclinicaldiseaseispresentintheflock,toreducemortality,morbidity,andclinicalsignsandto

reducelesionsduetoPasteurellosiscausedbyPasteurellamultocidaortoreducemorbidityand

lesionsinrespiratoryinfectionscausedbyOrnithobacteriumrhinotracheale(ORT).

7. METHODANDROUTESOFADMINISTRATION

Administrationroute:Indrinkingwateruse.

Pasteurellosis:10mgdoxycyclinehyclateperkgbw/dayfor3-4days.

ORT:20mgdoxycyclinehyclateperkgbw/dayfor3-4days.

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Meatandoffal:3daysincasesof10mg/kgbwforamaximumof4days.

Meatandoffal:12daysincasesof20mg/kgbwforamaximumof4days.

Eggs:Notauthorisedforuseinlayingbirdsproducingeggsforhumanconsumption.

9. SPECIALWARNING(S),IFNECESSARY

-------

10. EXPIRYDATE

EXP{month/year}

Shelf-lifeafterfirstopeningtheimmediatepackaging:12months.

Oncebroached,useby…

Shelf-lifeafterdilutionindrinkingwater:24hours.

11. SPECIALSTORAGECONDITIONS

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productshouldbedisposedofinaccordancewithlocalrequirements.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly.Tobesuppliedonlyonveterinaryprescription.

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

DIVASA-FARMAVICS.A.

Ctra.SantHipòlit,km71

08503Gurb-Vic

Barcelona(Spain)

16. MARKETINGAUTHORISATIONNUMBER(S)

-------

17. MANUFACTURER’SBATCHNUMBER

Batch{number}

LEAFLET

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERAND

OFTHEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFOR

BATCHRELEASE,IFDIFFERENT

Marketingauthorisationholderandmanufacturerforthebatchrelease:

DIVASA-FARMAVICS.A.

Ctra.SantHipòlit,km71

08503Gurb-Vic

Barcelona(Spain)

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

DOXIVET500mg/g,PowderforuseinDrinkingWaterforbroilerbreeders.

Doxycyclinehyclate

IT/CZ:DOXYCYCLINEDIVASA-FARMAVIC500mg/g,oralpowderforuseindrinkingwaterfor

broilerbreeders.

Doxycyclinehyclate

DK/SW:Doxivetvet,oralpowderforuseindrinkingwater.

Doxycyclinehyclate

3. STATEMENTOFTHEACTIVESUBSTANCEANDOTHERINGREDIENTS

1gofpowdercontains500mgofdoxycyclinehyclate(equivalentto433mgdoxycyclinebase).

4. INDICATIONS

Whereclinicaldiseaseispresentintheflock,toreducemortality,morbidity,andclinicalsignsandto

reducelesionsduetoPasteurellosiscausedbyPasteurellamultocidaortoreducemorbidityand

lesionsinrespiratoryinfectionscausedbyOrnithobacteriumrhinotracheale(ORT).

5. CONTRAINDICATIONS

Donotuseincaseofhypersensitivitytotheactivesubstanceortoanyofexcipients.

Donotuseinanimalswithanimpairedliverfunction.

6. ADVERSEREACTIONS

Tetracyclinesmay-inveryrarecases-inducephotosensitivityandallergicreactions.Ifsuspected

adversereactionsoccur,treatmentshouldbediscontinued.Ifyounoticeanyseriouseffectsorother

effectsnotmentionedinthisleaflet,pleaseinformyourveterinarysurgeon.

7. TARGETSPECIES

Broilerbreeders.

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOF

ADMINISTRATION

Administrationorallywiththedrinkingwater.

Therecommended dose is:10mgdoxycyclinehyclate(20mgproduct)perkgbodyweightperdayfor

3-4consecutivedaysincaseofinfectionscausedbyP.multocidaand20mgdoxycyclinehyclate(40

mgproduct)perkgbodyweightperdayfor3-4consecutivedaysincaseofinfectionscausedbyO.

rhinotracheale.

Basedonthedosetobeused,andthenumberandweightoftheanimalstobetreated,theexactdaily

amountofproductcanbecalculated.Thefollowingformulacanbeusedtocalculatetheconcentration

oftheproductindrinkingwater:

.....mgproduct/kgbody

weight/day x meanbodyweight(kg)ofanimals

tobetreated =....mgproductperl

drinkingwater

meandailywaterconsumption(l)peranimal

Toensureacorrectdosagebodyweightshouldbedeterminedasaccuratelyaspossible.Theuptakeof

medicateddrinkingwaterdependsontheclinicalconditionoftheanimals.Inordertoobtainthecorrect

dosagetheconcentrationofdoxycyclinehastobeadjustedaccordingly.Theuseofsuitablycalibrated

weighingequipmentisrecommendedifpartpacksareused.Thedailyamountistobeaddedtothe

drinkingwatersuchthatallmedicationwillbeconsumedin24hours.Medicateddrinkingwatershould

berefreshedorreplacedevery24hours.Itisrecommendedtoprepareaconcentratedpre-solution-

approximately100gramsproductperlitredrinkingwater-andtodilutethisfurthertotherapeutic

concentrationsifrequired.Alternatively,theconcentratedsolutioncanbeusedinaproportionalwater

medicator.SolubilityoftheproductispHdependentanditmayprecipitateifitismixedinhardalkaline

drinkingwater.Useatminimumconcentrationsof200mgpowderperlitredrinkingwaterinareaswith

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

periodanimalsshouldnothaveaccesstootherwatersourcesthanthemedicatedwater.

9. ADVICEONCORRECTADMINISTRATION

10. WITHDRAWALPERIODS

Meatandoffal:3daysincasesof10mg/kgbwforamaximumof4days.

Meatandoffal:12daysincasesof20mg/kgbwforamaximumof4days.

Eggs:Notauthorisedforuseinlayingbirdsproducingeggsforhumanconsumption.

11. SPECIALSTORAGEPRECAUTIONS

Keepoutofthereachandsightofchildren.

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

Donotuseaftertheexpirydatestatedonthelabel.

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years.

Shelf-lifeafterfirstopeningtheimmediatepackaging:12months.

Shelf-lifeafterdilutionorreconstitutionaccordingtodirections:24hoursafterdilutionindrinkingwater.

12. SPECIALWARNINGS

Specialprecautionsforuseinanimals

Duetolikelyvariability(time,geographical)insusceptibilityofbacteriafordoxycycline,especially

susceptibilityofO.rhinotrachealemaydifferfromcountrytocountryandevenfarmtofarm,

bacteriologicalsamplingandsusceptibilitytestingarerecommended.Useoftheproductshouldbe

basedoncultureandsensitivityofmicro-organismsfromdiseasedcasesonfarm.Ifthisisnotpossible,

therapyshouldbebasedonlocal(regional,farmlevel)epidemiologicalinformationaboutsusceptibility

ofthetargetbacteria.

Aseradicationofthetargetpathogensmaynotbeachieved,medicationshouldthereforebecombined

withgoodmanagementpractices,e.g.goodhygiene,properventilation,nooverstocking

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Ifyouknowyouareallergictothetetracyclineclassofantibiotics,specialcareshouldbetakenwhen

handlingthisproductorthemedicatedsolution.

Duringpreparationandadministrationofthemedicateddrinkingwater,skincontactwiththeproduct

andinhalationofdustparticlesshouldbeavoided.Wearimpermeablegloves(e.g.rubberorlatex)and

anappropriatedustmask(e.g.disposablehalf-maskrespiratorconformingtoEuropeanStandard

EN149)whenapplyingtheproduct.

Intheeventofeyeorskincontact,rinsetheaffectedareawithlargeamountsofcleanwaterandif

irritationoccurs,seekmedicalattention.Washhandsandcontaminatedskinimmediatelyafterhandling

theproduct.

Ifyoudevelopsymptomsfollowingexposuresuchasskinrash,youshouldseekmedicaladviceand

showthiswarningtothephysician.Swellingoftheface,lipsoreyes,ordifficultywithbreathingare

moreserioussymptomsandrequireurgentmedicalattention.

Donotsmoke,eatordrinkwhilehandlingtheproduct.

Takemeasurestoavoidproducingdustwhenincorporatingtheproductintowater.Avoiddirectcontact

withskinandeyeswhenhandlingtheproducttopreventsensitisationandcontactdermatitis.

Useduringpregnancy,lactationorlay

Doxycyclinehasalowaffinityforformingcomplexeswithcalciumandstudieshavedemonstratedthat

doxycyclinescarcelyaffectsskeletonformation.Nonegativeeffectswereobservedinpoultryafter

theadministrationoftherapeuticdosesofdoxycycline.

Interactionwithothermedicinalproductsandotherformsofinteractions

Donotcombinewithantibioticsthatarebacteriocidale.g.penicillinsorcephalosporins.

Absorptionofdoxycyclinecanbedecreasedinthepresenceofhighquantitiesofcalcium,iron,

magnesiumoraluminiuminthediet.Donotadministeredtogetherwithantacids,kaolinandiron

preparations.

Itisadvisedthattheintervalbetweentheadministrationofotherproductscontainingpolyvalentcations

shouldbe1-2hoursbecausetheylimittheabsorptionoftetracyclines.

Doxycyclineincreasestheactionofanticoagulants.

ThesolubilityoftheproductispHdependentandwillprecipitateifmixedinalkalinesolution.

Donotstorethedrinkingwaterinmetalliccontainers.

Overdose

Poultrytoleratedoubleoverdosesofdoxycycline(40mg/kgbodyweight)withoutanyclinicaleffect.

Incompatibilities

SolubilityofdoxycyclineispHdependent.Precipitationwilloccurinanalkalinesolution.Intheabsence

ofcompatibilitystudies,thisproductmustnotbemixedwithotherveterinarymedicinalproducts.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productshouldbedisposedofinaccordancewithlocalrequirements.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

15. OTHERINFORMATION

Pharmaceuticalform

Yellowtopaleyellowpowderforuseindrinkingwater

Packsize

Box10x100g–50x100gand250x100g

Bag1000and2500g.

Notallpacksizesmaybemarketed.

Foranimaltreatmentonly–tobesuppliedonlyonveterinaryprescription.

Authorisationnumber: