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
    Italy
  • 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:

19-12-2018

Safety and efficacy of vitamin B2 (riboflavin 5′‐phosphate ester monosodium salt) for all animal species when used in water for drinking

Safety and efficacy of vitamin B2 (riboflavin 5′‐phosphate ester monosodium salt) for all animal species when used in water for drinking

Published on: Tue, 18 Dec 2018 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on vitamin B2 in the form of riboflavin 5′‐phosphate ester monosodium salt as an additive for all animal species for use in water for drinking. The additive under assessment is obtained from ■■■■■ a source of riboflavin produced by Ashbya gossypii. No information was provided on the identity and character...

Europe - EFSA - European Food Safety Authority EFSA Journal

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