Doxivet 200 mg/ml concentrate for oral solution

Main information

  • Trade name:
  • Doxivet 20%
  • Pharmaceutical form:
  • Oral solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Doxivet 20%
    Germany
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • NL/V/0152/001
  • Authorization date:
  • 17-02-2012
  • EU code:
  • NL/V/0152/001
  • Last update:
  • 09-08-2016

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

PRODUCTLITERATURE

BOTTLELABEL

DOXIVET200mg/ml,

solutionforuseindrinkingwaterforbroilerbreeders.

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERAND

OFTHEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFOR

BATCHRELEASE,IFDIFFERENT

Marketingauthorisationholderandmanufacturerforthebatchrelease:

DIVASA-FARMAVICS.A.

Ctra.SantHipòlit,km71

08503Gurb-Vic

Barcelona(Spain)

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

DOXIVET200mg/ml,solutionforuseindrinkingwaterforbroilerbreeders.

(Doxycyclineasdoxycyclinehyclate)

IT/ES:DOXYCYCLINEDIVASA-FARMAVIC200mg/ml,solutionforuseindrinkingwaterfor

broilerbreeders.

DK/SE:Doxivetvet,solution.

(Doxycyclineasdoxycyclinehyclate)

3. STATEMENTOFTHEACTIVESUBSTANCEANDOTHERINGREDIENTS

1mlofsolutionforuseindrinkingwatercontains230mgofdoxycyclinehyclate(equivalentto200mg

ofdoxycycline).

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(0,04mlproduct)perkgbodyweightperday

for3-4consecutivedaysincaseofinfectionscausedbyP.multocidaand20mgdoxycyclinehyclate

(0,08mlproduct)perkgbodyweightperdayfor3-4consecutivedaysincaseofinfectionscausedby

O.rhinotracheale.

Basedonthedosetobeused,andthenumberandweightoftheanimalstobetreated,theexactdaily

amountofproductcanbecalculated.Thefollowingformulacanbeusedtocalculatetheconcentration

oftheproductindrinkingwater:

.....mlproduct/kgbody

weight/day x meanbodyweight(kg)ofanimalstobe

treated =....mlproductperl

drinkingwater meandailywaterconsumption(l)peranimal

atthepreviousday

Toensureacorrectdosagebodyweightshouldbedeterminedasaccuratelyaspossible.Theuptakeof

medicateddrinkingwaterdependsontheclinicalconditionoftheanimals.Inordertoobtainthecorrect

dosagetheconcentrationofdoxycyclinehastobeadjustedaccordingly.Theuseofsuitablycalibrated

equipmentisrecommendedifpartcontainersareused.Thedailyamountistobeaddedtothedrinking

watersuchthatallmedicationwillbeconsumedin24hours.Medicateddrinkingwatershouldbe

refreshedorreplacedevery24hours.SolubilityoftheproductispHdependentanditmayprecipitateif

itismixedinhardalkalinedrinkingwater.Duringthetreatmentperiodanimalsshouldnothaveaccess

tootherwatersourcesthanthemedicatedwater.

Weightcanalsobeusedtomeasuretheproductquantitytobeaddedindrinkingwater.Inthiscasethe

densitycorrectionshouldbeused,accordingtothefollowingformula:

Amounttobeaddedindrinking

water(g/L) = amounttobeaddedindrinkingwater(ml/L)x1.075(g/ml)

9. ADVICEONCORRECTADMINISTRATION

10. WITHDRAWALPERIOD

Meatandoffal:3daysincasesoftreatmentofpasteurellosiswithamaximumof10mg/kgbwfora

maximumof4days.

Meatandoffal:12daysincasesoftreatmentwithamaximumof20mg/kgbwforamaximumof4

days.

Eggs:Notauthorisedforuseinlayingbirdsproducingeggsforhumanconsumption.

11. SPECIALSTORAGEPRECAUTIONS

Keepoutofthereachandsightofchildren.

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

Donotuseaftertheexpirydatestatedonthelabel.

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:3years.

Shelf-lifeafterfirstopeningtheimmediatepackaging:6months.

Shelf-lifeafterdilutionorreconstitutionaccordingtodirections:24hoursafterdilutionindrinkingwater.

Oncebroached,useby:...

12. SPECIALWARNINGS

Specialwarningforeachtargetspecies

None.

Specialprecautionsforuseinanimals

Duetolikelyvariability(time,geographical)insusceptibilityofbacteriafordoxycycline,especially

susceptibilityofO.rhinotrachealemaydifferfromcountrytocountryandevenfarmtofarm,

bacteriologicalsamplingandsusceptibilitytestingarerecommended.

Useoftheproductshouldbebasedoncultureandsensitivityofmicro-organismsfromdiseasedcases

onfarm.Ifthisisnotpossible,therapyshouldbebasedonlocal(regional,farmlevel)epidemiological

informationaboutsusceptibilityofthetargetbacteria.

Aseradicationofthetargetpathogensmaynotbeachieved,medicationshouldthereforebecombined

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

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Ifyouknowyouareallergictothetetracyclineclassofantibiotics,specialcareshouldbetakenwhen

handlingthisproductorthemedicatedsolution.

Duringpreparationandadministrationofthemedicateddrinkingwater,skincontactwiththeproduct

shouldbeavoided.Wearimpermeablegloves(e.g.rubberorlatex)whenapplyingtheproduct.

Intheeventofeyeorskincontact,rinsetheaffectedareawithlargeamountsofcleanwaterandif

irritationoccurs,seekmedicalattention.Washhandsandcontaminatedskinimmediatelyafterhandling

theproduct.

Ifyoudevelopsymptomsfollowingexposuresuchasskinrash,youshouldseekmedicaladviceand

showthiswarningtothephysician.Swellingoftheface,lipsoreyes,ordifficultywithbreathingare

moreserioussymptomsandrequireurgentmedicalattention.

Donotsmoke,eatordrinkwhilehandlingtheproduct.

Avoiddirectcontactwithskinandeyeswhenhandlingtheproducttopreventsensitisationandcontact

dermatitis.

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

productsshouldbedisposedofinaccordancewithlocalrequirements.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

17February2012

15. OTHERINFORMATION

Pharmaceuticalform

Solutionforuseindrinkingwater.

Packsize

1litreand5litres.Notallpacksizesmaybemarketed.

Foranimaltreatmentonly–tobesuppliedonlyonveterinaryprescription.

Authorisationnumber:

EXP{month/year}

Batch{number}

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