Soludox 500 mg/g powder for use in drinking water for turkeys

Main information

  • Trade name:
  • Soludox 500 mg/g powder
  • Pharmaceutical form:
  • Powder for oral solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Soludox 500 mg/g powder
    Germany
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • doxycycline
  • Therapeutic area:
  • Turkeys

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0437/001
  • Authorization date:
  • 07-05-2012
  • EU code:
  • UK/V/0437/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Issued:August2012

AN:01495/2011

Page1of6

SummaryofProductCharacteristics

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Soludox500mg/gpowderforuseindrinkingwaterforturkeys

FR:Soludox433mg/gpowderforuseindrinkingwaterforturkeys

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

1gramofpowdercontains:

Activesubstance:

Doxycyclinehyclate 500mg,correspondingto433mgdoxycycline

FR:Doxycycline 433mg,correspondingto500mgdoxycyclinehyclate

Excipients:

Forafulllistofexcipients,seesection6.1

3 PHARMACEUTICALFORM

Powderforuseindrinkingwater

Yellowcrystallinepowder

4 CLINICALPARTICULARS

4.1Targetspecies

Turkeys(broilers,breeders).

4.2Indicationsforuse,specifyingthetargetspecies

Turkeys:treatmentofclinicalrespiratoryinfectionsassociatedwithMycoplasma

gallisepticumsusceptibletodoxycycline

4.3Contra-indications

Donotuseincaseofknownhypersensitivitytotheactivesubstanceortoanyofthe

excipients.

Donotuseinanimalswithhepaticdysfunction.

4.4Specialwarningforeachtargetspecies.

Theuptakeofmedicationbyanimalscanbealteredasaconsequenceofillness.In

caseofinsufficientuptakeofdrinkingwater,turkeysshouldbetreatedparenterally.

4.5Specialprecautionsforuse

Specialprecautionsforuseinanimals

Inappropriateuseoftheproductmayincreasetheprevalenceofbacteriaresistantto

tetracyclineduetothepotentialforcrossresistance.Donotusewhentetracycline

resistancehasbeendetectedintheherd/flock.

Issued:August2012

AN:01495/2011

Page2of6

Useoftheproductshouldbebasedonsusceptibilitytestingandtakeintoaccount

officialandlocalantimicrobialpolicies.

Aseradicationofthetargetpathogensmaynotbeachieved,medicationshould

thereforebecombinedwithgoodmanagementpractices,e.g.goodhygiene,proper

ventilation,nooverstocking.

Avoidadministrationinoxidiseddrinkingequipment.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Ifyouknowyouareallergictothetetracyclineclassofantibiotics,specialcare

shouldbetakenwhenhandlingthisproductorthemedicatedsolution.

Duringpreparationandadministrationofthemedicateddrinkingwater,skincontact

withtheproductandinhalationofdustparticlesshouldbeavoided.Wear

impermeablegloves(e.g.rubberorlatex)andanappropriatedustmask(e.g.

disposablehalf-maskrespiratorconformingtoEuropeanStandardEN149)when

applyingtheproduct.

Intheeventofeyeorskincontact,rinsetheaffectedareawithlargeamountsof

cleanwaterandifirritationoccurs,seekmedicalattention.Washhandsand

contaminatedskinimmediatelyafterhandlingtheproduct.

Ifyoudevelopsymptomsfollowingexposuresuchasskinrash,youshouldseek

medicaladviceandshowthiswarningtothephysician.Swellingoftheface,lipsor

eyes,ordifficultywithbreathingaremoreserioussymptomsandrequireurgent

medicalattention.

Donotsmoke,eatordrinkwhilehandlingtheproduct.

Takemeasurestoavoidproducingdustwhenincorporatingtheproductintowater.

Avoiddirectcontactwithskinandeyeswhenhandlingtheproducttoprevent

sensitisationandcontactdermatitis.

4.6Adversereactions(frequencyandseriousness)

Asforalltetracyclines,onrareoccasionsallergicreactionsandphotosensitivitymay

occur.Ifsuspectedadversereactionsoccur,treatmentshouldbediscontinued.Ifyou

noticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinform

yourveterinarysurgeon.

4.7Useduringpregnancy,lactationorlay

Laboratorystudiesinratsandrabbitshavenotproducedanyevidenceofa

teratogenic,foetotoxic,maternotoxiceffects.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Donotcombinewithantibioticsthatarebactericidale.g.penicillinsorcephalosporins.

Absorptionofdoxycyclinecanbedecreasedinthepresenceofhighquantitiesof

calcium,iron,magnesiumoraluminiuminthediet.Donotadministeredtogetherwith

antacids,kaolinandironpreparations.

Itisadvisedthattheintervalbetweentheadministrationofotherproductscontaining

polyvalentcationsshouldbe1-2hoursbecausetheylimittheabsorptionof

tetracyclines.

Doxycyclineincreasestheactionofanticoagulants.

Issued:August2012

AN:01495/2011

Page3of6

ThesolubilityoftheproductispHdependentandwillprecipitateifmixedinalkaline

solution.

4.9Amountstobeadministeredandadministrationroute

Administrationorallywiththedrinkingwater.

Dosageinturkeys:25mgdoxycyclinecorrespondingto29mgdoxycyclinehyclate

perkgofbodyweightdaily(equivalentto58mgproductperkgofbodyweight),

administeredinthedrinkingwaterfor5consecutivedays.

Theproductshouldbeadministeredcontinuouslyinthedrinkingwaterduringthe

wholeperiodoftreatment.Basedonthedosetobeused,andthenumberand

weightofthebirdstobetreated,theexactdailyamountofproductcanbecalculated.

Thefollowingformulacanbeusedtocalculatetheconcentrationoftheproductin

drinkingwater:

58mgproduct/kg

bodyweight/day X Meanbodyweight(kg)

ofbirdstobetreated

=....mgproductper

ldrinkingwater

Meandailywaterconsumption(l)perbird

Toensureacorrectdosagebodyweightshouldbedeterminedasaccuratelyas

possible.Theuptakeofmedicateddrinkingwaterdependsontheclinicalconditionof

thebirds.Inordertoobtainthecorrectdosagetheconcentrationofdoxycyclinehas

tobeadjustedaccordingly.Theuseofsuitablycalibratedweighingequipmentis

recommendedifpartpacksareused.Thedailyamountistobeaddedtothedrinking

watersuchthatallmedicationwillbeconsumedin24hours.Medicateddrinking

watershouldberefreshedorreplacedevery24hours.Itisrecommendedtoprepare

aconcentratedpre-solution-approximately100gramsproductperlitredrinking

water-andtodilutethisfurthertotherapeuticconcentrationsifrequired.

Alternatively,theconcentratedsolutioncanbeusedinaproportionalwater

medicator.SolubilityoftheproductispHdependentanditmayprecipitateifitis

mixedinhardalkalinedrinkingwater.Useatminimumconcentrationsof200mg

powderperlitredrinkingwaterinareaswithhardalkalinedrinkingwater(hardness

above10.2°dandpHmorethan8.1).Duringthetreatmentperiodbirdsshouldnot

haveaccesstootherwatersourcesthanthemedicatedwater.

4.10Overdose(symptoms,emergencyprocedures,antidotes)

Noadverseeffectswereobservedafteradministrationofdoxycyclinetoturkeysat

thefivefoldtherapeuticdoseforupto10days.Ifsuspectedtoxicreactionsdooccur

duetoextremeoverdose,themedicationshouldbediscontinuedandappropriate

symptomatictreatmentshouldbeinitiatedifnecessary.

4.11Withdrawalperiods

Turkeys:

-Meatandoffal:12days

-Eggs:Nottobeusedinbirdsproducingeggsforhumanconsumption

Issued:August2012

AN:01495/2011

Page4of6

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antibacterial-Tetracycline.ATCvetcode:QJ01AA02

5.1Pharmacodynamicproperties

Doxycyclinebelongstothegroupofthetetracyclineantibiotics.Theseantibiotics

haveabroadspectrumofantimicrobialactivity,sharingthesamebasicstructureof

polycyclicnaphthacenecarboxamide.

Doxycyclineisprimarilyabacteriostaticdrug.Itexertsitsactionbyinhibitingthe

proteinsynthesisofthebacterialcell.Inhibitionofbacterialproteinsynthesisresults

indisturbanceofallfunctionsnecessaryforthelifeofbacteria.Especiallycell-

divisionandtheformationofthecellwallareimpaired.

Doxycyclineisabroad-spectrumantibiotic,activeagainstalargenumberofGram-

positiveandGram-negative,aerobeandanaerobemicro-organisms,Mycoplasma

spp.,ChlamydiaeandRickettsia.

TheMIC90ofdoxycyclineagainstMycoplasmagallisepticumstrainsisolatedin

France,GermanyandHungary(2003-2009)wasreported0.5µg/ml.Theresistance

rateofM.gallisepticumisolatesagainstdoxycyclineislow.

Fourresistancemechanismsacquiredbymicroorganismsagainsttetracyclinesin

generalhavebeenreported:Decreasedaccumulationoftetracyclines(decreased

permeabilityofthebacterialcellwallandactiveefflux),proteinprotectionofthe

bacterialribosome,enzymaticinactivationoftheantibioticandrRNAmutations

(preventingthetetracyclinebindingtoribosome).Tetracyclineresistanceisusually

acquiredbymeansofplasmidsorothermobileelements(e.g.conjugative

transposones).Crossresistancebetweentetracyclineshasalsobeendescribed.

Duetothegreaterliposolubilityandgreaterfacilitytopassthroughcellmembranes

(incomparisontotetracycline),doxycyclineretainsacertaindegreeofefficacy

againstmicroorganismswithacquiredresistancetotetracyclines.

5.2Pharmacokineticproperties

Ingeneral,doxycyclineisquiterapidlyandextensivelyabsorbedfromthe

gastrointestinaltract,widelydistributedintheorganism,notmetabolisedtoany

significantextentandexcretedmostlyviathefaeces.

Pharmacokineticsofdoxycyclineaftersingleoraladministrationtoturkeysis

characterisedbyaquiterapidandsubstantialabsorptionfromthegastrointestinal

tractprovidingpeakplasmaconcentrationsbetween1.5to7.5hoursdependingon

ageandthepresenceoffood.ThedrugiswidelydistributedintheorganismwithVd

valuesclosetoorgreaterthan1,andexhibitsaneliminationhalf-lifeinturkeysof7.9

to10.8hours.Theproteinbindingratioattherapeuticplasmaconcentrationsisinthe

rangeof70-85%.Thebioavailabilityinturkeysmayvarybetween25and64%,also

dependingontheageandfeeding.Thepresenceoffoodinthegastrointestinaltract

determinesalowerbioavailabilitycomparedtothatobtainedinthefastedstate.

Aftercontinuousin-wateradministrationoftheproductatdosagesof25mg

doxycycline/kginturkeysfor5daystheaverageplasmaconcentrationsoverthe

wholetreatmentperiodwerereported2.24±1.02µg/mlinturkeys.PK/PDanalysisof

AUC/MIC90dataresultedin>24hvaluesthatmeettherequirementsfor

tetracyclines.

Issued:August2012

AN:01495/2011

Page5of6

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Tartaricacid

6.2Incompatibilities

SolubilityofdoxycyclineispHdependent.Precipitationwilloccurinanalkaline

solution.Intheabsenceofcompatibilitystudies,thisproductmustnotbemixedwith

otherveterinarymedicinalproducts.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:3years

Shelf-lifeafterfirstopeningtheimmediatepackaging:6months

Shelf-lifeafterdilutionorreconstitutionaccordingtodirections:Afterreconstitution

withwater,anyproductremainingafter24hoursshouldbediscarded.

6.4Storageprecautions

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

Keepthebagtightlyclosedafterfirstopeninginordertoprotectfrommoisture.

6.5Natureandcompositionofimmediatepackaging

Bagsof1kg.Sachetsof100gramspackedper10inacartonbox

1000gbag:polyester,polyethylene,aluminium,polyethyleneandaninnerlayerof

polyethylene

1000gbag:polyethyleneterephtalicacid,aluminium,polyamideandaninnerlayerof

polyethylene.

100gsachet:polyester,polyethylene,aluminiumandaninnerlayerofionomer

(surlyn).

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

Issued:August2012

AN:01495/2011

Page6of6

7. MARKETINGAUTHORISATIONHOLDER

EurovetAnimalHealthB.V.

Handelsweg25

5531AEBladel

TheNetherlands

8. MARKETINGAUTHORISATIONNUMBER

Vm16849/4046

9. DATEOFFIRSTAUTHORISATION

28August2012

10.DATEOFREVISIONOFTHETEXT

August2012

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