Powdox 100 mg/ ml Oral Solution for Use in Drinking Water for Chickens and Pigs

Main information

  • Trade name:
  • Powdox 100 mg/ ml Oral Solution for Use in Drinking Water for Chickens and Pigs
  • Pharmaceutical form:
  • Oral solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Powdox 100 mg/ml Oral Solution for Use in Drinking Water for Chickens and Pigs
    Spain
  • Language:
  • English

Therapeutic information

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

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0249/001
  • Authorization date:
  • 02-09-2012
  • EU code:
  • UK/V/0249/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Revised:September2013

AN:00843/2012

Page1of8

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

SOLDOXIN100mg/mloralsolutionforuseindrinkingwaterforchickens

andpigs [ES,FR,IT]

ORIDOX100mg/mloralsolutionforuseindrinkingwaterforchickens

andpigs [HU]

POWDOX100mg/mloralsolutionforuseindrinkingwaterforchickens

andpigs [UK]

FLUID-DOX100mg/mloralsolutionforuseindrinkingwaterfor

chickensandpigs [DK]

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Compositionperml:

Doxycycline.100mg

(equivalenttoDoxycyclinehyclate116.0mg)

Forafulllistofexcipients,seesection6.1

3. PHARMACEUTICALFORM

Oralsolutionforuseindrinkingwater.

Clear,dense,brownish-yellowsolution.

4. CLINICALPARTICULARS

4.1.Targetspecies

Chicken(broilers)andpigs.

4.2. Indicationsforuse,specifyingthetargetspecies

CHICKENS(BROILERS)

Preventionandtreatmentofchronicrespiratorydisease(CRD)and

mycoplasmosiscausedbymicroorganismssensitivetodoxycycline.

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PIGS

PreventionofclinicalrespiratorydiseaseduetoPasteurellamultocida

andMycoplasmahyopneumoniaesensitivetodoxycycline.

Thepresenceofthediseaseintheherdshouldbeestablishedbefore

treatment.

4.3.Contraindications

Donotuseincaseofhypersensitivitytotetracyclines.

Donotuseincasesofresistancetotetracyclines.

Donotuseinanimalswithhepaticdysfunction.

4.4. Specialwarningsforeachtargetspecies

Sickanimalsmayhaveareducedappetiteandaltereddrinkingpatterns

andshould,ifnecessary,bemedicatedparenterally.

Incasesofalteredfoodordrinkingwateruptake,theconcentrations

shouldbeadjustedinsuchawaythattherecommendeddosageis

achieved.

Donotadministertolayinghens.

4.5. Specialprecautionsforuse

Specialprecautionsforuseinanimals

Prolongedorrepeateduseofthisveterinarymedicinalproductis

discouraged.Attentionshouldbepaidtoavoidanceofstressful

conditionsandimprovementofmanagementpracticesandhygiene

standards.

Avoidadministrationinoxidiseddrinkingequipment.

Useoftheproductshouldbebasedonsusceptibilitytestingofthe

bacteriaisolatedfromtheanimal.Ifthisisnotpossible,therapyshould

bebasedonlocal(regionalandfarmlevel)epidemiologicalinformation

aboutsusceptibilityofthetargetbacteria,takingintoaccountofficial

nationalantimicrobialpolicies.Inappropriateuseoftheproductmay

increasetheprevalenceofbacteriaresistanttodoxycyclineandmay

decreasetheeffectivenessoftreatmentwithtetracyclines,duetothe

potentialforcross-resistance.

Duetovariability(time,geographical)insusceptibilityofbacteriafor

doxycycline,bacteriologicalsamplingandsusceptibilitytestingofmicro-

organismsfromdiseasedbirdsonfarmarehighlyrecommended.

AhighresistancerateofE.coli,isolatedfromchickens,against

tetracyclineshasbeendocumented.Thereforetheproductshouldbe

usedforthetreatmentofinfectionscausedbyE.colionlyafter

susceptibilitytestinghasbeencarriedout.

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Aseradicationofthetargetpathogensmaynotbeachieved,medication

shouldthereforebecombinedwithgoodmanagementpractices,e.g.

goodhygiene,properventilation,nooverstocking.

Specialprecautionstobetakenbythepersonadministeringthe

veterinarymedicinalproducttoanimals

Tetracyclinesmay –inveryrarecases–inducephotosensitivityand

allergicreactions.

Donothandletheproductifyouarehypersensitivetotetracyclines.

Weargloves,workoverallandapprovedsafetyglasses.

Thisproductisacidandlikelytobeirritant.Avoidcontactwithskinand

eyes.Incaseofcontactwithskin,rinseimmediatelywithplentyofwater.

Incaseofcontactwitheyes,rinseimmediatelywithcopiousamountsof

waterandseekmedicaladvice.

Donotsmoke,eatordrinkwhilehandlingthisproduct.

Theproductcanbeharmfulbyskincontactandinhalationandmay

causeeyeirritation.

Incaseofaccidentalingestionseekmedicaladviseandshowthelabelto

thedoctor.

Ifanysymptomshouldappear,suchasacutaneouseruption,seek

promptmedicaladvice.Swellingoftheface,lipsoreyesorrespiratory

difficultiesarethemostserioussignswhichrequireurgentmedical

attention.

4.6. Adversereactions(frequencyandseriousness)

Allergicandphotosensitivityreactionscanoccur.Intestinalfloramaybe

affectediftreatmentisveryprolonged,andthismayresultindigestive

disturbance.

Ifsuspectedadversereactionsoccur,treatmentshouldbediscontinued.

4.7. Useduringpregnancy,lactationorlay

Theproductshouldnotbeusedduringpregnancyorlactation

4.8.Interactionwithothermedicinalproductsandotherformsof

interaction

Doxycyclineabsorptionmaybereducedbythepresenceofhigh

quantitiesofcalcium,iron,magnesiumoraluminiuminthediet.Donot

administertogetherwithantacids,kaolinandironpreparations.

Donotadministertogetherwithbactericidalantibiotics.

ThesolubilityoftheproductispHdependentandwillprecipitateifmixed

inalkalinesolution

Donotadministerwithmilkreplacers

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4.9. Amountstobeadministeredandadministrationroute

Tobeadministeredindrinkingwater

-CHICKEN(broilers):11.5 –23mgdoxycyclinehyclate/kgbody

weight/day,correspondingto0.1-0.2mlofPOWDOXperkgbody

weight,for3-5consecutivedays.

-PIGS:11.5mgdoxycyclinehyclate/kgbodyweight/day,

correspondingto0.1mlofPOWDOXperkgbodyweight,for5

consecutivedays.

Basedontherecommendeddose,andthenumberandweightofthe

animalstobetreated,theexactdailyamountofPOWDOXshouldbe

calculatedaccordingtothefollowingformula:

XmlPOWDOX/kg

b.w./day

x Meanbody

weight(kg)of

animalstobe

treated

= XmlPOWDOX

perldrinking

water

Meandailywaterconsumption(l)peranimal

Toensureacorrectdosagebodyweightshouldbedeterminedas

accuratelyaspossibletoavoidunderdosing.Theuptakeofmedicated

waterisdependantontheclinicalconditionoftheanimals.Inorderto

obtainthecorrectdosage,theconcentrationindrinkingwatermayhave

tobeadjusted.

Theuseofsuitablycalibratedweighingequipmentisrecommendedif

partpacksareused.Thedailyamountistobeaddedtothedrinking

watersuchthatallmedicationwillbeconsumedin24hours.Medicated

drinkingwatershouldbefreshlypreparedevery24hours.Itis

recommendedtoprepareaconcentratedpre-solution –approximately

100gramsproductperlitredrinkingwater –andtodilutethisfurtherto

therapeuticconcentrationsifrequired.Alternatively,theconcentrated

solutioncanbeusedinaproportionalwatermedicator.

Medicatedwatershouldbetheonlydrinkingsource.

Theremainingmedicatedwatershouldbedisposedofinaccordance

withlocalrequirements.

Ifnoimprovementinclinicalsignsisseenwithinthetreatmentduration,

thediagnosisshouldbereviewedandtreatmentchanged.

4.10.Overdose(symptoms,emergencyprocedures,antidotes)

Nodataavailable.

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4.11.Withdrawalperiod

Meat&offal:

Chickens(broilers):7days

Pigs:7days.

Eggs:Notpermittedforuseinlayingbirdsproducingeggsforhuman

consumption

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antibiotic,Tetracyclines

ATCvetcode:QJ01AA02

5.1. Pharmacodynamicproperties

Doxycyclineisabacteriostaticagentthatactsbyinterferingwiththe

bacterialproteinsyntesisofsensitivespecies.

Doxycyclineisasemi-synthetictetracyclinederivedfromoxytetracicline.

Itactsonthesubunit30Softhebacterialribosome,towhichislinked

reversibly,blockingtheunionbetweenaminoacyl-tRNA(transferRNA)to

themRNA-ribosomecomplex,preventingtheadditionofnewaminoacids

intothegrowingpeptidechainandthusinterferingwithproteinsynthesis.

DoxycyclineisactiveagainstGram-positiveandGram-negativebacteria.

Spectrumofactivity:

Streptococcusspp.

Staphylococcusaureus

Chlamydiaspp.

Mycoplasmaspp.

Salmonellaspp.

Pasteurellamultocida

InvitrosensitivityofdoxycyclineagainstPasteurellamultocidaand

Bordetellabronchisepticastrainsisolatedfrompigshasbeendetermined

bymeansofaplatediffusionmethod,andagainstMycoplasma

hyopneumoniaebyadilutionmethod,withMIC

valuesof0.517

AccordingtotheNCCLSstandard,strainssensitivetodoxycyclinehave

Thereareatleasttwomechanismsofresistancetotetracyclines.The

mostimportantmechanismisduetodecreasedcellularaccumulationof

thedrug.Thisisduetotheestablishmentofeitherapumpelimination

pathoranalterationinthetransportsystemthatlimitstheuptakeof

tetracycline.Thealterationinthetransportsystemisproducedby

inducibleproteinscodifiedinplasmidsandtransposons.Theother

mechanismisevidencedbydecreasedribosomeaffinitiyforthe

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Tetracycline-Mg 2+ complex owing to chromosomal mutations.

Resistancetotetracyclinesmaynotonlybetheresultoftherapywith

tetracyclines,butmayalsobecausedbytherapywithotherantibiotics

leadingtoselectionofmulti-resistantstrainsincludingtetracyclines.

Althoughminimalinhibitoryconcentrations(MIC)tendtobelowerfor

doxycyclinethanforoldergenerationtetracyclines,pathogensresistant

toonetetracyclinearegenerallyalsoresistanttodoxycycline(cross

resistance).Bothlongtermtreatmentandtreatingforaninsufficient

lengthoftimeand/orsub-therapeuticdosagescanselectfor

antimicrobialresistanceandshouldbeavoided.

5.2. Pharmacokineticparticulars

Doxycyclineisbioavailableafteroraladministration.Whenorally

administered,itreachesvaluesgreaterthan70%inmostspecies.

Feedingcanmodifytheoralbioavailabilityofdoxycycline.Infasting

conditionsbioavailabilityisaround10-15%greaterthanwhentheanimal

isfed.

Doxycyclineiswelldistributedthroughthebodyasitishighlylipid

soluble.Itaccumulatedinliver,kidney,bonesandintestine;

enterohepaticrecyclingoccurs.Inlungs,italwaysreacheshigher

concentrationsthaninplasma.Therapeuticconcentrationshavebeen

detectedinaqueoushumour,myocardium,reproductivetissues,brain

andmammarygland.Plasmaproteinbindingis90-92%.

40%ofthedrugismetabolizedandlargelyexcretedthroughfaeces

(biliaryandintestinalroute),mainlyasmicrobiologicallyinactive

conjugates.

CHICKENS(broilers)

Afteroraladministration,doxycyclineisrapidlyabsorbedreaching

maximumconcentrations(C

)around1.5h.Bioavailabilitywasabout

75%.Thepresenceoffoodinthegastrointestinaltractreducesits

absorption,reachingabioavailabilityaround60%andextending

considerablythetimeatwhichitreachesthemaximumpeak

concentration,(t

)3.3h.

PIGS

Afteranoraldoseof10mg/kg/day,theconcentrationatsteadystate

(Css)wasaround1.30µg/mLandplasmaeliminationhalf-life(t1/2)was

7.01h.

6. PHARMACEUTICALPARTICULARS

6.1.Listofexcipients

Pyrrolidone

Propyleneglycol

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6.2.Incompatibilities

Donotmixwithotherveterinarymedicinalproducts.

6.3.Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:15

months

Shelflifeafterdilutionaccordingtodirections:24hours

Shelf-lifeafterfirstopeningtheimmediatepackaging:28days

6.4.Specialprecautionsforstorage

Donotstoreabove25ºC.

Protectfromlight.

6.5.Natureandcompositionofimmediatepackaging

Theproductispackagedinwhitehigh-densitypolyethylenecontainersof

1Land5L.Containersareclosedwithascrewcapofthesamematerial

withinductionsealing.

6.6. Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfrom

suchveterinarymedicinalproductsshouldbedisposedofinaccordance

withlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

VETPHARMAANIMALHEALTH,S.L.

LesCorts,23

08028Barcelona

SPAIN

8. MARKETINGAUTHORISATIONNUMBER

Vm32509/4006

9. DATEOFFIRSTAUTHORISATION

20August2008

10. DATEOFREVISIONOFTHETEXT

September2013

APPROVED 20/09/13

Revised:September2013

AN:00843/2012

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