Pulmodox 5% Premix

Main information

  • Trade name:
  • Pulmodox 5% Premix
  • Pharmaceutical form:
  • Premix for medicated feed
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Pulmodox 5% Premix
    Spain
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • doxycycline
  • Therapeutic area:
  • Pigs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0117/001
  • Authorization date:
  • 17-01-2006
  • EU code:
  • FR/V/0117/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SUMMARYOFPRODUCTCHARACTERISTICS

1. Nameoftheveterinarymedicinalproduct

PULMODOX5%PREMIX

(inAustriaandPortugalPULMODOX5%PREMIXformedicatedfeedingstuff)

2. Qualitativeandquantitativecomposition

Eachgramcontains

Activesubstance(s)

Doxycycline....................................................... 50mg

(ashyclateform)

Excipients

Forafulllistofexcipients,seesection6.1.

3. Pharmaceuticalform

Premixformedicatedfeedingstuff

4. Clinicalparticulars

4.1.Targetspecies

Pigs(afterweaning).

4.2.Indicationsforuse,specifyingthetargetspecies

PreventionofclinicalrespiratorydiseaseduetoPasteurellamultocidaandMycoplasma

hyopneumoniaesensitivetodoxycycline.Thepresenceofdiseaseintheherdshouldbeestablished

beforetreatment

4.3.Contraindications

Donotuseincaseofhypersensitivitytotheactivesubstanceortoanyoftheexcipients.

Donotuseinanimalswithhepaticdysfunction.

Seesection4.7.

4.4.Specialwarningsforeachtargetspecies

Theuptakeofmedicationbyanimalscanbealteredasaconsequenceofillness.Incaseofinsufficient

feedintake,animalsshouldbetreatedparenterally

4.5.Specialprecautionsforuse

i)Specialprecautionsforuseinanimals

Inappropriateuseoftheproductmayincreasetheprevalenceofbacteriaresistanttotetracyclinedueto

thepotentialforcrossresistance.Useoftheproductshouldbebasedonsusceptibilitytestingandtake

intoaccountofficialandlocalantimicrobialpolicies.

Donotusewhentetracyclineresistancehasbeendetectedintheherd/flockduetothepotentialfor

crossresistance.

Considerationshouldbegiventoimprovementofmanagementpracticeonthefarm,mainlyin

hygienemanagement,ventilationandpigmanagementavoidingstressconditions.

ii)Specialprecautionstobetakenbythepersonadministeringthemedicinalproductsto

animals

- Donothandlethisproductincaseofknownsensitisationtotetracyclines.

- Handlethisproductwithcaretoavoidexposureduringincorporationofpremixintofeed

andadministrationofmedicatedfeedtotheanimals,takingallrecommended

precautions:

- Takeadequatemeasurestoavoiddustformationwhenincorporationoftheproductinto

feedisoccurring.

- Wearadustmask(incompliancewithEN140FFP1),gloves,overalls,andapprovedsafety

glasses.

- Avoidcontactwithskinandeyes.Rinsethoroughlywithwaterincaseofexposure.

- Donotsmoke,eat,ordrinkwhenhandlingtheproduct.

- Ifyoudevelopsymptomsfollowingexposuresuchasskinrash,youshouldseekmedical

adviceandshowthepresentwarningtothedoctor.Swellingoftheface,lipsoreyesor

difficultywithbreathingaremoreserioussymptomsandrequireurgentmedicalattention.

iii)Otherprecautions

4.6.Adversesreactions(frequencyandseriousness)

Asforalltetracycline,allergicreactionsandphotosensitivitymayoccur.Incaseofoccurrenceof

allergicreaction,thediscontinuationofthetreatmentshouldberecommended.

4.7.Useduringpregnancy,lactationorlay

Studiesperformedinlaboratoryanimals(rat,rabbit),didnotshowateratogenic,embryotoxicor

maternotoxiceffectofdoxycycline.Safetyoftheproductinpregnantandnursingsowswasnot

demonstrated.Useoftheproductinpregnantornursingfemalesisnotrecommended.

4.8.Interactionwithothermedicinalproductsandotherformsofinteraction

DonotincorporatethemedicatedpremixinfeedoverloadedwithpolyvalentcationssuchasCa 2+ ,

,Zn 2+ andFe 3+ ,becausetheformationofdoxycyclinecomplexeswiththesecationsispossible.

Donotadministertogetherwithantacids,kaolinandironpreparations.Astetracyclinesare

bacteriostaticantimicrobials,donotadministerinconjunctionwithbactericidalantibioticslikebeta-

lactames.Itisadvisedthattheintervalbetweenadministrationofotherproductscontainingpolyvalent

cationsshouldbe1-2hoursbecausetheylimittheabsorptionoftetracycline.

Doxycyclineincreasestheactionofanticoagulants.

4.9.Amount(s)tobeadministeredandadministrationroute

Infeeduse.

12.5mgofdoxycycline/kgbodyweight/dayfor8consecutivedays.(i.e.250mgofdoxycyclineper

kgofcompletefeed-5kgpremixpertonofanimalfeed-accordingtoadailyfeedintakeof50g/kg

bw/d).

Thispremixhastobeincorporatedinacompletefeed,therateofincorporationshouldnotbebelow5

kg/ton.

Afterincorporationintofeedandifforuseintheformofpellets,thefollowingconditionshavebeen

showntobesuitable:Temperaturebeforeextrusionat55°C(2min)andtemperatureafterextrusionat

73°C(2min).

Theintakeofmedicatedfeeddependsontheclinicalconditionoftheanimals.Inordertoobtainthe

correctdosage,theconcentrationofdoxycyclinehastobeadjustedaccordingly.Toensureacorrect

dosagebodyweightshouldbedeterminedasaccuratelyaspossibletoavoidunderdosing.

4.10.Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Anincreaseofkidneyweightwasreportedinthesafetystudyinpigsat3foldtheproposeddosage

regimenafteratreatmentduration2.6foldtheproposedduration.Thisfindingwasnotconfirmed

eitherfromclinicalpathologicalnorfromhistopathologicalfindings.

4.11.Withdrawalperiod(s)

Meatandoffals:7days

5. Pharmacologicalproperties

Pharmacotherapeuticgroup:antibacterialforsystemicuse(tetracycline)

ATCVetcode:QJ01AA02

5.1.Pharmacodynamicproperties

Doxycyclineisabacteriostaticantibioticbelongingtothetetracyclinefamily.Givenitsmorelipid-

solublefeaturethatmakesthediffusionthroughthebacterialmembraneeasier,doxycyclineexertsa

greaterinvitroactivitythanfirstgenerationtetracyclines.Afterpenetrationintobacteria,doxycycline

actsbyinhibitingproteinsynthesis.

DoxycyclineexertsitsantibacterialactivityespeciallyagainstPasteurellamultocidaandagainst

Mycoplasmahyopneumoniaeisolatedfrompigrespiratoryinfections.

5.2.Pharmacokineticparticulars

Thebioavailabilityofdoxycyclineadministeredperosisabout33%.Thebindingratetoplasma

proteinsis93%.Atsteadystate,thevolumeofdistribution(Vss)ofdoxycyclineis1.2l/kg.Afteroral

administrationofdoxycyclineattherecommendeddoseof12.5mg/kg/dayfor8days,averagesteady

stateconcentrationis1.2µg/mlinplasma(withasteadystateCminof0.9µg/mlandasteadystate

Cmaxof1.5µg/ml).Theaccumulationfactor(betweenfirstandlastdays)is1.8.Theratiobetween

tissue-andplasmaconcentrationis1.3forlungand2.3fornasalmucosa.

Environmentalproperties

6. Pharmaceuticalparticulars

6.1.Listofexcipients

Wholemealwheat

6.2.Incompatibilities

TheformationofdoxycyclinecomplexeswithbivalentCa 2+ andtrivalentFe 3+ cationsispossible.

6.3.Shelf-life

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:1year

Shelf-lifeofthepremixafterincorporationinthefeed:3months.

6.4.Specialprecautionsforstorage

Donotstoreabove25°C.

6.5.Natureandcompositionofimmediatepackaging

-5kgpaperandpolyethylenelowdensitybag.

-25kgpaperandpolyethylenelowdensitybag.

-5kgwhitepolypropylenebucketcontaininga5kgtransparentpolyethylenebag.

Notallpacksizesmaybemarketed.

6.6.Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts,ifappropriate

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.

7. Marketingauthorisationholder

VIRBACS.A.

1ereAvenue-L.I.D.-2065m

06516Carros

France.

8. Marketingauthorisationnumber(s)

PACKAGELEAFLET

PULMODOX5%PREMIX

Premixformedicatedfeedingstuffforpigs(afterweaning)

5kgbag(or25kgbag)(or5kgbucket)

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERANDOF

THEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFORBATCH

RELEASE,IFDIFFERENT

Marketingauthorisationholder:

VIRBACS.A.–1èreAvenue-L.I.D.-2065m-06516Carros-France.

Manufacturerforthebatchrelease:

VIRBACS.A.-8–10ruedesAulnaies–92420Magny-en-vexin–France.

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

PULMODOX5%PREMIX

Premixformedicatedfeedingstuffforpigs(afterweaning)

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

Eachgramcontains:

Activesubstance(s)

Doxycycline(ashyclateform).............................. 50mg

4. INDICATION(S)

PreventionofclinicalrespiratorydiseaseduetoPasteurellamultocidaandMycoplasma

hyopneumoniaesensitivetodoxycycline.Thepresenceofdiseaseintheherdshouldbeestablished

beforetreatment.

5. CONTRAINDICATIONS

Donotuseincaseofhypersensitivitytotheactivesubstanceortoanyoftheexcipients.

Donotuseinanimalswithhepaticdysfunction.

Seesection“Useduringpregnancy,lactationorlay”

6. ADVERSEREACTIONS

Asforalltetracycline,allergicreactionsandphotosensitivitymayoccur.Incaseofoccurrenceof

allergicreaction,thediscontinuationofthetreatmentshouldberecommended.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinformyour

veterinarysurgeon.

7. TARGETSPECIES

Pigs(afterweaning).

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOFADMINISTRATION

Infeeduse.

12.5mgofdoxycycline/kgbodyweight/dayfor8consecutivedays.(i.e.250mgofdoxycyclineper

kgofcompletefeed-5kgpremixpertonofanimalfeed-accordingtoadailyfeedintakeof50g/kg

bw/d).

9. ADVICEONCORRECTADMINISTRATION

Thispremixhastobeincorporatedinacompletefeed,therateofincorporationshouldnotbebelow

5kg/ton.

Afterincorporationintofeedandifforuseintheformofpellets,thefollowingconditionshavebeen

showntobesuitable:Temperaturebeforeextrusionat55°C(2min)andtemperatureafterextrusionat

73°C(2min).

Theintakeofmedicatedfeeddependsontheclinicalconditionoftheanimals.Inordertoobtainthe

correctdosage,theconcentrationofdoxycyclinehastobeadjustedaccordingly.Toensureacorrect

dosagebodyweightshouldbedeterminedasaccuratelyaspossibletoavoidunderdosing.

10. WITHDRAWALPERIOD

Meatandoffals:7days

11. SPECIALSTORAGEPRECAUTIONS

Keepoutofreachandsightofchildren.

Donotstoreabove25°C.

Donotuseaftertheexpirydatestatedonthelabel.

Shelf-lifeofthepremixafterincorporationinthefeed:3months.

Foranimaltreatmentonly.

12. SPECIALWARNING(S)

Specialwarningsforeachtargetspecies

Theuptakeofmedicationbyanimalscanbealteredasaconsequenceofillness.Incaseofinsufficient

feedintake,animalsshouldbetreatedparenterally.

Specialprecautionsforuseinanimals

Inappropriateuseoftheproductmayincreasetheprevalenceofbacteriaresistanttotetracyclinedueto

thepotentialforcrossresistance.Useoftheproductshouldbebasedonsusceptibilitytestingandtake

intoaccountofficialandlocalantimicrobialpolicies.

Donotusewhentetracyclineresistancehasbeendetectedintheherd/flockduetothepotentialfor

crossresistance.

Considerationshouldbegiventoimprovementofmanagementpracticeonthefarm,mainlyin

hygienemanagement,ventilationandchickenmanagementavoidingstressconditions.

Specialprecautionstobetakenbythepersonadministeringthemedicinalproductstoanimals

Donothandlethisproductincaseofknownsensitisationtotetracyclines.

Handlethisproductwithcaretoavoidexposureduringincorporationofpremixintofeedand

administrationofmedicatedfeedtotheanimals,takingallrecommendedprecautions:

-Takeadequatemeasurestoavoiddustformationwhenincorporationoftheproductintofeedis

occurring.

-Wearadustmask(incompliancewithEN140FFP1),gloves,overalls,andapprovedsafetyglasses.

-Avoidcontactwithskinandeyes.Rinsethoroughlywithwaterincaseofexposure.

-Donotsmoke,eat,ordrinkwhenhandlingtheproduct.

-Ifyoudevelopsymptomsfollowingexposuresuchasskinrash,youshouldseekmedicaladvice

andshowthepresentwarningtothedoctor.Swellingoftheface,lipsoreyesordifficultywith

breathingaremoreserioussymptomsandrequireurgentmedicalattention.

Useduringpregnancy,lactationorlay

Studiesperformedinlaboratoryanimals(rat,rabbit),didnotshowateratogenic,embryotoxicor

maternotoxiceffectofdoxycycline.Safetyoftheproductinpregnantandnursingsowswasnot

demonstrated.Useoftheproductinpregnantornursingfemalesisnotrecommended.

Interactionwithothermedicinalproductsandotherformsofinteraction

DonotincorporatethemedicatedpremixinfeedoverloadedwithpolyvalentcationssuchasCa2+,

Mg2+,Zn2+andFe3+,becausetheformationofdoxycyclinecomplexeswiththesecationsis

possible.

Donotadministertogetherwithantacids,kaolinandironpreparations.Astetracyclinesare

bacteriostaticantimicrobials,donotadministerinconjunctionwithbactericidalantibioticslikebeta-

lactames.Itisadvisedthattheintervalbetweenadministrationofotherproductscontainingpolyvalent

cationsshouldbe1-2hoursbecausetheylimittheabsorptionoftetracycline.

Doxycyclineincreasestheactionofanticoagulants.

Overdose

Anincreaseofkidneyweightwasreportedinthesafetystudyinpigsat3foldtheproposeddosage

regimenafteratreatmentduration2.6foldtheproposedduration.Thisfindingwasnotconfirmed

eitherfromclinicalpathologicalnorfromhistopathologicalfindings.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTORWASTE

MATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

15. OTHERINFORMATION

Presentations:5kgbag-5kgbucket-25kgbag.

Notallpacksizesmaybemarketed.

MarketingAuthorisationNumber:

Batchnumber:

Expirydate:

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