Ladoxyn 500 mg/g granules for oral solution for pigs

Main information

  • Trade name:
  • Ladoxyn 500 mg/g granules for oral solution for pigs
  • Pharmaceutical form:
  • Granules for oral solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Ladoxyn 500 mg/g granules for oral solution for pigs
    Greece
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • HU/V/0104/001
  • Authorization date:
  • 16-02-2011
  • EU code:
  • HU/V/0104/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SUMMARYOFPRODUCTCHARACTERISTICS

1.NAMEOFTHEVETERINARYMEDICINALPRODUCT

Ladoxyn500mg/ggranulesfororalsolutionforpigs,chickensandturkeys

(inCyprus,CzechRepublic,Denmark,Greece,Hungary,Italy,PortugalandSpain)

Pulmodox500mg/ggranulesfororalsolutionforpigs,chickensandturkeys

(inAustria,France,Germany,SlovakiaandUnitedKingdom)

2.QUALITATIVEANDQUANTITATIVECOMPOSITION

Oneggranulesfororalsolutioncontains:

Activesubstance:

Doxycycline(ashyclate) 500.0mg

Forafulllistofexcipients,seesection6.1

3.PHARMACEUTICALFORM

Granulesfororalsolution.

Yellow,free-flowinggranules.

4.CLINICALPARTICULARS

4.1Targetspecies

Pigs(fatteningpigsafterweaning),chickens(broilers,broilerbreeders)andturkeys(broilers,

breeders).

4.2Indicationsforuse,specifyingthetargetspecies

Pigs:treatmentofclinicalrespiratoryinfectionscausedbyMycoplasmahyopneumoniaeand

Pasteurellamultocidasusceptibletodoxycycline.

Chickensandturkeys:treatmentofclinicalrespiratoryinfectionsassociatedwithMycoplasma

gallisepticumsusceptibletodoxycycline.

4.3Contraindications

Donotuseincaseofhypersensitivitytotheactivesubstanceortoanyoftheexcipients.

Donotusewhentetracyclineresistancehasbeendetectedintheherd/flockduetothepotentialfor

crossresistance.

Donotuseinanimalswithhepaticdysfunction.

4.4Specialwarningsforeachtargetspecies

Theuptakeofmedicationbyanimalscanbealteredasaconsequenceofillness.Incaseofinsufficient

uptakeofdrinkingwater,animalsshouldbetreatedparenterally.

4.5Specialprecautionsforuse

Specialprecautionsforuseinanimals

Inappropriateuseoftheproductmayincreasetheprevalenceofbacteriaresistanttotetracyclinedueto

thepotentialforcrossresistance.

Duetovariability(time,geographical)insusceptibilityofbacteriafordoxycycline,bacteriological

samplingandsusceptibilitytestingofmicro-organismsfromdiseasedanimalsonfarmarehighly

recommended.

AhighresistancerateofE.coli,isolatedfromchickens,againsttetracyclineshasbeendocumented.

ThereforetheproductshouldbeusedforthetreatmentofinfectionscausedbyE.colionlyafter

susceptibilitytestinghasbeencarriedout.

Aseradicationofthetargetpathogensmaynotbeachieved,medicationshouldthereforebecombined

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

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproductto

animals

Directcontactoftheproductwiththeskin,eyesandmucousmembranesshouldbeavoided.

Peoplewithknownhypersensitivitytotetracyclinesshouldavoidcontactwiththeveterinarymedicinal

product.

Wearprotectiveglovesandgoggleswhenreconstitutingoradministeringthesolution.Washexposed

skinafterpreparation.Incaseofaccidentalprojectionintotheeyes,rinseabundantlywithwater.Do

notsmoke,eatordrinkwhenhandlingtheproduct.

Incaseofaccidentalingestion,seekmedicaladviceimmediatelyandshowthepackageleafletorthe

labeltothephysician.Inflammationoftheface,lipsoreyesorrespiratorydifficultiesarethemost

serioussignswhichrequireurgentmedicalattention.

4.6Adversereactions(frequencyandseriousness)

Asforalltetracyclines,onrareoccasionsallergicreactionsandphotosensitivitymayoccur.If

suspectedadversereactionsoccur,treatmentshouldbediscontinued.Ifyounoticeanyseriouseffects

orothereffectsnotmentionedinthisleaflet,pleaseinformyourveterinarysurgeon.

4.7Useduringpregnancy,lactationorlay

Laboratorystudiesinratsandrabbitshavenotproducedanyevidenceofateratogenic,foetotoxic,

maternotoxiceffects.

Thesafetyoftheproducthasnotbeenestablishedinpregnantorlactatingsows.Theuseisnot

recommendedduringpregnancyandlactation.

Donotuseinbirdsinlayandwithin4weeksbeforetheonsetofthelayingperiod.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

DonotadministerconcurrentlywithfeedoverloadedwithpolyvalentcationssuchasCa 2+ ,Mg 2+ ,Zn 2+

andFe 3+ becausetheformationofdoxycyclinecomplexeswiththesecationsispossible.Donot

administertogetherwithantacids,kaolinandironpreparationsastetracyclinesarebacteriostatic

antimicrobials,donotadministerinconjunctionwithbactericidalantibioticslikebeta-lactames.Itis

advisedthattheintervalbetweenadministrationofotherproductscontainingpolyvalentcationsshould

be1-2hoursbecausetheylimittheabsorptionoftetracycline.

Doxycyclineincreasestheactionofanticoagulants.

4.9Amountstobeadministeredandadministrationroute

Tobeadministeredindrinkingwater.

Dosage:

Inpigsandchickens

20.0mgdoxycyclineperkgofbodyweightdaily(equivalentto40.0mgproductperkgofbody

weight),administeredinthedrinkingwaterfor5consecutivedays.

Inturkeys

25mgdoxycyclineperkgofbodyweightdaily(equivalentto50.0mgproductperkgofbody

weight),administeredinthedrinkingwaterfor5consecutivedays.

Administration:

Basedontherecommendeddose,andthenumberandweightoftheanimalstobetreated,theexact

dailyamountoftheproductshouldbecalculatedaccordingtothefollowingformula:

.....mgproductperkgbodyweightper

day x Meanbodyweight

(kg)ofanimalsto

betreated =....mgproductperlitreof

drinkingwater

Meandailywaterconsumption(litreperanimal)

Toensureacorrectdosagebodyweightshouldbedeterminedasaccuratelyaspossible.

Theuptakeofmedicatedwaterisdependantontheclinicalconditionsoftheanimals.Inorderto

obtainthecorrectdosage,theconcentrationindrinkingwatermayhavetobeadjusted.Theuseof

suitablycalibratedweighingequipmentisrecommendedifpartpacksareused.Thedailyamountisto

beaddedtothedrinkingwatersuchthatallmedicationwillbeconsumedin24hours.Medicated

drinkingwatershouldbefreshlypreparedevery24hours.Itisrecommendedtoprepareaconcentrated

pre-solution-approximately100gramsproductperlitredrinkingwater-andtodilutethisfurtherto

therapeuticconcentrations,ifrequired.Themaximumsolubilityoftheproductinwateris72g/L.

Alternatively;theconcentratedsolutioncanbeusedinaproportionalwatermedicator.

Itshouldbeensuredthatallanimalsintendedtotreatshouldhavefreeaccesstothedrinkingfacilities.

Attheendoftreatment,thewateringequipmentshouldbecleanedadequatelytoavoidtheuptakeof

remainingquantitiesinsub-therapeuticdoses.Themedicatedwatershouldbetheonlysourceof

drinkingwater,throughoutthetreatmentperiod.Themedicatedwatermustnotbemadeorstoredina

metalcontaineranduseinoxidizeddrinkingequipment.SolubilityoftheproductispHdependentand

itwillprecipitateifitismixedinanalkalinesolution.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Duringthetargetanimaltolerancestudy,noadverseeffectwasobservedevenatthefivefold

therapeuticdoseadministeredfortwotimestherecommendeddurationineithertargetanimalspecies.

Ifsuspectedtoxicreactionsdooccurduetoextremeoverdose,themedicationshouldbediscontinued

andappropriatesymptomatictreatmentshouldbeinitiatedifnecessary.

4.11Withdrawalperiod(s)

Meatandoffalofpigs:4days.

Meatandoffalofchickens:5days.

Meatandoffalofturkeys:12days.

Notpermittedforuseinlayingbirdsproducingeggsforhumanconsumption.

5.PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Anti-infectiveforsystemicuse,tetracyclines,ATCvetcode:QJ01AA02

5.1Pharmacodynamicproperties

Doxycyclineisasemisynthetictetracyclinederivative.Itactsbyinhibitingproteinsynthesisatthe

ribosomallevel,predominantlybybindingtothe30Sribosomalsubunitsofbacteria.Doxycyclineisa

broad-spectrumantibiotic.Itexhibitsawiderangeofactivityagainstgram-positiveandgram-

negative,aerobicandanaerobicpathogens,especiallyagainstPasteurellamultocidaandMycoplasma

hyopneumoniaeisolatedfrompigrespiratoryinfectionsandMycoplasmagallisepticumassociated

withclinicalrespiratoryinfectionsinchickensandturkeys.TheMIC

valuesofdoxycyclineagainst

MycoplasmahyopneumoniaestrainsisolatedinSpain(2001)andinBelgium(2000-2002)were

determinedas0.2and0.5µg/ml,respectively.TheMIC

valuesforPasteurellamultocidaisolatedin

FranceandtheUnitedKingdom(2002-2004),andGermany(2004-2006)werefoundtobe2.0µg/mL.

TheMIC

ofdoxycyclineagainstM.gallisepticumstrainsisolatedinFrance,GermanyandHungary

(2003-2009)wasreported0.5µg/ml.

TheresistancerateofM.hyopneumoniae,P.multocidaandM.gallisepticumisolatesagainst

doxycyclineislow(0-6%).Resistanceismostlyduetointerferencewiththeactivetransportofthe

tetracyclinesinto,andincreasedeffluxfromthecells,orribosomalprotectioninwhichprotein

synthesisbecomesresistanttoinhibition.Basicallythereisacompletecross-resistancewithintheclass

oftetracyclines.Doxycyclinemaybeeffectiveagainstcertainstrainsresistanttoconventional

tetracyclinesduetoribosomalprotectionoreffluxpumpmechanisms.

AccordingtotheCLSIregulation,organismsotherthanstreptococciwithMICvalues≤4µg/mlare

consideredsensitive,at8µg/mlintermediateandwithMICvalues≥16µg/mresistanttodoxycycline.

5.2Pharmacokineticparticulars

Ingeneral,doxycyclineisquiterapidlyandextensivelyabsorbedfromthegastrointestinaltract,

widelydistributedintheorganism,notmetabolisedtoanysignificantextentandexcretedmostlyvia

thefaeces.

Afteroraladministrationtopigs,doxycyclineissubstantiallyabsorbedfromthegastrointestinaltract.

Thebindingratetoplasmaproteinsis93%.Itiswidelydistributedintheorganisms;atthesteady

state,thevolumeofdistribution(V

)is1.2L/kg.Doxycyclineisnotmetabolisedtoanysignificant

extentanditisexcretedprimarilyinfaeces,mostlyinamicrobiologicallyinactiveform.The

eliminationhalf-lifewasreportedtobe4-4.2hoursinpigs.Thesteady-stateplasmaconcentrationsof

doxycyclineafterrepeatedoraladministrationsofLadoxyn/Pulmodox500mg/ggranulesfororal

solutionforpigsatadoseof20mg/kgbodyweightfor5daysrangedfrom1.0and1.5µg/ml.Both

thelungandnasalmucosaconcentrationsatsteady-statewerehigherthantheplasmalevel.Theratio

betweentissue-andplasmaconcentrationwasfoundtobe1.3forlungand3.4fornasalmucosa.The

doxycyclineconcentrationsbothinthelungandthenasalmucosaexceededtheMIC

ofthedrug

againstthetargetrespiratorypathogens.

Pharmacokineticsofdoxycyclineaftersingleoraladministrationtochickensandturkeysis

characterisedbyaquiterapidandsubstantialabsorptionfromthegastrointestinaltractprovidingpeak

plasmaconcentrationsbetween0.4and3.3hoursinchickensand1.5to7.5hoursinturkeys

dependingonageandthepresenceoffood.ThedrugiswidelydistributedintheorganismwithV

valuesclosetoorgreaterthan1,andexhibitsshortereliminationhalf-lifeinchickens(4.8to9.4

hours)thaninturkeys(7.9to10.8hours).Theproteinbindingratioattherapeuticplasma

concentrationsisintherangeof70-85%.Thebioavailabilityinchickensandturkeysmayvary

between41and73%,and25and64%,respectivelyalsodependingontheageandfeeding.The

presenceoffoodinthegastrointestinaltractdeterminesalowerbioavailabilitycomparedtothat

obtainedinthefastedstate.

Aftercontinuousin-wateradministrationofLadoxyn/Pulmodox500mg/ggranulesatdosagesof20

mgdoxycycline/kg(chickens)and25mgdoxycycline/kg(turkeys)for5daystheaverageplasma

concentrationsoverthewholetreatmentperiodwerereported1.86±0.71µg/mlinchickensand

2.24±1.02µg/mlinturkeys.InbothavianspeciesthePK/PDanalysisof 

AUC/MIC

dataresultedin

>24hvaluesthatmeettherequirementsfortetracyclines.

6.PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Citricacid(anhydrous)

Lactosemonohydrate

6.2Incompatibilities

Doxycyclinemayforminsolublecomplexeswithdivalentions,especiallyironorcalcium,zincand

magnesium.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years

Shelf-lifeafterfirstopeningtheimmediatepackaging:3months

Shelf-lifeafterdilutionorreconstitutionaccordingtodirections:24hours

6.4.Specialprecautionsforstorage

Donotstoreabove25

C.

Storeintheoriginalcontainertightlyclosedinordertoprotectfrommoisture.

6.5Natureandcompositionofimmediatepackaging

100gpolypropylenecontainerwithpolypropylenelidandinnerbagofLDPE.

1kgroundpolypropylenecontainerwithpolypropylenelidandinnerbagofLDPE.

1kgsquarepolypropylenecontainerwithpolypropylenelidandinnerbagofLDPE.

5kgroundpolypropylenecontainerwithpolypropylenelidandinnerbagofLDPE.

5kgsquarepolypropylenecontainerwithpolypropylenelidandinnerbagofLDPE.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.

7.MARKETINGAUTHORISATIONHOLDER

LavetPharmaceuticalsLtd.

1161Budapest

Ottóu.14.

Hungary

8.MARKETINGAUTHORISATIONNUMBER(S)

9.DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10.DATEOFREVISIONOFTHETEXT

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable.

InItaly:

Ricettamedicoveterinariaintriplicecopianonripetibile.

InSpain:

Tobesuppliedonlyonveterinaryprescription.

A.LABELLING

PARTICULARSTOAPPEARONTHEIMMEDIATEPACKAGE

100gpolypropylenecontainerwithpolypropylenelidandinnerbagofLDPE.

1kgroundpolypropylenecontainerwithpolypropylenelidandinnerbagofLDPE.

1kgsquarepolypropylenecontainerwithpolypropylenelidandinnerbagofLDPE.

5kgroundpolypropylenecontainerwithpolypropylenelidandinnerbagofLDPE.

5kgsquarepolypropylenecontainerwithpolypropylenelidandinnerbagofLDPE.

1.NAMEOFTHEVETERINARYMEDICINALPRODUCT

Ladoxyn500mg/ggranulesfororalsolutionforpigs,chickensandturkeys

(inCyprus,CzechRepublic,Denmark,Greece,Hungary,Italy,PortugalandSpain)

Pulmodox500mg/ggranulesfororalsolutionforpigs,chickensandturkeys

(inAustria,France,Germany,SlovakiaandUnitedKingdom)

Doxycycline(ashyclate)

2.STATEMENTOFACTIVEANDOTHERSUBSTANCES

Activesubstance: Doxycycline(ashyclate) 500.0mg/g

3.PHARMACEUTICALFORM

Granulesfororalsolution

4.PACKAGESIZE

100g

1kg

5kg

5.TARGETSPECIES

Pigs(fatteningpigsafterweaning),chickens(broilers,broilerbreeders)andturkeys(broilers,

breeders).

6.INDICATION(S)

Pigs:treatmentofclinicalrespiratoryinfectionscausedbyMycoplasmahyopneumoniaeand

Pasteurellamultocidasusceptibletodoxycycline.

Chickensandturkeys:TreatmentofclinicalrespiratoryinfectionsassociatedwithMycoplasma

gallisepticumsusceptibletodoxycycline.

7.METHODANDROUTE(S)OFADMINISTRATION

Readthepackageleafletbeforeuse.

8.WITHDRAWALPERIOD

Withdrawalperiod:

Meatandoffalofpigs:4days.

Meatandoffalofchickens:5days.

Meatandoffalofturkeys:12days.

Notpermittedforuseinlayingbirdsproducingeggsforhumanconsumption.

9.SPECIALWARNING(S),IFNECESSARY

Readthepackageleafletbeforeuse.

10.EXPIRYDATE

EXP{month/year}

Shelflifeafterfirstopeningofcontainer:3months

Shelflifeafterreconstitutionindrinkingwater:24hours.

Oncebroached/opened,useby……..

11.SPECIALSTORAGECONDITIONS

Donotstoreabove25°C.

Storeintheoriginalcontainertightlyclosedinordertoprotectfrommoisture.

12.SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSORWASTE

MATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.

13.THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly-tobesuppliedonlyonveterinaryprescription.

14.THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15.NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

LavetPharmaceuticalLtd.

1161Budapest

Ottóu.14.

Hungary

16.MARKETINGAUTHORISATIONNUMBER(S)

17.MANUFACTURER’SBATCHNUMBER

Batch:{number}

PACKAGELEAFLET

Ladoxyn/Pulmodox

500mg/ggranulesfororalsolutionforpigs,chickensandturkeys

1.NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERANDOF

THEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFORBATCH

RELEASE,IFDIFFERENT

Marketingauthorisationholder:

LavetPharmaceuticalsLtd.,1161Budapest,Ottóu.14.,Hungary

Manufacturerresponsibleforbatchrelease:

LavetPharmaceuticalsLtd.,2143Kistarcsa,Batthyányu.6.,Hungary

2.NAMEOFTHEVETERINARYMEDICINALPRODUCT

Ladoxyn500mg/ggranulesfororalsolutionforpigs,chickensandturkeys

(inCyprus,CzechRepublic,Denmark,Greece,Hungary,Italy,PortugalandSpain)

Pulmodox500mg/ggranulesfororalsolutionforpigs,chickensandturkeys

(inAustria,France,Germany,SlovakiaandUnitedKingdom)

Doxycycline(ashyclate)

3.STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

Activesubstance: Doxycycline(ashyclate) 500.0mg/g

Yellow,free-flowinggranules.

4.INDICATION(S)

Pigs:treatmentofclinicalrespiratoryinfectionscausedbyMycoplasmahyopneumoniaeand

Pasteurellamultocidasusceptibletodoxycycline.

Chickensandturkeys:treatmentofclinicalrespiratoryinfectionsassociatedwithMycoplasma

gallisepticumsusceptibletodoxycycline.

5.CONTRAINDICATIONS

Donotuseincaseofhypersensitivitytotheactivesubstanceortoanyoftheexcipients.

Donotusewhentetracyclineresistancehasbeendetectedintheherd/flockduetothepotentialfor

crossresistance.

Donotuseinanimalswithhepaticdysfunction.

6.ADVERSEREACTIONS

Asforalltetracyclines,onrareoccasionsallergicreactionsandphotosensitivitymayoccur.If

suspectedadversereactionsoccur,treatmentshouldbediscontinued.Ifyounoticeanyseriouseffects

orothereffectsnotmentionedinthisleaflet,pleaseinformyourveterinarysurgeon.

7.TARGETSPECIES

Pigs(fatteningpigsafterweaning),chickens(broilers,broilerbreeders)andturkeys(broilers,

breeders).

8.DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOFADMINISTRATION

Dosage:

Inpigsandchickens

20.0mgdoxycyclineperkgofbodyweightdaily(equivalentto40.0mgproductperkgofbody

weight),administeredinthedrinkingwaterfor5consecutivedays.

Inturkeys

25mgdoxycyclineperkgofbodyweightdaily(equivalentto50.0mgproductperkgofbody

weight),administeredinthedrinkingwaterfor5consecutivedays.

9.ADVICEONCORRECTADMINISTRATION

Thefollowingdosageadviceshouldbefollowed:

Inpigsandchickens

20.0mgdoxycyclineperkgofbodyweightdaily(equivalentto40.0mgproductperkgofbody

weight),administeredinthedrinkingwaterfor5consecutivedays.

Inturkeys

25mgdoxycyclineperkgofbodyweightdaily(equivalentto50.0mgproductperkgofbody

weight),administeredinthedrinkingwaterfor5consecutivedays.

Administration:

Basedontherecommendeddose,andthenumberandweightoftheanimalstobetreated,theexact

dailyamountoftheproductshouldbecalculatedaccordingtothefollowingformula:

.....mgproductperkgbodyweightper

day x Meanbodyweight

(kg)ofanimalsto

betreated =....mgproductperlitreof

drinkingwater

Meandailywaterconsumption(litreperanimal)

Toensureacorrectdosagebodyweightshouldbedeterminedasaccuratelyaspossible.

Theuptakeofmedicatedwaterisdependantontheclinicalconditionsoftheanimals.Inorderto

obtainthecorrectdosage,theconcentrationindrinkingwatermayhavetobeadjusted.Theuseof

suitablycalibratedweighingequipmentisrecommendedifpartpacksareused.Thedailyamountisto

beaddedtothedrinkingwatersuchthatallmedicationwillbeconsumedin24hours.Medicated

drinkingwatershouldbefreshlypreparedevery24hours.Itisrecommendedtoprepareaconcentrated

pre-solution-approximately100gramsproductperlitredrinkingwater-andtodilutethisfurtherto

therapeuticconcentrations,ifrequired.Themaximumsolubilityoftheproductinwateris72g/L.

Alternatively;theconcentratedsolutioncanbeusedinaproportionalwatermedicator.

Itshouldbeensuredthatallanimalsintendedtotreatshouldhavefreeaccesstothedrinkingfacilities.

Attheendoftreatment,thewateringequipmentshouldbecleanedadequatelytoavoidtheuptakeof

remainingquantitiesinsub-therapeuticdoses.

Themedicatedwatershouldbetheonlysourceofdrinkingwater,throughoutthetreatmentperiod.

Themedicatedwatermustnotbemadeorstoredinametalcontaineranduseinoxidizeddrinking

equipment.SolubilityoftheproductispHdependentanditwillprecipitateifitismixedinanalkaline

solution.

10.WITHDRAWALPERIOD

Meatandoffalofpigs:4days.

Meatandoffalofchickens:5days.

Meatandoffalofturkeys:12days.

Notpermittedforuseinlayingbirdsproducingeggsforhumanconsumption.

11.SPECIALSTORAGEPRECAUTIONS

Keepoutofthereachandsightofchildren.

Donotstoreabove25

C.

Storeintheoriginalcontainertightlyclosedinordertoprotectfrommoisture.

Donotuseaftertheexpirydatestatedonthelabel.

Shelf-lifeafterfirstopeningthecontainer:3months.

Shelf-lifeafterdilutionorreconstitutionaccordingtodirections:24hours.

12.SPECIALWARNING(S)

Specialprecautionsforuseinanimals

Duringthetargetanimaltolerancestudy,noadverseeffectwasobservedevenatthefivefold

therapeuticdoseadministeredfortwotimestherecommendeddurationineithertargetanimalspecies.

Ifsuspectedtoxicreactionsdooccurduetoextremeoverdose,themedicationshouldbediscontinued

andappropriatesymptomatictreatmentshouldbeinitiatedifnecessary.

Theuptakeofmedicationbyanimalscanbealteredasaconsequenceofillness.Incaseofinsufficient

uptakeofwater,animalsshouldbetreatedparenterally.

Inappropriateuseoftheproductmayincreasetheprevalenceofbacteriaresistanttotetracyclinedueto

thepotentialforcrossresistance.

Duetovariability(time,geographical)insusceptibilityofbacteriafordoxycycline,bacteriological

samplingandsusceptibilitytestingofmicro-organismsfromdiseasedanimalsonfarmarehighly

recommended.

AhighresistancerateofE.coli,isolatedfromchickens,againsttetracyclineshasbeendocumented.

ThereforetheproductshouldbeusedforthetreatmentofinfectionscausedbyE.colionlyafter

susceptibilitytestinghasbeencarriedout.

Aseradicationofthetargetpathogensmaynotbeachieved,medicationshouldthereforebecombined

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

Laboratorystudiesinratsandrabbitshavenotproducedanyevidenceofateratogenic,foetotoxic,

maternotoxiceffects.

Thesafetyoftheproducthasnotbeenestablishedinpregnantorlactatingsows.Theuseisnot

recommendedduringpregnancyandlactation.

Donotuseinbirdsinlayandwithin4weeksbeforetheonsetofthelayingperiod.

DonotadministerconcurrentlywithfeedoverloadedwithpolyvalentcationssuchasCa 2+ ,Mg 2+ ,Zn 2+

andFe 3+ becausetheformationofdoxycyclinecomplexeswiththesecationsispossible.Donot

administertogetherwithantacids,kaolinandironpreparationsastetracyclinesarebacteriostatic

antimicrobials,donotadministerinconjunctionwithbactericidalantibioticslikebeta-lactames.Itis

advisedthattheintervalbetweenadministrationofotherproductscontainingpolyvalentcationsshould

be1-2hoursbecausetheylimittheabsorptionoftetracycline.

Doxycyclineincreasestheactionofanticoagulants.

Doxycyclinemayforminsolublecomplexeswithdivalentions,especiallyironorcalcium,zincand

magnesium.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproductto

animals

Directcontactoftheproductwiththeskin,eyesandmucousmembranesshouldbeavoided.

Peoplewithknownhypersensitivitytotetracyclinesshouldavoidcontactwiththeveterinarymedicinal

product.

Wearprotectiveglovesandgoggleswhenreconstitutingoradministeringthesolution.Washexposed

skinafterpreparation.Incaseofaccidentalprojectionintotheeyes,rinseabundantlywithwater.Do

notsmoke,eatordrinkwhenhandlingtheproduct.

Incaseofaccidentalingestion,seekmedicaladviceimmediatelyandshowthepackageleafletorthe

labeltothephysician.Inflammationoftheface,lipsoreyesorrespiratorydifficultiesarethemost

serioussignswhichrequireurgentmedicalattention.

13.SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTORWASTE

MATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.

Medicinesshouldnotbedisposedofviawastewaterorhouseholdwaste.

Askyourveterinarysurgeonhowtodisposeofmedicinesnolongerrequired.Thesemeasuresshould

helptoprotecttheenvironment.

14.DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

15.OTHERINFORMATION

Packsizes:

100gpolypropylenecontainerwithpolypropylenelidandinnerbagofLDPE.

1kgroundpolypropylenecontainerwithpolypropylenelidandinnerbagofLDPE.

1kgsquarepolypropylenecontainerwithpolypropylenelidandinnerbagofLDPE.

5kgroundpolypropylenecontainerwithpolypropylenelidandinnerbagofLDPE.

5kgsquarepolypropylenecontainerwithpolypropylenelidandinnerbagofLDPE.

Notallpacksizesmaybemarketed.

Foranyinformationaboutthisveterinarymedicinalproduct,pleasecontactthelocalrepresentativeof

themarketingauthorisationholder.

OntheUKpackageleaflet:

Whenthecontainerisopenedforthefirsttime,usingthein-useshelf-lifewhichisspecifiedonthis

packageleaflet,thedateonwhichanyproductremaininginthecontainershouldbediscardedshould

beworkedout.Thisdiscarddateshouldbewritteninthespaceprovidedonthelabel.

14-12-2018

Analysis of hunting statistics collection frameworks for wild boar across Europe and proposals for improving the harmonisation of data collection

Analysis of hunting statistics collection frameworks for wild boar across Europe and proposals for improving the harmonisation of data collection

Published on: Thu, 13 Dec 2018 Heterogeneities in the wild boar data collection frameworks across Europe were analysed using questionnaires to explore comparability of hunting data in the short term and propose a common framework for future collection. Fifty‐seven respondents representing 32 countries covering more than 95% of European territory participated to the questionnaire. The most frequently recorded information in the official statistics included the quantity of animals shot per hunting ground ...

Europe - EFSA - European Food Safety Authority Publications

27-11-2018

INNUENDO: A cross‐sectoral platform for the integration of genomics in the surveillance of food‐borne pathogens

INNUENDO: A cross‐sectoral platform for the integration of genomics in the surveillance of food‐borne pathogens

Published on: Mon, 26 Nov 2018 Abstract In response to the EFSA call New approaches in identifying and characterizing microbial and chemical hazards, the project INNUENDO (https://sites.google.com/site/theinnuendoproject/) aimed to design an analytical platform and standard procedures for the use of whole‐genome sequencing in surveillance and outbreak investigation of food‐borne pathogens. The project firstly attempted to identify existing flaws and needs, and then to provide applicable cross‐sectorial ...

Europe - EFSA - European Food Safety Authority Publications

23-11-2018

FDA Classifies Field Action Related to Fc 500™ And Epics® As Class 1 Recall Beckman Coulter Life Sciences Committed to Helping Customers Take Prompt, Appropriate Actions

FDA Classifies Field Action Related to Fc 500™ And Epics® As Class 1 Recall Beckman Coulter Life Sciences Committed to Helping Customers Take Prompt, Appropriate Actions

Beckman Coulter Life Sciences today announced the previously communicated global voluntary recall launched in January 2018 related to the FC 500™ Series Flow Cytometers (FC 500), COULTER® EPICS® XL™ and COULTER® EPICS® XL-MCL™ Flow Cytometer with System II Software (together referred to as the EPICS) has been classified as Class 1 by the U.S. Food and Drug Administration (FDA).

FDA - U.S. Food and Drug Administration

22-11-2018

Foreign Product Alert: Black Ant King tablets, Gold Viagra 9800mg capsules, LIPRO Dietary capsules, Stree Overlord Strong tablets (pills), Vegetal Vigra capsules, ViaGro 500mg Male Enhancement capsules

Foreign Product Alert: Black Ant King tablets, Gold Viagra 9800mg capsules, LIPRO Dietary capsules, Stree Overlord Strong tablets (pills), Vegetal Vigra capsules, ViaGro 500mg Male Enhancement capsules

These foreign health products have been found by regulators in other countries to contain undeclared drug ingredients.

Health Canada

31-10-2018

Efficacy of Bergazym® P100 (endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening and weaned piglets

Efficacy of Bergazym® P100 (endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening and weaned piglets

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The product Bergazym® P100 contains a xylanase which is produced by a non‐genetically modified strain of Trichoderma reesei. The additive is available in a coated granular form and it is intended to be used as a zootechnical additive (functional group: digestibility enhancers) for chickens for fattening, and weaned piglets at the dose of 1,500 EPU/kg feed. The production strain and the additive were fully characterised in a previous assessment of the Panel o...

Europe - EFSA - European Food Safety Authority Publications

24-10-2018

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

Published on: Tue, 23 Oct 2018 00:00:00 +0200 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 the safety and efficacy of HOSTAZYM® X as a feed additive for sows in order to have benefit in piglets. The additive HOSTAZYM® X contains endo‐1,4‐beta‐xylanase and is available in liquid and solid formulations. This product is authorised as a feed additive for chickens for fattening, tu...

Europe - EFSA - European Food Safety Authority Publications

1-10-2018

Public Notification: FX75000 contains hidden drug ingredient

Public Notification: FX75000 contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use FX75000, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

29-8-2018

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Published on: Thu, 16 Aug 2018 00:00:00 +0200 4,15‐Diacetoxyscirpenol (DAS) is a mycotoxin primarily produced by Fusarium fungi and occurring predominantly in cereal grains. As requested by the European Commission, the EFSA Panel on Contaminants in the Food Chain (CONTAM) assessed the risk of DAS to human and animal health related to its presence in food and feed. Very limited information was available on toxicity and on toxicokinetics in experimental and farm animals. Due to the limitations in the avai...

Europe - EFSA - European Food Safety Authority Publications

31-7-2018

Public Notification: Black Rhino 25000 contains hidden drug ingredient

Public Notification: Black Rhino 25000 contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Black Rhino 25000, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

31-7-2018

Public Notification: Krazzy Rhino 25000 contains hidden drug ingredient

Public Notification: Krazzy Rhino 25000 contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Krazzy Rhino 25000, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

31-7-2018

Public Notification: Gold Rhino 25000 contains hidden drug ingredient

Public Notification: Gold Rhino 25000 contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Gold Rhino 25000, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

31-7-2018

Public Notification: Platinum Rhino 25000 contains hidden drug ingredient

Public Notification: Platinum Rhino 25000 contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Platinum Rhino 25000, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

13-7-2018

Hospira Issues Voluntary Nationwide Recall of Daptomycin for Injection Lyophilized Powder for Solution, Due to Infusion Reactions

Hospira Issues Voluntary Nationwide Recall of Daptomycin for Injection Lyophilized Powder for Solution, Due to Infusion Reactions

Hospira, Inc., a Pfizer company, is voluntarily recalling 8 lots of Hospira’s Daptomycin for Injection 500 mg, Lyophilized Powder For Solution, Single Dose Vial (NDC 0409-0106-01) to the Hospital/Retail level. The product is being recalled due to adverse event reports indicative of infusion reactions.

FDA - U.S. Food and Drug Administration

26-6-2018

Huish Outdoors recalls Oceanic and Hollis Scuba Diving Regulators

Huish Outdoors recalls Oceanic and Hollis Scuba Diving Regulators

The scuba diving regulators can restrict airflow at low tank pressures (below 500 psi), posing a drowning hazard to divers.

Health Canada

25-6-2018

FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy

FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy

FDA approved Epidiolex (cannabidiol) oral solution, the first drug comprised of an active ingredient derived from marijuana, to treat two rare and severe forms of epilepsy.

FDA - U.S. Food and Drug Administration

22-6-2018

Metronidazole intravenous infusion 500 mg/100 mL bag

Metronidazole intravenous infusion 500 mg/100 mL bag

Shortage and althernative supply of Metronidazole intravenous infusion 500 mg/100 mL bag

Therapeutic Goods Administration - Australia

20-6-2018

Public Notification: Black Stallion 35000 contains hidden drug ingredient

Public Notification: Black Stallion 35000 contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Black Stallion 35000, a product promoted for sexual enhancement. This product was identified by FDA during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

24-5-2018

FDA Approves Semintra, the First FDA-approved Animal Drug for the Control of Systemic Hypertension in Cats

FDA Approves Semintra, the First FDA-approved Animal Drug for the Control of Systemic Hypertension in Cats

The FDA has approved Semintra (telmisartan oral solution), the first FDA-approved animal drug to control systemic hypertension in cats. Semintra is an oral solution administered either directly into the cat’s mouth or on top of a small amount of food.

FDA - U.S. Food and Drug Administration

21-5-2018

Melanie Wholesale Inc. Issues Allergy Alert on Undeclared Peanuts in Melanie Mini Cookies with Caramel Flavor

Melanie Wholesale Inc. Issues Allergy Alert on Undeclared Peanuts in Melanie Mini Cookies with Caramel Flavor

Melanie Wholesale Inc. of Brooklyn, NY is recalling its 17.6 oz (500g) package of “Melanie Mini Cookies with Caramel Flavor”, because they contain undeclared peanuts. People who have allergies to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

21-5-2018

Melanie Wholesale Issues Allergy Alert on Undeclared Peanuts in Cookies

Melanie Wholesale Issues Allergy Alert on Undeclared Peanuts in Cookies

Melanie Wholesale Inc. of Brooklyn, NY is recalling its 17.6 oz (500g) package of “Melanie Liubitelskie Cookies”, because they contain undeclared peanuts. People who have allergies to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

17-5-2018

Shoreside Enterprises Issues Voluntary Nationwide Recall of 7K and Poseidon 4500 (Extreme 1000 Mg) Due to Presence of Undeclared Sildenafil and Tadalafil

Shoreside Enterprises Issues Voluntary Nationwide Recall of 7K and Poseidon 4500 (Extreme 1000 Mg) Due to Presence of Undeclared Sildenafil and Tadalafil

Shoreside Enterprises, Inc. is voluntarily recalling 7K (Lot specific: Lot #RO) and Poseidon 4500 (Extreme 1000 mg) (Lot specific: Lot #20117BL) to the consumer level. FDA analysis found the samples of these products to contain undeclared Sildenafil and/or Tadalafil. Sildenafil and Tadalafil are active ingredients in two FDA-approved prescription drugs used for the treatment of erectile dysfunction (ED).

FDA - U.S. Food and Drug Administration

18-4-2018

ViaGro 500mg Male Enhancement capsules

ViaGro 500mg Male Enhancement capsules

Safety advisory

Therapeutic Goods Administration - Australia

14-4-2018

'Rhino 69 Extreme 50000' Recalled due to Presence of Active Ingredient 'Tadalafil'

'Rhino 69 Extreme 50000' Recalled due to Presence of Active Ingredient 'Tadalafil'

AMA Wholesale Inc. (Distributor/Re-seller), is voluntarily recalling Rhino 69 Extreme 50000 capsules to the consumer level. FDA analysis found the product to be tainted with undeclared tadalafil. Tadalafil is an active ingredient in a FDA-approved prescription drug that is used for erectile dysfunction.

FDA - U.S. Food and Drug Administration

28-3-2018

Public Notification: Rhino 69 Extreme 50000 contains hidden drug ingredient

Public Notification: Rhino 69 Extreme 50000 contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Rhino 69 Extreme 50000, a product promoted and sold for sexual enhancement on various websites, including www.bonanza.com, and possibly in some retail stores.

FDA - U.S. Food and Drug Administration

14-12-2017

Marmex Corp Issues Voluntary Nationwide Recall Of Blue Pearl All Natural Male Enhancement Supplement, Due To Undeclared Sildenafil

Marmex Corp Issues Voluntary Nationwide Recall Of Blue Pearl All Natural Male Enhancement Supplement, Due To Undeclared Sildenafil

Orange, CA, Marmex Corp is voluntarily recalling All lots of Blue Pearl All Natural Male Enhancement Supplement, 500mg to the consumer level. FDA analysis has found the products to contain sildenafil.

FDA - U.S. Food and Drug Administration

25-9-2017

Global operation against illegal medicines

Global operation against illegal medicines

A global operation against illegal medicines has been completed. 123 countries participated, and the operation resulted in 354 arrests or further investigations and the suspension of more than 3,500 websites.

Danish Medicines Agency

20-11-2018

.@US_FDA issues Class I Medical Device Recall, the most serious type of recall: Beckman Coulter Life Sciences Beckman Coulter Life Sciences recalls the FC500 Series Flow Cytometers and EPICS XL Series Flow Cytometers. Find out more:  https://go.usa.gov/xP

.@US_FDA issues Class I Medical Device Recall, the most serious type of recall: Beckman Coulter Life Sciences Beckman Coulter Life Sciences recalls the FC500 Series Flow Cytometers and EPICS XL Series Flow Cytometers. Find out more: https://go.usa.gov/xP

. @US_FDA issues Class I Medical Device Recall, the most serious type of recall: Beckman Coulter Life Sciences Beckman Coulter Life Sciences recalls the FC500 Series Flow Cytometers and EPICS XL Series Flow Cytometers. Find out more: https://go.usa.gov/xPAtn  #MedicalDevice #FDA pic.twitter.com/6e064UQ2wg

FDA - U.S. Food and Drug Administration