Doxyval 500 mg/g, oraal poeder voor gebruik in drinkwater

Main information

  • Trade name:
  • Doxyval 500 mg/g, oraal poeder voor gebruik in drinkwater
  • Pharmaceutical form:
  • Oral powder
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Doxyval 500 mg/g, oraal poeder voor gebruik in drinkwater
    France
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • NL/V/0153/001
  • Authorization date:
  • 17-02-2012
  • EU code:
  • NL/V/0153/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Doxyval500mg/gpowderforuseindrinkingwaterforsows,broilerbreedersandlayinghens

Sogedoxy500mg/gpowderforuseindrinkingwaterforsows,broilerbreedersandlayinghens(CZ)

DoxyvalVet(DK)

Doxyval433mg/gpowderforuseindrinkingwaterforsows,broilerbreedersandlayinghens(FR)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Compositionfor1g:

Activesubstance:

Doxycyclinehyclate 500mg

(equivalentto433mgdoxycyclinebase)

Excipients:

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Powderforuseindrinkingwater.

Yellowtopaleyellowpowder.

4. CLINICALPARTICULARS

4.1 Targetspecies

Sows,broilerbreedersandlayinghens.

4.2 Indicationsforuse,specifyingthetargetspecies

Sows:

Treatmentofinfectionscausedbymicro-organismsthataresusceptibletodoxycyclinesuchas:

AtrophicrhinitiscausedbyPasteurellaspp.andBordetellabronchiseptica;

BronchialpneumoniacausedbyPasteurellamultocida,StreptococcussuisandMycoplasma

hyorhinis;

PleuropneumoniacausedbyActinobacilluspleuropneumoniae.

Broilerbreedersandlayinghens:

PasteurellosiscausedbyPasteurellamultocida;

RespiratoryinfectionscausedbyOrnithobacteriumrhinotracheale(ORT).

Thepresenceofthediseaseintheherdshouldbeestablishedbeforetreatment.

4.3 Contraindications

Donotuseincaseofhypersensitivitytotetracyclines;

Donotuseinanimalswithrenalorhepaticdisorders;

Donotuseincaseofknownresistancetotetracyclines.

4.4 Specialwarningsforeachtargetspecies

Sickanimalsmayhaveareducedappetiteandanaltereddrinkingpatternandshould,ifnecessary,be

medicatedparenterally.

Incasesofalteredfoodordrinkingwateruptake,theconcentrationsshouldbeadjustedinsuchaway

thattherecommendeddosageisachieved.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Useoftheproductshouldbebasedonsusceptibilitytestingofthebacteriaisolatedfromtheanimal.If

thisisnotpossible,therapyshouldbebasedonlocal(regionalandfarmlevel)epidemiological

informationaboutsusceptibilityofthetargetbacteriaaswellasbytakingintoaccountofficialnational

antimicrobialpolicies.

Inappropriateuseoftheproduct,e.g.toolowadosage,mayincreasetheprevalenceofbacteria

resistanttodoxycyclineandmaydecreasetheeffectivenessoftreatmentwithothertetracyclinesdue

tothepotentialforcross-resistance.

Aseradicationofthetargetpathogensmaynotbeachieved,medicationshouldbecombinedwithgood

managementpractices,e.g.goodhygiene,properventilation,nooverstocking.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Tetracyclinesmay-inrarecases-inducephotosensitivityandallergicreactions.

Donothandlethisproductifyouarehypersensitivetotetracyclines.

Thisproductmaybeirritatingafterskincontact,eyecontactorinhalationaswellascausehepatotoxic

effects.Avoidcontactwithskin,eyesandmucousmembranes.Avoidinhalation.

Wearprotectivegloves,safetyglassesanddustmask.Donotsmoke,eatordrinkwhilehandlingthis

product.Washhandsafteruse.

Incaseofaccidentalskincontact,washimmediatelywithplentyofwater.Incaseofaccidentaleye

contact,rinseimmediatelywithcopiousamountsoffreshwaterandseekmedicaladvice.

Ifsymptomsshouldappear,seekmedicaladviceimmediatelyandshowthelabeltothephysician.

Swellingoftheface,lipsoreyesorrespiratorydifficultiesarethemostserioussignswhichrequire

urgentmedicalattention.

Thisproductmayhaveanadverseeffectonthedevelopingfoetusandyoungchildren(hepatotoxicity

andreducedbonegrowth).

Donothandlewhenpregnantorbreast-feeding.

Preventchildrenfromcontactwithemptybags.

4.6 Adversereactions(frequencyandseriousness)

Inrarecasestetracyclinesmayinducephotosensitivityandallergicreactions.Intestinalfloramaybe

affectediftreatmentisveryprolonged,andthismayresultindigestivedisturbance.Ifsuspected

adversereactionsoccur,treatmentshouldbediscontinued.

4.7 Useduringpregnancy,lactationorlay

Doxycyclinehasalowaffinityforcomplexformationwithcalcium,andstudieshaveshownthat

doxycycline(virtually)hasnoeffectonskeletalformation.

Afteradministrationoftherapeuticdosesofdoxycycline,nonegativeeffectswereobservedinpoultry.

Laboratorystudieshavenotproducedanyevidenceofateratogenic,foetotoxicormaternotoxiceffect.

Intheabsenceofspecificstudiestheuseoftheproductisnotrecommendedduringpregnancyor

lactation.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Absorptionofdoxycyclinecanbedecreasedinthepresenceofhighquantitiesofcalcium,iron,

magnesiumoraluminiuminthediet.Donotadministertogetherwithantacids,kaolinandiron

preparations.

Itisadvisedthattheintervalbetweentheadministrationsofotherproductscontainingpolyvalent

cationsshouldbe1-2hoursbecausetheylimittheabsorptionoftetracyclines.

Doxycyclineincreasestheactionofanticoagulants.

ThesolubilityoftheproductispHdependentanditwillprecipitateifmixedinalkalinesolution.

Donotstorethedrinkingwaterinmetalliccontainers.

4.9 Amountstobeadministeredandadministrationroute

Administrationroute:Indrinkingwateruse.

Sows:

10mgdoxycyclinehyclate/kgbw/dayfor3-4days,correspondingto0.2goftheproductper10

kgbwor0.2goftheproductperlitreofdrinkingwater/dayfor3-4days,basedonawater

consumptionof1litreper10kgofbodyweight/day.

Broilerbreedersandlayinghens:

Pasteurellosis:10mgdoxycyclinehyclate/kgbw/dayfor3-4days,correspondingto0.1gofthe

productperlitreofdrinkingwater/dayfor3-4days,basedonawaterconsumptionof1litreper

5kgofbodyweight/day.

ORT:20mgdoxycyclinehyclate/kgbw/dayfor3-4days,correspondingto0.2goftheproduct

perlitreofdrinkingwater/dayfor3-4days,basedonawaterconsumptionof1litreper5kgof

bodyweight/day.

Basedontherecommendeddose,andthenumberandweightoftheanimalstobetreated,theexact

amountoftheproductshouldbecalculatedaccordingtothefollowingformula:

.....mgproduct/kgbody

weight/day x meanbodyweight(kg)ofanimals

tobetreated =....mgproductperl

drinkingwater

meandailywaterconsumption(l)peranimal

Toensureacorrectdosagebodyweightshouldbedeterminedasaccuratelyaspossible.

Theuptakeofmedicatedwaterisdependentontheclinicalconditionoftheanimals.Inordertoobtain

thecorrectdosage,theconcentrationindrinkingwatermayhavetobeadjusted.

Theuseofsuitablycalibratedweighingequipmentisrecommendedifpartpacksareused.Thedaily

amountistobeaddedtothedrinkingwatersuchthatallmedicationwillbeconsumedin24hours.

Medicateddrinkingwatershouldbefreshlypreparedevery24hours.Itisrecommendedtopreparea

concentratedpre-solution-approximately100gramsproductperlitredrinkingwater-andtodilutethis

furthertotherapeuticconcentrationsifrequired.Alternatively,theconcentratedsolutioncanbeusedin

aproportionalwatermedicator.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Poultryandpigstoleratetwo-foldoverdosesofdoxycycline(40and20mg/kgrespectively)withoutany

clinicaleffect.

4.11Withdrawalperiod(s)

Sows:

Meatandoffal:5days.

Broilerbreedersandlayinghens:

Meatandoffal:5daysincasesof10mg/kgbwforamaximumof4days.

Meatandoffal:12daysincasesof20mg/kgbwforamaximumof4days.

Notauthorisedforuseinlayingchickensproducingeggsforhumanconsumption.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antiinfectivesforsystemicuse,antibacterialsforsystemicuse,

tetracycline,doxycycline

ATCvetcode:QJ01AA02

5.1 Pharmacodynamicproperties

Thesiteofactionofthetetracyclinesisthebacterialribosome,withatleasttwoprocessesbeing

necessaryfortheseantibioticsinordertoreachtheseribosomes.Thefirstinvolvespassagethrough

theoutercellmembraneofGram-negativebacteria.Theolder-generationtetracyclinesarethoughtto

findtheirwaythroughproteinformedpores,butonaccountofgreaterlipophilicitydoxycyclineis

thoughttodiffusedirectlythroughthelipiddoublelayer.Thesecondprocessinvolvespassagethrough

thecytoplasmicmembraneofGram-negativeandGram-positivebacteria.Thisisanenergy-dependent

transportmechanismthatcanprobablytakeplacebymeansofprotein-carriermolecules.Finally,the

tetracyclinesbindforthemostpartreversiblytothe30Sribosomes,asaresultofwhichthebindingof

transferRNAtothemessengerRNAisprevented.Thereversiblebindingtothe30Sribosomesis

probablyresponsiblefortheantibacterialeffectasaresultofinhibitionofproteinsynthesis,which

resultsinabacteriostaticeffect.

5.2 Pharmacokineticparticulars

Absorption:

Theabsorptionofdoxycyclinetakesplacerapidlyandalmostcompletelyinthestomachandthefirst

partofthesmallintestine.Comparedwiththeoldertetracyclines,theabsorptionofdoxycyclineis

influencedtoafarlesserdegreebythepresenceoffood,andalsothepresenceofcalciumandzinc

ionscauselessdelayinabsorption,whilethechelateformationwithdivalentironisthoughttocause

moredelay.

Distribution:

Doxycyclinehasgoodliposolubilityandpenetratesintovirtuallyalltissues.

Elimination:

Theeliminationofdoxycyclinetakesplacepredominantlyinunchangedforminthefaeces.

Doxycyclineundergoesvirtuallynometabolism.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Silicacolloidalanhydrous

Citricacidanhydrous

6.2 Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixedwithother

veterinarymedicinalproducts.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years.

Shelf-lifeafterfirstopeningtheimmediatepackaging:12months.

Shelf-lifeafterdilutionorreconstitutionaccordingtodirections:24hoursafterdilutionindrinkingwater.

6.4.Specialprecautionsforstorage

Thisveterinarymedicinalproductdoesnotrequireanyspecialconditions.

6.5 Natureandcompositionofimmediatepackaging

Natureofcontainer:

Bagsformedbypolyester,aluminiumandpolyethylene.

Packagesizes:

100g,100x10g,1000gand2500g.

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productshouldbedisposedofinaccordancewithlocalrequirements

7. MARKETINGAUTHORISATIONHOLDER

SOGEVAL

RoutedeMayenne–ZoneIndustrielledesTouches

53000Laval

France

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

<{DD/MM/YYYY}><{DDmonthYYYY}>…

10 DATEOFREVISIONOFTHETEXT

{MM/YYYY}or<monthYYYY>

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable.

PRODUCTLITERATURE

<PARTICULARSTOAPPEARONTHEOUTERPACKAGE>

CARTONBOX:10X100g

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Doxyval500mg/gpowderforuseindrinkingwaterforsows,broilerbreedersandlayinghens

Doxycyclinehyclate

Sogedoxy500mg/gpowderforuseindrinkingwaterforsows,broilerbreedersandlayinghens(CZ)

Doxycyclinehyclate

DoxyvalVet(DK)

Doxycyclinehyclate

Doxyval433mg/gpowderforuseindrinkingwaterforsows,broilerbreedersandlayinghens(FR)

Doxycyclinehyclate

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

1gofpowdercontains500mgofdoxycyclinehyclate

(equivalentto433mgdoxycyclinebase)

3. PHARMACEUTICALFORM

Yellowtopaleyellowpowderforuseindrinkingwater.

4. PACKAGESIZE

10x100g

5. TARGETSPECIES

Sows,broilerbreedersandlayinghens.

6. INDICATION(S)

Sows:

Treatmentofinfectionscausedbymicro-organismsthataresusceptibletodoxycyclinesuchas:

AtrophicrhinitiscausedbyPasteurellaspp.andBordetellabronchiseptica;

BronchialpneumoniacausedbyPasteurellamultocida,StreptococcussuisandMycoplasma

hyorhinis;

PleuropneumoniacausedbyActinobacilluspleuropneumoniae.

Broilerbreedersandlayinghens:

PasteurellosiscausedbyPasteurellamultocida;

RespiratoryinfectionscausedbyOrnithobacteriumrhinotracheale(ORT).

Thepresenceofthediseaseintheherdshouldbeestablishedbeforetreatment.

7. METHODANDROUTE(S)OFADMINISTRATION

Administrationroute:Indrinkingwateruse.

Sows:10mgdoxycyclinehyclateperkgbw/dayfor3-4days

Broilerbreedersandlayinghens

Pasteurellosis:10mgdoxycyclinehyclateperkgbw/dayfor3-4days

ORT:20mgdoxycyclinehyclateperkgbw/dayfor3-4days.

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Sows:

Meatandoffal:5days.

Broilerbreedersandlayinghens:

Meatandoffal:5daysincasesof10mg/kgbwforamaximumof4days.

Meatandoffal:12daysincasesof20mg/kgbwforamaximumof4days.

Notauthorisedforuseinlayingchickensproducingeggsforhumanconsumption.

9. SPECIALWARNING(S),IFNECESSARY

-------

10. EXPIRYDATE

EXP{month/year}

Shelf-lifeafterfirstopeningtheimmediatepackaging:12months.

Shelf-lifeafterdilutionindrinkingwater:24hours.

11. SPECIALSTORAGECONDITIONS

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productshouldbedisposedofinaccordancewithlocalrequirements.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly.Tobesuppliedonlyonveterinaryprescription.

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

MarkeyingAuthorisationHolder

SOGEVAL

RoutedeMayenne–ZoneIndustrielledesTouches

53000Laval

France

Manufacturerforthebatchrelease

DIVASA-FARMAVICS.A.

Ctra.SantHipòlit,km71

08503Gurb-Vic

Barcelona(Spain)

16. MARKETINGAUTHORISATIONNUMBER(S)

-------

17. MANUFACTURER’SBATCHNUMBER

Batch{number}

<PARTICULARSTOAPPEARONTHEINMEDIATEPACKAGE>

LABEL/LEAFLET:BAGof100g,1kgAND2.5kg

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERAND

OFTHEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFOR

BATCHRELEASE,IFDIFFERENT

Marketingauthorisationholder:

SOGEVAL

RoutedeMayenne–ZoneIndustrielledesTouches

53000Laval

France

Manufacturerforthebatchrelease

DIVASA-FARMAVICS.A.

Ctra.SantHipòlit,km71

08503Gurb-Vic

Barcelona(Spain)

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Doxyval500mg/gpowderforuseindrinkingwaterforsows,broilerbreedersandlayinghens

Doxycyclinehyclate

Sogedoxy500mg/gpowderforuseindrinkingwaterforsows,broilerbreedersandlayinghens(CZ)

Doxycyclinehyclate

DoxyvalVet(DK)

Doxycyclinehyclate

Doxyval433mg/gpowderforuseindrinkingwaterforsows,broilerbreedersandlayinghens(FR)

Doxycyclinehyclate

3. STATEMENTOFTHEACTIVESUBSTANCEANDOTHERINGREDIENTS

1gofpowdercontains500mgofdoxycyclinehyclate(equivalentto433mgdoxycyclinebase)

4. INDICATIONS

Sows:

Treatmentofinfectionscausedbymicro-organismsthataresusceptibletodoxycyclinesuchas:

AtrophicrhinitiscausedbyPasteurellaspp.andBordetellabronchiseptica;

BronchialpneumoniacausedbyPasteurellamultocida,StreptococcussuisandMycoplasma

hyorhinis;

PleuropneumoniacausedbyActinobacilluspleuropneumoniae.

Broilerbreedersandlayinghens:

PasteurellosiscausedbyPasteurellamultocida;

RespiratoryinfectionscausedbyOrnithobacteriumrhinotracheale(ORT).

Thepresenceofthediseaseintheherdshouldbeestablishedbeforetreatment.

5. CONTRAINDICATIONS

Donotuseincaseofhypersensitivitytotetracyclines;

Donotuseinanimalswithrenalorhepaticdisorders;

Donotuseincaseofknownresistancetotetracyclines.

6. ADVERSEREACTIONS

Inrarecasestetracyclinesmayinducephotosensitivityandallergicreactions.Intestinalfloramaybe

affectediftreatmentisveryprolonged,andthismayresultindigestivedisturbance.Ifsuspected

adversereactionsoccur,treatmentshouldbediscontinued.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinformyour

veterinarysurgeon.

7. TARGETSPECIES

Sows,broilerbreedersandlayinghens.

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOF

ADMINISTRATION

Administrationroute:Indrinkingwateruse.

Sows:

10mgdoxycyclinehyclate/kgbw/dayfor3-4days,correspondingto0.2goftheproductper10

kgbwor0.2goftheproductperlitreofdrinkingwater/dayfor3-4days,basedonawater

consumptionof1litreper10kgofbodyweight/day.

Broilerbreedersandlayinghens:

Pasteurellosis:10mgdoxycyclinehyclate/kgbw/dayfor3-4days,correspondingto0.1gofthe

productperlitreofdrinkingwater/dayfor3-4days,basedonawaterconsumptionof1litreper

5kgofbodyweight/day.

ORT:20mgdoxycyclinehyclate/kgbw/dayfor3-4days,correspondingto0.2goftheproduct

perlitreofdrinkingwater/dayfor3-4days,basedonawaterconsumptionof1litreper5kgof

bodyweight/day.

Basedontherecommendeddose,andthenumberandweightoftheanimalstobetreated,theexact

amountoftheproductshouldbecalculatedaccordingtothefollowingformula:

.....mgproduct/kgbody

weight/day x meanbodyweight(kg)ofanimals

tobetreated =....mgproductperl

drinkingwater

meandailywaterconsumption(l)peranimal

Toensureacorrectdosagebodyweightshouldbedeterminedasaccuratelyaspossible.

Theuptakeofmedicatedwaterisdependentontheclinicalconditionoftheanimals.Inordertoobtain

thecorrectdosage,theconcentrationindrinkingwatermayhavetobeadjusted.

Theuseofsuitablycalibratedweighingequipmentisrecommendedifpartpacksareused.Thedaily

amountistobeaddedtothedrinkingwatersuchthatallmedicationwillbeconsumedin24hours.

Medicateddrinkingwatershouldbefreshlypreparedevery24hours.Itisrecommendedtopreparea

concentratedpre-solution-approximately100gramsproductperlitredrinkingwater-andtodilutethis

furthertotherapeuticconcentrationsifrequired.Alternatively,theconcentratedsolutioncanbeusedin

aproportionalwatermedicator.

9. ADVICEONCORRECTADMINISTRATION

10. WITHDRAWALPERIOD(S)

Sows:

Meatandoffal:5days.

Broilerbreedersandlayinghens:

Meatandoffal:5daysincasesof10mg/kgbwforamaximumof4days.

Meatandoffal:12daysincasesof20mg/kgbwforamaximumof4days.

Notauthorisedforuseinlayingchickensproducingeggsforhumanconsumption.

11. SPECIALSTORAGEPRECAUTIONS

Keepoutofthereachandsightofchildren.

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

Donotuseaftertheexpirydatestatedonthelabel.

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years.

Shelf-lifeafterfirstopeningtheimmediatepackaging:12months.

Shelf-lifeafterdilutionorreconstitutionaccordingtodirections:24hoursafterdilutionindrinkingwater.

12. SPECIALWARNINGS

Specialwarningforeachtargetspecies

Sickanimalsmayhaveareducedappetiteandanaltereddrinkingpatternandshould,ifnecessary,be

medicatedparenterally.

Incasesofalteredfoodordrinkingwateruptake,theconcentrationsshouldbeadjustedinsuchaway

thattherecommendeddosageisachieved.

Specialprecautionsforuseinanimals

Useoftheproductshouldbebasedonsusceptibilitytestingofthebacteriaisolatedfromtheanimal.If

thisisnotpossible,therapyshouldbebasedonlocal(regionalandfarmlevel)epidemiological

informationaboutsusceptibilityofthetargetbacteriaaswellasbytakingintoaccountofficialnational

antimicrobialpolicies.

Inappropriateuseoftheproduct,e.g.toolowadosage,mayincreasetheprevalenceofbacteria

resistanttodoxycyclineandmaydecreasetheeffectivenessoftreatmentwithothertetracyclinesdue

tothepotentialforcross-resistance.

Aseradicationofthetargetpathogensmaynotbeachieved,medicationshouldbecombinedwithgood

managementpractices,e.g.goodhygiene,properventilation,nooverstocking.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Tetracyclinesmay-inrarecases-inducephotosensitivityandallergicreactions.

Donothandlethisproductifyouarehypersensitivetotetracyclines.

Thisproductmaybeirritatingafterskincontact,eyecontactorinhalationaswellascausehepatotoxic

effects.Avoidcontactwithskin,eyesandmucousmembranes.Avoidinhalation.

Wearprotectivegloves,safetyglassesanddustmask.Donotsmoke,eatordrinkwhilehandlingthis

product.Washhandsafteruse.

Incaseofaccidentalskincontact,washimmediatelywithplentyofwater.Incaseofaccidentaleye

contact,rinseimmediatelywithcopiousamountsoffreshwaterandseekmedicaladvice.

Ifsymptomsshouldappear,seekmedicaladviceimmediatelyandshowthelabeltothephysician.

Swellingoftheface,lipsoreyesorrespiratorydifficultiesarethemostserioussignswhichrequire

urgentmedicalattention.

Thisproductmayhaveanadverseeffectonthedevelopingfoetusandyoungchildren(hepatotoxicity

andreducedbonegrowth).

Donothandlewhenpregnantorbreast-feeding.

Preventchildrenfromcontactwithemptybags.

Useduringpregnancy,lactationorlay

Doxycyclinehasalowaffinityforcomplexformationwithcalcium,andstudieshaveshownthat

doxycycline(virtually)hasnoeffectonskeletalformation.

Afteradministrationoftherapeuticdosesofdoxycycline,nonegativeeffectswereobservedinpoultry.

Laboratorystudieshavenotproducedanyevidenceofateratogenic,foetotoxicormaternotoxiceffect.

Intheabsenceofspecificstudiestheuseoftheproductisnotrecommendedduringpregnancyor

lactation

Interactionwithothermedicinalproductsandotherformsofinteractions

Absorptionofdoxycyclinecanbedecreasedinthepresenceofhighquantitiesofcalcium,iron,

magnesiumoraluminiuminthediet.Donotadministertogetherwithantacids,kaolinandiron

preparations.

Itisadvisedthattheintervalbetweentheadministrationsofotherproductscontainingpolyvalent

cationsshouldbe1-2hoursbecausetheylimittheabsorptionoftetracyclines.

Doxycyclineincreasestheactionofanticoagulants.

ThesolubilityoftheproductispHdependentandwillprecipitateifmixedinalkalinesolution.

Donotstorethedrinkingwaterinmetalliccontainers.

Overdose

Poultryandpigstoleratetwo-foldoverdosesofdoxycycline(40and20mg/kgrespectively)withoutany

clinicaleffect.

Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixedwithother

veterinarymedicinalproducts.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productshouldbedisposedofinaccordancewithlocalrequirements.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

15. OTHERINFORMATION

Pharmaceuticalform

Yellowtopaleyellowpowderforuseindrinkingwater.

Packsize

Bag,100,1000and2500g.Box10x100g

Notallpacksizesmaybemarketed.

Foranimaltreatmentonly–tobesuppliedonlyonveterinaryprescription.

Authorisationnumber:

EXP{month/year}

Batch{number}

Oncebroached,useby…

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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

10-10-2018

Minister Bruins tekent Green Deal voor duurzame zorg

Minister Bruins tekent Green Deal voor duurzame zorg

Minister Bruno Bruins voor Medische Zorg en Sport heeft vandaag de Green Deal ‘Duurzame zorg voor een gezonde toekomst’ getekend. Hiermee maken 132 partijen uit de zorg, overheid en bedrijfsleven afspraken om de zorg in Nederland duurzamer te maken. Inzet is het terugdringen van CO2-uitstoot, zuiniger gebruik van grondstoffen, minder medicijnresten in het water en een gezonde leefomgeving voor patiënt, cliënt en zorgmedewerkers.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

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

12-9-2018

Blokhuis: Samen aan de slag met nieuwe aanpak onbedoelde zwangerschappen

Blokhuis: Samen aan de slag met nieuwe aanpak onbedoelde zwangerschappen

In de komende jaren investeert staatssecretaris Paul Blokhuis (VWS) 53 miljoen euro in een nieuwe aanpak voor het voorkomen van en begeleiden bij onbedoelde (tiener)zwangerschappen. Op scholen wordt de komende jaren meer aandacht besteed aan gezond seksueel gedrag en anticonceptie. Er komt een landelijke campagne over bewust anticonceptiegebruik en de consequenties van onbedoelde zwangerschap. Kennisinstellingen gaan extra onderzoek doen naar wat in de praktijk het beste werkt om onbedoelde zwangerschapp...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

17-8-2018

Middel tegen ziekte van Kahler in basispakket na succesvolle prijsonderhandelingen

Middel tegen ziekte van Kahler in basispakket na succesvolle prijsonderhandelingen

Minister Bruno Bruins (Medische Zorg) heeft met succes onderhandeld over de prijs van het middel daratumumab in twee verschillende combinatietherapieën voor de vervolgbehandeling van de ziekte van Kahler (multipel myeloom). Bij deze ziekte is er sprake van kwaadaardige woekering van plasmacellen in het beenmerg. Daratumumab was al beschikbaar als zogenaamde monotherapie voor patiënten die al eerder zijn behandeld. Door de prijsafspraken wordt het middel vanaf 1 september voor deze patiënten ook vergoed u...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

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

26-7-2018

Subsidie voor duurzame zorg

Subsidie voor duurzame zorg

Zorginstellingen kunnen dit jaar subsidie krijgen voor energiebesparende maatregelen en het opwekken van duurzame energie. In totaal is hiervoor 4,7 miljoen euro beschikbaar. Deze subsidieregeling geeft (deels) uitvoering aan het regeerakkoord om ook in de zorgsector energiebesparingen en gebruik van duurzame energie verder te stimuleren.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

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

10-7-2018

Preventieve HIV-remmers (PrEP) worden verstrekt voor een periode van vijf jaar

Preventieve HIV-remmers (PrEP) worden verstrekt voor een periode van vijf jaar

PrEP wordt binnen een onderzoekssetting voor een periode van vijf jaar verstrekt aan de hoogrisicogroep van mannen die seks hebben met mannen (MSM). Dat heeft minister Bruno Bruins (Medische Zorg) vandaag bekend gemaakt. Op basis van schattingen van het RIVM zullen ongeveer 6500 mannen hiervan gebruik gaan maken en kunnen hiermee  250 hiv-infecties per jaar worden voorkomen. Voor gebruikers gaat een eigen bijdrage gelden van maximaal 25%, dat komt overeen met ongeveer 12 euro per maand. Ook wordt hen gev...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

6-7-2018

Wietexperiment meet effect op criminaliteit, veiligheid, overlast en volksgezondheid

Wietexperiment meet effect op criminaliteit, veiligheid, overlast en volksgezondheid

Het rapport van de Adviescommissie Experiment gesloten cannabisketen biedt voor het kabinet concrete handvatten voor de uitwerking van het experiment met cannabisteelt voor recreatief gebruik in de gesloten coffeeshopketen. De ministerraad heeft op voorstel van minister Bruins voor Medische Zorg en Sport en minister Grapperhaus van Justitie en Veiligheid besloten het wietteeltexperiment zodanig op te zetten dat het effect goed te meten is op criminaliteit, veiligheid, overlast en volksgezondheid.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

26-6-2018

Blokhuis: 1 miljoen euro voor Caribisch Preventie- en Sportakkoord

Blokhuis: 1 miljoen euro voor Caribisch Preventie- en Sportakkoord

Voor Caribisch Nederland is er met ingang van 2019 jaarlijks zo’n 1 miljoen euro extra beschikbaar om roken, overgewicht en problematisch alcoholgebruik tegen te gaan en gezond eten, bewegen en sporten te bevorderen. Dat heeft staatssecretaris Paul Blokhuis (VWS) bekend gemaakt bij zijn bezoeken aan Saba en Sint Eustatius.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

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

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

20-6-2018

Advies experiment gesloten coffeeshopketen aangeboden aan ministers

Advies experiment gesloten coffeeshopketen aangeboden aan ministers

Het rapport van de Adviescommissie Experiment gesloten coffeeshopketen is vandaag aangeboden aan minister Grapperhaus van Justitie en Veiligheid en minister Bruins van Medische Zorg en Sport. Het advies van de commissie onder leiding van voorzitter professor André Knottnerus is van belang voor de inrichting van het experiment met cannabisteelt voor recreatief gebruik in de gesloten coffeeshopketen.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

12-6-2018

Blokhuis: harde feiten gif in sigaretten zeer zorgelijk

Blokhuis: harde feiten gif in sigaretten zeer zorgelijk

Teer, nicotine en koolmonoxide gehalten in sigaretten die gemeten worden volgens de Canadian Intense (CI) methode zijn minimaal twee keer zo hoog als de gehalten gemeten met de wettelijke voorgeschreven ISO methode waarmee de EU en dus ook Nederland werkt. In sommige gevallen liggen de gehaltes zelfs tot meer dan 20 keer hoger. Dat blijkt uit onderzoek van het RIVM, dat 100 sigaretten onder de loep nam. Staatssecretaris Paul Blokhuis (VWS) heeft als opdrachtgever het onderzoek vandaag in ontvangst genome...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

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

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