Centidox 100%, powder for use in drinking water or milk/milk replacer for calves and pigs

Main information

  • Trade name:
  • Centidox 100%, powder for use in drinking water or milk/milk replacer for calves and pigs
  • Pharmaceutical form:
  • Powder for oral solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Centidox 100%, powder for use in drinking water or milk/milk replacer for calves and pigs
    Austria
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • doxycycline
  • Therapeutic area:
  • Cattle Young, Pigs Food

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • NL/V/0142/001
  • Authorization date:
  • 28-07-2010
  • EU code:
  • NL/V/0142/001
  • Last update:
  • 09-08-2016

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

PartIB-2

LABELLINGSACHETS/BAGS

CENTIDOX100%

POWDERFORUSEINDRINKINGWATERORMILK/MILKREPLACER

FORCALVESANDPIGS

Onelanguage

ThefulltextwillbeprintedontheAlufoilsachet/bag

FormatusedisrequiredbyDutchlawforthistypeoflabelling

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

+

IMMEDIATEPACKAGE

+

LEAFLET

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Centidox100%, powderforuseindrinkingwaterormilk/milkreplacerforcalvesandpigs

IT,ES:Centidox1000 mg/g,powderforuseindrinkingwaterormilk/milkreplacerfor

calvesandpigs

Doxycyclinehyclate

2. STATEMENTOFTHEACTIVESUBSTANCEANDOTHERINGREDIENT

Compositionpergramproduct

ActiveSubstance:

Doxycyclinehyclate

1000 mgequivalentto867 mg/gdoxycyclinebase.

3. PHARMACEUTICALFORM

Yellowpowderforuseindrinkingwaterormilk/milkreplacer.

4. PACKAGESIZE

100 g,10x100gram,250 g,500 g,1 kg,.

5. TARGETSPECIES

Calvesandpigs

6. INDICATION(S)

Calvesandpigs:

PreventionandtreatmentofrespiratorydiseasecausedbyPasteurellamultocidaand

Mycoplasmaspp.susceptibletodoxycycline.Thepresenceoftheclinicaldiseaseintheherd

shouldbeestablishedbeforepreventivetreatmentisstarted.

7. CONTRAINDICATIONS

Donotuseinanimalswithanactivemicrobiologicaldigestionintherumen.

Donotuseinanimalswithknownhypersensitivityto tetracyclines.

Donotuseinanimalswithhepaticdisorders.

Donotuseinanimalswithrenaldisorders.

8. ADVERSEREACTIONS

Incalvesanacute,sometimesfatalhartmuscledegenerationoccursafteroneormore

administrations.Sinceinmostcasesthisisrelatedto overdosing,itisimportanttosecurely

measurethedose.

Tetracyclinesmay-inrarecases-inducephotosensitivityandallergicreactions.Ifsuspected

adversereactionsoccur,treatmentshouldbediscontinued.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisproductinformation,

pleaseinformyourveterinarysurgeonorpharmacist.

9. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOF

ADMINISTRATION

Dosage:

Calves:10 mgdoxycyclinehyclateperkgbodyweightperdayduring5 days

Pigs:10 mgdoxycyclinehyclateperkgbodyweightperdayduring5 days

Modeofadministration:

Calves:orallywiththemilk(replacer)

Pigs: orallywiththedrinkingwater.

Calves:

Basedonthedoseto beused,andthenumberandweightofthecalvestobetreated,theexact

dailyamountofproductcanbecalculated.Toensureacorrectdosagebodyweightshouldbe

determinedasaccuratelyaspossibleto avoidunder-dosing.Theuseofsuitablycalibrated

weighingequipmentisrecommendedifpartpacksareused.

Thefollowingformulacanbeusedtocalculatetheconcentrationoftheproductperlitermilk/

milkreplacer:

10 mgdoxycyclinehyclateper

kgbodyweightperday

x Meanbodyweight(kg)of

animalsto betreated

= .... mgproductperl

milk(replacer)

Meandailymilk(replacer)consumption(l)peranimal

Afterreconstitutionwith(artificial)milkthesolutionshouldbeconsumedwithin6 hours.

Themedicatedmilk(replacer)shouldnotcontainlessthan100 mgproductperlitre.

Pigs:

Aconcentrateddrinkingwatersolutionshouldbegiventwicedaily(morning/evening)such

thathalfofthetotaldailydoseisconsumedpermedicationperiodof4 hours.Thisdrinking

watersolutionshouldcontainatminimum400 mgproductperlitredrinkingwater.Basedon

thedoseto beused,theminimumconcentrationof400 mgproductperlitre,meandrinking

waterconsumption,andthenumberandweightofthepigstobetreated,theexactamountof

medicateddrinkingwatercanbecalculated.Toensureacorrectdosagebodyweightshould

bedeterminedasaccuratelyaspossibleto avoidunder-dosing.Theuseofsuitablycalibrated

weighingequipmentisrecommendedifpartpacksareused.Forexample,asolution

containing400 mgproductperlitredrinkingwaterissufficientwhengiventwiceonelitreper

daytoadministerthefulltreatmentdoseof10 mg/kgforpigsof80 kgbodyweight

consuming100 mldrinkingwaterperkgbodyweight.

Medicateddrinkingwatersolutionshouldbeconsumedwithin4 hours.Donotpreparemore

medicateddrinkingwaterthanwillbeconsumedwithinthat4 hourperiod.Itisadvisableto

restrictdrinkingwaterforapproximately2 hours(lessinhotweather)priortothemedication

periodandto ensurethereareenoughdrinkingpointsforadequatewaterconsumptionforall

pigsto betreated.Noothersourceofdrinkingwatershouldbeavailableduringthe

medicationperiod.Onceallthemedicatedwaterhasbeendrunk,turnthedrinkingwater

systembackon.

SolubilityoftheproductispHdependentandinareaswithhardalkalinewaterformationof

complexesmayoccurinthedrinkingwater.Theproductshouldnotbeusedinveryhardwater

above17.5°dandpHmorethan8.1.

10.WITHDRAWALPERIODS

Calves:

-Meatandoffal:16days

Pigs:

-Meatandoffal: 8 days

11.SPECIALWARNINGS

Specialprecautionsforuseinanimals

Severelydiseasedanimalshaveadifferentdrinkingpatternandmustconsequentlybetreated

parenterally.

Itisrequiredto administerthemedicatedmilkpercalfindividually.Oneshouldalsotakeinto

accountthatde-mixingmayoccurinthemilk(replacer).Topreventthis,oneshouldkeep the

mixerturnedonduringtappingofthemilk

Dueto likelyvariability(time,geographical)insusceptibilityofbacteriafordoxycycline,

bacteriologicalsamplingandsusceptibilitytestingarerecommended.Ifthisisnotpossible,

therapyshouldbebased onlocal(regionalandfarmlevel)epidemiologicalinformationabout

susceptibilityofthetargetbacteriaaswellasbytakingintoaccountofficialnational

antimicrobialpolicies

Inappropriateuseoftheproductmayincreasetheprevalenceofbacteriaresistantto

doxycyclineandmaydecreasetheeffectivenessoftreatmentwithothertetracyclinesdueto

thepotentialforcross-resistance.

Avoidadministrationinoxidiseddrinkingequipment

Specialprecautionsto betakenby thepersonadministeringtheveterinarymedicinal

producttoanimals

Ifyouknowyouareallergicto thetetracyclineclassofantibiotics,specialcareshouldbe

takenwhenhandlingthisproductorthemedicatedsolution.

Duringpreparationandadministrationofthemedicateddrinkingwater,skincontactwiththe

productandinhalationofdustparticlesshouldbeavoided.Wearimpermeablegloves(e.g.

rubberorlatex)andanappropriatedustmask(e.g.disposablehalf-maskrespirator

conformingto EuropeanStandardEN149)whenapplyingtheproduct.

Intheeventofeyeorskincontact,rinsetheaffectedareawithlargeamountsofcleanwater

andifirritationoccurs,seek medicalattention.Washhandsandcontaminatedskin

immediatelyafterhandlingtheproduct.

Ifyoudevelopsymptomsfollowingexposuresuchasskinrash,youshouldseek medical

adviceandshowthiswarningtothephysician.Swellingoftheface,lipsoreyes,ordifficulty

withbreathingaremoreserioussymptomsandrequireurgentmedicalattention.

Donotsmoke,eatordrinkwhilehandlingtheproduct.

Takemeasuresto avoidproducingdustwhenincorporatingtheproductintowater.Avoid

directcontactwithskinandeyeswhenhandlingtheproductto preventsensitisationand

contactdermatitis.

Useduringpregnancyandlactation

Laboratorystudieshavenotproducedanyevidenceofateratogenic,foetotoxic,maternotoxic

effects.Intheabsenceofspecificstudiestheuseoftheproductisnotrecommendedduring

pregnancyorlactation.

Interactionswithothermedicinalproductsandotherformsofinteraction

Donotcombinewithantibioticsthatarebacteriocidallikepenicillinsorcephalosporins .

Absorptionofdoxycyclinecanbedecreasedinthepresenceofhighquantitiesofcalcium,

iron,magnesiumoraluminiuminthediet.Donotadministeredtogetherwithantacids,kaolin

andironpreparations.

Itisadvisedthattheintervalbetweentheadministrationofotherproductscontaining

polyvalentcationsshouldbe1-2hoursbecausetheylimittheabsorptionoftetracyclines.

Doxycyclineincreasestheactionofanticoagulants.

ThesolubilityoftheproductispHdependentandwillprecipitateifmixedinalkalinesolution.

Donotstorethedrinkingwaterinmetalliccontainers

Intheabsenceofcompatibilitystudies,thisproductmustnotbemixedwithotherveterinary

medicinalproducts.

Overdose(symptoms,emergency procedures,antidotes),ifnecessary

Overdosingincalvescouldinsomecasesresultinanacute,sometimesfatalheartmuscle

degeneration,seealso:Specialprecautionsforuseinanimals

12. EXPIRYDATE

EXP{month/year};DonotuseaftertheexpirydatestatedonthelabelafterEXP.

13.SPECIALSTORAGEPRECAUTIONS

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

Keep thebagtightlyclosedafterfirstopeninginordertoprotectfrommoisture.

-Shelf-lifeafterdilutionorreconstitutionaccordingtodirections:

Solutionsinwater:Afterreconstitutionwithwateranyproductremainingafter4 hours

shouldbediscarded

Milksolutions:Afterreconstitutionwith(artificial)milkanyproductremainingafter6 hours

shouldbediscarded.

-Shelf-lifeafterfirstopeningtheimmediatepackaging:6 months

14.SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialderivedfromsuchveterinary

medicinalproductshouldbedisposedofinaccordancewithlocalrequirements.

15. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly.

Prescriptiononlymedicine

16. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keep outofthereachandsightofchildren.

17.NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

ANDOFTHEMANUFACTURINGAUTHORISATIONHOLDER

RESPONSIBLEFORBATCHRELEASE,IFDIFFERENT

EurovetAnimalHealthBV,

Handelsweg25, 5531-AEBladel,

TheNetherlands

18. MARKETINGAUTHORISATIONNUMBER(S)

{NumberallocatedbyMS}

19. MANUFACTURER’SBATCHNUMBER

Lot{number}

20. DATEONWHICHTHETEXTWASLASTAPPROVED

xxJuly2010

21. OTHERINFORMATION

Notallpack sizesmaybemarketed.

PartIB-2

LABELLINGSACHETS/BAGS

CENTIDOX100%

POWDERFORUSEINDRINKINGWATERORMILK/MILKREPLACER

FORCALVESANDPIGS

Multilinguallabel

Withleaflet

Andcartonboxforthe10x100 gramsAlufoilsachetswithleaflet

Andcartonboxforthe1 x 1kgPEbagwithleaflet

<PARTICULARSTOAPPEARONTHEOUTERPACKAGE>

{NATURE/TYPE} CARTON10 X100 GRAMORCARTON1 X1000 GRAM

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Centidox100%, powderforuseindrinkingwaterormilk/milkreplacerforcalvesandpigs.

IT,ES:Centidox1000 mg/g,powderforuseindrinkingwaterormilk/milkreplacerfor

calvesandpigs.

Doxycyclinehyclate

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Compositionpergramproduct

ActiveSubstance:

Doxycyclinehyclate

1000 mgequivalentto867 mg/gdoxycyclinebase.

3. PHARMACEUTICALFORM

Yellowpowderforuseindrinkingwaterormilk/milkreplacer

4. PACKAGESIZE

10x100gramor 1x1kilogram

5. TARGETSPECIES

Calvesandpigs

6. INDICATION(S)

Calvesandpigs:

PreventionandtreatmentofrespiratorydiseasecausedbyPasteurellamultocidaand

Mycoplasmaspp.susceptibletodoxycycline.Thepresenceoftheclinicaldiseaseintheherd

shouldbeestablishedbeforepreventivetreatmentisstarted.

7. METHODANDROUTE(S)OFADMINISTRATION

Calves:orallywiththemilk(replacer)

Pigs: orallywiththedrinkingwater.

8. WITHDRAWALPERIOD

Calves:Meatandoffal:16 days

Pigs:Meatandoffal: 8 days

9. SPECIALWARNING(S),IFNECESSARY

Specialprecautionsforuseinanimals

Readthepackageleafletbeforeuse.

Specialprecautionsto betakenby thepersonadministeringtheveterinarymedicinal

producttoanimals

Readthepackageleafletbeforeuse.

10.EXPIRYDATE

EXP{month/year};DonotuseaftertheexpirydatestatedonthelabelafterEXP.

11.SPECIALSTORAGECONDITIONS

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

12.SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialderivedfromsuchveterinary

medicinalproductshouldbedisposedofinaccordancewithlocalrequirements.

13.THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly.

Prescriptiononlymedicine(orsimilarwording,nationalissue)

14.THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keep outofthereachandsightofchildren.

15.NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

EurovetAnimalHealthBV

Handelsweg25, 5531 AEBladel,theNetherlands

16.MARKETINGAUTHORISATIONNUMBER(S)

MAnumber/0/00/000/000

17.MANUFACTURER’SBATCHNUMBER

Lot{number}

<PARTICULARSTOAPPEARONTHEIMMEDIATEPACKAGE>

{NATURE/TYPE} AluminiumFoilBags100g, 250 g, 500 g, 1 kg

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Centidox100%, powderforuseindrinkingwaterormilk/milkreplacerforcalvesandpigs.

IT,ES:Centidox1000 mg/g,powderforuseindrinkingwaterormilk/milkreplacerfor

calvesandpigs.

Doxycyclinehyclate

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Compositionpergramproduct

ActiveSubstance:

Doxycyclinehyclate

1000 mgequivalentto867 mg/gdoxycyclinebase.

3. PHARMACEUTICALFORM

Yellowpowderforuseindrinkingwaterormilk/milkreplacer

4. PACKAGESIZE

100 g,250 g,500 g,1 kg,.

5. TARGETSPECIES

Calvesandpigs

6. INDICATION(S)

Calvesandpigs:

PreventionandtreatmentofrespiratorydiseasecausedbyPasteurellamultocidaand

Mycoplasmaspp.susceptibletodoxycycline.Thepresenceoftheclinicaldiseaseintheherd

shouldbeestablishedbeforepreventivetreatmentisstarted.

7. METHODANDROUTE(S)OFADMINISTRATION

Calves:orallywiththemilk(replacer)

Pigs: orallywiththedrinkingwater.

8. WITHDRAWALPERIOD

Calves:Meatandoffal:16 days

Pigs:Meatandoffal: 8 days

9. SPECIALWARNING(S),IFNECESSARY

Specialprecautionsforuseinanimals

Readthepackageleafletbeforeuse.

Specialprecautionsto betakenby thepersonadministeringtheveterinarymedicinal

producttoanimals

Readthepackageleafletbeforeuse.

10.EXPIRYDATE

EXP{month/year};DonotuseaftertheexpirydatestatedonthelabelafterEXP.

11.SPECIALSTORAGECONDITIONS

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

12.SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialderivedfromsuchveterinary

medicinalproductshouldbedisposedofinaccordancewithlocalrequirements.

13.THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly.

Prescriptiononlymedicine(orsimilarwording,nationalissue)

14.THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keep outofthereachandsightofchildren.

15.NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

EurovetAnimalHealthBV

Handelsweg25, 5531AEBladel,theNetherlands

16.MARKETINGAUTHORISATIONNUMBER(S)

MAnumber/0/00/000/000

17.MANUFACTURER’SBATCHNUMBER

Lot{number}

PACKAGELEAFLET

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

ANDOFTHEMANUFACTURINGAUTHORISATIONHOLDER

RESPONSIBLEFORBATCHRELEASE,IFDIFFERENT

EurovetAnimalHealthBV

Handelsweg25, 5531 AEBladel

TheNetherlands

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Centidox100%, powderforuseindrinkingwaterormilk/milkreplacerforcalvesandpigs

IT,ES:Centidox1000 mg/g,powderforuseindrinkingwaterormilk/milkreplacerfor

calvesandpigs

Doxycyclinehyclate

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHER

INGREDIENT(S)

Compositionpergramproduct

ActiveSubstance:

Doxycyclinehyclate

1000 mgequivalentto867 mg/gdoxycyclinebase.

4. INDICATION(S)

Calvesandpigs:

PreventionandtreatmentofrespiratorydiseasecausedbyPasteurellamultocidaand

Mycoplasmaspp.susceptibletodoxycycline.Thepresenceoftheclinicaldiseaseintheherd

shouldbeestablishedbeforepreventivetreatmentisstarted.

5. CONTRAINDICATIONS

Donotuseinanimalswithanactivemicrobiologicaldigestionintherumen.

Donotuseinanimalswithknownhypersensitivityto tetracyclines.

Donotuseinanimalswithhepaticdisorders.

Donotuseinanimalswithrenaldisorders.

6. ADVERSEREACTIONS

Incalvesanacute,sometimesfatalhartmuscledegenerationoccursafteroneormore

administrations.Sinceinmostcasesthisisrelatedto overdosing,itisimportanttosecurely

measurethedose.

Tetracyclinesmay-inrarecases-inducephotosensitivityandallergicreactions.Ifsuspected

adversereactionsoccur,treatmentshouldbediscontinued.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisproductinformation,

pleaseinformyourveterinarysurgeonorpharmacist.

7. TARGETSPECIES

Calvesandpigs

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOF

ADMINISTRATION

Dosage:

Calves:10 mgdoxycyclinehyclateperkgbodyweightperdayduring5 days

Pigs:10 mgdoxycyclinehyclateperkgbodyweightperdayduring5 days

Modeofadministration:

Calves:orallywiththemilk(replacer)

Pigs: orallywiththedrinkingwater.

9. ADVICEONCORRECTADMINISTRATION

Calves:

Basedonthedoseto beused,andthenumberandweightofthecalvestobetreated,theexact

dailyamountofproductcanbecalculated.Toensureacorrectdosagebodyweightshouldbe

determinedasaccuratelyaspossibleto avoidunder-dosing.Theuseofsuitablycalibrated

weighingequipmentisrecommendedifpartpacksareused.

Thefollowingformulacanbeusedtocalculatetheconcentrationoftheproductperlitermilk/

milkreplacer:

10 mgdoxycyclinehyclateper

kgbodyweightperday

x Meanbodyweight(kg)of

animalsto betreated

= .... mgproductperl

milk(replacer) Meandailymilk(replacer)consumption(l)peranimal

Afterreconstitutionwith(artificial)milkthesolutionshouldbeconsumedwithin6 hours.

Themedicatedmilk(replacer)shouldnotcontainlessthan100 mgproductperlitre.

Pigs:

Aconcentrateddrinkingwatersolutionshouldbegiventwicedaily(morning/evening)such

thathalfofthetotaldailydoseisconsumedpermedicationperiodof4 hours.Thisdrinking

watersolutionshouldcontainatminimum400 mgproductperlitredrinkingwater.Basedon

thedoseto beused,theminimumconcentrationof400 mgproductperlitre,meandrinking

waterconsumption,andthenumberandweightofthepigstobetreated,theexactamountof

medicateddrinkingwatercanbecalculated.Toensureacorrectdosagebodyweightshould

bedeterminedasaccuratelyaspossibleto avoidunder-dosing.Theuseofsuitablycalibrated

weighingequipmentisrecommendedifpartpacksareused.Forexample,asolution

containing400 mgproductperlitredrinkingwaterissufficientwhengiventwiceonelitreper

daytoadministerthefulltreatmentdoseof10 mg/kgforpigsof80 kgbodyweight

consuming100 mldrinkingwaterperkgbodyweight.

Medicateddrinkingwatersolutionshouldbeconsumedwithin4 hours.Donotpreparemore

medicateddrinkingwaterthanwillbeconsumedwithinthat4 hourperiod.Itisadvisableto

restrictdrinkingwaterforapproximately2 hours(lessinhotweather)priortothemedication

periodandto ensurethereareenoughdrinkingpointsforadequatewaterconsumptionforall

pigsto betreated.Noothersourceofdrinkingwatershouldbeavailableduringthe

medicationperiod.Onceallthemedicatedwaterhasbeendrunk,turnthedrinkingwater

systembackon.

SolubilityoftheproductispHdependentandinareaswithhardalkalinewaterformationof

complexesmayoccurinthedrinkingwater.Theproductshouldnotbeusedinveryhardwater

above17.5°dandpHmorethan8.1.

10.WITHDRAWALPERIOD

Calves:

-Meatandoffal:16 days

Pigs:

-Meatandoffal: 8 days

11.SPECIALSTORAGEPRECAUTIONS

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

Keep thebagtightlyclosedafterfirstopeninginordertoprotectfrommoisture.

-Shelf-lifeafterdilutionorreconstitutionaccordingtodirections:

Solutionsinwater:Afterreconstitutionwithwateranyproductremainingafter4 hours

shouldbediscarded

Milksolutions:Afterreconstitutionwith(artificial)milkanyproductremainingafter6 hours

shouldbediscarded.

Shelf-lifeafterfirstopeningtheimmediatepackaging:6 months

12.SPECIALWARNING(S)

Specialprecautionsforuse

(i)Specialprecautionsforuseinanimals

Severelydiseasedanimalshaveadifferentdrinkingpatternandmustconsequentlybetreated

parenterally.

Itisrequiredto administerthemedicatedmilkpercalfindividually.Oneshouldalsotakeinto

accountthatde-mixingmayoccurinthemilk(replacer).Topreventthis,oneshouldkeep the

mixerturnedonduringtappingofthemilk

Dueto likelyvariability(time,geographical)insusceptibilityofbacteriafordoxycycline,

bacteriologicalsamplingandsusceptibilitytestingarerecommended.Ifthisisnotpossible,

therapyshouldbebased onlocal(regionalandfarmlevel)epidemiologicalinformationabout

susceptibilityofthetargetbacteriaaswellasbytakingintoaccountofficialnational

antimicrobialpolicies

Inappropriateuseoftheproductmayincreasetheprevalenceofbacteriaresistantto

doxycyclineandmaydecreasetheeffectivenessoftreatmentwithothertetracyclinesdueto

thepotentialforcross-resistance.

Avoidadministrationinoxidiseddrinkingequipment

(ii)Specialprecautionsto betakenbythepersonadministeringtheveterinary

medicinalproductto animals

Ifyouknowyouareallergicto thetetracyclineclassofantibiotics,specialcareshouldbe

takenwhenhandlingthisproductorthemedicatedsolution.

Duringpreparationandadministrationofthemedicateddrinkingwater,skincontactwiththe

productandinhalationofdustparticlesshouldbeavoided.Wearimpermeablegloves(e.g.

rubberorlatex)andanappropriatedustmask(e.g.disposablehalf-maskrespirator

conformingto EuropeanStandardEN149)whenapplyingtheproduct.

Intheeventofeyeorskincontact,rinsetheaffectedareawithlargeamountsofcleanwater

andifirritationoccurs,seek medicalattention.Washhandsandcontaminatedskin

immediatelyafterhandlingtheproduct.

Ifyoudevelopsymptomsfollowingexposuresuchasskinrash,youshouldseek medical

adviceandshowthiswarningtothephysician.Swellingoftheface,lipsoreyes,ordifficulty

withbreathingaremoreserioussymptomsandrequireurgentmedicalattention.

Donotsmoke,eatordrinkwhilehandlingtheproduct.

Takemeasuresto avoidproducingdustwhenincorporatingtheproductintowater.Avoid

directcontactwithskinandeyeswhenhandlingtheproductto preventsensitisationand

contactdermatitis.

Useduringpregnancy,lactationorlay

Laboratorystudieshavenotproducedanyevidenceofateratogenic,foetotoxic,maternotoxic

effects.Intheabsenceofspecificstudiestheuseoftheproductisnotrecommendedduring

pregnancyorlactation.

Interactionwithothermedicinalproductsandotherformsofinteraction

Donotcombinewithantibioticsthatarebacteriocidallikepenicillinsorcephalosporins .

Absorptionofdoxycyclinecanbedecreasedinthepresenceofhighquantitiesofcalcium,

iron,magnesiumoraluminiuminthediet.Donotadministeredtogetherwithantacids,kaolin

andironpreparations.

Itisadvisedthattheintervalbetweentheadministrationofotherproductscontaining

polyvalentcationsshouldbe1-2hoursbecausetheylimittheabsorptionoftetracyclines.

Doxycyclineincreasestheactionofanticoagulants.

ThesolubilityoftheproductispHdependentandwillprecipitateifmixedinalkalinesolution.

Donotstorethedrinkingwaterinmetalliccontainers

Intheabsenceofcompatibilitystudies,thisproductmustnotbemixedwithotherveterinary

medicinalproducts.

Overdose(symptoms,emergency procedures,antidotes),ifnecessary

Overdosingincalvescouldinsomecasesresultinanacute,sometimesfatalheartmuscle

degeneration,seealso:Specialprecautionsforuseinanimals

13.SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialderivedfromsuchveterinary

medicinalproductshouldbedisposedofinaccordancewithlocalrequirements.

14.DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

xxJuly2010

15.OTHERINFORMATION

Notallpack sizesmaybemarketed.

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Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Published on: Wed, 07 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of the additive Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials. It is a family of mixtures combining the four lanthanides lanthanum (La), europium (Eu), gadolinium (Gd) and/or terbium (Tb) in different proportions as their 1,4‐benzene dicarboxylate complexes, used as a taggant in plastics for authentication and ...

Europe - EFSA - European Food Safety Authority Publications

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

20-10-2018

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Published on: Fri, 19 Oct 2018 00:00:00 +0200 EFSA was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide [FL‐no: 16.133], in the Flavouring Group Evaluation 411 (FGE.411), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intende...

Europe - EFSA - European Food Safety Authority Publications

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