Methoxasol-T oral solution for pigs and broilers

Main information

  • Trade name:
  • Methoxasol-T oral solution for pigs and broilers
  • Pharmaceutical form:
  • Oral solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Methoxasol-T oral solution for pigs and broilers
    Netherlands
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Sulfamethoxazole and trimethoprime
  • Therapeutic area:
  • Chicken Broilers, Pigs Food

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • NL/V/0131/001
  • Authorization date:
  • 29-08-2008
  • EU code:
  • NL/V/0131/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SUMMARYOFPRODUCTCHARACTERISTICS

ANDIMMEDIATEPACKAGING

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Methoxasol-T20/100mg/mloralsolutionforpigsandbroilers

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Permlsolution

Activesubstances: Trimethoprim 20.0mg

Sulfamethoxazole 100.0mg

Excipients: N-methyl-pyrrolidone 690.8mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Oralsolution.

Clearandyellow.

4. CLINICALPARTICULARS

4.1 Targetspecies

Pigsandbroilers.

4.2 Indicationsforuse,specifyingthetargetspecies

Pigs:TreatmentandpreventionofrespiratoryinfectionscausedbyActinobacilluspleuropneumoniae

susceptibletotrimethoprimandsulfamethoxazolewherethediseasehasbeendiagnosedintheherd.

Broilers:TreatmentandpreventionofrespiratoryinfectionscausedbyEscherichiacolisusceptibleto

trimethoprimandsulfamethoxazolewherethediseasehasbeendiagnosedintheflock.

Resistanceagainstpotentiatedsulphonamidesmayvary.Thereforetheuseoftheproductshouldbebasedon

cultureandsensitivityofmicro-organismsfromdiseasedcasesonfarmorfromrecentpreviousexperience

onthefarm.

4.3 Contraindications

Donotuseinanimalssufferingfromsevereliverorkidneydisease,oliguriaoranuria.

Donotuseinanimalswithimpairedhaematopoieticsystems.

4.4 Specialwarningsforeachtargetspecies

Inbroilerswaterintakeshouldbecheckedregularly.

Severelydiseasedanimalscanhaveadecreasedappetiteandwaterconsumption.Ifnecessarythe

concentrationoftheVMPinthedrinkingwatershouldbeadjustedtomakesurethattherecommended

dosageisbeingconsumed.Howeveriftheconcentrationoftheproductisincreasedtoomuch,theintakeof

themedicateddrinkingwaterdecreasesforpalatabilityreasons.Thereforewaterintakeshouldbemonitored,

especiallyinbroilers.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Duetothelikelyvariability(time,geographical)intheoccurrenceofresistanceofbacteriafor

trimethoprim/sulfamethoxazolebacteriologicalsamplingandsusceptibilitytestingarerecommended.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproductto

animals

Duringpreparationandadministrationofthemedicateddrinkingwater,skincontactwiththedrugshouldbe

avoided.Thereforeitisrecommendedtowearimpermeableglovese.g.rubberorlatexwhenapplyingthe

product.Incaseofallergytotrimethoprimorsulfonamides,specialcareshouldbetakenwhenhandlingthis

productorthemedicatedsolution.Intheeventofeyecontact,rinsetheeyewithcopiousamountsofclean

waterandifirritationoccurs,seekmedicalattention.Intheeventofaccidentalingestion,seekmedical

advice.Washhandsandcontaminatedskinimmediatelyafterhandlingtheproduct.

4.6 Adversereactions(frequencyandseriousness)

Adiminishedwaterintakeinchickensmayoccuroccasionally.

Hypersensitivityreactionscanoccurrarely.

4.7 Useduringpregnancy,lactationorlay

Thesafetyoftheveterinarymedicinalproducthasnotbeenestablishedduringpregnancy,lactationorlay.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Donotcombinewithotherveterinarymedicinalproducts.

4.9 Amountstobeadministeredandadministrationroute

Methoxasol-Tisintendedfororaladministrationwithdrinkingwater:

Pigs:25mg/kgbodyweight,correspondingtoapproximately1litreofthedrugin500Ldrinkingwater,for

3-4days.

Broilers:33mg/kgbodyweight,correspondingtoapproximately1litreofthedrugin750Ldrinkingwater,

for3-4days.

Toensureacorrectdosagebodyweightshouldbedeterminedasaccuratelyaspossibletoavoidunderdosing.

Theuptakeofmedicatedwaterdependsontheclinicalconditionoftheanimals.Inordertoobtainthecorrect

dosagetheconcentrationofMethoxasol-Thastobeadjustedaccordingly.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

A2½foldoverdoseiswelltoleratedbypigs.

Inchickenanacuteoverdosewillnotoccurbecausethebirdswillbereluctanttodrinkthestrongly

concentrateddrinkingwater(toobittertasteifabove2litresMethoxasol-Tper1000litredrinkingwater).

Chronicoverdoseinchickenwillresultinastronglydiminishedwater-andfeedintakeandretardedgrowth.

4.11Withdrawalperiod(s)

Pigs: 5days

Broilers: 6days

Notauthorisedforuseinlayingbirdsproducingeggsforhumanconsumption

5. PHARMACOLOGICALPROPERTIES

Trimethoprimisadiaminopyrimidine,asyntheticfolicacidantagonist.Sulfamethoxazoleisabroad-

spectrumantimicrobialagentbelongingtothesulfonamides.

ATCvetclassification(ofthecombination):QJ01EW11

5.1 Pharmacodynamicproperties

Invitrotrimethoprimisgenerallybacteriostaticandhasabroadspectrumofactivityagainstbothgram-

positiveandgram-negativebacteria.Asynergisticandbactericidaleffectoccurswhentrimethoprimis

combinedwithsulfamethoxazole,becausetrimethoprimandsulfamethoxazoleinhibitsequentialstepsinthe

synthesisoftetrahydrofolicacid,anessentialmetaboliccofactorinbacterialsynthesisofpurineand,

subsequently,DNA.

5.2 Pharmacokineticparticulars

Followingoraladministrationbothactiveingredientsarerapidlyabsorbedfromthegut.TheC

of

sulfamethoxazoleinpigsisapproximately6.2µg/g.TheC

oftrimethoprimis0.29µg/g.TheC

of

sulfamethoxazoleinchickensisapproximately9.0µg/g,whereasthatoftrimethoprimis0.12µg/g.

Hightrimethoprimconcentrationsarefoundinthekidneys,theliverandthelungs.Withtheexceptionofthe

kidneys,sulfamethoxazoleconcentrationsinthetissuesaresignificantlylowerthanintheplasma.Protein

bindingforTMPandSMXisnotveryhigh.

Thedrugisprimarilyexcretedthroughthekidneys(bothactivelyandpassively),buteliminationalsooccurs

throughthefaeces.Eliminationisrelativelyfastbothinpoultryandpigs.Plasmaeliminationhalf-lifefor

trimethopriminpoultryislessthan1hourandthatofsulfamethoxazole,approximately1.5hours.Inpigs,

eliminationhalf-lifeforbothsubstancesisapproximately2.5hours.Within48hoursafterthelastmedication

trimethoprim,sulfamethoxazoleandtheirmetabolitesareundetectableinurineandfaeces.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Propyleneglycol,

Sodiumhydroxide,

Water,purified,

N-methyl-pyrrolidone

6.2 Incompatibilities

SolubilityandstabilityofMethoxasol-TindrinkingwaterarepH-dependent.

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixedwithother

veterinarymedicinalproducts.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:3years

Afterfirstopeningtheremainingshelflifeis12months.

Shelf-lifeafterdilutionorreconstitutionaccordingtodirections:24hours

6.4.Specialprecautionsforstorage

Donotfreeze

6.5 Natureandcompositionofimmediatepackaging

HDPEbottle/can:volume1000ml/5000ml.

The1000mlbottleisclosedwithatamper-proofLDPEscrew-cap.

The5000mlcanisclosedwithatamper-proofHDPEscrew-cap.

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwastematerials

derivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinalproducts

shouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

EurovetAnimalHealthB.V.

Handelsweg25,P.O.Box179,5530ADBladel,

TheNetherlands

8. MARKETINGAUTHORISATIONNUMBER(S)

xxxxxxxxxx

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

xxxxxxxxxx

10 DATEOFREVISIONOFTHETEXT

27-08-2008

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable.

IMMEDIATEPACKAGING

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

(WhiteHDPEbottle/can:volume1000ml/5000ml)

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Methoxasol-T20/100mg/mloralsolutionforpigsandbroilers.

Trimethoprimandsulfamethoxazole.

2. STATEMENTOFTHEACTIVESUBSTANCESANDOTHERINGREDIENTS

Permlsolution:Activesubstances: Trimethoprim 20.0mg

Sulfamethoxazole 100.0mg

Excipients: N-methyl-pyrrolidone

3. PHARMACEUTICALFORM

Oralsolution.

4. PACKAGESIZE

HDPEbottle/can:volume1000ml/5000ml.

The1000mlbottleisclosedwithatamper-proofLDPEscrew-cap.

The5000mlcanisclosedwithatamper-proofHDPEscrew-cap.

Notallpacksizesmaybemarketed.

5. TARGETSPECIES

Pigsandbroilers

6. INDICATION(S)

Pigs:TreatmentandcontrolofrespiratoryinfectionscausedbyActinobacilluspleuropneumoniaesusceptible

totrimethoprimandsulfamethoxazolewherethediseasehasbeendiagnosedintheherd.

Broilers:TreatmentandcontrolofrespiratoryinfectionscausedbyEscherichiacolisusceptibleto

trimethoprimandsulfamethoxazolewherethediseasehasbeendiagnosedintheflock.

Resistanceagainstpotentiatedsulphonamidesmayvary.Thereforetheuseoftheproductshouldbebasedon

cultureandsensitivityofmicro-organismsfromdiseasedcasesonfarmorfromrecentpreviousexperience

onthefarm.

7. DOSAGEFOREACHSPECIES,ROUTEANDMETHODOFADMINISTRATION

Methoxasol-Tisintendedfororaladministrationwithdrinkingwater:

Pigs:25mg/kgbodyweight,correspondingtoapproximately1litreofthedrugin500Ldrinkingwater,for

3-4days.

Broilers:33mg/kgbodyweight,correspondingtoapproximately1litreofthedrugin750Ldrinkingwater,

for3-4days.

Adviceoncorrectadministration

Toensureacorrectdosagebodyweightshouldbedeterminedasaccuratelyaspossibletoavoidunderdosing.

Theuptakeofmedicatedwaterdependsontheclinicalconditionoftheanimals.Inordertoobtainthecorrect

dosagetheconcentrationofMethoxasolhastobeadjustedaccordingly.

8. WITHDRAWALPERIOD

Pigs: 5days

Broilers: 6days

Notauthorisedforuseinlayingbirdsproducingeggsforhumanconsumption

9. SPECIALWARNING(S),IFNECESSARY

Contraindications

Donotuseinanimalssufferingfromsevereliverorkidneydisease,oliguriaoranuria.

Donotuseinanimalswithimpairedhaematopoieticsystems.

Adversereactions

Hypersensitivityreactionscanoccurrarely.

Adiminishedwaterintakeinchickensmayoccuroccasionally.

Severelydiseasedanimalscanhaveadecreasedappetiteandwaterconsumption.Ifnecessarythe

concentrationoftheVMPinthedrinkingwatershouldbeadjustedtomakesurethattherecommended

dosageisbeingconsumed.Howeveriftheconcentrationoftheproductisincreasedtoomuch,theintakeof

themedicateddrinkingwaterdecreasesforpalatabilityreasons.Thereforewaterintakeshouldbemonitored,

especiallyinbroilers.

Specialprecautionsforuseinanimals

Duetothelikelyvariability(time,geographical)intheoccurrenceofresistanceofbacteriafor

trimethoprim/sulfamethoxazolebacteriologicalsamplingandsusceptibilitytestingarerecommended.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproductto

animals

Duringpreparationandadministrationofthemedicateddrinkingwater,skincontactwiththedrugshouldbe

avoided.Thereforeitisrecommendedtowearimpermeableglovese.g.rubberorlatexwhenapplyingthe

product.Incaseofallergytotrimethoprimorsulfonamides,specialcareshouldbetakenwhenhandlingthis

productorthemedicatedsolution.Intheeventofeyecontact,rinsetheeyewithcopiousamountsofclean

waterandifirritationoccurs,seekmedicalattention.Intheeventofaccidentalingestion,seekmedical

advice.Washhandsandcontaminatedskinimmediatelyafterhandlingtheproduct.

Useduringpregnancyandlactation

Thesafetyoftheveterinarymedicinalproducthasnotbeenestablishedduringpregnancyorlactation.

Interactions

SolubilityandstabilityofMethoxasol-TindrinkingwaterarepH-dependent.Intheabsenceofcompatibility

studies,thisveterinarymedicinalproductmustnotbemixedwithotherveterinarymedicinalproducts

Donotcombinewithotherveterinarymedicinalproducts.

Overdose

A2½foldoverdoseiswelltoleratedbypigs.

Inchickenanacuteoverdosewillnotoccurbecausethebirdswillbereluctanttodrinkthestrongly

concentrateddrinkingwater(toobittertasteifabove2litresMethoxasolper1000litredrinkingwater).

Overdoseinchickenwillresultinastronglydiminishedwater-andfeedintakeandretardedgrowth.

10. EXPIRYDATE

EXP

11. SPECIALSTORAGECONDITIONS

Donotfreeze

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTORWASTE

MATERIALS,IFANY

Medicinesshouldnotbedisposedofviawastewaterorhouseholdwaste.

Askyourveterinarysurgeonhowtodisposeofmedicinesnolongerrequired.Thesemeasuresshouldhelpto

protecttheenvironment.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOF

RESTRICTIONSREGARDINGSUPPLYANDUSE

Foranimaltreatmentonly.Tobesuppliedonlyonveterinaryprescription.

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERANDOFTHE

MANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFORBATCHRELEASE,

IFDIFFERENT

EurovetAnimalHealthB.V.,Handelsweg25,P.O.Box179,5530ADBladel,TheNetherlands

16. MARKETINGAUTHORISATIONNUMBER

-------

17. MANUFACTURER’SBATCHNUMBER

Batch.

18. DATEONWHICHTHEPRODUCTINFORMATIONWASLASTAPPROVED

27August2008

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