Methoxasol 20/100 mg/ml solution for use in drinking water for pigs and broilers

Main information

  • Trade name:
  • Methoxasol 20/100 mg/ml solution for use in drinking water for pigs and broilers
  • Pharmaceutical form:
  • Oral solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Methoxasol 20/100 mg/ml solution for use in drinking water for pigs and broilers
    Italy
  • 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/0166/001
  • Authorization date:
  • 20-06-2012
  • EU code:
  • NL/V/0166/001
  • Last update:
  • 09-08-2016

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

PartIB-2A

FULL LABELTEXT

1LITREBOTTLE/5LITRECAN

METHOXASOL

SOLUTIONFORUSEINDRINKINGWATER

FORPIGSANDBROILERS

NL/V/0166/001/DC.

Thefulltextwillbeprintedonthebottle/can

Formatusedisespeciallyforthistypeoflabelling

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

=

IMMEDIATEPACKAGE

=

LEAFLET

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Methoxasol20/100mg/mlsolutionforuseindrinkingwaterforpigsandchickens.

FI/DK:Methoxasolvet20/100mg/mlsolutionforuseindrinkingwaterforpigsandchickens.

Trimethoprim/Sulfamethoxazole

2. STATEMENTOFTHEACTIVESUBSTANCEANDOTHERINGREDIENT

Eachmlcontains:

ActiveSubstance:

Trimethoprim

Sulfamethoxazole

20mg

100mg

3. PHARMACEUTICALFORM

Clearandyellowsolutionforuseindrinkingwater

4. PACKAGESIZE

1litre(5litre)

5. TARGETSPECIES

Pigsandchickens(broilers).

6. INDICATION(S)

Pigs:TreatmentandpreventionofrespiratoryinfectionscausedbyActinobacilluspleuropneumoniae

susceptibletotrimethoprimandsulfamethoxazolewherethediseasehasbeendiagnosedintheherd.

Broilers:TreatmentandpreventionofrespiratoryinfectionscausedbyEscherichiacolisusceptibleto

trimethoprimandsulfamethoxazolewherethediseasehasbeendiagnosedintheflock.

7. CONTRAINDICATIONS

Donotuseinanimalssufferingfromsevereliverorkidneydisease,oliguriaoranuria.

Donotuseinanimalswithimpairedhaematopoieticsystems.

Donotuseincaseofknownhypersensitivitytosulfonamidesortrimethoprim.

8. ADVERSEREACTIONS

Adiminishedwaterintakeinchickensmayoccuroccasionally.

Hypersensitivityreactionscanoccurrarely

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisproductinformation,pleaseinform

yourveterinarysurgeonorpharmacist.

9. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOFADMINISTRATION

Administrationorallywiththedrinkingwater.Theproductcanbeaddeddirectlytothedrinkingwaterto

prepareatherapeuticsolutionatthecalculatedconcentration,butcanalsobeusedinaconcentratedstock

solutionbyadding200mloftheveterinarymedicinalproductperlitrewateranddilutingthisfurtherif

required.Donotusethisveterinarymedicinalproductundilutedorinhigherconcentratedstocksolutions.

Pigs:25mgTMPSperkgbodyweightperdayfor3-4days,correspondingto1mloftheveterinary

medicinalproductper4,8kgbodyweightperday.Thiscorrespondstoapproximately1litreoftheveterinary

medicinalproductin500Ldrinkingwater.

Basedontherecommendeddose,dailywaterconsumption,andthenumberandweightofthepigstobe

treated,theexactdailyamountoftheveterinaryproductcanbecalculatedaccordingtothefollowing

formula:

Meanbodyweight(kg)ofpigstobetreated =xxmlveterinaryproductperl

drinkingwater

Meandailywaterconsumption(l)perpigx4.8

Broilers:33mgTMPSperkgbodyweightperdayfor3-4days,correspondingto1mloftheveterinary

medicinalproductper3,64kgbodyweightperday.Thiscorrespondstoapproximately1litreofthe

veterinarymedicinalproductin750Ldrinkingwater.

Basedontherecommendeddose,dailywaterconsumption,andthenumberandweightofthebirdstobe

treated,theexactdailyamountoftheveterinaryproductcanbecalculatedaccordingtothefollowing

formula:

Meanbodyweight(kg)ofbroilerstobetreated =xxmlveterinaryproductper

ldrinkingwater

Meandailywaterconsumption(l)perbirdx3.64

Onelitreoftheveterinarymedicinalproductweighs1079gram;thereforeweightcanalsobeusedto

measuretheproductquantitytobeaddedindrinkingwater,accordingtothefollowingformula:

Amounttobeaddedindrinkingwater(g/L)=calculatedml/Lx1.079.

Thedailyamountistobeaddedtothedrinkingwatersuchthatallmedicationwillbeconsumedin24hours.

Medicateddrinkingwaterandstocksolutionsshouldbefreshlypreparedevery24hours.Duringthe

treatmentperiodanimalsshouldnothaveaccesstootherwatersourcesthanthemedicatedwaterthedilution

ofwhichshouldbecalculatedtoensurethatanimalsalwayshavesufficientwateravailable.Toensurea

correctdosagebodyweightshouldbedeterminedasaccuratelyaspossibletoavoidunderdosing.Theuptake

ofmedicatedwaterdependsontheclinicalconditionoftheanimals.Inordertoobtainthecorrectdosagethe

concentrationoftheveterinarymedicinalproductshastobeadjustedaccordingly.

10. WITHDRAWALPERIODS

Meatandoffal:

Pigs: 5days

Broilers: 6days

Eggs:

Notauthorisedforuseinlayingbirdsproducingeggsforhumanconsumption.

11. SPECIALWARNINGS

Specialprecautionsforuse

(i)Specialprecautionsforuseinanimals

Duetothelikelyvariability(time,geographical)insusceptibilityofbacteriaforpotentiatedsulphonamides,

occurrenceofresistanceofbacteriamaydifferfromcountrytocountryandevenfromfarmtofarm,and

thereforebacteriologicalsamplingandsusceptibilitytestingarerecommended.Useoftheproductshouldbe

basedoncultureandsensitivityofmicro-organismsfromdiseasedcasesonfarmorfromrecentprevious

experienceonthefarm.

UseoftheproductdeviatingfromtheinstructionsgivenintheSPCmayincreasetheprevalenceofbacteria

resistanttosulfamethoxazoleandtrimethoprimandmayalsodecreasetheeffectivenessofcombinationsof

trimethoprimwithothersulphonamidesduetothepotentialforcrossresistance.

Severelydiseasedanimalscanhaveadecreasedappetiteandwaterconsumption.Ifnecessarythe

concentrationoftheVMPinthedrinkingwatershouldbeadjustedtomakesurethattherecommended

dosageisbeingconsumed.Howeveriftheconcentrationoftheproductisincreasedtoomuch,theintakeof

themedicateddrinkingwaterdecreasesforpalatabilityreasons.Thereforewaterintakeshouldbemonitored

regularly,especiallyinbroilers.Incaseofinsufficientuptakeofwater,pigsshouldbetreatedparenterally.

(ii)Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproductto

animals

Duringpreparationandadministrationofthemedicateddrinkingwater,skincontactwiththedrugshouldbe

avoided.Thereforeitisrecommendedtowearimpermeableglovese.g.rubberorlatexwhenapplyingthe

product.Donothandlethisproductifyouknowyouareallergictotrimethoprimorsulphonamides.

Donotsmoke,drinkoreatwhenhandlingtheproduct.

Intheeventofeyecontact,rinsetheeyewithcopiousamountsofcleanwaterandifirritationoccurs,seek

medicalattention.Intheeventofaccidentalingestion,seekmedicaladvice.Washhandsandcontaminated

skinimmediatelyafterhandlingtheproduct.

Ifyoudevelopsymptomsfollowingexposuretotheproductsuchasskinrash,youshouldseekmedical

adviceandshowthepresentwarningtothedoctor.Swellingoftheface,lipsoreyesordifficultywith

breathingaremoreserioussymptomsandrequireurgentmedicalattention.

Useduringpregnancyorlactation

Laboratorystudiesinratsconductedwithtrimethoprimhaveshownevidenceofteratogenicityathigher

dosesthatrecommendedtherapeuticones.Thesafetyoftheproductduringpregnancyandlactationhasnot

beenestablishedinsows.Theuseoftheproductisnotrecommendedinsowsduringpregnancyand

lactation.

Interactionswithothermedicinalproductsandotherformsofinteraction

SolubilityandstabilityofMethoxasolindrinkingwaterarepH-dependent.

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbeusedormixedwith

otherveterinarymedicinalproducts.

12. EXPIRYDATE

EXP{month/year};DonotuseaftertheexpirydatestatedonthelabelafterEXP.

Onceopened/broached,useby:

13. SPECIALSTORAGEPRECAUTIONS

Donotfreeze.

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:3years

Shelf-lifeafterfirstopeningtheimmediatepackaging:maximum1yearandneverbeyondtheexpirydate

Shelf-lifeafterdilutionorreconstitutionaccordingtodirections:24hours

14. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTORWASTE

MATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialderivedfromsuchveterinarymedicinalproduct

shouldbedisposedofinaccordancewithlocalrequirements.

15. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly.Prescriptiononlymedicine.Tobecompletednationally

16. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

17. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

EurovetAnimalHealthBV,Handelsweg25,5531-AEBladel,TheNetherlands

18. MARKETINGAUTHORISATIONNUMBER(S)

Tobecompletednationally

19. MANUFACTURER’SBATCHNUMBER

Lot{number}

20. DATEONWHICHTHETEXTWASLASTAPPROVED

19-06-2012

21. OTHERINFORMATION

Packsizes:1litreand5litre

Notallpacksizesmaybemarketed.

PartIB-2B

LABELLING

WITHTEAR-OPENLEAFLET

1LITREBOTTLE/5LITRECAN

METHOXASOL

SOLUTIONFORUSEINDRINKINGWATER

FORPIGSANDBROILERS

NL/V/0166/001/DC.

Labelforimmediatepackage

withtear-openleaflet

<PARTICULARSTOAPPEARONTHEIMMEDIATEPACKAGE>

{NATURE/TYPE}1LITERBOTTLE/5LITRECAN

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Methoxasol20/100mg/mlsolutionforuseindrinkingwaterforpigsandchickens.

FI/DK:Methoxasolvet20/100mg/mlsolutionforuseindrinkingwaterforpigsandchickens.

Trimethoprim/Sulfamethoxazole

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Eachmlcontains:

ActiveSubstance:

Trimethoprim

Sulfamethoxazole

20mg

100mg

3. PHARMACEUTICALFORM

Clearyellowsolutionforuseindrinkingwater

4. PACKAGESIZE

1litre(5litre)

5. TARGETSPECIES

Pigsandchickens(broilers).

6. INDICATION(S)

Pigs:TreatmentandpreventionofrespiratoryinfectionscausedbyActinobacilluspleuropneumoniae

susceptibletotrimethoprimandsulfamethoxazolewherethediseasehasbeendiagnosedintheherd.

Broilers:TreatmentandpreventionofrespiratoryinfectionscausedbyEscherichiacolisusceptibleto

trimethoprimandsulfamethoxazolewherethediseasehasbeendiagnosedintheflock.

7. METHODANDROUTE(S)OFADMINISTRATION

Tobeadministeredorallyinthedrinkingwater.

8. WITHDRAWALPERIOD

Meatandoffal:Pigs: 5days

Broilers: 6days

Eggs: Notauthorisedforuseinlayingbirdsproducingeggsforhumanconsumption.

9. SPECIALWARNING(S),IFNECESSARY

Specialprecautionsforuseinanimals

Readthepackageleafletbeforeuse.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproductto

animals

Readthepackageleafletbeforeuse.

10. EXPIRYDATE

EXP{month/year};DonotuseaftertheexpirydatestatedonthelabelafterEXP.

Onceopened/broached,useby:

11. SPECIALSTORAGECONDITIONS

Donotfreeze.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSORWASTE

MATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialderivedfromsuchveterinarymedicinalproduct

shouldbedisposedofinaccordancewithlocalrequirements.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly.

Prescriptiononlymedicine(orsimilarwording,nationalissue)

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

EurovetAnimalHealthB.V.,

Handelsweg25,5531AEBladel,TheNetherlands.

16. MARKETINGAUTHORISATIONNUMBER(S)

Tobecompletednationally

17. MANUFACTURER’SBATCHNUMBER

Lot{number}

PACKAGELEAFLET

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERANDOFTHE

MANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFORBATCHRELEASE,

IFDIFFERENT

EurovetAnimalHealthBV

Handelsweg25,5531AEBladel

TheNetherlands

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Methoxasol20/100mg/mlsolutionforuseindrinkingwaterforpigsandchickens.

FI/DK:Methoxasolvet20/100mg/mlsolutionforuseindrinkingwaterforpigsandchickens.

Trimethoprim/Sulfamethoxazole.

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

Eachmlcontains:

ActiveSubstance:

Trimethoprim

Sulfamethoxazole

20mg

100mg

4. INDICATION(S)

Pigs:TreatmentandpreventionofrespiratoryinfectionscausedbyActinobacilluspleuropneumoniae

susceptibletotrimethoprimandsulfamethoxazolewherethediseasehasbeendiagnosedintheherd.

Broilers:TreatmentandpreventionofrespiratoryinfectionscausedbyEscherichiacolisusceptibleto

trimethoprimandsulfamethoxazolewherethediseasehasbeendiagnosedintheflock

5. CONTRAINDICATIONS

Donotuseinanimalssufferingfromsevereliverorkidneydisease,oliguriaoranuria.

Donotuseinanimalswithimpairedhaematopoieticsystems.

Donotuseincaseofknownhypersensitivitytosulfonamidesortrimethoprim.

6. ADVERSEREACTIONS

Adiminishedwaterintakeinchickensmayoccuroccasionally.

Hypersensitivityreactionscanoccurrarely

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisproductinformation,pleaseinform

yourveterinarysurgeonorpharmacist.

7. TARGETSPECIES

Pigsandchickens(broilers).

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOFADMINISTRATION

Administrationorallywiththedrinkingwater.

Pigs:25mgTMPSperkgbodyweightperdayfor3-4days,correspondingto1mloftheveterinary

medicinalproductper4,8kgbodyweightperday.Thiscorrespondstoapproximately1litreoftheveterinary

medicinalproductin500Ldrinkingwater.

Basedontherecommendeddose,dailywaterconsumption,andthenumberandweightofthepigstobe

treated,theexactdailyamountoftheveterinaryproductcanbecalculatedaccordingtothefollowing

formula:

Meanbodyweight(kg)ofpigstobetreated =xxmlveterinaryproductperl

drinkingwater

Meandailywaterconsumption(l)perpigx4.8

Broilers:33mgTMPSperkgbodyweightperdayfor3-4days,correspondingto1mloftheveterinary

medicinalproductper3,64kgbodyweightperday.Thiscorrespondstoapproximately1litreofthe

veterinarymedicinalproductin750Ldrinkingwater.

Basedontherecommendeddose,dailywaterconsumption,andthenumberandweightofthebirdstobe

treated,theexactdailyamountoftheveterinaryproductcanbecalculatedaccordingtothefollowing

formula:

Meanbodyweight(kg)ofbroilerstobetreated =xxmlveterinaryproductper

ldrinkingwater

Meandailywaterconsumption(l)perbirdx3.64

OnelitreMethoxasolweighs1079gram;thereforeweightcanalsobeusedtomeasuretheproductquantity

tobeaddedindrinkingwater,accordingtothefollowingformula:

Amounttobeaddedindrinkingwater(g/L)=calculatedml/Lx1.079.

Thedailyamountistobeaddedtothedrinkingwatersuchthatallmedicationwillbeconsumedin24hours.

9. ADVICEONCORRECTADMINISTRATION

Theproductcanbeaddeddirectlytothedrinkingwatertoprepareatherapeuticsolutionatthecalculated

concentration,butcanalsobeusedinaconcentratedstocksolutionbyadding200mloftheveterinary

medicinalproductperlitrewateranddilutingthisfurtherifrequired.DonotuseMethoxasolundilutedorin

higherconcentratedstocksolutions.

Medicateddrinkingwaterandstocksolutionsshouldbefreshlypreparedevery24hours.Duringthe

treatmentperiodanimalsshouldnothaveaccesstootherwatersourcesthanthemedicatedwaterthedilution

ofwhichshouldbecalculatedtoensurethatanimalsalwayshavesufficientwateravailable.Toensurea

correctdosagebodyweightshouldbedeterminedasaccuratelyaspossibletoavoidunderdosing.Theuptake

ofmedicatedwaterdependsontheclinicalconditionoftheanimals.Inordertoobtainthecorrectdosagethe

concentrationoftheveterinarymedicinalproductshastobeadjustedaccordingly.

10. WITHDRAWALPERIOD

Meatandoffal:

Pigs: 5days

Broilers: 6days

Eggs:

Notauthorisedforuseinlayingbirdsproducingeggsforhumanconsumption.

11. SPECIALSTORAGEPRECAUTIONS

Donotfreeze.

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:3years

Shelf-lifeafterfirstopeningtheimmediatepackaging:maximum1yearandneverbeyondtheexpirydate

Shelf-lifeafterdilutionorreconstitutionaccordingtodirections:24hours.

Keepoutofthereachandsightofchildren.

12. SPECIALWARNING(S)

Specialprecautionsforuse

(i)Specialprecautionsforuseinanimals

Duetothelikelyvariability(time,geographical)insusceptibilityofbacteriaforpotentiatedsulphonamides,

occurrenceofresistanceofbacteriamaydifferfromcountrytocountryandevenfromfarmtofarm,and

thereforebacteriologicalsamplingandsusceptibilitytestingarerecommended.Useoftheproductshouldbe

basedoncultureandsensitivityofmicro-organismsfromdiseasedcasesonfarmorfromrecentprevious

experienceonthefarm.

UseoftheproductdeviatingfromtheinstructionsgivenintheSPCmayincreasetheprevalenceofbacteria

resistanttosulfamethoxazoleandtrimethoprimandmayalsodecreasetheeffectivenessofcombinationsof

trimethoprimwithothersulphonamidesduetothepotentialforcrossresistance.

Severelydiseasedanimalscanhaveadecreasedappetiteandwaterconsumption.Ifnecessarythe

concentrationoftheVMPinthedrinkingwatershouldbeadjustedtomakesurethattherecommended

dosageisbeingconsumed.Howeveriftheconcentrationoftheproductisincreasedtoomuch,theintakeof

themedicateddrinkingwaterdecreasesforpalatabilityreasons.Thereforewaterintakeshouldbemonitored

regularly,especiallyinbroilers.Incaseofinsufficientuptakeofwater,pigsshouldbetreatedparenterally.

(ii)Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproductto

animals

Duringpreparationandadministrationofthemedicateddrinkingwater,skincontactwiththedrugshouldbe

avoided.Thereforeitisrecommendedtowearimpermeableglovese.g.rubberorlatexwhenapplyingthe

product.Donothandlethisproductifyouknowyouareallergictotrimethoprimorsulphonamides.

Donotsmoke,drinkoreatwhenhandlingtheproduct.

Intheeventofeyecontact,rinsetheeyewithcopiousamountsofcleanwaterandifirritationoccurs,seek

medicalattention.Intheeventofaccidentalingestion,seekmedicaladvice.Washhandsandcontaminated

skinimmediatelyafterhandlingtheproduct.

Ifyoudevelopsymptomsfollowingexposuretotheproductsuchasskinrash,youshouldseekmedical

adviceandshowthepresentwarningtothedoctor.Swellingoftheface,lipsoreyesordifficultywith

breathingaremoreserioussymptomsandrequireurgentmedicalattention.

Useduringpregnancyorlactation

Laboratorystudiesinratsconductedwithtrimethoprimhaveshownevidenceofteratogenicityathigher

dosesthatrecommendedtherapeuticones.Thesafetyoftheproductduringpregnancyandlactationhasnot

beenestablishedinsows.Theuseoftheproductisnotrecommendedinsowsduringpregnancyand

lactation.

Interactionswithothermedicinalproductsandotherformsofinteraction.

SolubilityandstabilityofMethoxasolindrinkingwaterarepH-dependent.

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbeusedormixedwith

otherveterinarymedicinalproducts.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTORWASTE

MATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialderivedfromsuchveterinarymedicinalproduct

shouldbedisposedofinaccordancewithlocalrequirements.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

19June2012

15. OTHERINFORMATION

Packsizes:1litreand5litres

Notallpacksizesmaybemarketed.

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Danish Pharmacovigilance Update, 20 October 2011

Danish Pharmacovigilance Update, 20 October 2011

In this edition of Danish Pharmacovigilance Update, you can read about: Use of medicines involving a risk of serious and life-threatening skin reactions, the European Medicines Agency to investigate the possible connection between orlistat and rare cases of severe liver toxicity, and the EMA’s review of peritoneal dialysis solutions from Baxter A/S.

Danish Medicines Agency

21-8-2018

Always use contact lens solution, not water, to clean and store your lenses!  #OnePairTakeCare  https://go.usa.gov/xUs89 pic.twitter.com/Jm50z0UFVu

Always use contact lens solution, not water, to clean and store your lenses! #OnePairTakeCare https://go.usa.gov/xUs89 pic.twitter.com/Jm50z0UFVu

Always use contact lens solution, not water, to clean and store your lenses! #OnePairTakeCare https://go.usa.gov/xUs89  pic.twitter.com/Jm50z0UFVu

FDA - U.S. Food and Drug Administration