Suramox 50% OSP Poultry

Main information

  • Trade name:
  • Suramox 50% OSP Poultry
  • Pharmaceutical form:
  • Powder for oral solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Suramox 50% OSP Poultry
    France
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • amoxicillin
  • Therapeutic area:
  • Chicken Broilers

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0122/001
  • Authorization date:
  • 24-07-2011
  • EU code:
  • FR/V/0122/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

[June2010

ANNEXI

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

SURAMOX/STABOX50%O.S.P.POULTRY

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachgramcontains:

Activesubstance:

Amoxicillin(astrihydrateform).............................500.00mg

Excipient(s):

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Powderfororalsolution.

4. CLINICALPARTICULARS

4.1 Targetspecies

Chicken(broilers).

4.2 Indicationsforuse,specifyingthetargetspecies

Preventionatthegrouplevel,whendiseaseispresent,ofrespiratoryinfectionscausedbyEscherichia

coli(sensitivetoamoxicillin).

4.3 Contraindications

Donotuseinanimalswithknownhypersensitivitytopenicillinsorothersubstancesoftheß-

lactamgroup.

Donotuseinanimalswithseriouskidneymalfunctionincludinganuriaandoliguria.

Presenceofβ-lactamaseproducingbacteria.

Donotuseinlagomorphsandrodentssuchasrabbits,guineapigs,hamstersorgerbils.

Donotuseinruminantsorhorses.

4.4 Specialwarningsforeachtargetspecies

None.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Useoftheproductshouldbebasedonsusceptibilitytestingofthebacteriaisolatedfromtheanimal.If

thisisnotpossible,therapyshouldbebasedonlocal(regional,farmlevel)epidemiologicalinformation

aboutsusceptibilityofthetargetbacteria.

Inappropriateuseoftheproductmayincreasetheprevalenceofbacteriaresistanttoamoxicillinand

maydecreaseitseffectiveness..

Narrowspectrumantibacterialtherapyshouldbeusedforfirstlinetreatmentwheresusceptibility

testingsuggeststhelikelyefficayofthisapproach.Inappropriateuseoftheproductmayincreasethe

prevalenceofbacteriaresistanttoamoxicillinandotherpenicillins.Considerationshouldbegivento

improvementofmanagementpracticeonthefarm,mainlyinhygienemanagement,ventilationand

chickenmanagementavoidingstressconditions.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Penicillinsandcephalosporinsmaycausehypersensitivity(allergy)followinginjection,inhalation,

ingestionorskincontact.Hypersensitivitytopenicillinsmayleadtocrossreactionsto

cephalosporinsandviceversa.Allergicreactionstothesesubstancesmayoccasionallybe

serious.

Donothandlethisproductifyouknowyouaresensitised,orifyouhavebeenadvisednottowork

withsuchpreparations.

Handlethisproductwithgreatcaretoavoidexposure,takingallrecommendedprecautions.Ifyou

developsymptomsfollowingexposuresuchasaskinrash,youshouldseekmedicaladviceand

showthedoctorthiswarning.Swellingoftheface,lipsoreyesordifficultywithbreathing,are

moreserioussymptomsandrequireurgentmedicalattention.

Useinhalationprotectionandglovesduringpreparation.

Washtheexposedskin.

Avoidintroductionofcontaminationduringtheadministrationoftheproduct.

4.6 Adversereactions(frequencyandseriousness)

Penicillinsandcephalosporinsmaycausehypersensitivityfollowingadministration.Allergicreactionsto

thesesubstancesmayoccasionallybeserious.

4.7 Useduringpregnancy,lactationorlay

Donotuseinbirdsinlay.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Thebactericidaleffectofamoxicillinisneutralizedbysimultaneoususeofpharmaceuticalswith

bacteriostaticmodeofaction.

Nottobeusedsimultaneouslywithneomycinsinceitblockstheabsorptionoforalpenicillins.

4.9 Amountstobeadministeredandadministrationroute

20mgofamoxicillin(astrihydrate)perkgbodyweightinacontinuousadministrationintodrinking

water(i.e.400mgoftheproductper10kgbodyweightandperday)for5consecutivedays.

Therouteofadministrationistheoralroute.

Theproductmustfirstbedilutedinasmallquantityofwaterinordertoobtainastocksolutionwhichis

thendilutedinthedrinkingwatertank.Turnoffthewatersupplytothetankuntilallthemedicated

solutionisconsumed.Thisdilutionprocessproducesafinalsolutionwithabetterhomogeneity.The

concentratedsolutioncanalsobedispensedbymeansofawaterproportionerpump.

Theintakeofmedicatedwaterdependsontheclinicalconditionoftheanimals.Inordertoobtainthe

correctdosagetheconcentrationofamoxicillinhastobeadjustedaccordingly.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Nosideeffectswereobservedafteradministrationat5timestherecommendeddosage.

4.11Withdrawalperiod(s)

Meatandoffal:1day.

.

Intheabsenceofawithdrawalperiodforeggs,donotusetheproductinlayinghensthatproduceeggs

forhumanconsumption(4weeksbeforethestartofegglayingandduringthelayingperiod).

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Penicillinswithextendedspectrum.

ATCvetcode:QJ01CA04

5.1 Pharmacodynamicproperties

Amoxicillinisasemi-syntheticpenicillinderivedfromthe6APAcore(6amino-penicillicacid).Itisa

broadspectrumantibiotic,bactericidalagainstGram+andGram-bacteria,inparticularEscherichia

coliisolatedinbroilers.

5.2 Pharmacokineticparticulars

Inbroilers,aftertheadministrationoftheproductattherecommendeddosage,theactiveingredient

plasmaconcentrationsrangebetween0.03and0.2µg/mlduringthetreatment.Therepeated

administrationofthedrugdoesnotleadtoaccumulationphenomena.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Sodiumglycinecarbonate,

Colloidalanhydroussilica,

Vanillin,

Sodiumhexametaphospate.

6.2 Incompatibilities

Noneknown.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years.

Shelf-lifeafterfirstopeningthecontainer:10days

Shelf-lifeafterdissolutionindrinkingwater:24hours.

6.4.Specialprecautionsforstorage

Keepintheoriginalpackage.

6.5 Natureandcompositionofimmediatepackaging

1boxwith50ghighdensitypolyethylenejarhermeticallyclosedbythermosealedaluminium

polyethylenesealandoverscrewcap,witha5gspoon.

1boxwith100ghighdensitypolyethylenejarhermeticallyclosedbythermosealedaluminium

polyethylenesealandoverscrewcap,witha5gspoon.

200ghighdensitypolyethylenejarhermeticallyclosedbythermosealedaluminiumpolyethylene

sealandoverscrewcap,witha5gspoon.

500and1000ghighdensitypolyethylenejarshermeticallyclosedbythermosealedaluminium

polyethylenesealandoverscrewcap,withan8gspoon.

1500and3000ghighdensitypolyethylenebarrelsclosedhermeticallybyscrewcapsequippedwith

aninternalrubbersealandanexternalsecuritycompactsealwithan8gspoon.

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

VIRBAC–1 ère avenue-2065mL.I.D.-F-06516Carros-France

Tel:+33492087304

Fax:+33492087348

e-mail: dar@virbac.fr

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateofthefirstauthorisation:22March2001.

Dateoflastrenewal:17/10/2005.

10 DATEOFREVISIONOFTHETEXT

ANNEXIII

LABELLINGANDPACKAGELEAFLET

A.LABELLING

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

Boxof50gor100g

Jarof200gor500gor1kg

Barrelof1,5kgor3kg

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Suramox/Stabox50%O.S.P.Poultry

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Eachgramcontains:

Amoxicillin(astrihydrateform).............................500.00 mg

3. PHARMACEUTICALFORM

Powderfororalsolution.

4. PACKAGESIZE

50g

100g

200g

500g

1kg

1,5kg

3kg

5. TARGETSPECIES

Chicken(broilers).

6. INDICATION(S)

Readthepackageleafletbeforeuse.

Ifyounoticeseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinformyourveterinary

surgeon.

7. METHODANDROUTE(S)OFADMINISTRATION

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Meatandoffal:1day.

Donotuseinlayinghensproducingeggsforhumanconsumption.

9. SPECIALWARNING(S),IFNECESSARY

Readthepackageleafletbeforeuse.

10. EXPIRYDATE

EXP:{month/year}

Onceopened,usewithin10days.

Afterdissolutionindrinkingwater:24hours.

11. SPECIALSTORAGECONDITIONS

Readthepackageleafletbeforeuse.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Readthepackageleafletbeforeuse.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly.

Tobesuppliedonlyonveterinaryprescription.

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

VIRBAC

ère

avenue-2065m-L.I.D.

F-06516Carros

France

16. MARKETINGAUTHORISATIONNUMBER(S)

17. MANUFACTURER’SBATCHNUMBER

Batch:{number}

MINIMUMPARTICULARSTOAPPEARONSMALLIMMEDIATEPACKAGING

UNITS

Jarof50gor100g

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Suramox/Stabox50%O.S.P.POULTRY

2. QUANTITYOFTHEACTIVESUBSTANCE(S)

Eachgramcontains:

Amoxicillin(astrihydrateform).............................500.00 mg

3. CONTENTSBYWEIGHT,BYVOLUMEORBYNUMBEROFDOSES

50g

100g

4. ROUTE(S)OFADMINISTRATION

Oraluse.

5. WITHDRAWALPERIOD

Meatandoffal:7days.

Donotuseinlayinghensproducingeggsforhumanconsumption.

6. BATCHNUMBER

Batch:{number}

7. EXPIRYDATE

EXP:{month/year}

Shelf-lifeafterfirstopeningthecontainer:10days.

Shelf-lifeafterdissolutionindrinkingwater:24hours.

8. THEWORDS“FORANIMALTREATMENTONLY”

Foranimaltreatmentonly.

Readthepackageleafletbeforeuse.

B.PACKAGELEAFLET

PACKAGELEAFLET

SURAMOX/STABOX50%O.S.P.POULTRY

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERAND

OFTHEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFOR

BATCHRELEASE,IFDIFFERENT

Marketingauthorisationholder:

VIRBAC

1èreavenue–2065M–L.I.D.

F-06516Carros

France

Marketingauthorisationmanufacturerforthebatchrelease:

VIRBAC

8-10ruedesAulnaies

95420Magny-En-Vexin

France

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

SURAMOX/STABOX50%O.S.P.POULTRY

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

Eachgramcontains:

Activesubstance:

Amoxicillin(astrihydrateform).............................500.00 mg

4. INDICATION(S)

Preventionatthegrouplevel,whendiseaseispresent,ofrespiratoryinfectionscausedbyEscherichia

coli(sensitivetoamoxicillin).

5. CONTRAINDICATIONS

Donotuseinanimalswithknownhypersensitivitytopenicillinsorothersubstancesoftheß-

lactamgroup.

Donotuseinanimalswithseriouskidneymalfunctionincludinganuriaandoliguria.

Presenceofβ-lactamaseproducingbacteria.

Donotuseinlagomorphsandrodentssuchasrabbits,guineapigs,hamstersorgerbils.

Donotuseinruminantsorhorses.

6. ADVERSEREACTIONS

Penicillinsandcephalosporinsmaycausehypersensitivityfollowingadministration.Allergicreactionsto

thesesubstancesmayoccasionallybeserious.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinformyour

veterinarysurgeon.

7. TARGETSPECIES

Chicken(broilers).

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOF

ADMINISTRATION

20mgofamoxicillin(astrihydrate)perkgbodyweightinacontinuousadministrationintodrinking

water(i.e.400mgoftheproductper10kgbodyweightandperday)for5consecutivedays.

9. ADVICEONCORRECTADMINISTRATION

Therouteofadministrationistheoralroute.

Theproductmustfirstbedilutedinasmallquantityofwaterinordertoobtainastocksolutionwhichis

thendilutedinthedrinkingwatertank.Turnoffthewatersupplytothetankuntilallthemedicated

solutionisconsumed.Thisdilutionprocessproducesafinalsolutionwithabetterhomogeneity.The

concentratedsolutioncanalsobedispensedbymeansofawaterproportionerpump.

Theintakeofmedicatedwaterdependsontheclinicalconditionoftheanimals.Inordertoobtainthe

correctdosagetheconcentrationofamoxicillinhastobeadjustedaccordingly.

10. WITHDRAWALPERIOD

Meatandoffal:1day.

Intheabsenceofawithdrawalperiodforeggs,donotusetheproductinlayinghensthatproduceeggs

forhumanconsumption(4weeksbeforethestartofegglayingandduringthelayingperiod).

11. SPECIALSTORAGEPRECAUTIONS

Keepoutofthereachandsightofchildren.

Shelf-lifeafterfirstopeningthecontainer:10days

Shelf-lifeafterdissolutionindrinkingwater:24hours.

Keepintheoriginalpackage.

12. SPECIALWARNING(S)

Specialprecautionsforuseinanimals

Useoftheproductshouldbebasedonsusceptibilitytestingofthebacteriaisolatedfromtheanimal.If

thisisnotpossible,therapyshouldbebasedonsusceptibilitytestingofthebacteriaisolatedfromthe

animal.Ifthisisnotpossible,therapyshouldbebasedonlocal(regional,farmlevel)epidemiological

informationaboutsusceptibilityofthetargetbacteria.

Inappropriateuseoftheproductmayincreasetheprevalenceofbacteriaresistanttoamoxicillinand

maydecreaseitseffectiveness.

Narrowspectrumantibacterialtherapyshouldbeusedforfirstlinetreatmentwheresusceptibility

testingsuggeststhelikelyefficayofthisapproach.Inappropriateuseoftheproductmayincreasethe

prevalenceofbacteriaresistanttoamoxicillinandotherpenicillins.Considerationshouldbegivento

improvementofmanagementpracticeonthefarm,mainlyinhygienemanagement,ventilationand

chickenmanagementavoidingstressconditions.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Penicillinsandcephalosporinsmaycausehypersensitivity(allergy)followinginjection,inhalation,

ingestionorskincontact.Hypersensitivitytopenicillinsmayleadtocrossreactionsto

cephalosporinsandviceversa.Allergicreactionstothesesubstancesmayoccasionallybe

serious.

Donothandlethisproductifyouknowyouaresensitised,orifyouhavebeenadvisednottowork

withsuchpreparations.

Handlethisproductwithgreatcaretoavoidexposure,takingallrecommendedprecautions.Ifyou

developsymptomsfollowingexposuresuchasaskinrash,youshouldseekmedicaladviceand

showthedoctorthiswarning.Swellingoftheface,lipsoreyesordifficultywithbreathing,are

moreserioussymptomsandrequireurgentmedicalattention.

Useinhalationprotectionandglovesduringpreparation.

Washtheexposedskin.

Avoidintroductionofcontaminationduringtheadministrationoftheproduct.

Useduringpregnancy,lactationorlay

Donotuseinbirdsinlay.

Interactionwithothermedicinalproductsandotherformsofinteraction

Thebactericidaleffectofamoxicillinisneutralizedbysimultaneoususeofpharmaceuticalswith

bacteriostaticmodeofaction.

Nottobeusedsimultaneouslywithneomycinsinceitblockstheabsorptionoforalpenicillins.

Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Nosideeffectswereobservedafteradministrationat5timestherecommendeddosage.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalnationalrequirements.

14. DATEONWICHTHEPACKAGELEAFLETWASLASTAPPROVED

15. OTHERINFORMATION

1boxwitha50gjar,withaspoon.

1boxwitha100g,jarwithaspoon.

200gjar,withaspoon.

500and1000gjars,withaspoon.

1500and3000gbarrelswithaspoon.

Notallpacksizesmaybemarketed.

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

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