SURAMOX/STABOX 50% OSP Pig

Main information

  • Trade name:
  • SURAMOX/STABOX 50% OSP Pig
  • Pharmaceutical form:
  • Powder for oral suspension
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • SURAMOX/STABOX 50% OSP Pig
    Spain
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • amoxicillin
  • Therapeutic area:
  • Pigs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0120/001
  • Authorization date:
  • 24-07-2011
  • EU code:
  • FR/V/0120/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

[Version7.2,12/2009]

ANNEXI

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

SURAMOX/STABOX50%ww/wwPowderforOralSolutionforPigs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachgramcontains:

Activesubstance:

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

Excipient(s):

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Powderfororalsolution.

Whitetoalmostwhiteandslightlygranularpowder.

4. CLINICALPARTICULARS

4.1 Targetspecies

Pig(pigsafterweaning).

4.2 Indicationsforuse,specifyingthetargetspecies

TreatmentofswinepleuropneumoniaduetoActinobacilluspleuropneumoniae(susceptibleto

amoxicillin).

4.3 Contraindications

Donotuseinanimalswithknownhypersensitivitytopenicillinsorothersubstancesofthe

ß-lactamgroup.

Donotuseinanimalswithseriouskidneymalfunctionincludinganuriaandoliguria.

Presenceofβ-lactamaseproducingbacteria.

Donotuseinlagomorphsandrodentssuchasrabbits,guineapigs,hamstersorgerbils.

Donotuseinruminantsorhorses.

4.4 Specialwarningsforeachtargetspecies

None.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Theuptakeofmedicationbyanimalscanbealteredasaconsequenceofillness.Incaseofinsufficient

uptakeoffeed/wateranimalsshouldbetreatedparenterally.

Useoftheproductshouldbebasedonsusceptibilitytestingofthebacteriaisolatedfromtheanimal.

Ifthisisnotpossible,therapyshouldbebasedonlocal(regional,farmlevel)epidemiologicalinformation

aboutsusceptibilityofthetargetbacteria.

UseoftheproductdeviatingfromtheinstructionsgivenintheSPCmayincreasetheprevalenceof

bacteriaresistanttoamoxicillin.

Narrowspectrumantibacterialtherapyshouldbeusedforfirstlinetreatmentwheresusceptibility

testingsuggestthelikelyefficacyofthisapproach.

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.

Useglovesduringtheadministrationoftheliquidfeedtothepigs.

Washtheexposedskin.

Avoidintroductionofcontaminationduringtheadministrationoftheproduct.

4.6 Adversereactions(frequencyandseriousness)

Penicillinsandcephalosporinsmaycausehypersensitivityfollowingadministration.Allergicreactionsto

thesesubstancesmayoccasionallybeserious.

4.7 Useduringpregnancy,lactationorlay

StudiesperformedinLaboratoryanimals(rat,rabbit),didnotshowateratogenic,embryotoxicor

maternotoxiceffectofamoxicillin.Safetyoftheproductinthepregnantandlactatingsowswasnot

demonstrated..Useonlyaccordinglytothebenefit/riskassessmentbytheresponsibleveterinarian

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Thebactericidaleffectofamoxicillinisneutralizedbysimultaneoususeofpharmaceuticalswith

bacteriostaticmodeofaction.

Nottobeusedsimultaneouslywithneomycinsinceitblockstheabsorptionoforalpenicillins.

4.9 Amountstobeadministeredandadministrationroute

20mgofamoxicillin(astrihydrate)perkgbodyweightdaily(i.e.400mgoftheproductper10

kgbodyweightperday),administeredfor5consecutivedaysorallyinliquidfeed.

Shaketheproductcontainerwellbeforeuse.

Afterdilutionoftheproductinasmallquantityofwater,thedilutionmustbemixedintheliquid

mealuntilhomogenous.

Wheneverpossible,therequiredamountofproductshouldbeaccuratelyweighedbytheuser.

Thecorrectdoseoftheproductcanalsobemeasuredusingthe5gmeasuringspoonwithpack

sizesof50,100and200gand8gmeasuringspoonwithpacksizesof500,1000,1500and3000

g,accordingtothefollowingrecommendations:

Alevel5gmeasuringspoonholds5gofproduct,i.e.theamountofproducttotreat125kg

ofbodyweightperday.

Alevel8gmeasuringspoonholds8gofproduct,i.e.theamountofproducttotreat200kg

ofbodyweightperday.

Useincommercialfeedonly

Toensureacorrectdosagebodyweightshouldbedetermniedasaccuratelyaspossibletoavoid

underdosing.Theintakeofmedicatedfeeddependsontheclinicalconditionoftheanimals.Inorderto

obtainthecorrectdosagetheconcentrationofSuramoxhastobeadjustedaccordingly.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Nosideeffectswereobservedafteradministrationat5timestherecommendeddosage.

4.11Withdrawalperiod(s)

Meatandoffal:14days.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Penicillinswithextendedspectrum.

ATCvetcode:QJ01CA04

5.1 Pharmacodynamicproperties

Amoxicillinisasemi-syntheticpenicillinderivedfromthe6APAcore(6amino-penicillicacid).Itisa

broadspectrumantibiotic,bactericidalagainstGram+andGram-bacteria,inparticularActinobacillus

pleuropneumoniae,isolatedinpigs.

Amoxicillinactsbyinhibitionofbacterialcellwallsynthesisoractivationofenzymesdisruptingcell

walls(bactericidalaction).

5.2 Pharmacokineticparticulars

Inpigs,aftertheadministrationoftheproductatadoseof20mg/kginliquidfeed,amoxicillinmaximal

plasmaconcentrationof2.0µg/mlisreached1.8hoursaftertheadministration.Therepeated

administrationofthedrugdoesnotleadtoaccumulation.Theaverageabsolutebioavailabilityof

amoxicillininliquidfeedisestimatedtobe12%.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Sodiumglycinecarbonate,

Colloidalanhydroussilica,

Vanillin,

Sodiumhexametaphospate.

6.2 Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixedwithother

veterinaryproducts.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years.

Shelf-lifeafterfirstopeningthecontainer:10days

Shelf-lifeafterdissolutioninliquidfeed:2hours.

6.4.Specialprecautionsforstorage

Thismedicinalproductdoesnotrequireanyspecialstorageconditions.

6.5 Natureandcompositionofimmediatepackaging

1boxwith50ghighdensitypolyethylenejarhermeticallyclosedbythermosealedaluminium

polyethylenesealandoverscrewcap,withaspoon.

1boxwith100ghighdensitypolyethylenejarhermeticallyclosedbythermosealedaluminium

polyethylenesealandoverscrewcap,withaspoon.

200ghighdensitypolyethylenejarhermeticallyclosedbythermosealedaluminiumpolyethylene

sealandoverscrewcap,withaspoon.

500and1000ghighdensitypolyethylenejarshermeticallyclosedbythermosealedaluminium

polyethylenesealandoverscrewcap,withaspoon.

1500and3000ghighdensitypolyethylenebarrelsclosedhermeticallybyscrewcapsequippedwith

aninternalrubbersealandanexternalsecuritycompactsealwithaspoon.

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

VIRBACS.A.–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:22February2001.

Dateoflastrenewal:10/01/2005.

10 DATEOFREVISIONOFTHETEXT

ANNEXIII

LABELLINGANDPACKAGELEAFLET

A.LABELLING

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

Boxof50gor100g

Jarof200gor500gor1kg

Barrelof1,5kgor3kg

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Suramox/Stabox50%ww/wwPowderforOralSolutionforPigs

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Eachgramcontains:

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

3. PHARMACEUTICALFORM

Powderfororalsolution.

4. PACKAGESIZE

50g

100g

200g

500g

1kg

1,5kg

3kg

5. TARGETSPECIES

Pig.

6. INDICATION(S)

Readthepackageleafletbeforeuse.

Ifyounoticeseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinformyourveterinary

surgeon.

7. METHODANDROUTE(S)OFADMINISTRATION

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Meatandoffal:14days.

9. SPECIALWARNING(S),IFNECESSARY

Readthepackageleafletbeforeuse.

Toensureacorrectdosagebodyweightshouldbedeterminedasaccuratelyaspossibletoavoid

underdosing.Theintakeofmedicatedfeeddependsontheclinicalconditionoftheanimal.Inorderto

obtainthecorrectdosagetheconcentrationofSuramoxhastobeadjustedaccordingly.

10. EXPIRYDATE

EXP:{month/year}

Onceopened,usewithin10days.

Afterdissolutioninliquidfeed,usewithin2hours.

11. SPECIALSTORAGECONDITIONS

Readthepackageleafletbeforeuse.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Readthepackageleafletbeforeuse.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly.

Tobesuppliedonlyonveterinaryprescription.

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

VIRBACS.A.

ère

avenue-2065m-L.I.D.

F-06516Carros

France

16. MARKETINGAUTHORISATIONNUMBER(S)

17. MANUFACTURER’SBATCHNUMBER

Batch:{number}

MINIMUMPARTICULARSTOAPPEARONSMALLIMMEDIATEPACKAGING

UNITS

Jarof50gor100g

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Suramox/Stabox50%ww/wwPowderforOralSolutionforPigs

2. QUANTITYOFTHEACTIVESUBSTANCE(S)

Eachgramcontains:

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

3. CONTENTSBYWEIGHT,BYVOLUMEORBYNUMBEROFDOSES

50g

100g

4. ROUTE(S)OFADMINISTRATION

Oraluse.

5. WITHDRAWALPERIOD

Meatandoffal:14days.

6. BATCHNUMBER

Batch:{number}

7. EXPIRYDATE

EXP:{month/year}

8. THEWORDS“FORANIMALTREATMENTONLY”

Foranimaltreatmentonly.

Readthepackageleafletbeforeuse.

B.PACKAGELEAFLET

PACKAGELEAFLET

SURAMOX/STABOX50%ww/wwPowderforOralSolutionforPigs

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERAND

OFTHEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFOR

BATCHRELEASE,IFDIFFERENT

Marketingauthorisationholder:

VIRBACS.A.

1èreavenue–2065M–L.I.D.

F-06516Carros

France

Marketingauthorisationmanufacturerforthebatchrelease:

VIRBAC

8-10ruedesAulnaies

95420Magny-En-Vexin

France

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

SURAMOX/STABOX50%ww/wwPowderforOralSolutionforPigs

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

Eachgramcontains:

Activesubstance:

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

4. INDICATION(S)

TreatmentofswinepleuropneumoniaduetoActinobacilluspleuropneumoniae(susceptibleto

amoxicillin).

5. CONTRAINDICATIONS

Donotuseinanimalswithknownhypersensitivitytopenicillinsorothersubstancesofthe

ß-lactamgroup.

Donotuseinanimalswithseriouskidneymalfunctionincludinganuriaandoliguria.

Presenceofβ-lactamaseproducingbacteria.

Donotuseinlagomorphsandrodentssuchasrabbits,guineapigs,hamstersorgerbils.

Donotuseinruminantsorhorses.

6. ADVERSEREACTIONS

Penicillinsandcephalosporinsmaycausehypersensitivityfollowingadministration.Allergicreactionsto

thesesubstancesmayoccasionallybeserious.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinformyour

veterinarysurgeon.

7. TARGETSPECIES

Pig(pigsafterweaning).

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOF

ADMINISTRATION

20mgofamoxicillin(astrihydrate)perkgbodyweightdaily(i.e.400mgoftheproductper10kg

bodyweightperday),administeredfor5consecutivedaysorallyinliquidfeed.

9. ADVICEONCORRECTADMINISTRATION

Shaketheproductcontainerwellbeforeuse.

Afterdilutionoftheproductinasmallquantityofwater,thedilutionmustbemixedintheliquid

mealuntilhomogenous.

Wheneverpossible,therequiredamountofproductshouldbeaccuratelyweighedbytheuser.

Thecorrectdoseoftheproductcanalsobemeasuredusingthe5gmeasuringspoonwithpack

sizesof50,100and200gand8gmeasuringspoonwithpacksizesof500,1000,1500and3000

g,accordingtothefollowingrecommendations:

Alevel5gmeasuringspoonholds5gofproduct,i.e.theamountofproducttotreat125kg

ofbodyweightperday.

Alevel8gmeasuringspoonholds8gofproduct,i.e.theamountofproducttotreat200kg

ofbodyweightperday.

Useincommercialfeedonly

Toensureacorrectdosagebodyweightshouldbedeterminedasaccuratelyaspossibletoavoid

underdosing.Theintakeofmedicatedfeeddependsontheclinicalconditionoftheanimals.Inorderto

obtainthecorrectdosagetheconcentrationofSuramoxhastobeadjustedaccordingly.

10. WITHDRAWALPERIOD

Meatandoffal:14days.

11. SPECIALSTORAGEPRECAUTIONS

Keepoutofthereachandsightofchildren.

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

DonotuseaftertheexpirydatewhichisstatedonthelabelandcartonafterEXP.

Shelf-lifeafterfirstopeningthecontainer:10days

Shelf-lifeafterdissolutioninliquidfeed:2hours.

12. SPECIALWARNING(S)

Specialprecautionsforuseinanimals

Theuptakeofmedicationbyanimalscanbealteredasaconsequenceofillness.Incaseofinsufficient

uptakeoffeed/wateranimalsshouldbetreatedparenterally.

Useoftheproductshouldbebasedonsusceptibilitytestingofthebacteriaisolatedfromtheanimal.If

thisisnotpossible,therapyshouldbebasedonlocal(regional,farmlevelepidemiologicalinformation

aboutsusceptibilityofthetargetbacteria.

UseoftheproductdeviatingfromtheinstructionsgivenintheSPCmayincreasetheprevalenceof

bacteriaresistanttoamoxicillin

Narrowspectrumantibacterialtherapyshouldbeusedforfirstlinetreatmentwheresusceptibility

testingsuggestthelikelyefficacyofthisapproach.

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.

Useglovesduringtheadministrationoftheliquidfeedtothepigs.

Washtheexposedskin.

Avoidintroductionofcontaminationduringtheadministrationoftheproduct.

Useduringpregnancy,lactationorlay

StudiesperformedinLaboratoryanimals(rat,rabbit),didnotshowateratogenic,embryotoxicor

maternotoxiceffectofamoxicillin.Safetyoftheproductinthepregnantandlactatingsowswasnot

demonstrated.Useonlyaccordinglytothebenefit/riskassessmentbytheresponsibleveterinarian

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.

Whenthecontainerisopenedforthefirsttime,usingtheinuseshelf-lifewhichisspecifiedonthis

packageleaflet,thedateonwhichanyproductremaininginthecontainershouldbediscardedshould

beworkedout.Thisdiscarddateshouldbewritteninthespaceprovidedonthelabel.”

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