Octacillin, 800 mg/g powder for oral solution for chickens

Main information

  • Trade name:
  • Octacillin, 800 mg/g powder for oral solution for chickens
  • Pharmaceutical form:
  • Powder for oral solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Octacillin, 800 mg/g powder for oral solution for chickens
    Germany
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • amoxicillin
  • Therapeutic area:
  • Chicken Food

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • NL/V/0144/001
  • Authorization date:
  • 24-02-2010
  • EU code:
  • NL/V/0144/001
  • Last update:
  • 09-08-2016

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

PartIB-2

LABELLING

OCTACILLIN

POWDERFORUSEINDRINKINGWATER

FORCHICKENS

Thefulltextwillbeprintedonthesachet/bag

FormatusedisrequiredbyDutchlawforthistypeoflabelling

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

=

IMMEDIATEPACKAGE

=

LEAFLET

Plastic/Aluminiumsachet

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Octacillin800 mg/gpowderforuseindrinkingwaterforchickens

NL:Octacillin800 mg/gpoedervoorgebruikinhetdrinkwatervoorkippen

DE:Octacillin800 mg/gPulverzumEingebenüberdasTrinkwasserfürHühner

FR:Octacillin697 mg/gpoudreàadministrerdansl'eaudeboissondespoulets

2. STATEMENTOFTHEACTIVESUBSTANCEANDOTHERINGREDIENT

Compositionpergramproduct

ActiveSubstance:Amoxicillintrihydrate800 mgcorrespondingto 697 mgamoxicillin

3. PHARMACEUTICALFORM

Powderforuseindrinkingwater.Whitetopaleyellow-whitepowder.

4. PACKAGESIZE

100 g,250 g,500 g,1.0kg.

5. TARGETSPECIES

Chicken(excludinglayingbirdsproducingeggsforhumanconsumption):broiler,pullet,

breeder.

6. INDICATION(S)

Whereclinicaldiseaseispresentintheflock,treatmentandpreventionofrespiratoryor

gastrointestinaldiseaseduetopathogenssensitiveto amoxicillin.

7. CONTRAINDICATIONS

Noneknownforthistargetspecies.

Donotuseinlagomorphsandrodentssuchasrabbits,guineapigs,hamsterandgerbilsasthis

maycausesevereenterotoxaemia.

8. ADVERSEREACTIONS

Noneknown.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisproductinformation,

pleaseinformyourveterinarysurgeonorpharmacist.

9. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOF

ADMINISTRATION

Chickens:20 mgamoxicillinperkgbodyweightperdayfor3-5daysadministeredinthe

drinkingwater.Thiscorrespondsto 28.7 mgproductperkgbodyweight.

Prepareanamountofmedicatedwaterto beconsumedwithinthenext12 hours.Anyunused

medicatedwatershouldbediscardedafter12 hours,andfreshmedicatedwater-forthenext12

hours-shouldbeprepared.

Thefollowingformulamaybeusedto calculatetheamountofproduct(ingrams)requiredper

dayper1000 litredrinkingwater.

gramproductperdayper1000litre=numberofbirdsxaverageliveweight(kg)x28.7

totalwaterintake(inlitres)oftheflockperday

Theuseofsuitablycalibratedweighingequipmentfortheadministrationofthecalculated

amountofproductisrecommended.Itisrecommended-afteradditionofthepowderto the

drinkingwater-tothoroughlystiruntiltheproductiscompletelydissolved.

10.WITHDRAWALPERIODS

Meatandoffal:1day

Notpermittedforuseinlayingbirdsproducingeggsforhumanconsumption.

Donotusewithin4 weeksbeforetheonsetofthelayingperiod.

11.SPECIALWARNINGS

Specialprecautionsforuseinanimals

Useoftheproductshouldbebasedonsusceptibilitytestinganditshouldtakeintoaccount

officialandlocalantimicrobialpolicies.Resistanceagainstamoxicillinmayvary.Therefore

theuseoftheproductshouldbebased oncultureandsensitivityofmicro-organismsfrom

diseasedcasesonfarmorfromrecentpreviousexperienceonthefarm

Inappropriateuseoftheproductmayincreasetheprevalenceofbacteriaresistanceto

amoxicillineandmaydecreaseitseffectiveness.

Incaseofachangedindrinkingwaterconsumption,theconcentrationshouldbeadjusted

suchthattherecommendeddosageinmgactiveingredientperkgbodyweightisrealised.

Duringthetreatmentperiodanimalsshouldnothaveaccesstootherwatersourcesthanthe

medicatedwater.

Specialprecautionsto betakenby thepersonadministeringtheveterinarymedicinal

producttoanimals

Penicillinsandcephalosporinsmaycausehypersensitivity(allergy)followinginjection,

inhalation,ingestionorskincontact.Hypersensitivityto penicillinsmayleadtocross

sensitivityto cephalosporinsandviceversa.Allergicreactionstothesesubstancesmay

occasionallybeserious.

Donothandlethisproductifyouknowyouaresensitisedorifyouhavebeenadvisednotto

workwithsuchpreparations.Wearglovesandarespiratorordustmask.

Handlethisproductwithcaretoavoidexposure,takingallrecommendedprecautions.Inthe

eventofskincontactwashexposedskinwithsoapandwater.

Ifyoudevelopsymptomsfollowingexposure,suchasskinrash,youshouldseek medical

adviceandshowthedoctorthiswarning.Swellingoftheface,lipsoreyesordifficultyin

breathingaremoreserioussymptomsandrequireurgentmedicalattention.

Useduringlay

Notapplicable.

Interactionswithothermedicinalproductsandotherformsofinteraction

Donotcombinewithbacteriostaticantimicrobialagents

Donotmixwithotherveterinarymedicinalproducts.

Overdose(symptoms,emergency procedures,antidotes),ifnecessary

No effectsknown.

12. EXPIRYDATE

EXP{month/year};DonotuseaftertheexpirydatestatedonthelabelafterEXP.

13.SPECIALSTORAGEPRECAUTIONS

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:3 years

Shelf-lifeafterfirstopeningthepackaging:3months.

Keep thebagtightlyclosedafterfirstopeninginordertoprotectfrommoisture

Shelf-lifeafterdilutionorreconstitutionaccordingtodirections:12hours.

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

XX/XX/XXXXX

21. OTHERINFORMATION

Notallpack sizesmaybemarketed.

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