Octacillin

Main information

  • Trade name:
  • Octacillin 697 mg/g Powder for use in drinking water for Chickens
  • Pharmaceutical form:
  • Powder and solvent for oral solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Octacillin 697 mg/g Powder for use in drinking water for Chickens
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Penicillins with extended spectrum
  • Therapeutic area:
  • Chicken Non Food

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0214/001
  • Authorization date:
  • 02-09-2011
  • EU code:
  • UK/V/0214/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:July2011

An:00487/2010

SUMMARYOFPRODUCTCHARACTERISTICS

1 NAMEOFTHEVETERINARYMEDICINALPRODUCT

Octacillin697mg/gpowderforuseindrinkingwaterforchickens

2 QUALITATIVEANDQUANTITATIVECOMPOSITION

Activesubstance:

Amoxicillin(asAmoxicillintrihydratePh.Eur.) 697mg/g

Forafulllistofexcipients,seesection6.1

3 PHARMACEUTICALFORM

Powderforuseindrinkingwater

Whitetopaleyellow-whitepowder

4 CLINICALPARTICULARS

4.1 Targetspecies

Chickens(excludinglayingbirdsproducingeggsforhumanconsumption).

4.2 Indicationsforuse,specifyingthetargetspecies

Treatmentofinfectionsinchickenscausedbybacteriasusceptibletoamoxicillin.

Noteffectiveagainstbeta-lactamaseproducingorganisms.

4.3 Contra-indications

Donotuseinknowncasesofhypersensitivitytopenicillinorothersubstancesofthebeta-

lactamgroup.

Donotuseinrabbits,guineapigs,hamsters,gerbilsoranyothersmallherbivores.

4.4 Specialwarningforeachtargetspecies.

None.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Useoftheproductshouldbebasedonsusceptibilitytestinganditshouldtakeintoaccount

officialandlocalantimicrobialpolicies.

Inappropriateuseoftheproductmayincreasetheprevalenceofbacteriaresistanceto

amoxicillineandmaydecreaseitseffectiveness.

Revised:July2011

An:00487/2010

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Penicillinsandcephalosporinsmaycausehypersensitivity(allergy)followinginjection,

inhalation,ingestionorskincontact.Hypersensitivitytopenicillinsmaycausecross

reactionstocephalosporinsandviceversa.Allergicreactionstothesesubstancesmay

occasionallybeserious.

1. Peoplewithknownhypersensitivitytopenicillinorcephalosporinshouldavoidcontact

withtheproduct.

2. Handlethisproductwithgreatcaretoavoidexposure,takingallrecommended

precautions.Wearprotectiveclothing,imperviousglovesandeitheradisposablehalf

maskrespiratorconformingtoEuropeanStandardEN149oranon-disposable

respiratorconformingtoEuropeanStandardEN140withafiltertoEN143when

mixingandhandlingtheproduct.Washhandsafteruse.

3. Ifyoudevelopsymptomsfollowingexposure,suchasaskinrash,youshouldseek

medicaladviceandshowthedoctorthiswarning.Swellingoftheface,lipsoreyesor

difficultywithbreathingaremoreserioussymptomsandrequireurgentmedical

attention.

4.6 Adversereactions(frequencyandseriousness)

Hypersensitivityreactionsmayoccur.

4.7 Useduringpregnancy,lactationorlay

Donotuseinbirdsinlayproducingeggsforhumanconsumption.Useinbreedersonly

accordingtothebenefit/riskassessmentbytheresponsibleveterinarian

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Amoxicillinexertsitsbactericidalactionbyinhibitionofbacterialcellwallsynthesisduring

multiplication.Itisthereforeinprinciplenotcompatiblewithbacteriostaticantibiotics(e.g.

tetracyclines)whichinhibitmultiplication.Synergismoccurswithß-lactamantibioticsand

aminoglycosides.

Revised:July2011

An:00487/2010

4.9 Amountstobeadministeredandadministrationroute

Therecommendeddosageis10-20mgoftheproductperkgliveweight(8-16mg/kg

amoxicillintrihydrate)perdayadministeredinthedrinkingwater.Thehigherdoseis

advisedwhentreatingsevereinfections.Treatmentshouldbegivenforaperiodof3-5

consecutivedays.Thefollowingformulamaybeusedtocalculatetheamountofproduct

requiredperday:

gramproductperday=numberofbirdsxaverageliveweight(kg)

50(for20mg/kg)or100(for10mg/kg)

Iftherequiredamountofproductiscalculatedbythetotaldailywaterintake,thefollowing

isaguide:

Birds0-4weeksofage: 6-12gproduct/100litreswateruptake/day

Birdsolderthan4weeks: 10-20gproduct/100litreswateruptake/day

Itisrecommendedthattheproductbeadministeredoncedailyinthedrinkingwater.Itis

advisabletorestrictdrinkingwaterforapproximately2hours(lessinhotweather)priorto

medication.Theuseofsuitablycalibratedweighingequipmentfortheadministrationofthe

calculatedamountofproductisrecommended.Thecalculatedtotaldailyamountof

powderisscatteredontothesurfaceof5-10litresofcleanwaterandstirreduntilevenly

dispersed.Thissolutionisthenadded,whilststirring,intoanamountofdrinkingwaterthat

willbeconsumedwithinapproximately2hours.Maximumsolubilityoftheproductinwater

isapproximately6g/litre.

If,however,continuousmedicationispreferredthenthedrinkingwatershouldbe

refreshedwithmedicatedwateratleasttwicedaily.Inallcasesensurethatthereisno

accesstounmedicatedwaterwhilstmedicatedwaterisbeingoffered.Whenallmedicated

waterhasbeenconsumed,turnonthenormalwatersupplyagain.Anyunusedmedicated

watershouldbediscardedafter12hours.

Toensureacorrectdosagebodyweightshouldbedeterminedasaccuratelyaspossible

toavoidunderdosing.Theuptakeofmedicatedwaterdependsontheclinicalconditionof

theanimals.Inordertoobtainthecorrectdosagetheconcentrationofamoxicillinhastobe

adjustedaccordingly.

4.10Overdose(symptoms,emergencyprocedures,antidotes)

Noneknown.

4.11Withdrawalperiods

Meatandoffal:1day

Eggs:Notauthorisedforuseinlayingbirdsproducingeggsforhumanconsumption.

5 PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Beta-lactamantibacterial,Penicillin

ATCvetcode:QJ01CA04

Revised:July2011

An:00487/2010

5.1. Pharmacodynamicproperties

Theactiveingredient,amoxicillin,isabactericidalantibioticofthebeta-lactamclass.It

actsbyinhibitionofbacterialcellwallsynthesis.Amoxicillinisnotresistanttotheactionof

beta-lactamases,whichcanhydrolysethemoleculescausingthebeta-lactamring

structuretoopen,renderingitantibioticallyinactive.

Theinformationforstaphylococcalbeta-lactamaseisencodedinaplasmidandmaybe

transferredbybacteriophagetootherbacteria.InG-bacteriabeta-lactamasesare

encodedineitherchromosomesorinplasmidsandtheymaybeconstitutiveorinducible.

Plasmidsmaybetransferredbetweenbacteriathroughconjugation.

Somebacteriaareintrinsicallyresistanttoamoxicillin,becausetheyhavedecreased

affinityfortheantibiotic.Decreasedaffinitymayalsobeacquiredbyhomologous

recombinationbetweengenesofdifferentspecies.Otherinstancesofbacterialresistance

arecausedbytheinabilityoftheagenttopenetratetoitssiteofaction(someG-bacteria)

orbyenergydependenteffluxsystemsforpumpingtheantibioticoutofthebacteria.

Ingeneral,practicaldevelopmentofresistanceinvitroagainstamoxicillinlikeallpenicillins

occursslowlyandstepwise,withanexistingcross-resistancewithotherpenicillinswhichis

ofpracticalsignificancebystaphylococci.

Bothlongtermtreatmentandsub-therapeuticdosagescanselectforantimicrobial

resistance.AmoxicillinisgenerallyactiveagainstsomeGram-negativeandmostGram-

positivebacteriae.g.penicillinsensitiveStaphylococci,Streptococci,Pasteurellaspp.,

Clostridiumspp.,Salmonellaspp.,Haemophilusparagallinarum,andE.coli.Resistance

amongstE.colistrainsisnotuncommon.

5.2 Pharmacokineticproperties

Followingoralmedicationamoxicillinisrapidlyabsorbed.Maximumamoxicillin

concentrations(between1-2µg/ml)arereachedwithin1-2hours.Serumproteinbindingis

low.Amoxicilliniswidelydistributedthroughoutthebody.Amoxicillinismainlyeliminated

viathekidneysintheactiveform.Asmallerpartoftheadministereddoseofamoxicillinis

excretedinthebile.Plasmahalf-lifetimeofamoxicillininchickensisapproximately1hour.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Sodiumcarbonatemonohydrate

Sodiumcitrate

Silicacolloidalanhydrous

6.2 Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbe

mixedwithotherveterinarymedicinalproducts.

6.3 Shelflife

-Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years

-Shelf-lifeafterfirstopeningtheimmediatepackaging:3months

-Shelf-lifeafterdilutionorreconstitutionaccordingtodirections:12hours

Revised:July2011

An:00487/2010

6.4 Storageprecautions

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditionspriorto

opening.Afteropening,anyremainingcontentcanbestoredfor3monthsifstoreddryand

re-closedwithclip(afterfoldingtheedgeoftheopenedsachet).Asmetaltanksmay

negativelyinfluencestabilityoftheproduct,metaltanksshouldnotbeusedforstorageof

solutions.

6.5 Natureandcompositionofimmediatepackaging

Theprimarypackagingmaterialoftheproductcomprisesaluminiumsachetsof100,250,

500and1000gram.Notallpacksizesmaybemarketed.

Thesachetsconsistofthefollowingmaterials:ontheoutsideawhitelayer,insidedifferent

transparentlayers,asub-layerofaluminiumandaninnerlayerofpolyethylene.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproduct

orwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

EurovetAnimalHealthB.V.

Handelsweg25

5531AEBladel

TheNetherlands

8. MARKETINGAUTHORISATIONNUMBER

Vm16849/4004

9. DATEOFFIRSTAUTHORISATION

6September2004

10 DATEOFREVISIONOFTHETEXT

July2011

11-7-2018

Pylobactell (Torbet Laboratories Limited)

Pylobactell (Torbet Laboratories Limited)

Pylobactell (Active substance: 13C-urea) - Centralised - Yearly update - Commission Decision (2018)4517 of Wed, 11 Jul 2018

Europe -DG Health and Food Safety

24-5-2018

#ThrowBackThursday- May 24, 1977- Bureau of Medical Devices and Diagnostic Products renamed Bureau of Medical Devices and new Office of Small Manufacturers Assistance created, as required by law. #OnThisDay #FDAHistory

#ThrowBackThursday- May 24, 1977- Bureau of Medical Devices and Diagnostic Products renamed Bureau of Medical Devices and new Office of Small Manufacturers Assistance created, as required by law. #OnThisDay #FDAHistory

#ThrowBackThursday- May 24, 1977- Bureau of Medical Devices and Diagnostic Products renamed Bureau of Medical Devices and new Office of Small Manufacturers Assistance created, as required by law. #OnThisDay #FDAHistory

FDA - U.S. Food and Drug Administration

18-5-2018

EU/3/17/1936 (Pharma Gateway AB)

EU/3/17/1936 (Pharma Gateway AB)

EU/3/17/1936 (Active substance: 1-[4-bromo-5-[1-ethyl-7-(methylamino)-2-oxo-1,2-dihydro-1,6-naphthyridin-3-yl]-2-fluorophenyl]-3-phenylurea) - Transfer of orphan designation - Commission Decision (2018)3133 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/119/17/T/01

Europe -DG Health and Food Safety

17-5-2018

#ThrowBackThursday: May 17, 1971- The Public Health Service Bureau of Radiological Health transferred to FDA. It’s Mission: Protect against unnecessary human exposure to radiation from electronic products in the home and industry. #OnThisDay #FDAHistory

#ThrowBackThursday: May 17, 1971- The Public Health Service Bureau of Radiological Health transferred to FDA. It’s Mission: Protect against unnecessary human exposure to radiation from electronic products in the home and industry. #OnThisDay #FDAHistory

#ThrowBackThursday: May 17, 1971- The Public Health Service Bureau of Radiological Health transferred to FDA. It’s Mission: Protect against unnecessary human exposure to radiation from electronic products in the home and industry. #OnThisDay #FDAHistory

FDA - U.S. Food and Drug Administration