CEFTIOCYL

Main information

  • Trade name:
  • CEFTIOCYL
  • Pharmaceutical form:
  • Suspension for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CEFTIOCYL
    Portugal
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • LACTAM ANTIBACTERIALS
  • Therapeutic area:
  • Cattle, Pigs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0214/001
  • Authorization date:
  • 06-02-2010
  • EU code:
  • FR/V/0214/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SUMMARYOFPRODUCTCHARACTERISTICS

1.NAMEOFTHEVETERINARYMEDICINALPRODUCT

Ceftiocyl50mg/ml,suspensionforinjectionforcattleandpigs

2.QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontains:

Activesubstance:

Ceftiofur(ashydrochloride)50.0mg

Excipients:

Forafulllistofexcipients,seesection6.1

3.PHARMACEUTICALFORM

Suspensionforinjection.

Slightlyyellowtoslightlypink,milkysuspension.

4.CLINICALPARTICULARS

4.1Targetspecies

Cattleandpigs.

4.2Indicationsforuse,specifyingthetargetspecies

Infectionsassociatedwithbacteriasensitivetoceftiofur:

Inpigs:

ForthetreatmentofbacterialrespiratorydiseaseassociatedwithPasteurellamultocida,Actinobacillus

pleuropneumoniaeandStreptococcussuis.

Incattle:

ForthetreatmentofbacterialrespiratorydiseaseassociatedwithPasteurellahaemolytica(Mannheimiaspp.),

PasteurellamultocidaandHaemophilussomnus.

Forthetreatmentofacuteinterdigitalnecrobacillosis(panaritium,footrot),associatedwithFusobacterium

necrophorumandBacteroidesmelaninogenicus(Porphyromonasasaccharolytica).

Fortreatmentofthebacterialcomponentofacutepost-partum(puerperal)metritiswithin10daysaftercalving

associatedwithEscherichiacoli,ArcanobacteriumpyogenesandFusobacteriumnecrophorum,sensitiveto

ceftiofur.Theindicationisrestrictedtocaseswheretreatmentwithanotherantimicrobialhasfailed.

4.3Contraindications

Donotadministertoananimalpreviouslyfoundtobehypersensitivetoceftiofurandotherβ-lactamantibiotics.

Donotuseincaseofknownresistancetotheactivesubstance.

Donotuseinpoultry(includingeggs)duetoriskofspreadofantimicrobialresistancetohuman.

4.4Specialwarnings<foreachtargetspecies>

None.

4.5Specialprecautionsforuse

Specialprecautionsforuseinanimals

Shakethebottlewellbeforeusetobringtheproductbackintosuspension.

Incaseoftheoccurrenceofallergicreactionthetreatmentshouldbewithdrawn.

Ceftiocylselectsforresistantstrainssuchasbacteriacarryingextendedspectrumbetalactamases(ESBL)and

mayconstitutearisktohumanhealthifthesestrainsdisseminatetohumanse.g.viafood.Forthisreason,

Ceftiocylshouldbereservedforthetreatmentofclinicalconditionswhichhaverespondedpoorly,orare

expectedtorespondpoorly(referstoveryacutecaseswhentreatmentmustbeinitiatedwithoutbacteriological

diagnosis)tofirstlinetreatment.Official,nationalandregionalantimicrobialpoliciesshouldbetakeninto

accountwhentheproductisused.Increaseduse,includinguseoftheproductdeviatingfromtheinstructions

givenintheSPC,mayincreasetheprevalenceofsuchresistance.Wheneverpossible,Ceftiocylshouldonlybe

usedbasedonsusceptibilitytesting.

Ceftiocylisintendedfortreatmentofindividualanimals.Donotusefordiseasepreventionorasapartofheard

healthprogrammes.Treatmentofgroupsofanimalsshouldbestrictlyrestrictedtoongoingdiseaseoutbreaks

accordingtotheapprovedconditionsofuse.

Donotuseasprophylaxisincaseofretainedplacenta.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproductto

Animals

Penicillinsandcephalosporinsmaycausehypersensitivity(allergy)followinginjection,inhalation,ingestionor

skincontact.Hypersensitivitytopenicillinsmayleadtocrossreactionstocephalosporinsandviceversa.

Allergicreactionstothesesubstancesmayoccasionallybeserious.

1.Donothandlethisproductifyouknowyouaresensitised,orifyouhavebeenadvisednottowork

withsuchpreparations.

2.Handlethisproductwithgreatcaretoavoidexposuretakingallrecommendedprecautions.

3.Incaseofaccidentalinjectionorifyoudevelopsymptomsfollowingexposuresuchasaskinrash,

youshouldseekmedicaladviceandshowthedoctorthiswarning.Swellingoftheface,lipsoreyesor

difficultyinbreathingaremoreserioussymptomsandrequireurgentmedicalattention.

Washhandsafteruse.

4.6Adversereactions(frequencyandseriousness)

Hypersensitivityreactionsunrelatedtodosecanoccur.Allergicreactions(e.g.skinreactions,anaphylaxia)may

occasionallyoccur.

Inpigs,mildreactionsattheinjectionsite,suchasdiscolorationofthefasciaorfat,havebeenobservedinsome

animalsforupto20daysafterinjection.

Incattle,mildinflammatoryreactionsattheinjectionsite,suchastissueoedemaanddiscolorationofthe

subcutaneoustissueand/orfascialsurfaceofthemusclemaybeobserved.Clinicalresolutionisreachedinmost

animalsby10daysafterinjectionalthoughslighttissuediscolorationmaypersistfor28daysormore.

4.7Useduringpregnancy,lactationorlay

Eventhoughstudiesinlaboratoryanimalsshownoevidenceofteratogenesis,abortionorinfluenceon

reproduction,thereproductivesafetyofceftiofurhasnotbeenspecificallyinvestigatedinpregnantsowsor

cows.

Useonlyaccordingtoabenefit/riskassessmentbytheresponsibleveterinarian.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Erythromycinsandtetracyclinesmayhaveanantagonisticeffectoncephalosporinswhereasaminoglycosides

mayhaveapotentiatingeffect.

4.9Amountstobeadministeredandadministrationroute

Pigs:

3mgceftiofur/kgbw/dayfor3daysviaintramuscularroute,i.e.1ml/16kgbwateachinjection.

Cattle:

Respiratorydisease:1mgceftiofur/kgbw/dayfor3to5daysbysubcutaneousinjection,i.e.1ml/50kgbwat

eachinjection.

Acuteinterdigitalnecrobacillosis:1mg/kgbw/dayfor3daysbysubcutaneousinjection,i.e.1ml/50kgbwat

eachinjection.

Acutepost-partummetritiswithin10daysaftercalving:1mg/kgbw/dayfor5consecutivedaysbysubcutaneous

injection,i.e.1ml/50kgbwateachinjection.

Subsequentinjectionsmustbegivenatdifferentsites.Fortheinjections,theneckshouldbepreferredincattle.

Incaseofacutepost-partummetritis,additionalsupportivetherapymightberequiredinsomecases.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Thelowtoxicityofceftiofurhasbeendemonstratedinpigsusingceftiofursodiumatdosesinexcessof8times

therecommendeddailydoseofceftiofurintramuscularlyadministeredfor15consecutivedays.

Incattle,nosignsofsystemictoxicityhavebeenobservedfollowingsubstantialparenteraloverdosages.

4.11Withdrawalperiods

Pigs:

Meatandoffal:6days.

Cattle:

Meatandoffal:8days.

Milk:zerohour.

5.PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antibacterialsforsystemicuse

ATCvetcode:QJ01DD90

5.1Pharmacodynamicproperties

Ceftiofurisalategenerationcephalosporin,whichisactiveagainstmanyGram-positiveandGram-negative

bacteria.Ceftiofurinhibitsthebacterialcellwallsynthesis,therebyexertingbactericidalproperties.Beta-lactams

actbyinterferingwithsynthesisofthebacterialcellwall.Cellwallsynthesisisdependentonenzymesthatare

calledpenicillin-bindingproteins(PBP's).

Bacteriadevelopresistancetocephalosporinsbyfourbasicmechanisms:1)alteringoracquiringpenicillin

bindingproteinsinsensitivetoanotherwiseeffectiveβ-lactam;2)alteringthepermeabilityofthecelltoβ-

lactams;3)producingβ-lactamasesthatcleavetheβ-lactamringofthemolecule,or4)activeefflux.

Someβ-lactamases,documentedinGram-negativeentericorganisms,mayconferelevatedMICstovarying

degreestothirdandfourthgenerationcephalosporins,aswellaspenicillins,ampicillins,β-lactaminhibitor

combinations,andfirstandsecondgenerationcephalosporins.

Ceftiofurisactiveagainstthefollowingmicroorganismswhichareinvolvedinrespiratorydiseasesinpigs:

Pasteurellamultocida,ActinobacilluspleuropneumoniaeandStreptococcussuis.Bordetellabronchisepticais

intrinsicallynon-susceptibletoceftiofur.Itisalsoactiveagainstbacteriainvolvedinrespiratorydiseaseincattle:

Pasteurellamultocida,Mannheimiaspp.(formerPasteurellahaemolytica),Haemophilussomnus;bacteria

involvedinacutebovinefootrot(interdigitalnecrobacillosis)incattle:Fusobacteriumnecrophorum,

Bacteroidesmelaninogenicus(Porphyromonasasaccharolytica);andbacteriaassociatedwithacutepost-partum

(puerperal)metritisincattle:Escherichiacoli,ArcanobacteriumpyogenesandFusobacteriumnecrophorum.

ThefollowingMinimumInhibitoryConcentrations(MIC)havebeendeterminedforceftiofurinEuropean

isolatesoftargetbacteria,isolatedfromdiseasedanimals:

Pigs

Organism(numberofisolates) MICrange(µg/mL) MIC

90 (µg/mL)

A.pleuropneumoniae(28) ≤0.03 * ≤0.03

Pasteurellamultocida(37) ≤0.03-0.13 ≤0.03

Streptococcussuis(495) ≤0.03-0.25 ≤0.03

Haemophilusparasuis(16) ≤0.03-0.13 ≤0.03

Cattle

Organism(numberofisolates) MICrange(µg/mL) MIC

90 (µg/mL)

Mannheimiaspp.(87) ≤0.03 * ≤0.03

P.multocida(42) ≤0.03-0.12 ≤0.03

H.somnus(24) ≤0.03 * ≤0.03

Arcanobacteriumpyogenes(123) ≤0.03-0.5 0.25

Escherichiacoli(188) 0.13->32.0 0.5

Fusobacteriumnecrophorum(67)(isolates

fromcasesoffootrot) ≤0.06-0.13 ND

Fusobacteriumnecrophorum(2)(isolates

fromcasesofacutemetritis) ≤0.03-0.06 ND

*Norange;allisolatesyieldedthesamevalue.ND:notdetermined.

ThefollowingbreakpointsarerecommendedbyNCCLSforbovineandporcinerespiratorypathogenscurrently

onthelabelforCeftiocyl:

ZoneDiameter(mm) MIC(μg/mL) Interpretation

≥21 ≤2.0 (S)Susceptible

18-20 4.0 (I)Intermediate

≤17 ≥8.0 (R)Resistant

Nobreakpointshavebeendeterminedtodateforthepathogensassociatedwithfootrotoracutepost-partum

metritisincows.

5.2Pharmacokineticparticulars

Afteradministration,ceftiofurisquicklymetabolisedtodesfuroylceftiofur,theprincipalactivemetabolite.

Desfuroylceftiofurhasanequivalentanti-microbialactivitytoceftiofuragainstthebacteriainvolvedin

respiratorydiseaseinanimals.Theactivemetaboliteisreversiblyboundtoplasmaproteins.Dueto

transportationwiththeseproteins,themetaboliteconcentratesatasiteofinfection,isactiveandremainsactive

inthepresenceofnecrotictissueanddebris.

Inpigsgivenasingleintramusculardoseof3mg/kgbodyweight(bw),maximumplasmaconcentrationsof

10.58±2.06µg/mLwerereachedafter1hour(1.6±0.7h);theterminaleliminationhalf-life(t½)of

desfuroylceftiofurwas15.56±4.32hours.Noaccumulationofdesfuroylceftiofurhasbeenobservedafteradose

of3mgceftiofur/kgbw/dayadministereddailyover3days.

Theeliminationoccurredmainlyviatheurine(morethan70%).Averagerecoveriesinfaecesaccountedfor

approximately12-15%ofthedrug.

Ceftiofuriscompletelybioavailablefollowingintramuscularadministration.

Afterasingle1mg/kgdosegivensubcutaneouslytocattle,maximumplasmalevelsof7.08±4.32µg/mLare

reachedwithin2hours(1.9±0.9h)afteradministration.Inhealthycows,aCmaxof2.25±0.79µg/mLwas

reachedintheendometrium5±2hoursafterasingleadministration.Maximumconcentrationsreachedin

carunclesandlochiaeofhealthycowswere1.11±0.24µg/mLand0.98±0.25µg/mL,respectively.

Theterminaleliminationhalf-life(t½)ofdesfuroylceftiofurincattleis11.38±2.33hours.Noaccumulationwas

observedafteradailytreatmentover5days.Theeliminationoccurredmainlyviatheurine(morethan55%);31

%ofthedosewasrecoveredinthefaeces.

Ceftiofuriscompletelybioavailablefollowingsubcutaneousadministration.

6.PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Hydrogenatedsoyalecithin

Sorbitanmonooleate

Cottonseedoil

6.2Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixedwithother

veterinarymedicinalproducts.

6.3Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:3years

Shelflifeafterfirstopeningtheimmediatepackaging:28days

6.4.Specialprecautionsforstorage

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

6.5Natureandcompositionofimmediatepackaging

50,100and250mldarktypeIvialclosedwithabromobutylrubberstopperandaluminiumcap.

Cardboardboxwith1glassvialof50mlwitharubberstopperandaluminiumcap.

Cardboardboxwith1glassvialof100mlwitharubberstopperandaluminiumcap.

Cardboardboxwith1glassvialof250mlwitharubberstopperandaluminiumcap.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproductsorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinalproducts

shouldbedisposedofinaccordancewithlocalrequirements.

7.MARKETINGAUTHORISATIONHOLDER

VETOQUINOLSA

MAGNYVERNOIS

BP189

70204LURECedex

FRANCE

8.MARKETINGAUTHORISATIONNUMBERS

Cardboardboxwith1glassvialof50ml:

Cardboardboxwith1glassvialof100ml:

Cardboardboxwith1glassvialof250ml:

9.DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10.DATEOFREVISIONOFTHETEXT

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Ariclaim (Eli Lilly Nederland B.V.)

Ariclaim (Active substance: duloxetine hydrochloride) - Centralised - Withdrawal - Commission Decision (2018)4515 of Wed, 11 Jul 2018

Europe -DG Health and Food Safety

5-7-2018

Scientific guideline:  Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance, draft: consultation open

Scientific guideline: Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance, draft: consultation open

This document provides product-specific guidance on the demonstration of the bioequivalence of pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml.

Europe - EMA - European Medicines Agency

3-7-2018

Efficib (Merck Sharp and Dohme B.V.)

Efficib (Merck Sharp and Dohme B.V.)

Efficib (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4254 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/896/T/90

Europe -DG Health and Food Safety

3-7-2018

Ristfor (Merck Sharp and Dohme B.V.)

Ristfor (Merck Sharp and Dohme B.V.)

Ristfor (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4249 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1235/T/77

Europe -DG Health and Food Safety

3-7-2018

Velmetia (Merck Sharp and Dohme B.V.)

Velmetia (Merck Sharp and Dohme B.V.)

Velmetia (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4252 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/862/T/93

Europe -DG Health and Food Safety

3-7-2018

Janumet (Merck Sharp and Dohme B.V.)

Janumet (Merck Sharp and Dohme B.V.)

Janumet (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4251 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/861/T/90

Europe -DG Health and Food Safety

29-6-2018

EU/3/18/2028 (BioCryst UK Ltd)

EU/3/18/2028 (BioCryst UK Ltd)

EU/3/18/2028 (Active substance: (R)-1-(3-(aminomethyl) phenyl)-N-(5-((3-cyanophenyl)(cyclopropylmethylamino)methyl)-2-fluorophenyl)-3-(trifluoromethyl)-1H-pyrazole-5-carboxamide dihydrochloride) - Orphan designation - Commission Decision (2018)4173 of Fri, 29 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/003/18

Europe -DG Health and Food Safety

14-6-2018

Kuvan (BioMarin International Limited)

Kuvan (BioMarin International Limited)

Kuvan (Active substance: sapropterin dihydrochloride) - Centralised - Yearly update - Commission Decision (2018)3859 of Thu, 14 Jun 2018

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/811 (Celgene Europe B.V.)

EU/3/10/811 (Celgene Europe B.V.)

EU/3/10/811 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3809 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/092/10/T/03

Europe -DG Health and Food Safety