CEVAXEL

Main information

  • Trade name:
  • CEVAXEL RTU 50 mg/ml Suspension for Injection
  • Pharmaceutical form:
  • Suspension for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CEVAXEL RTU 50 mg/ml Suspension for Injection
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Ceftiofur
  • Therapeutic area:
  • Cattle, Pigs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0218/001
  • Authorization date:
  • 13-02-2012
  • EU code:
  • FR/V/0218/001
  • Last update:
  • 09-08-2016

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

A.LABELLING

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

PARTICULARSTOAPPEARONTHEIMMEDIATEPACKAGE

Cardboardboxesof100&250ml

Vialsof100&250ml

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Cevaxel-RTU50mg/ml,suspensionforinjectionforcattleandpigs

Ceftiofur

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

1vialcontains:

Ceftiofur(ashydrochloride) 50mg/ml

3. PHARMACEUTICALFORM

Suspensionforinjection.

4. PACKAGESIZE

100ml

250ml

5. TARGETSPECIES

Cattleandpigs.

6. INDICATION(S)

Readthepackageleafletbeforeuseanddisposal.

7. METHODANDROUTE(S)OFADMINISTRATION

Cattle:Subcutaneoususe.

Pigs:Intramuscularuse.

Readthepackageleafletbeforeuseanddisposal.

8. WITHDRAWALPERIOD

Meat&offal:

Pigs:5days.

Cattle:8days

Milk:0hours

9. SPECIALWARNING(S),IFNECESSARY

Penicillinsandcephalosporinsmayoccasionallycausesevereallergicreactions.Seepackageleafletfor

userwarnings.

10. EXPIRYDATE

EXP:

Oncebroached,useby:___/___/___

Shelf-lifeafterfirstopening:28days.

11. SPECIALSTORAGECONDITIONS

Keepthevialintheoutercartoninordertoprotectfromlight.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Readpackageleafletbeforeuseanddisposal.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly.

Tobesuppliedonlyonveterinaryprescription.

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

16. MARKETINGAUTHORISATIONNUMBER(S)

17. MANUFACTURER’SBATCHNUMBER

Lot:

B.PACKAGELEAFLET

PACKAGELEAFLET

Cevaxel-RTU50mg/ml,suspensionforinjectionforcattleandpigs

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERAND

OFTHEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFOR

BATCHRELEASE,IFDIFFERENT

Marketingauthorisationholder:

Manufacturerforthebatchrelease:

CevaSantéAnimale-10,av.deLaBallastière-33500Libourne-France

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Cevaxel-RTU50mg/ml,suspensionforinjectionforcattleandpigs

Ceftiofur

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

1vialcontains:

Ceftiofur(ashydrochloride) 50mg/ml

4. INDICATION(S)

Infectionsassociatedwithbacteriasensitivetoceftiofur.

Incattle:

ForthetreatmentofbacterialrespiratorydiseaseassociatedwithPasteurellamultocida,

MannheimiahaemolyticaandHaemophilussomnus.

Forthetreatmentofacuteinterdigitalnecrobacillosis(panaritium,footrot),associatedwith

FusobacteriumnecrophorumandBacteroidesmelaninogenicus(Porphyromonas

asaccharolytica).

Fortreatmentofthebacterialcomponentofacutepost-partum(puerperal)metritiswithin10daysafter

calvingassociatedwithEscherichiacoli,ArcanobacteriumpyogenesandFusobacterium

necrophorum:thisindicationisrestrictedtocaseswheretreatmentwithanotherantimicrobialhas

failed

Inpigs:

ForthetreatmentofbacterialrespiratorydiseaseassociatedwithPasteurellamultocida,

ActinobacilluspleuropneumoniaeandStreptococcussuis.

5. CONTRAINDICATIONS

Donotadministertoananimalpreviouslyfoundtobehypersensitivetoceftiofurandother 

-lactam

antibiotics.

Donotuseincaseofknownresistancetoothercephalosporinsorbeta-lactamantibiotics.

Donotuseinpoultry(includingeggs)duetoriskofspreadofantimicrobialresistancetohumans.

6. ADVERSEREACTIONS

Hypersensitivityreactionsunrelatedtodosecanoccur.Allergicreactions(e.g.skinreactions,

anaphylaxia)mayoccasionallyoccur.Incaseoftheoccurrenceofallergicreactionthetreatment

shouldbewithdrawn.

Inpigs,mildreactionsattheinjectionsite,suchasdiscolorationofthefasciaorfat,havebeenobserved

insomeanimalsforupto20daysafterinjection.

Incattle,mildinflammatoryreactionsattheinjectionsite,suchastissueoedema,thickeningof

connectivetissueanddiscolorationofthesubcutaneoustissueand/orfascialsurfaceofthemusclemay

beobserved.Clinicalresolutionisreachedinmostanimalsby10daysafterinjectionalthoughslight

tissuediscolorationmaypersistfor28daysormore.

7. TARGETSPECIES

Cattleandpigs.

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOF

ADMINISTRATION

Cattle:Subcutaneoususe

-Respiratorydisease:1mgceftiofur(ashydrochloride)/kg/dayfor3to5days,i.e.1ml/50kgateach

injection.

-Acuteinterdigitalnecrobacillosis:1mgceftiofur(ashydrochloride)/kg/dayfor3days,i.e.1ml/50kg

ateachinjection.

-Acutepost-partummetritiswithin10daysaftercalving:1mgceftiofur(ashydrochloride)/kg/dayfor

5consecutivedays,i.e.1ml/50kgateachinjection.

Incaseofacutepost-partummetritis,additionalsupportivetherapymightberequiredinsomecases.

Pigs:Intramuscularuse

3mgceftiofur(ashydrochloride)/kg/dayfor3days,i.e.1ml/16kgateachinjection.

Shakethebottlewellbeforeusetobringtheproductbackintosuspension.

Toensureacorrectdosage,bodyweightshouldbedeterminedasaccuratelyaspossibleinorderto

avoidunder-dosing.Subsequentinjectionsmustbegivenatdifferentsites.

Asthevialcannotbebroachedmorethan50times,theusershouldchoosethemoreappropriatevial

size.

9. ADVICEONCORRECTADMINISTRATION

10. WITHDRAWALPERIOD

Cattle:

Meatandoffal:8days.

Milk:zerohours.

Pigs:

Meatandoffal:5days.

11. SPECIALSTORAGEPRECAUTIONS

Keepoutofthereachandsightofchildren.

Keepthevialintheoutercartoninordertoprotectfromlight.

Shelf-lifeafterfirstopeningthevial:28days.

DonotuseaftertheexpirydatewhichisstatedonthecartonafterEXP.

12. SPECIALWARNING(S)

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Penicillinsandcephalosporinsmaycausehypersensitivity(allergy)followinginjection,inhalation,

ingestionorskincontact.Hypersensitivitytopenicillinsmayleadtocrossreactionstocephalosporins

andviceversa.Allergicreactionstothesesubstancesmayoccasionallybeserious.

-Donothandlethisproductifyouknowyouaresensitisedorifyouhavebeenadvisednottowork

withsuchpreparations.

-Handlethisproductwithgreatcaretoavoidexposure.Washhandsafteruse.

-Ifyoudevelopsymptomsfollowingexposure,suchasaskinrash,youshouldseekmedicaladviceand

showthedoctorthiswarning.

Swellingoftheface,lipsoreyesordifficultywithbreathingaremoreserioussymptomsandrequire

urgentmedicalattention.

Donotuseasprophylaxisincaseofretainedplacenta.

Pregnancyandlactation

Studiesinlaboratoryanimalshavenotproducedanyevidenceofteratogenic,foetotoxicor

maternotoxiceffects.Thesafetyoftheproducthasnotbeenestablishedinsowsorcowsduring

pregnancyandlactation.

Useonlyaccordingtoabenefit/riskassessmentbytheresponsibleveterinarian.

Interactionwithothermedicinalproductsandotherformsofinteraction

Thebactericidalpropertiesofcephalosporinsareantagonizedbysimultaneoususeofbacteriostatic

antibiotics(macrolides,sulfonamidesandtetracyclines).

Overdose

Thelowtoxicityofceftiofurhasbeendemonstratedinpigsusingceftiofursodiumatdosesinexcessof

8timestherecommendeddailydoseofceftiofurintramuscularlyadministeredfor15consecutivedays.

Incattle,nosignsofsystemictoxicityhavebeenobservedfollowingsubstantialparenteral

overdosages.

Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixedwithother

veterinarymedicinalproducts.

UseofCevaxelRTUmayconstitutearisktopublichealthduetospreadofantimicrobial

resistance.

CevaxelRTUshouldbereservedforthetreatmentofclinicalconditionswhichhaverespondedpoorly,

orareexpectedtorespondpoorlytofirstlinetreatment.Official,nationalandregionalantimicrobial

policiesshouldbetakenintoaccountwhentheproductisused.Increaseduse,includinguseofthe

productdeviatingfromtheinstructionsgiven,mayincreasetheprevalenceofresistance.Whenever

possible,CevaxelRTUshouldonlybeusedbasedonsusceptibilitytesting.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIAL,IFANY

Disposeofanyunusedproductandemptycontainersinaccordancewithguidancefromyourlocalwaste

regulationauthority.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

15. OTHERINFORMATION

Packsizes:

Cardboardboxcontainingone100mlvial

Cardboardboxcontainingone250mlvial

Notallpacksizesmaybemarketed.

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