Virbacef Sterile Powder for Solution for Injection

Main information

  • Trade name:
  • Virbacef Sterile Powder for Solution for Injection
  • Pharmaceutical form:
  • Powder for solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Virbacef Sterile Powder for Solution for Injection
    Hungary
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Cefalexin
  • Therapeutic area:
  • Cattle, Horses, Pigs

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0322/001
  • Authorization date:
  • 20-12-2012
  • EU code:
  • UK/V/0322/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Revised:February2010

(ATCVetcodeamended)

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

VirbacefPowderforSolutionforInjectionforcattleandpigs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Activesubstance:

Eachvialcontains1gor4gofceftiofurasceftiofursodium.

Reconstitutedsolution:

Ceftiofur(asceftiofursodium)50mg/ml

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Powderforsolutionforinjection.

Creamtoyellowishpowder.

4. CLINICALPARTICULARS

4.1Targetspecies

Cattleandpigs.

4.2Indicationsforuse,specifyingthetargetspecies

Cattle

TreatmentofcattlewithacutebacterialrespiratorydiseaseinwhichMannheimia

haemolytica,Pasteurellamultocida,Histophilussomniorothersensitivebacterial

pathogensoftherespiratorytractareinvolved.

Treatmentofcattlewithacuteinterdigitalnecrobacillosis(foulinthefoot)inwhich

FusobacteriumnecrophorumandBacteroidesmelaninogenicusareinvolved.

Pigs

TreatmentofpigswithbacterialrespiratorydiseaseinwhichActinobacillus

(Haemophilus)pleuropneumoniae,Pasteurellamultocidaand/orStreptococcussuis

areinvolved.

4.3Contraindications

Donotuseinanimalspreviouslyfoundtobehypersensitivetoceftiofur.

4.4Specialwarningsforeachtargetspecies

Onlythe20-mlvialshouldbeusedfortreatinggroupsofsmallpiglets.

Revised:February2010

(ATCVetcodeamended)

4.5 Specialprecautionsforuse

i. Specialprecautionsforuseinanimals

Official,nationalandregionalantimicrobialpoliciesshouldbetakenintoaccount

whentheproductisused.

Useofproductshouldbebasedonthesusceptibilitytestingthebacteriaisolated

fromtheanimal.Ifthisisnotpossible,therapyshouldbebasedonthelocal

(regional,farmlevel)epidiomologicalinformationaboutsusceptibilityofthetarget

bacteria.

ii. Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Penicillinsandcephalosporinsmaycausehypersensitivity(allergy)following

injection,inhalation,ingestionorskincontact.Hypersensitivitytopenicillinsmay

leadtocrossreactionstocephalosporinsandviceversa.Allergicreactionsto

thesesubstancesmayoccasionallybeserious.

Donothandlethisproductifyouknowyouaresensitisedorifyouhavebeen

advisednottoworkwithsuchpreparations.

Handlethisproductwithgreatcaretoavoidexposure,takingallrecommended

precautions.

Ifyoudevelopsymptomsfollowingexposuresuchasaskinrash,youshouldseek

medicaladviceandshowthedoctorthiswarning.Swellingoftheface,lipsoreyes

ordifficultywithbreathingaremore-serioussymptomsandrequireurgentmedical

attention.

Washhandsafteruse.

4.6Adversereactions(frequencyandseriousness)

Theuseoftheproductmaycauseoccasionallocaldiscomfortuponinjectionbutthis

isatransienteffect.

4.7Useduringpregnancy,lactationorlay

Nodataareavailableforcattle.Intherat,noteratogenicsigns,abortionorinfluence

onreproductionhavebeenobserved.

Thesafetyoftheproducthasnotbeenassessedinpregnantcowsandsows.Use

onlyaccordingtothebenefit/riskassessmentbytheresponsibleveterinarian.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

Revised:February2010

(ATCVetcodeamended)

4.9Amountstobeadministeredandadministrationroute

Reconstitution

1gvial:reconstitutebyadding20mlofwaterforinjection.

4gvial:reconstitutebyadding80mlofwaterforinjection.

Foreaseofreconstitution,usean18-gaugeneedle.Rapidadditionofdiluentwill

givebestresults.Theresultingsolutioncontains50mgofceftiofurperml.

Toensurecorrectdosagebodyweightshouldbedeterminedasaccuratelyas

possibletoavoidunderdosing.

Dosageincattle

1mgceftiofur/kgofbodyweight.Thisisequivalentto1mlofthereconstituted

solutionper50kgofbodyweight.

Forrespiratorydisease,thedoseshouldbegivenoncedailyat24-hourintervalsfor

3to5daysintotal.

Forfoulinthefoot,thedoseshouldbegivenoncedailyat24-hourintervalsfor3

daysintotal.

Dosageinpigs

3mgceftiofur/kgofbodyweight.Thisisequivalentto1mlofthereconstituted

solutionper16kgofbodyweight.Thedoseshouldbegivenoncedailyat24-hour

intervalsfor3daysintotal.Anappropriately-graduatedsyringemustbeusedto

allowaccurateadministrationoftherequireddosevolume.Thisisparticularly

importantwheninjectingpigletsweighinglessthan16kg.Onlythe1-gvialshould

beusedfortreatingsmallgroupsofpiglets.

Administration

Theintramuscularrouteonlyshouldbeusedincattleandpigs.Inthepig,particular

caremustbetakentoavoidinjectionintofattissue.Normalaseptic-injection

techniquesshouldbepracticed.

Ifnoresponseisseenwithin4-5days,thediagnosisshouldberedetermined.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

None.

4.11Withdrawalperiod(s)

Cattle(meat):1day.

Cattle(milk):zeroday.

Pigs(meat):2days.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:

Antibacterialsforsystemicuse,otherbeta-lactamantibacterials,thirdgeneration

cephalosporins

ATCVetcode:QJ01DD90

Revised:February2010

(ATCVetcodeamended)

5.1Pharmacodynamicproperties

Theactiveingredient,ceftiofursodium,isathird-generationcephalosporin(beta-

lactamantibiotic)whichactsagainstbothgram-positiveandgram-negativebacteria,

includingbetalactamases-producingbacteria.

Ceftiofurisabactericidalantibioticinvitrowhichactsbyinterferingwithbacterial

cell-wallsynthesis.

Incattle,ceftiofurisactiveagainstthefollowingmicroorganismsfoundin

respiratory-tractinfections:Mannheimiahaemolytica,Pasteurellamultocida,

Histophilussomniaswellasinthefollowingbacteriaresponsibleforacute

interdigital necrobacillosis: Fusobacterium necrophorum and Bacteroides

melaninogenicus.

Inpigs,ceftiofurisactiveagainstthefollowingmicroorganisms:Actinobacillus

(Haemophilus)pleuropneumoniae,Pasteurellamultocidaand/orStreptococcussuis.

5.2Pharmacokineticparticulars

After intramuscular administration, ceftiofur is quickly metabolised to

desfuroylceftiofurwhichreachesmaximumplasmaconcentrationwithin1hour.The

plasmahalf-lifefordesfuroylceftiofurisonaverageover9hoursincattleand13

hoursinpigs.Noaccumulationhasbeenshownafterseveraladministrations.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Sodiumhydroxide

Potassiumdihydrogenphosphate.

6.2Incompatibilities

None.

6.3Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:3years.

6.4.Specialprecautionsforstorage

Storeinarefrigerator(2°C-8°C).Protectfromlight.

Keepthecontainerintheoutercarton.

Afterreconstitution,theproductmaybestoredat2°C –8°Cfor7daysand12

hoursifstoredbelow25°C.Anyreconstitutedproductremainingafterthestated

periodsshouldbediscarded.

Revised:February2010

(ATCVetcodeamended)

6.5Natureandcompositionofimmediatepackaging

20-mltype-1-glassvialsclosedbyrubberinjectorstoppersandanaluminiumflip-off

sealcontaining1gofceftiofur.

100-mltype-1-glassvialsclosedbyrubberinjectorstoppersandanaluminiumflip-

offsealcontaining4gofceftiofur.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproduct

orwastematerialsderivedfromtheuseofsuchproducts

Anyunusedproductorwastematerialshouldbedisposedofinaccordancewith

nationalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

Virbac

ère

avenue-2065m-L.I.D.

06516CarrosCedex

France

8. MARKETINGAUTHORISATIONNUMBER

Vm 05653/4134

9. DATEOFFIRSTAUTHORISATION

28September2007

10.DATEOFREVISIONOFTHETEXT

February2010(ATCVetcodeamended)