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
    Spain
  • Language:
  • English

Therapeutic information

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

Other information

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)

13-7-2018

Hospira Issues Voluntary Nationwide Recall of Daptomycin for Injection Lyophilized Powder for Solution, Due to Infusion Reactions

Hospira Issues Voluntary Nationwide Recall of Daptomycin for Injection Lyophilized Powder for Solution, Due to Infusion Reactions

Hospira, Inc., a Pfizer company, is voluntarily recalling 8 lots of Hospira’s Daptomycin for Injection 500 mg, Lyophilized Powder For Solution, Single Dose Vial (NDC 0409-0106-01) to the Hospital/Retail level. The product is being recalled due to adverse event reports indicative of infusion reactions.

FDA - U.S. Food and Drug Administration

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