Ubiflox 20 mg/ ml Solution for Injection for Cattle and Pigs

Main information

  • Trade name:
  • Ubiflox 20 mg/ ml Solution for Injection for Cattle and Pigs
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Ubiflox 20 mg/ml Solution for Injection for Cattle and Pigs
    Austria
  • Language:
  • English

Therapeutic information

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

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0360/001
  • Authorization date:
  • 23-03-2011
  • EU code:
  • UK/V/0360/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Issued:October2011

AN:00043/2010

Page1of5

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Ubiflox20mg/mlsolutionforinjectionforcattleandpigs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

1mlofsolutionforinjectioncontains:

Activesubstance:

Marbofloxacin 20mg

Excipients:

Metacresol 2mg

Disodiumedetate0.10mg

Monothioglycerol 0.50mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Solutionforinjection.

Clear,greenishyellowtobrownishyellowsolution.

4. CLINICALPARTICULARS

4.1Targetspecies

Cattle(pre-ruminantcalvesupto100kgb.w).

Pigs.

4.2Indicationsforuse,specifyingthetargetspecies

Cattle(pre-ruminantcalvesupto100kgb.w)

TreatmentofrespiratoryinfectionscausedbysensitivestrainsofPasteurella

multocida,MannheimiahaemolyticaandMycoplasmabovis.

Fatteningpigs

TreatmentofrespiratoryinfectionscausedbysensitivestrainsofActinobacillus

pleuropneumoniae,Mycoplasmahyopneumoniae,Pasteurellamultocida.

4.3Contraindications

Donotadministerinanimalswithknownhypersensitivitytomarbofloxacinorany

otherquinoloneortoanyoftheexcipients.

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Donotuseincaseswherethepathogeninvolvedisresistanttoother

fluoroquinolones(crossresistance).

4.4Specialwarningsforeachtargetspecies

None.

4.5Specialprecautionsforuse

Specialprecautionsforuseinanimals

Officialandlocalantimicrobialpoliciesshouldbetakenintoaccountwhenthe

productisused.Fluoroquinolesshouldbereservedforthetreatmentofclinical

conditionswhichhaverespondedpoorly,orareexpectedtorespondpoorly,toother

classesofantimicrobials.Wheneverpossible,fluoroquinolonesshouldonlybeused

basedonsusceptibilitytesting.Useoftheproductdeviatingfromtheinstructions

givenintheSPCmayincreasetheprevalenceofbacteriaresistanttothe

fluoroquinolonesandmaydecreasetheeffectivenessoftreatmentwithother

quinolonesduetothepotentialforcrossresistance.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Peoplewithknownhypersensitivityto(fluoro)quinolonesshouldavoidcontactwith

theproduct.

Incaseofcontactwithskinoreyes,rinsewithplentyofwater.

Careshouldbetakentoavoidaccidentalselfinjection.

Incaseofaccidentalselfinjection,seekmedicaladviceandshowthelabeltothe

doctor.

Accidentalself-injectioncaninduceaslightirritation.

Washhandsafteruse.

4.6Adversereactions(frequencyandseriousness)

Administrationbysubcutaneousandintramuscularroutemayinducetransitory

oedema.Administrationbytheintramuscularroutemaycausepainreactionand

inflammatorylesionsatthesiteofinjection.Inflammatorylesionspersist6daysin

pigsand12daysincalves.

4.7Useduringpregnancy,lactationorlay

Notapplicable.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

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4.9Amountstobeadministeredandadministrationroute

Therecommendeddosageis2mg/kg/day(1ml/10kg)inasingledailyinjectionby

subcutaneousorintramuscularroutesincattle(thefirstinjectionmayalsobegiven

byintravenousroute),andbyintramuscularrouteinpigs.

Treatmentdurationisasfollows:

- cattle,IM,SCroute:3to5days

- pigs,IMroute:3to5days

Toensureadministrationofacorrectdose,bodyweightshouldbedeterminedas

accuratelyaspossible,toavoidunderdosing.

Thedosevolumegivenatoneinjectionsiteshouldnotexceed6mlincalves,and3

mlinpigs.

Thecapmaybesafelypuncturedupto20times.Theusershouldchoosethemost

appropriatevialsizeaccordingtothetargetspeciestotreat.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Nosignofoverdosehasbeenobservedafteradministrationof3timesthe

recommendeddose.

Overdosemaycauseacutesignsintheformofneurologicaldisorderswhichshould

betreatedsymptomatically.

4.11Withdrawalperiod(s)

Meatandoffal

Preruminatingcalves(up

to100kgbodyweight 6days

Pigs 4days

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antibacterialsforsystemicuse,Fluoroquinolones,

ATCvetcode:QJ01MA93

5.1Pharmacodynamicproperties

Marbofloxacinisasynthetic,bactericidalantimicrobial,belongingtothe

fluoroquinolonegroupwhichactsbyinhibitionofDNAgyrase.Itiseffectiveagainsta

widerangeofGrampositivebacteria(inparticularStaphylococci)andGramnegative

bacteria(Escherichiacoli,Salmonellatyphymurium,Campylobacterjejuni,

Citrobacter,Enterobacter,Proteusspp.,Klebsiellaspp.,Actinobacillus

pleuropneumoniae,Bordetellabronchiseptica,Mannheimiahaemolytica,Pasteurella

multocida,Histophilusspp.,Moraxellaspp.,Pseudomonasaeruginosa)aswellas

Mycoplasma(Mycoplasmabovis,Mycoplasmadispar,Mycoplasmahyopneumoniae).

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ResistanceinStreptococcusmayoccur.

Resistancetofluoroquinolonesoccursbychromosomalmutationwiththree

mechanisms:decreaseofthebacterialwallpermeability,expressionofeffluxpump

ormutationofenzymesresponsibleformoleculebinding.

5.2Pharmacokineticparticulars

Aftersubcutaneousadministrationincattleandpigsattherecommendeddoseof2

mg/kg,marbofloxacinisreadilyabsorbedanditsbioavailabilityiscloseto100%.Itis

weaklyboundtoplasmaproteins(lessthan10%inpigsand30%incattle),

extensivelydistributedandinmosttissues(liver,kidney,skin,lung,bladder,uterus,

digestivetract)itachieveshigherconcentrationsthaninplasma.

Incattle,marbofloxaciniseliminatedslowlyinpre-ruminatingcalves(t

1/2 β=5-9h)

predominantlyintheactiveforminurine(3/4)andfaeces(1/4).

Inpigs,marbofloxaciniseliminatedslowly(t

1/2 β=8-10h)predominantlyintheactive

forminurine(2/3)andfaeces(1/3).

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Gluconolactone

Disodiumedetate

Mannitol

Metacresol

Monothioglycerol

Waterforinjections

6.2Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbe

mixedwithotherveterinarymedicinalproducts.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years.

Shelf-lifeafterfirstopeningtheimmediatepackaging:28days.

6.4.Specialprecautionsforstorage

Storeintheoriginalpackageinordertoprotectfromlight.

Donotfreeze.

6.5Natureandcompositionofimmediatepackaging

Bottle(amberglassPh.Eur.typeII),bromobutylrubberstopper,aluminiumclosure:

50mlsolutionforinjection,inabox.

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Bottle(amberglassPh.Eur.typeII),bromobutylrubberstopper,aluminiumclosure:

100mlsolutionforinjection,inabox.

Bottle(amberglassPh.Eur.typeII),bromobutylrubberstopper,aluminiumclosure:

250mlsolutionforinjection,inabox.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedproductorwastematerialsshouldbedisposedofinaccordancewith

nationalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

MiklichLaboratoriosS.L.

CalleCuevasBajas

s/n –Of.23

EdificioPicasso

29004Málaga

Spain

8. MARKETINGAUTHORISATIONNUMBER

Vm35084/4000

9. DATEOFFIRSTAUTHORISATION

10October2011

10.DATEOFREVISIONOFTHETEXT

October2011

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Veterinaryprescription.