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

Main information

  • Trade name:
  • Marbocare 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:
  • Marbocare 20 mg/ml Solution for Injection for Cattle and Pigs
    Netherlands
  • Language:
  • English

Therapeutic information

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

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0409/001
  • Authorization date:
  • 26-09-2012
  • EU code:
  • UK/V/0409/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Issued:December2012

AN:01044/2011

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SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Marbocare20mg/mlsolutionforinjectionforcattleandpigs(UK,IE,FR)

Odimar20mg/mlsolutionforinjectionforcattleandpigs(BE,NL,LU,ES,PT,DE,AT)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontains:

Activesubstance:

Marbofloxacin 20.0mg

Excipients:

Metacresol 2.0mg

Monothioglycerol 0.5mg

Disodiumedetate 0.1mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Solutionforinjection

Clearyellowishsolution.

4. CLINICALPARTICULARS

4.1Targetspecies

-Cattle:pre-ruminantsupto100kgb.w.

-Pigs

4.2Indicationsforuse,specifyingthetargetspecies

Pre-ruminantcalves:

TreatmentofrespiratoryinfectionscausedbysensitivestrainsofPasteurellamultocida,

MannheimiahaemolyticaandMycoplasmabovis.

Pigs:

TreatmentofrespiratoryinfectionscausedbysensitivestrainsofActinobacillus

pleuropneumoniae,MycoplasmahyopneumoniaeandPasteurellamultocida.

4.3Contraindications

Donotuseinanimalswithknownhypersensitivitytomarbofloxacinortoanyother

quinoloneortoanyoftheexcipients.

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Donotuseincaseswherethepathogeninvolvedisresistanttootherfluoroquinolones

(crossresistance).

4.4Specialwarnings

None.

4.5Specialprecautionsforuse

(i) Specialprecautionsforuseinanimals

Officialandlocalantimicrobialpoliciesshouldbetakenintoaccountwhentheproductis

used.Fluoroquinolonesshouldbereservedforthetreatmentofclinicalconditionswhich

haverespondedpoorly,orareexpectedtorespondpoorly,tootherclassesof

antimicrobials.Wheneverpossible,fluoroquinolonesshouldonlybeusedbasedon

susceptibilitytesting.Useoftheproductdeviatingfromtheinstructionsgiveninthe

SPCmayincreasetheprevalenceofbacteriaresistanttothefluoroquinolonesandmay

decreasetheeffectivenessoftreatmentwithotherquinolonesduetothepotentialfor

crossresistance.

(ii)Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Peoplewithknownhypersensitivityto(fluoro)quinolonesshouldavoidanycontact

withtheproduct.

Iftheproductcomesintocontactwiththeskinoreyes,rinsewithlargeamountsof

water.

Avoidaccidentalself-injection,sincethiscancauselocalirritation.

Washhandsafteruse.

Incaseofaccidentalself-injectionoringestion,seekmedicaladviceimmediately

andshowpackageleafletorthelabeltothephysician.

4.6Adversereactions(frequencyandseriousness)

Intramuscularorsubcutaneousinjectionsarewelltoleratedalthoughtheymaycause

transitorypainfulswellingswithoutclinicalimpact.

Administrationbytheintramuscularroutemaycausetransientlocalreactionssuchas

painandswellingattheinjectionsiteandinflammatorylesionswhichmaypersistfor6

daysinpigsandfor12daysincattle.

4.7Useduringpregnancy,lactationorlay

Marbofloxacinmaybeusedinpregnantandlactatingsows.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9Amountstobeadministeredandadministrationroute

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Toensureadministrationofthecorrectdose,bodyweightshouldbedeterminedas

accuratelyaspossible,toavoidunderdosing.

Therecommendeddosageis2mg/kgbodyweight/day(1ml/10kgBW)incattleand

pigs.

Thesingledailydoseforcalvesshouldbeadministeredbysubcutaneousor

intramuscularinjection,for3-5days.Thefirstinjectionmayalsobegivenbythe

intravenousroute.

Thesingledailydoseforpigsshouldbeadministeredbyintramuscularinjection,for3-5

days.

Thevolumeofinjectionshouldbelimitedto10mlateachsiteofinjectionforpigs.

Inordertoreducetheriskofparticulatecontaminationoftheproduct,itisrecommended

thatadraw-offneedlebeusedtoreducethenumberoftimestheseptumispunctured.

Donotbroachthe100mL-vialmorethan25timesanda250mL-vialmorethan50times

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Nosevereside-effectsaretobeexpectedatdosesupto5timestherecommended

doseincattleandpigs.

Overdosagemaycauseacutesignsintheformofneurologicaldisorderswhichshould

betreatedsymptomatically.

4.11Withdrawalperiod(s)

MEATAND

OFFAL

Pre-ruminatingcalves(upto

100kgbodyweight) 6days

Pigs 4days

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antibacterialsforsystemicuse,Fluoroquinolones

ATCVetCode:QJ01MA93

5.1Pharmacodynamicproperties

Marbofloxacinisasynthetic,bactericidalantimicrobial,belongingtothefluoroquinolone

group.ItactsbyinhibitionofDNAgyraseandshowsconcentrationdependant

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bactericidalactivity.Ithasabroad-spectrumactivityagainstGram-positivebacteriaand

Gram-negativebacteria(e.g.Pasteurellamultocida,Mannheimiahaemolyticaand

Actinobacilluspleuropneumoniae)aswellasagainstmycoplasmas(Mycoplasma

bovisandMycoplasmahyopneumoniae).

Themarbofloxacininvitroactivityagainstpathogensisolatedin2004frombovine

respiratorydiseasesduringaclinicalfieldtrialinFrance,Germany,SpainandBelgium,

isgood:MICvaluesarecomprisedbetween0.015and0.25µg/mlforM.haemolytica

(MIC

=0.124µg/ml;MIC

=0.025µg/ml)andbetween0.004and0.12µg/mlforP.

multocida(MIC

=0.022µg/ml;MIC

=0.009µg/ml). StrainswithaMIC≤1µg/mlare

sensitivetomarbofloxacinwhereasstrainswithaMIC≥4µg/mlareresistantto

marbofloxacin.

Resistancetofluoroquinolonesoccursmostlybychromosomalmutationwiththree

mechanisms:decreaseofthebacterialwallpermeability,expressionofeffluxpumpor

mutationofenzymesresponsibleformoleculebinding.

5.2Pharmacokineticparticulars

Aftersubcutaneousadministrationincattleandpigsattherecommendeddoseof2

mg/kgbodyweight,marbofloxacinisreadilyabsorbedanditsbioavailabilityiscloseto

100%.Itisweaklyboundtoplasmaproteins(lessthan10%inpigsand30%incattle),

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

digestivetract)itachieveshigherconcentrationsthaninplasma.

Incattle,marbofloxaciniseliminatedslowlyinpre- ruminatingcalves(t1/2β=5-9h)

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

Inpigs,marbofloxaciniseliminatedslowly(t1/2β=8-10h)predominantlyintheactive

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

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Disodiumedetate

Metacresol

Monothioglycerol

Gluconolactone

Mannitol

Waterforinjections

6.2Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbe

mixedwithotherveterinarymedicinalproducts.

6.3Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:3years.

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Shelflifeafterfirstopeningtheimmediatepackaging(20,50,100,250mlvials):28

days.The10mlvialsmustbeusedimmediatelyafterthefirstopening.

6.4.Specialprecautionsforstorage

Keepthecontainerintheoutercartoninordertoprotectfromlight.

10mlvials:Followingwithdrawaloftherequireddose,theremaindertothecontentsof

thevialshouldbediscarded.

6.5Natureandcompositionofimmediatepackaging

PackagedinAmbertypeIIglassvialsof10,20,50ml100and250ml.

Thevialsareclosedwithafluorinatedbromobutylrubberstopperandoversealedwith

analuminiumcap.

Eachvialispackagedinacardboardbox.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

7. MARKETINGAUTHORISATIONHOLDER

AnimalcareLtd

CommonRoad

Dunnington

York

YO195RU

UK

8. MARKETINGAUTHORISATIONNUMBER

Vm10347/4034

9. DATEOFFIRSTAUTHORISATION

19December2012

10.DATEOFREVISIONOFTHETEXT

December2012

Issued:December2012

AN:01044/2011

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Approved: 19/12/2012