Marbocare 100 mg/ml Solution for Injection for Cattle and Pigs

Main information

  • Trade name:
  • Marbocare 100 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 100 mg/ml Solution for Injection for Cattle and Pigs
    France
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0409/002
  • Authorization date:
  • 26-09-2012
  • EU code:
  • UK/V/0409/002
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Issued:December2012

AN:01043/2011

Page1of6

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Marbocare100mg/mlSolutionforInjectionforCattleandPigs(UK,IE,FR)

Odimar100mg/mlSolutionforInjectionforCattleandPigs(BE,NL,LU,ES,PT,DE,

AT)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontains:

Activesubstance:

Marbofloxacin 100.0mg

Excipients:

Metacresol 2.0mg

Monothioglycerol 1.0mg

Disodiumedetate 0.1mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Solutionforinjection.

Clear,yellowishsolution.

4. CLINICALPARTICULARS

4.1Targetspecies

CattleandPigs.

4.2Indicationsforuse,specifyingthetargetspecies

Incattle:

TreatmentofrespiratoryinfectionscausedbysensitivestrainsofPasteurellamultocida,

Mannheimiahaemolytica,HistophilussomniandMycoplasmabovis

TreatmentofacutemastitiscausedbyE.colistrainssensitivetomarbofloxacinduring

thelactationperiod.

Inpigs:

Issued:December2012

AN:01043/2011

Page2of6

TreatmentofMetritisMastitisAgalactiasyndrome(postpartumdysgalactiaesyndrome,

PDS)causedbysusceptiblestrainsoforganisms.

4.3Contraindications

Donotuseinanimalswithknownhypersensitivitytomarbofloxacinortoanyother

quinoloneortoanyoftheexcipients

Donotuseincaseswherethepathogeninvolvedisresistanttootherfluoroquinolones

(crossresistance).

4.4Specialwarningsforeachtargetspecies

None

4.5Specialprecautionsforuse

Specialprecautionsforuseinanimals

Officialandlocalantimicrobialpoliciesshouldbetakenintoaccountwhentheproductis

used.Fluoroquinolonesshouldbereservedforthetreatmentofclinicalconditionswhich

haverespondedpoorly,orareexpectedtorespondpoorly,tootherclassesof

antimicrobials.Wheneverpossible,fluoroquinolonesshouldonlybeusedbasedon

susceptibilitytesting.Useoftheproductdeviatingfromtheinstructionsgiveninthe

SPCmayincreasetheprevalenceofbacteriaresistanttothefluoroquinolonesandmay

decreasetheeffectivenessoftreatmentwithotherquinolonesduetothepotentialfor

crossresistance.Efficacydatahaveshownaninsufficientefficacyoftheproductforthe

treatmentofacutemastitiscausedbyGrampositivestrains.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Peoplewithknownhypersensitivityto(fluoro)quinolonesshouldavoidanycontact

withtheproduct.

Iftheproductcomesintocontactwiththeskinoreyes,rinsewithlargeamountsof

water.

Avoidaccidentalself-injection,sincethiscancauselocalirritation.

Washhandsafteruse.

Incaseofaccidentalself-injectionoringestion,seekmedicaladviceimmediately

andshowpackageleafletorthelabeltothephysician.

4.6Adversereactions(frequencyandseriousness)

Intramuscularorsubcutaneousinjectionsarewelltoleratedalthoughtransitory

inflammatorylesionswithoutclinicalimpactcanoccurattheinjectionsite.

Issued:December2012

AN:01043/2011

Page3of6

Administrationbytheintramuscularroutemaycausetransientlocalreactionssuchas

painandswellingattheinjectionsiteandinflammatorylesionswhichmaypersistforat

least12daysafterinjection.Nootheradverseeffectwasobservedoncattle.

4.7Useduringpregnancy,lactationorlay

Laboratorystudiesintheratandrabbithavenotproducedanyevidenceofa

teratogenic,foetoxicormaternotoxiceffect.

Doseof2mg/kgbodyweight:

Safetyoftheproducthasbeenestablishedinpregnantandlactatingcowsandsows.

Doseof8mg/kgbodyweight:

Thesafetyoftheveterinarymedicinalproducthasnotbeenestablishedinthepregnant

coworinsucklingcalveswhenusedinthecow.Therefore,thisdoseregimenshouldbe

usedonlyaccordingtothebenefit/riskassessmentbytheresponsibleveterinarian.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9Amountstobeadministeredandadministrationroute

Toensureadministrationofthecorrectdose,bodyweightshouldbedeterminedas

accuratelyaspossible,toavoidunderdosing.

Cattle:

Respiratoryinfections:

Thisproductmaybeadministeredasasingledosegivenononedayonlyorasa

multipledoseinjectiongivenover3-5days.

Singledose –Intramuscularuse:

Therecommendeddosageis8mg/kgbodyweight(i.e.2mlofproduct/25kg

bodyweightinasingleinjection).Thisoptimiseddosingregimenshouldbeconsidered

asthedosingregimenofchoiceinthetreatmentofcattlerespiratorydiseasewiththe

exceptionofthesituationslistedbelow.

Multipledose –Intramuscular,intravenousorsubcutaneoususe:

Therecommendeddosageis2mg/kgbodyweight(i.e.1mlofproduct/50kg

bodyweightinasingledailyinjectionfor3-5days).Thisdosingregimenshouldbeused

fortreatmentofspecificcasessuchasthosewhichrequireintravenoustreatmentor

infectionscausedbyMycoplasmabovis).

Acutemastitis:

-Intramuscularorsubcutaneoususe:

Therecommendeddosageis2mg/kgbodyweight(i.e.1mlofproduct/50kg

bodyweightinasingledailyinjection,for3consecutivedays.

Thefirstinjectionmayalsobegivenbytheintravenousroute.

Pigs(sows):

-Intramuscularuse:

Issued:December2012

AN:01043/2011

Page4of6

Therecommendeddosageis2mg/kgbodyweight(i.e.1mlofproduct/50kg

bodyweightinasingledailyinjection,for3consecutivedays).

Itispreferabletoinjectcattleandpigsintheneck.

Ifthevolumetobeinjectedismorethan20ml,itshouldbedividedbetweentwoormore

injectionsites.

Inordertoreducetheriskofparticulatecontaminationoftheproduct,itisrecommended

thatadraw-offneedlebeusedtoreducethenumberoftimestheseptumispunctured.

Donotbroachthe100mL-vialmorethan25timesanda250mL-vialmorethan50times

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Nosevereside-effectsaretobeexpectedatdosesupto3or5timesthe

recommendeddoseincattleandpigsrespectively.

Overdosagemaycauseacutesignsintheformofneurologicaldisorderswhichwould

havetobetreatedsymptomatically.

4.11Withdrawalperiods

Meatandoffal Milk

Cattle2mg/kgfor3to5days(IV/IM/SC) 6days 36hours

Cattle8mg/kgonasingleoccasion(IM) 3days 72hours

Pigs 4days

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antibacterialsforsystemicuse,Fluoroquinolones.

ATCVetcode:QJ01MA93

5.1Pharmacodynamicproperties

Marbofloxacinisasynthetic,bactericidalantimicrobial,belongingtothefluoroquinolone

group. ItactsbyinhibitionofDNAgyraseandshowsconcentrationdependant

bactericidalactivity.Ithasabroad-spectrumactivityagainstGram-positivebacteriaand

Gram-negativebacteria(e.g.Pasteurellamultocida,Mannheimiahaemolytica,

Histophilussomni,E.coli)aswellasagainstmycoplasmas(Mycoplasmabovis).

Themarbofloxacininvitroactivityagainstpathogensisolatedin2004frombovine

respiratorydiseasesduringaclinicalfieldtrialinFrance,Germany,SpainandBelgium,

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

Issued:December2012

AN:01043/2011

Page5of6

(MIC90=0.124µg/ml;MIC50=0.025µg/ml),between0.004and0.12µg/mlforP.

multocida(MIC90=0.022µg/ml;MIC50=0.009µg/ml)andbetween0.015and2µg/ml

forHistophilussomni .StrainswithMIC≤1µg/mlaresensitivetomarbofloxacin

whereasstrainswithMIC≥4µg/mlareresistanttomarbofloxacin.

Resistancetofluoroquinolonesoccursmostlybychromosomalmutationwiththree

mechanisms:decreaseofthebacterialwallpermeability,expressionofeffluxpumpor

mutationofenzymesresponsibleformoleculebinding.

5.2Pharmacokineticparticulars

Aftersubcutaneousorintramuscularadministrationincattleandintramuscular

administrationinpigsattherecommendeddoseof2mg/kgbodyweight,marbofloxacin

isreadilyabsorbedandreachesmaximalplasmaconcentrationsof1.5µg/mlwithinless

than1hour.Itsbioavailabilityiscloseto100%.

Afterasingleintramuscularadministrationincattleattherecommendeddoseof8

mg/kgbodyweight,themaximumplasmaconcentrationofmarbofloxacin(Cmax)is7.3

µg/mlreachedin=0.78h(Tmax).Bindingtoplasmaproteinsisabout30%.

Marbofloxaciniseliminatedslowly( t½β=15.60h),predominantlyintheactiveformin

urineandfaeces.

Itisweaklyboundtoplasmaproteins(lessthan10%inpigsand30%incattle),

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

digestivetract)itachievesahigherconcentrationthaninplasma.

Incattle,marbofloxaciniseliminatedslowlyinpre- ruminatingcalves(t½β=5-9h)but

fasterinruminantcattle(t½β=4-7h)predominantlyintheactiveforminurine(3/4in

pre-ruminatingcalves,1/2inruminants)andfaeces(1/4inpre-ruminatingcalves,1/2in

ruminants).

Inpigs,marbofloxaciniseliminatedslowly(t½β=8-10h)predominantlyintheactive

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

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Disodiumedetate

Metacresol

Monothioglycerol

Gluconolactone

Waterforinjections

6.2Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbe

mixedwithotherveterinarymedicinalproducts.

Issued:December2012

AN:01043/2011

Page6of6

6.3Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:3years.

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

The10mLvialsmustbeusedimmediatelyafterthefirstopening.

6.4.Specialprecautionsforstorage

Keepthecontainerintheoutercartoninordertoprotectfromlight

10mlvials:Followingwithdrawaloftherequireddose,theremaindertothecontentsof

thevialshouldbediscarded.

6.5Natureandcompositionofimmediatepackaging

PackagedinAmbertypeIIglassvialsof10,20,50ml100and250ml.

Thevialsareclosedwithafluorinatedbromobutylrubberstopperoversealedwithan

aluminiumcap.Eachvialispackagedinacardboardbox.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

AnimalcareLtd

CommonRd

Dunnington

York

YO195RU

UK

8. MARKETINGAUTHORISATIONNUMBER

Vm10347/4035

9. DATEOFFIRSTAUTHORISATION

21December2012

10.DATEOFREVISIONOFTHETEXT

December2012

Approved: 21/12/2012

31-10-2018

Efficacy of Bergazym® P100 (endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening and weaned piglets

Efficacy of Bergazym® P100 (endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening and weaned piglets

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The product Bergazym® P100 contains a xylanase which is produced by a non‐genetically modified strain of Trichoderma reesei. The additive is available in a coated granular form and it is intended to be used as a zootechnical additive (functional group: digestibility enhancers) for chickens for fattening, and weaned piglets at the dose of 1,500 EPU/kg feed. The production strain and the additive were fully characterised in a previous assessment of the Panel o...

Europe - EFSA - European Food Safety Authority Publications

15-6-2018

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

At least 43 patient reported adverse event after receiving eye injections of Guardian’s Pharmacy Services compounded triamcinolone-moxifloxacin product during cataract surgery. The patients reportedly experienced various symptoms, including vision impairment, poor night vision, loss of color perception, and significant reductions in best-corrected visual acuity and visual fields. FDA identified multiple substances in Guardian’s product, including poloxamer 407 and poloxamer 407 degradants. FDA prepared i...

FDA - U.S. Food and Drug Administration

There are no news related to this product.