Actimarbo 100 mg/ml, Solution for Injection for Cattle and Pigs

Main information

  • Trade name:
  • Actimarbo 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:
  • Actimarbo 100 mg/ml, Solution for Injection for Cattle and Pigs
    United Kingdom
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0460/001
  • Authorization date:
  • 24-04-2013
  • EU code:
  • UK/V/0460/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Issued:August2013

AN:00146/2012

Page1of7

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Actimarbo100mg/mlSolutionforInjectionforCattleandPigs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontains:

Activesubstance:

Marbofloxacin 100.0mg

Excipients:

Metacresol 2.0mg

Monothioglycerol 1.0mg

Disodiumedetate(E386)0.1mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Solutionforinjection

Aclearpaleyellowtogreenish –brownishyellowaqueoussolution.

4. CLINICALPARTICULARS

4.1 Targetspecies

Cattle&pigs.

4.2 Indicationsforuse,specifyingthetargetspecies

Incattle:

Treatmentofrespiratoryinfectionscausedbysusceptiblestrainsof

Pasteurellamultocida,MannheimiahaemolyticaandHistophilussomni.

TreatmentofacutemastitiscausedbyEscherichiacolistrainssusceptibleto

marbofloxacinduringlactation.

Inpigs:

TreatmentofMetritisMastitisAgalactiasyndromecausedbysusceptible

strainsoforganisms.

Issued:August2013

AN:00146/2012

Page2of7

4.3 Contraindications

Donotuseinanimalswithknownhypersensitivitytomarbofloxacin,orany

quinolones,ortoanyoftheexcipients.

Donotuseincaseswherethepathogeninvolvedisresistanttoother

fluoroquinolones(crossresistance).

4.4 Specialwarningsforeachtargetspecies

None.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Donotuseincaseofconfirmedorsuspectedresistancetofluoroquinolones(cross

resistance).

Officialandlocalantimicrobialpoliciesshouldbetakenintoaccountwhentheproduct

isused.Fluoroquinolonesshouldbereservedforthetreatmentofclinicalconditions

whichhaverespondedpoorly,orareexpectedtorespondpoorly,tootherclassesof

antimicrobials.

Wheneverpossible,fluoroquinolonesshouldonlybeusedbaseduponsusceptibility

testing.UseoftheproductdeviatingfromtheinstructionsgivenintheSPCmay

increasetheprevalenceofbacteriaresistanttothefluoroquinolonesandmay

decreasetheeffectivenessoftreatmentwithotherquinolonesduetothepotentialfor

crossresistance.

Theefficacydatashowedthattheproducthasinsufficientefficacyforthetreatment

ofacuteformsofmastitisinducedbygrampositivebacteria.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Peoplewithknownhypersensitivityto(fluoro)quinolonesshouldavoidusing

thisproduct.

Incaseofcontactwithskinoreyes,rinsewithplentyofwater.Careshouldbe

takentoavoidaccidentalselfinjection.

Accidentalself-injectioncaninduceaslightirritation.

Incaseofaccidentalselfinjection,seekmedicaladviceandshowthelabelto

thedoctor.

Washhandsafteruse.

4.6Adversereactions(frequencyandseriousness)

Transitoryinflammatorylesionswithoutclinicalimpactcanoccurattheinjectionsite

afterintramuscularorsubcutaneousinjections.

Administrationbytheintramuscularroutemaycausetransientlocalreactionssuchas

painandswellingattheinjectionsiteandinflammatorylesions,whichmaypersist,for

Issued:August2013

AN:00146/2012

Page3of7

atleast12daysafterinjection.

Incattle,thesubcutaneousroutewasshowntobebettertoleratedlocallythan

intramuscularroute.

4.7 Useduringpregnancy,lactationorlay

Laboratorystudiesinratsandrabbitshavenotproducedanyevidenceofa

teratogenic,foetotoxicormaternotoxiceffects.

Doseof2mg/kgbodyweight:

Canbeusedduringpregnancyandlactation.

Thesafetyoftheveterinarymedicinalproducthasbeenestablishedincowduring

gestationandsucklingpigsandcalveswhenusedincowandsow.

Doseof8mg/kgbodyweight:

Thesafetyoftheveterinarymedicinalproducthasnotbeenestablishedinpregnant

coworinsucklingcalveswhenusedincow.Therefore,thisdoseregimenshouldbe

useonlyaccordinglytothebenefit/riskassessmentbytheresponsibleveterinarian.

Incaseofuseinlactatingcow,seesection4.11.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9 Amountstobeadministeredandadministrationroute

Toensureadministrationofacorrectdose,bodyweightshouldbedeterminedas

accuratelyaspossibletoavoidunderdosing.

Cattle:

Respiratoryinfections:

Intramuscularuse:

Therecommendeddosageis8mg/kgbodyweighti.e.2ml/25kgbodyweightina

singleinjection.Ifthevolumetobeinjectedismorethan20ml,itshouldbedivided

between2ormoreinjectionsites.

Acutemastitis:

Intramuscularorsubcutaneoususe:

Therecommendeddosageis2mg/kg/day(1ml/50kg)inasingledailyinjection.

Treatmentdurationis3to5days.

Thefirstinjectionmayalsobegivenbytheintravenousroutetoo.Thesubcutaneous

routeisrecommendedinheavycattle(seesection4.6).

Pigs:

Acutemastitis:

Intramuscularuse:

Therecommendeddosageis2mg/kg/day(1ml/50kg)inasingledailyinjection.

Issued:August2013

AN:00146/2012

Page4of7

Treatmentdurationis3days.

Inordertoreducetheriskofparticulatecontaminationoftheproduct,itis

recommendedthatadraw-offneedlebeusedtoreducethenumberoftimesthe

septumispunctured.

Theseptumcanbepuncturedupto27times.Theusershouldchoosethemost

appropriatevialsizeaccordingtothetargetspeciestotreat.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Nosevereside-effectsaretobeexpectedatdosesupto3or5timesthe

recommendeddoseincattleandpigsrespectively.

Nosignofoverdosagehasbeenobservedafteradministrationof3timesthe

recommendeddose.

Overdosagemaycausesignssuchasacuteneurologicaldisorderswhichshouldbe

treatedsymptomatically.

4.11Withdrawalperiod(s)

Cattle:

Respiratoryinfections(intramuscularuse,8mg/kgsingledose)

Meatandoffal:3days

Milk:72hours

Acutemastitis(intramuscularorsubcutaneoususe,2mg/kgsingledaily

injectionfor3to5days)

Meatandoffal:6days

Milk:36hours

Pigs(sows):

Intramuscularuse

Meatandoffal:4days

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antibacterialsforsystemicuse,fluoroquinolones

ATCvetcode:QJ01MA93

5.1 Pharmacodynamicproperties

Marbofloxacinisasynthetic,bactericidalantimicrobial,belongingtothe

fluoroquinolonegroupwhichactsbyinhibitionofDNAgyrase.Itiseffectiveagainsta

widerangeofGrampositivebacteria(inparticularStaphylococci)andGramnegative

bacteria(Escherichiacoli,Pasteurellaspp).

Themarbofloxacininvitroactivityagainstpathogensisolatedin2004frombovine

respiratorydiseasesduringaclinicalfieldtrialinFrance,Germany,Spainand

Belgium,isgood:MICvaluesarecomprisedbetween0.015and0.25µg/mlfor

Mannheimiahaemolytica(MIC

=0.124µg/ml;MIC

=0.025µg/ml),between0.004

Issued:August2013

AN:00146/2012

Page5of7

and0.12µg/mlforPasteurellamultocida(MIC

=0.022µg/ml;MIC

=0.009µg/ml)

andbetween0.015and2µg/mlforHistophilussomni.Strains withMIC≤1µg/mlare

sensitivetomarbofloxacinwhereasstrainswithMIC≥4µg/mlareresistantto

marbofloxacin.

Marbofloxacinsusceptibilityofbacteria,isolatedbetween2002and2008fromcattle

withrespiratorydiseaseandmastitisinEurope,isgood:Pasteurellamultocidaand

Mannheimiahaemolyticaisolates(751and514strains,respectively)werehighly

susceptibletomarbofloxacin(MIC≤0.03μg/mlfor77.39%thestrains).Histophilus

somniisolates(73strains)werehighlysusceptibletomarbofloxacin(0.008to0.06

μg/ml).ThemajorityofEscherichiacoliisolateswerehighlysusceptibleto

marbofloxacin(95.8%of617strains).

Themarbofloxacinactivityforthetreatmentofmastitis,metritisandagalactia

syndromeinacontrolledandrandomizedtrialinFranceandtheNetherlands

involving93sowsandpublishedin2000isgood:MIC

=0.017µg/mlandMIC

=

0.21µg/mlforEscherichiacoli;MIC

=1.71µg/mlforStreptococciandMIC

=0.27

µg/mlforStaphylococci.

Resistancetofluoroquinolonesoccursbychromosomalmutationwith3mechanisms:

decreaseofthebacterialwallpermeability,expressionofeffluxpumpormutationof

enzymesresponsibleformoleculebinding.

5.2 Pharmacokineticparticulars

Aftersubcutaneousorintramuscularadministrationincattleandintramuscular

administrationinpigsattherecommendeddoseof2mg/kg,marbofloxacinisreadily

absorbedandreachesmaximalplasmaconcentrationsof1.5µg/mlwithinlessthan1

hour.Itsbioavailabilityiscloseto100%.

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,1/2

inruminants).

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

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

Afterasingleintramuscularadministrationincattleattherecommendeddoseof8

mg/kg,themaximumplasmaconcentrationofmarbofloxacin(Cmax)is7.3µg/ml

reachedin=0.78h(Tmax).Bindingtoplasmaproteinsisabout30%.Marbofloxacin

iseliminatedslowly(T1/2 

=15.60h),predominantlyintheactiveforminurineand

faeces.

Issued:August2013

AN:00146/2012

Page6of7

6.PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Disodiumedetate(E386)

Monothioglycerol

Metacresol

Gluconolactone

Waterforinjection

6.2Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbe

mixedwithotherveterinarymedicinalproducts.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:30months

Shelf-lifeafterfirstopeningtheimmediatepackaging:28days

6.4.Specialprecautionsforstorage

Storeintheoriginalpackageinordertoprotectfromlight.

6.5Natureandcompositionofimmediatepackaging

TypeIamberglassvials(20ml,50mland100ml)closedwithachlorobutylrubber

stopperwithanaluminiumcapsuleandaflipoffseal.

Eachvialispackagedinacardboardbox.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

7. MARKETINGAUTHORISATIONHOLDER

EcupharNV

Legeweg157-i

8020Oostkamp

Belgium

Issued:August2013

AN:00146/2012

Page7of7

8. MARKETINGAUTHORISATIONNUMBER

Vm32742/4008

9. DATEOFFIRSTAUTHORISATION

14August2013

10. DATEOFREVISIONOFTHETEXT

August2013

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable.

Approved: 14/08/2013

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.