MARBOCYL 2%

Main information

  • Trade name:
  • MARBOCYL 2%
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • MARBOCYL 2%
    Portugal
  • Language:
  • English

Therapeutic information

  • Therapeutic area:
  • CATTLE, SOWS CATTLE, SOWS cattle

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0107/002
  • Authorization date:
  • 22-12-2010
  • EU code:
  • FR/V/0107/002
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

MARBOCYL2%-EuropeanRenewal–July2007V2

SUMMARYOFPRODUCTCHARACTERISTICS,

MARBOCYL2%

MARBOCYL2%-EuropeanRenewal–July2007V2

1.NAMEOFTHEVETERINARYMEDICINALPRODUCT

MARBOCYL2%solutionforinjectionforcattleandpigs

2.QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontains:

Marbofloxacin.....................................20.0mg

Disodiumedetate...............................0.1mg

Thioglycerol.....................................0.5mg

m-crésol ......................................2.0mg

Forafulllistofexcipients,seesection6.1.

3.PHARMACEUTICALFORM

Solutionforinjection.

Yellow-greenishtoyellow-brownishaqueoussolution.

4.CLINICALPARTICULARS

4.1Targetspecies

Cattleandfatteningpigs.

4.2Indicationsforuse,specifyingthetargetspecies

Inpreruminatingandruminatingcalves

TreatmentofrespiratoryinfectionscausedbysensitivestrainsofPasteurella

multocida,Mannheimia(Pasteurella)haemolyticaandMycoplasmabovis.

Inpigs

TreatmentofrespiratoryinfectionscausedbysensitivestrainsofActinobacillus

pleuropneumoniae,Mycoplasmahyopneumoniae,Pasteurellamultocida.

Theveterinarymedicinalproductshouldonlybeusedbasedonsusceptibilitytesting.

4.3Contraindications

Bacterialinfectionswithresistancetootherfluoroquinolones(crossresistance).

Donotadministertoananimalpreviouslyfoundtobehypersensitiveto

marbofloxacineorotherquinolone

4.4Specialwarningsforeachtargetspecies

None.

MARBOCYL2%-EuropeanRenewal–July2007V2

4.5Specialprecautionsforuse

i)Specialprecautionsforuseinanimals

Fluoroquinolonesshouldbereservedforthetreatmentofclinicalconditionswhich

haverespondedpoorly,orareexpectedtorespondpoorly,tootherclassesof

antimicrobials.

Wheneverpossible,fluoroquinolonesshouldonlybeusedbasedonsusceptibility

testingofficialandlocalantimicrobialpoliciesshouldbetakenintoaccountwhenthe

veterinarymedicinalproductisused.

Useoftheveterinarymedicinalproductdeviatingfromtheinstructionsgiveninthe

SPCmayincreasetheprevalenceofbacteriaresistanttothefluoroquinolonesand

maydecreasetheeffectivenessoftreatmentwithotherquinolonesduetothepotential

forcrossresistance.

ii)Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

None

iii)Otherprecautions

None

4.6Adversereactions(frequencyandseriousness)

Administrationbysubcutaneousandintramuscularroutemayinducetransitory

oedema.Administrationbytheintramuscularroutemaycausepainreactionand

inflammatorylesionsatthesiteofinjection.Inflammatorylesionspersist6daysinpigs

and12daysincalves.

4.7Useduringpregnancy,lactationorlay

Studiesinlaboratoryanimals(rats,rabbits),didnotshowanyteratogenic,embryotoxic

effectsoranymaternaltoxicityofmarbofloxacin.

Tobeusedonlyaccordingtotherisk/benefitassessmentbytheveterinarian.

Seealsoparagraph4.11.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Unknown.

4.9Amountstobeadministeredandadministrationroute

Inpreruminatingandruminatingcalves

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

subcutaneousorintramuscularroute,for3to5days.Thefirstinjectionmayalsobe

givenbytheintravenousroute.

In pigs

Treatmentofrespiratorydiseases:therecommendeddosageis2mg/kg(1ml/10kg

bw)inasingledailyinjectionbytheintramuscularroute,for3to5days.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Nosignofoverdosagehasbeenobservedwiththemarbofloxacinafteradministration

of3timestherecommendeddose.

Overdosagemaycausesignsintheformofacuteneurologicaldisorderswhichwould

havetobetreatedsymptomatically.

MARBOCYL2%-EuropeanRenewal–July2007V2

4.11Withdrawalperiod(s)

preruminatingandruminatingcalves Pigs

Meatandoffals 6days 4days

Theveterinarymedicinalproductisnotauthorisedforuseinlactatinganimalsproducingmilk

forhumanconsumption.

5.PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:anti-infectiveforsystemicuse(fluoroquinolone)

ATCVETCODE:QJ01MA93

5.1 Pharmacodynamicproperties

Marbofloxacinisasynthetic,bactericidalantimicrobial,belongingtothe

fluoroquinolonegroupwhichactsbyinhibitionofDNAgyrase.Itiseffectiveagainsta

widerangeofGrampositivebacteria(inparticularStaphylococci)andGramnegative

bacteria(Escherichiacoli,Pasteurellamultocida,Pasteurellahaemolyticaand

Actinobacilluspleuropneumoniae)aswellasMycoplasma(Mycoplasmabovis,

Mycoplasmahyopneumoniae).

ResistancetoStreptococcusmayoccur.

5.2 Pharmacokineticparticulars

Aftersubcutaneousorintramuscularadministrationincattleandpigsatthe

recommendeddoseof2mg/kg,marbofloxacinisreadilyabsorbedandreaches

maximalplasmaconcentrationsof1,5µg/mlwithinlessthan1hour.

Itsbioavailabilityiscloseto100%.

Marbofloxacinisweaklyboundtoplasmaproteins(lessthan10%inpigsand30%

incattle),extensivelydistributedandinmosttissues(liver,kidney,skin,lung,uterus)

itachieveshigherconcentrationsthaninplasma.

Marbofloxaciniseliminatedslowlyinpre-ruminatingcalves(t

=5-9hours)andpigs

=8-10hours),fasterinruminantcattle(t

=4-7hours)predominantlyinthe

activeforminurineandfaeces.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Gluconolactone,di-sodiumedetate,mannitol,thioglycerol,metacresol,waterfor

injection

6.2Incompatibilities

Donotmixtheveterinarymedicinalproductwithothermedicinalproducts.

6.3Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:24months

Shelflifeafterfirstopeningtheimmediatepackaging:28days.

MARBOCYL2%-EuropeanRenewal–July2007V2

6.4.Specialprecautionsforstorage

None.

6.5Natureandcompositionofimmediatepackaging

Primarypackaging

AmbertypeIIglassvials

chlorobutylrubberstoppers

Aluminiumoversealedcaps.

Presentation

Boxofonevialof10ml

Boxofonevialof20ml

Boxofonevialof50ml

Boxofonevialof100ml

Boxofonevialof250ml

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproductor

wastematerialsderivedfromtheuseofsuchproducts

Anyunusedproductorwastematerialshouldbedisposedofinaccordancewith

nationalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10 DATEOFREVISIONOFTHETEXT

MARBOCYL2%-EuropeanRenewal–July2007V2

LABELLINGANDPACKAGELEAFLET

MARBOCYL2%

MARBOCYL2%-EuropeanRenewal–July2007V2

L L A A B B E E L L 1 1 0 0 - - 2 2 0 0

5 5 0 0 m m l l

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

MARBOCYL2%solutionforinjectionforcattleandpigs

2. QUANTITYOFTHEACTIVESUBSTANCE(S)

Marbofloxacin.................................20.0mg

3. CONTENTSBYWEIGHT,BYVOLUMEORBYNUMBEROFDOSES

10ml

20ml

50ml

4. ROUTE(S)OFADMINISTRATION

ForS.C.andI.M.route

5. WITHDRAWALPERIOD

preruminatingandruminatingcalves Pigs

Meatandoffals 6days 4days

Theveterinarymedicinalproductisnotauthorisedforuseinlactatinganimals

producingmilkforhumanconsumption.

6. BATCHNUMBER

7. EXPIRYDATE

[ ]

Afterfirstopeningofthecontainer:28days

8. THEWORDS“FORANIMALTREATMENTONLY”

Foranimaltreatmentonly.

MARBOCYL2%-EuropeanRenewal–July2007V2

L L A A B B E E L L 1 1 0 0 0 0 - - 2 2 5 5 0 0 m m l l

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

MARBOCYL2%solutionforinjectionforcattleandpigs

2. STATEMENTOFTHEACTIVEANDOTHERSUBSTANCES

Eachmlcontains:

Marbofloxacin............................. 20.0mg

Disodiumedentate............................0.1mg

Thioglycerol....................................0.5mg

m-crésol.........................................2.0mg

3. PHARMACEUTICALFORM

Solutionforinjection

4. CONTENTSBYWEIGHT,BYVOLUMEORBYNUMBEROFDOSES

100ml

250ml

5. TARGETSPECIES

Cattleandfatteningpigs.

6. INDICATIONS

Readthepackageleafletbeforeuse.

7. METHODANDROUTE(S)OFADMINISTRATION

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

preruminatingandruminatingcalves Pigs

Meatandoffals 6days 4days

Theveterinarymedicinalproductisnotauthorisedforuseinlactatinganimals

producingmilkforhumanconsumption.

MARBOCYL2%-EuropeanRenewal–July2007V2

9. SPECIALWARNING(S)

Readthepackageleafletbeforeuse;

10.EXPIRYDATE

11.SPECIALSTORAGECONDITIONS

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

Shelflifeafterfirstopeningthecontainer:28days.

12.THEWORDS:FORANIMALTREATMENTONLYANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE

FORANIMALTREATMENTONLY

TOBESUPPLIEDONLYONVETERINARYPRESCRIPTION

13.KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN

14.NAMEANDADRESSOFTHEMARKETINGAUTHORISATIONHOLDER

15.MARKETINGAUTHORISATIONNUMBER(S)

16.BATCHNUMBER

MARBOCYL2%-EuropeanRenewal–July2007V2

B B O O X X

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

MARBOCYL2%solutionforinjectionforcattleandpigs

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Eachmlcontains:

Marbofloxacin................................... 20.0mg

Disodiumedetate............................. 0.1mg

Thioglycerol..................................... 0.5mg

m-crésol........................................... 2.0mg

3. PHARMACEUTICALFORM

Solutionforinjection.

4. PACKAGESIZE

Boxofonevialof10ml

Boxofonevialof20ml

Boxofonevialof50ml

Boxofonevialof100ml

Boxofonevialof250ml

5. TARGETSPECIES

Cattleandfatteningpigs.

6. INDICATION(S)

Inpreruminatingandruminatingcalves

TreatmentofrespiratoryinfectionscausedbysensitivestrainsofPasteurella

multocida,Mannheimia(Pasteurella)haemolyticaandMycoplasmabovis.

Inpigs

TreatmentofrespiratoryinfectionscausedbysensitivestrainsofActinobacillus

pleuropneumoniae,Mycoplasmahyopneumoniae,Pasteurellamultocida.

Theveterinarymedicinalproductshouldonlybeusedbasedonsusceptibilitytesting.

MARBOCYL2%-EuropeanRenewal–July2007V2

7. METHODANDROUTE(S)OFADMINISTRATION

Inpreruminatingandruminatingcalves

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

subcutaneousorintramuscularroute,for3to5days.Thefirstinjectionmayalsobe

givenbytheintravenousroute.

In pigs

Treatmentofrespiratorydiseases:therecommendeddosageis2mg/kg(1ml/10kg

bw)inasingledailyinjectionbytheintramuscularroute,for3to5days.

8. WITHDRAWALPERIOD(S)

preruminatingandruminatingcalves Pigs

Meatandoffals 6days 4days

Theveterinarymedicinalproductisnotauthorisedforuseinlactatinganimals

producingmilkforhumanconsumption.

9. SPECIALWARNING(S),IFNECESSARY

Readpackageleafletbeforeuse.

10.EXPIRYDATE

[ ]

11.SPECIALSTORAGECONDITIONS

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

Shelflifeafterfirstopeningthecontainer:28days.

12.SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Askyourveterinarysurgeonhowtodisposeofmedicinesnolongerrequired.These

measuresshouldhelptoprotecttheenvironment.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

FORANIMALTREATMENTONLY

TOBESUPPLIEDONLYONVETERINARYPRESCRIPTION

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

MARBOCYL2%-EuropeanRenewal–July2007V2

15.NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

16.MARKETINGAUTHORISATIONNUMBER(S)

17. MANUFACTURER’SBATCHNUMBER

MARBOCYL2%-EuropeanRenewal–July2007V2

P P A A C C K K A A G G E E L L E E A A F F L L E E T T

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERANDOF

THEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFORBATCH

RELEASE,IFDIFFERENT

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

MARBOCYL2%solutionforinjectionforcattleandpigs

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

Eachmlcontains:

Marbofloxacin.............................20.0mg

Disodiumedetate......................0.1mg

Thioglycerol..............................0.5mg

m-crésol.....................................2.0mg

4. INDICATION(S)

Inpreruminatingandruminatingcalves

TreatmentofrespiratoryinfectionscausedbysensitivestrainsofPasteurella

multocida,Mannheimia(Pasteurella)haemolyticaandMycoplasmabovis.

Inpigs

TreatmentofrespiratoryinfectionscausedbysensitivestrainsofActinobacillus

pleuropneumoniae,Mycoplasmahyopneumoniae,Pasteurellamultocida.

Theveterinarymedicinalproductshouldonlybeusedbasedonsusceptibilitytesting.

5. CONTRAINDICATIONS

Bacterialinfectionswithresistancetootherfluoroquinolones(crossresistance).

Donotadministertoananimalpreviouslyfoundtobehypersensitivetomarbofoxacine

orotherquinolone.

6. ADVERSEREACTION

Administrationbysubcutaneousandintramuscularroutemayinducetransitory

oedema.Administrationbytheintramuscularroutemaycausepainreactionand

inflammatorylesionsatthesiteofinjection.Inflammatorylesionspersist6daysinpigs

and12daysincalves.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,please

informyourveterinarysurgeon.

MARBOCYL2%-EuropeanRenewal–July2007V2

7. TARGETSPECIES

Cattleandfatteningpigs.

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOFADMINISTRATION

Inpreruminatingandruminatingcalves

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

subcutaneousorintramuscularroute,for3to5days.Thefirstinjectionmayalsobe

givenbytheintravenousroute.

In pigs

Treatmentofrespiratorydiseases:therecommendeddosageis2mg/kg(1ml/10kg

bw)inasingledailyinjectionbytheintramuscularroute,for3to5days.

9. ADVICEONCORRECTADMINISTRATION

None.

10.WITHDRAWALPERIOD

preruminatingandruminatingcalves Pigs

Meatandoffals 6days 4days

Theveterinarymedicinalproductisnotauthorisedforuseinlactatinganimals

producingmilkforhumanconsumption.

11.SPECIALSTORAGEPRECAUTIONS

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

Shelflifeafterfirstopeningthecontainer:28days.

12.SPECIALWARNING(S)

Specialprecautionsforuseinanimals

Fluoroquinolonesshouldbereservedforthetreatmentofclinicalconditionswhich

haverespondedpoorly,orareexpectedtorespondpoorly,tootherclassesof

antimicrobials.

Wheneverpossible,fluoroquinolonesshouldonlybeusedbasedonsusceptibility

testingofficialandlocalantimicrobialpoliciesshouldbetakenintoaccountwhenthe

veterinarymedicinalproductisused.

Useoftheveterinarymedicinalproductdeviatingfromtheinstructionsgiveninthe

SPCmayincreasetheprevalenceofbacteriaresistanttothefluoroquinolonesand

maydecreasetheeffectivenessoftreatmentwithotherquinolonesduetothepotential

forcrossresistance.

MARBOCYL2%-EuropeanRenewal–July2007V2

Useduringpregnancy,lactationorlay

Studiesinlaboratoryanimals(rats,rabbits),didnotshowanyteratogenic,embryotoxic

effectsoranymaternaltoxicityofmarbofloxacin.

Tobeusedonlyaccordingtotherisk/benefitassessmentbytheveterinarian.

Seealsoparagraph“withdrawalperiod”.

Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Nosignofoverdosagehasbeenobservedwiththemarbofloxacinafteradministration

of3timestherecommendeddose.

Overdosagemaycausesignsintheformofacuteneurologicaldisorderswhichwould

havetobetreatedsymptomatically.

Incompatibilities

Donotmixtheveterinarymedicinalproductwithothermedicinalproducts

13.SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIALS,IFANY

Askyourveterinarysurgeonhowtodisposeofmedicinesnolongerrequired.These

measuresshouldhelptoprotecttheenvironment.

14.DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

15.OTHERINFORMATION

PHARMACOLOGICALPROPERTIES

Pharmacodynamicproperties

Marbofloxacinisasynthetic,bactericidalantimicrobial,belongingtothe

fluoroquinolonegroupwhichactsbyinhibitionofDNAgyrase.Itiseffectiveagainsta

widerangeofGrampositivebacteria(inparticularStaphylococci)andGramnegative

bacteria(Escherichiacoli,Pasteurellamultocida,Pasteurellahaemolyticaand

Actinobacilluspleuropneumoniae)aswellasMycoplasma(Mycoplasmabovis,

Mycoplasmahyopneumoniae).

ResistancetoStreptococcusmayoccur.

Pharmacokineticparticulars

Aftersubcutaneousorintramuscularadministrationincattleandpigsatthe

recommendeddoseof2mg/kg,marbofloxacinisreadilyabsorbedandreaches

maximalplasmaconcentrationsof1,5µg/mlwithinlessthan1hour.

Itsbioavailabilityiscloseto100%.

Marbofloxacinisweaklyboundtoplasmaproteins(lessthan10%inpigsand30%

incattle),extensivelydistributedandinmosttissues(liver,kidney,skin,lung,uterus)

itachieveshigherconcentrationsthaninplasma.

Marbofloxaciniseliminatedslowlyinpre-ruminatingcalves(t

=5-9hours)andpigs

=8-10hours),fasterinruminantcattle(t

=4-7hours)predominantlyinthe

activeforminurineandfaeces.

MARBOCYL2%-EuropeanRenewal–July2007V2

Presentation

Boxofonevialof10ml

Boxofonevialof20ml

Boxofonevialof50ml

Boxofonevialof100ml

Boxofonevialof250ml

Notallpacksizesmaybemarketed.