MARBOSYVA 100 mg/ml solution for injection for cattle and pigs.

Main information

  • Trade name:
  • MARBOSYVA 100 mg/ml solution for injection for cattle and pigs.
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • MARBOSYVA 100 mg/ml solution for injection for cattle and pigs.
    Netherlands
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • ES/V/0188/001
  • Authorization date:
  • 24-10-2012
  • EU code:
  • ES/V/0188/001
  • Last update:
  • 09-08-2016

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

[Version7.3.2,10/2011]

ANNEXI

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Marboquinol100mg/mlsolutionforinjectionforcattleandpigs(sows)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

1mlcontains:

Activesubstance:

Marbofloxacin 100mg

Excipients:

Metacresol 2mg

Monothioglycerol 1mg

Disodiumedetate 0.1mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Solutionforinjection

Clear,yellowishsolution

4. CLINICALPARTICULARS

4.1 Targetspecies

Cattleandpigs(sows).

4.2 Indicationsforuse,specifyingthetargetspecies

Incattle:

-TreatmentofrespiratoryinfectionscausedbysusceptiblestrainsofHistophilussomni,Mannheimia

haemolytica,PasteurellamultocidaandMycoplasmabovis.

-Treatmentofacuteformsofmastitisinducedbymarbofloxacin-susceptibleEscherichiacolistrains,

duringlactation.

Inpigs(sows):

-TreatmentofPostpartumDysgalactiaeSyndrome,PDS(MetritisMastitisAgalactiaSyndrome)

causedbymarbofloxacin-susceptiblebacterialstrains.

4.3 Contraindications

Donotuseincaseswherethepathogeninvolvedisresistanttootherfluoroquinolones(crossresistance

Donotuseinanimalswithknownhypersensitivitytotheactivesubstanceortoanyotherquinoloneor

toanyoftheexcipients.

4.4 Specialwarningsforeachtargetspecies

None.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Officialandlocalantimicrobialpoliciesshouldbetakenintoaccountwhentheproductisused.

Fluoroquinolonesshouldbereservedforthetreatmentofclinicalconditionswhichhaveresponded

poorly,orareexpectedtorespondpoorly,tootherclassesofantimicrobials.

Wheneverpossible,fluoroquinolonesshouldonlybeusedbasedonsusceptibilitytesting.

UseoftheproductdeviatingfromtheinstructionsgivenintheSPCmayincreasetheprevalenceof

bacteriaresistanttothefluoroquinolonesandmaydecreasetheeffectivenessoftreatmentwithother

quinolonesduetothepotentialforcrossresistance.

Theefficacydatashowedthattheproducthasinsufficientefficacyforthetreatmentofacuteformsof

mastitisinducedbygram-positivebacteria.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Peoplewithknownhypersensitivityto(fluoro)quinolonesshouldavoidcontactwiththeproduct.

Careshouldbetakentoavoidaccidentalselfinjection,itcaninduceaslightirritation.

Incaseofaccidentalselfinjection,seekmedicaladviceandshowthepackageleafletorthelabeltothe

physician.

Incaseofcontactwithskinoreyes,rinsewithplentyofwater.

Washhandsafteruse.

4.6 Adversereactions(frequencyandseriousness)

Transitoryinflammatorylesionscanoccurattheinjectionsite,withoutclinicalimpact,when

administeredviatheintramuscularorsubcutaneousroute.

Administrationbytheintramuscularroutemaycausetransientlocalreactionssuchaspainandswelling

attheinjectionsite,andinflammatorylesions,whichmaypersist,foratleast12daysafterinjection.

However,incattle,subcutaneousroutewasshowntobebettertoleratedlocallythanintramuscular

route.Therefore,thesubcutaneousrouteisrecommendedinheavycattle.

4.7 Useduringpregnancy,lactationorlay

Laboratorystudiesinratsandrabbitshavenotproducedanyevidenceofteratogenic,foetotoxicor

maternotoxiceffects.

Doseof2mg/kgbodyweight:

Canbeusedduringpregnancyandlactation.

Thesafetyoftheveterinarymedicinalproducthasbeenestablishedincowduringgestationand

sucklingpigsandcalveswhenusedincowandsow.

Doseof8mg/kgbodyweight:

Thesafetyoftheveterinarymedicinalproducthasnotbeenestablishedinpregnantcoworinsuckling

calveswhenusedincow.Therefore,thisdoseregimenshouldbeuseonlyaccordinglytothe

benefit/riskassessmentbytheresponsibleveterinarian.

Incaseofuseinlactatingcow,seesection4.11

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9 Amountstobeadministeredandadministrationroute

Cattle:

Respiratoryinfections:

Therecommendeddosageis8mg/kgbodyweight(2ml/25kgBW)inasingleinjectionby

intramuscularroute.Ifthevolumetobeinjectedismorethan20ml,itshouldbedividedbetweentwo

ormoreinjectionsites.

IncasesofrespiratoryinfectionscausedbyMycoplasmabovis,therecommendeddoseis2mg/kg

bodyweight(1ml/50kg bodyweightBW ),inasingledailyinjectionfor3to5consecutivedays,by

intramuscularorsubcutaneousroute.Thefirstinjectionmaybegivenbytheintravenousroute.

Acutemastitis:

Therecommendeddosageis2mg/kgbodyweight(1ml/50kgBW)inasingledailyinjection,by

subcutaneousorintramuscularroute,for3consecutivedays.Thefirstinjectionmaybegivenbythe

intravenousroute.

Pigs(sows):

Therecommendeddosageis2mg/kgbodyweight(1ml/50kgBW)inasingledailyinjectionbythe

intramuscularroute,for3consecutivedays.

Incattleandpigs,thepreferredinjectionsiteistheneckarea.

Toensureacorrectdosagebodyweightshouldbedeterminedasaccuratelyaspossibletoavoid

underdosing.

Inordertoreducetheriskofparticulatecontaminationoftheproduct,itisrecommendedthatadraw-

offneedlebeusedtoreducethenumberoftimestheseptumispunctured.

Asthevialcannotbebroachedmorethan50times,theusershouldchoosethemostappropriatevial

sizeaccordingtothetargetspeciestotreat.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Nosignofoverdosagehasbeenobservedwiththeproductafteradministrationof3timesthe

recommendeddose.

Signsasneurologicaldisordersmayoccurwhenthedoseisexceed.Donotexceedtherecommended

dose.Thesesignswouldhavetobetreatedsymptomatically.

4.11Withdrawalperiods

Cattle:

Intramuscularuse(8mg/kgsingledose):

Meatandoffal:3days

Milk:72hours

Intramuscularorsubcutaneoususe(2mg/kgsingledailyinjection,for3days):

Meatandoffal:6days

Milk:36hours

Pigs(sows):

Intramuscularuse:

Meatandoffal:4days

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antibacterialsforsystemicuse,Fluoroquinolones,ATCvetcode:

QJ01MA93

5.1 Pharmacodynamicproperties

Marbofloxacinisasynthetic,bactericidalantimicrobial,belongingtothefluoroquinolonegroupwhich

actsbyinhibitionofDNAgyrase.Ithasabroad-spectrumactivityinvitroagainstGram-positive

bacteria(inparticularStaphylococcus),againstGram-negative(E.coli,Histophilussomni,

MannheimiahaemolyticaandPasteurellamultocida)andagainstMycoplasma(Mycoplasma

bovis).ResistancetoStreptococcusmayoccur.

StrainswithMIC≤1µg/mlaresusceptibletomarbofloxacinwhereasstrainswithMIC≥4µg/mlare

resistanttomarbofloxacin.

Resistancetofluoroquinolonesoccursbychromosomalmutationwiththreemechanisms:decreaseof

thebacterialwallpermeability,expressionofeffluxpumpormutationofenzymesresponsiblefor

moleculebinding.

5.2 Pharmacokineticparticulars

Aftersubcutaneousorintramuscularadministrationincattleandintramuscularadministrationinpigsat

therecommendeddoseof2mg/kgbodyweight,marbofloxacinisreadilyabsorbedandreachesmaximal

plasmaconcentrationsof1.5µg/mlwithinlessthan1hour.Itsbioavailabilityiscloseto100%.

Itisweaklyboundtoplasmaproteins(lessthan10%inpigs,and30%incattle),extensivelydistributed

andinmosttissues(liver,kidney,skin,lung,bladder,uterus,digestivetract)itachievesahigher

concentrationthaninplasma.

Incattle,marbofloxaciniseliminatedslowlyinpre-ruminatingcalves(t

β=5-9h)butfasterin

ruminantcattle(t

β=4-7h)predominantlyintheactiveforminurine(3/4inpre-ruminatingcalves,½

inruminants)andfaeces(1/4inpre-ruminatingcalves,½inruminants).

Afterasingleintramuscularadministrationincattleattherecommendeddoseof8mg/kgbodyweight,

themaximumplasmaconcentrationofmarbofloxacin(C

)is7.3µg/mlreachedin0.78hours(t

).

Marbofloxaciniseliminatedslowly(t

1/2 terminal=15.60hours).

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

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

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Metacresol

Monothioglycerol

Glucono-Delta-Lactone

Disodiumedetate

Waterforinjections

6.2 Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixedwithother

veterinaryproducts.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years

Shelf-lifeafterfirstopeningtheimmediatepackaging:28days

6.4.Specialprecautionsforstorage

Keepthevialintheoutercartoninordertoprotectfromlight.

Donotfreeze.

6.5 Natureandcompositionofimmediatepackaging

CardboardboxcontainingoneTypeIIamberglassvialof50ml,100mlor250ml,withaTypeI

bromobutylrubberstopperandanaluminiumcap.

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

LaboratoriosSYVA,S.A.U.

Avda.PárrocoPabloDíez,49-57

24010–León

SPAIN

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10 DATEOFREVISIONOFTHETEXT

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable.

ANNEXII

LABELLINGANDPACKAGELEAFLET

A.LABELLING

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

{Cardboardbox}

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Marboquinol100mg/mlsolutionforinjectionforcattleandpigs(sows)

Marbofloxacin

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Marbofloxacin100mg/ml

Metacresol2mg/ml

Monothioglycerol1mg/ml

Disodiumedetate0.1mg/ml

3. PHARMACEUTICALFORM

4. PACKAGESIZE

50ml/

100ml/250ml

5. TARGETSPECIES

6. INDICATION(S)

7. METHODANDROUTESOFADMINISTRATION

Cattle:Intramuscular,subcutaneousorintravenoususe

Pigs(sows):Intramuscularuse

Readthepackageleafletbeforeuse

8. WITHDRAWALPERIODS

Cattle:

Intramuscularuse(8mg/kgsingledose):

Meatandoffal:3days

Milk:72hours

Intramuscularorsubcutaneoususe(2mg/kgsingledailyinjection,for3days):

Meatandoffal:6days

Milk:36hours

Pigs(sows):

Intramuscularuse:

Meatandoffal:4days

9. SPECIALWARNING(S),IFNECESSARY

Readthepackageleafletbeforeuse.

10. EXPIRYDATE

EXP{month/year}

Oncebroached,useby…

Shelf-lifeafterfirstopeningthecontainer:28days.

11. SPECIALSTORAGECONDITIONS

Keepthevialintheoutercartoninordertoprotectfromlight.

Donotfreeze.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Disposal:Readpackageleaflet

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly-tobesuppliedonlyonveterinaryprescription.

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

LaboratoriosSYVA,S.A.U.

Avda.PárrocoPabloDíez,49-57

24010–León

SPAIN

16. MARKETINGAUTHORISATIONNUMBER(S)

17. MANUFACTURER’SBATCHNUMBER

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Marboquinol100mg/mlsolutionforinjectionforcattleandpigs(sows)

Marbofloxacin

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Marbofloxacin100mg/ml

Metacresol2mg/ml

Monothioglycerol1mg/ml

Disodiumedetate0.1mg/ml

3. PHARMACEUTICALFORM

4. PACKAGESIZE

50ml/

100ml/250ml

5. TARGETSPECIES

6. INDICATION(S)

7. METHODANDROUTESOFADMINISTRATION

Cattle:Intramuscular,subcutaneousorintravenoususe

Pigs(sows):Intramuscularuse

Readthepackageleafletbeforeuse

8. WITHDRAWALPERIODS

Cattle:

Intramuscularuse(8mg/kgsingledose):

Meatandoffal:3days

Milk:72hours

Intramuscularorsubcutaneoususe(2mg/kgsingledailyinjection,for3days):

Meatandoffal:6days

Milk:36hours

Pigs(sows):

Intramuscularuse:

Meatandoffal:4days

9. SPECIALWARNING(S),IFNECESSARY

Readthepackageleafletbeforeuse.

10. EXPIRYDATE

EXP{month/year}

Oncebroached,useby…

Shelf-lifeafterfirstopeningthecontainer:28days.

11. SPECIALSTORAGECONDITIONS

Keepthevialintheoutercartoninordertoprotectfromlight.

Donotfreeze.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Disposal:Readpackageleaflet

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly-tobesuppliedonlyonveterinaryprescription.

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

LaboratoriosSYVA,S.A.U.

Avda.PárrocoPabloDíez,49-57

24010–León

SPAIN

16. MARKETINGAUTHORISATIONNUMBER(S)

17. MANUFACTURER’SBATCHNUMBER

Batch{number

B.PACKAGELEAFLET

PACKAGELEAFLET

Marboquinol100mg/mlsolutionforinjectionforcattleandpigs(sows)

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERAND

OFTHEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFOR

BATCHRELEASE,IFDIFFERENT

LaboratoriosSYVA,S.A.U.

Avda.PárrocoPabloDíez,49-57

24010–León

SPAIN

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Marboquinol100mg/mlsolutionforinjectionforcattleandpigs(sows)

Marbofloxacin

3. STATEMENTOFTHEACTIVESUBSTANCEANDOTHERINGREDIENTS

Marbofloxacin100mg/ml

Metacresol2mg/ml

Monothioglycerol1mg/ml

Disodiumedetate0.1mg/ml

Clear,yellowishsolution

4. INDICATIONS

Incattle:

-TreatmentofrespiratoryinfectionscausedbysusceptiblestrainsofHistophilussomni,

Mannheimiahaemolytica,PasteurellamultocidaandMycoplasmabovis.

-Treatmentofacuteformsofmastitisinducedbymarbofloxacin-susceptibleEscherichiacolistrains,

duringlactation.

Inpigs(sows)

-TreatmentofPostpartumDysgalactiaeSyndrome,PDS(MetritisMastitisAgalactiaSyndrome)

causedbymarbofloxacin-susceptiblebacterialstrains.

5. CONTRAINDICATIONS

Donotuseincaseswherethepathogeninvolvedisresistanttootherfluoroquinolones(cross

resistance).

Donotuseinanimalswithknownhypersensitivitytotheactivesubstanceortoanyotherquinoloneor

toanyoftheexcipients.

6. ADVERSEREACTIONS

Transitoryinflammatorylesionscanoccurattheinjectionsite,withoutclinicalimpact,when

administeredviatheintramuscularorsubcutaneousroute.

Administrationbytheintramuscularroutemaycausetransientlocalreactionssuchaspainandswelling

attheinjectionsiteandinflammatorylesions,whichmaypersist,foratleast12daysafterinjection.

However,incattle,subcutaneousroutewasshowntobebettertoleratedlocallythanintramuscular

route.Therefore,thesubcutaneousrouteisrecommendedinheavycattle.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinformyour

veterinarysurgeon.

7. TARGETSPECIES

Cattleandpigs(sows).

8. DOSAGEFOREACHSPECIES,ROUTESANDMETHODOFADMINISTRATION

Cattle:

Respiratoryinfections:

Therecommendeddosageis8mg/kgbodyweight(2ml/25kgBW)inasingleinjectionby

intramuscularroute.Ifthevolumetobeinjectedismorethan20ml,itshouldbedividedbetweentwo

ormoreinjectionsites.

IncasesofrespiratoryinfectionscausedbyMycoplasmabovis,therecommendeddoseis2mg/kg

bodyweight(1ml/50kg bodyweightBW )inasingledailyinjection,for3to5consecutivedays,by

intramuscularorsubcutaneousroute.Thefirstinjectionmaybegivenbytheintravenousroute.

Acutemastitis:

Therecommendeddosageis2mg/kgbodyweight(1ml/50kgBW)inasingledailyinjectionby

subcutaneousorintramuscularroute,for3consecutivedays.Thefirstinjectionmaybegivenbythe

intravenousroute.

Pigs(sows):

Therecommendeddosageis2mg/kgbodyweight(1ml/50kgBW)inasingledailyinjection,bythe

intramuscularroute,for3consecutivedays.

Incattleandpigs,thepreferredinjectionsiteistheneckarea.

Toensureadministrationofacorrectdose,bodyweightshouldbedeterminedasaccuratelyaspossible,

toavoidunderdosing.

Inordertoreducetheriskofparticulatecontaminationoftheproduct,itisrecommendedthatadraw-

offneedlebeusedtoreducethenumberoftimestheseptumispunctured.

Asthevialcannotbebroachedmorethan50times,theusershouldchoosethemostappropriatevial

sizeaccordingtothetargetspeciestotreat.

9. ADVICEONCORRECTADMINISTRATION

Notapplicable

10. WITHDRAWALPERIODS

Cattle:

Intramuscularuse(8mg/kgsingledose):

Meatandoffal:3days

Milk:72hours

Intramuscularorsubcutaneoususe(2mg/kgsingledailyinjection,for3days):

Meatandoffal:6days

Milk:36hours

Pigs(sows):

Intramuscularuse:

Meatandoffal:4days

11. SPECIALSTORAGEPRECAUTIONS

Keepoutofthereachandsightofchildren.

Keepthevialintheoutercartoninordertoprotectfromlight.

Donotfreeze.

Donotuseaftertheexpirydatestatedonthelabelandcarton.

Shelf-lifeafterfirstopeningthecontainer:28days.

12. SPECIALWARNINGS

Specialprecautionsforuseinanimals

Officialandlocalantimicrobialpoliciesshouldbetakenintoaccountwhentheproductisused.

Fluoroquinolonesshouldbereservedforthetreatmentofclinicalconditionswhichhaveresponded

poorly,orareexpectedtorespondpoorly,tootherclassesofantimicrobials.

Wheneverpossible,fluoroquinolonesshouldonlybeusedbasedonsusceptibilitytesting.

Useoftheproductdeviatingfromtheinstructionsgiveninthepackageleafletmayincreasethe

prevalenceofbacteriaresistanttothefluoroquinolonesandmaydecreasetheeffectivenessof

treatmentwithotherquinolonesduetothepotentialforcrossresistance.

Theefficacydatashowedthattheproducthasinsufficientefficacyforthetreatmentofacuteformsof

mastitisinducedbygram-positivebacteria.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Peoplewithknownhypersensitivityto(fluoro)quinolonesshouldavoidcontactwiththeproduct.

Careshouldbetakentoavoidaccidentalselfinjection,itcaninduceaslightirritation.

Incaseofaccidentalselfinjection,seekmedicaladviceandshowthepackageleafletorthelabelto

thephysician.

Incaseofcontactwithskinoreyes,rinsewithplentyofwater.

Washhandsafteruse.

Useduringpregnancy,lactationorlay

Laboratorystudiesinratsandrabbitshavenotproducedanyevidenceofteratogenic,foetotoxicor

maternotoxiceffects.

Doseof2mg/kgbodyweight:

Canbeusedduringpregnancyandlactation.

Thesafetyoftheveterinarymedicinalproducthasbeenestablishedincowduringgestationand

sucklingpigsandcalveswhenusedincowandsow.

Doseof8mg/kgbodyweight:

Thesafetyoftheveterinarymedicinalproducthasnotbeenestablishedinpregnantcoworinsuckling

calveswhenusedincow.Therefore,thisdoseregimenshouldbeuseonlyaccordinglytothe

benefit/riskassessmentbytheresponsibleveterinarian.

Incaseofuseinlactatingcow,seesection10

Overdose

Nosignofoverdosagehasbeenobservedwiththeproductafteradministrationof3timesthe

recommendeddose.

Signsasneurologicaldisordersmayoccurwhenthedoseisexceed.Donotexceedtherecommended

dose.Thesesignswouldhavetobetreatedsymptomatically.

Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixedwithother

veterinaryproducts.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

15. OTHERINFORMATION

CardboardboxcontainingoneTypeIIamberglassvialof50ml,100mlor250ml,withaTypeI

bromobutylrubberstopperandanaluminiumcap.

Notallpacksizesmaybemarketed.

Foranyinformationaboutthisveterinarymedicinalproduct,pleasecontactthelocalrepresentativeof

themarketingauthorisationholder.

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.