Marbotab

Main information

  • Trade name:
  • Marbotab 80 mg Tablets for Dogs
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Marbotab 80 mg Tablets for Dogs
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • marbofloxacin
  • Therapeutic area:
  • Dogs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0431/002
  • Authorization date:
  • 21-12-2012
  • EU code:
  • UK/V/0431/002
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Issued:March2013

AN:01689/2011

Page1of6

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

MarbotabP80mgtabletsfordogs

ListofagreednamesintheMemberStateswhereproductisauthorized.

Italy,Germany,France,TheNetherlands,

Belgium,Hungary MarbotabP80mgtabletsfordogs

Denmark MarbotabP,80mgtablets,fordogs

UnitedKingdom,Ireland,Poland,Spain,

Austria Marbotab80mgtabletsfordogs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains:

Activesubstance:

Marbofloxacin 80mg

Excipients:

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Tablet

Beigeoblongtablet,whitespeckled,withbreakingnotchonbothsides.

Thetabletscanbedividedintohalves.

4. CLINICALPARTICULARS

4.1 Targetspecies

Dogs

4.2 Indicationsforuse,specifyingthetargetspecies

Treatmentofinfectionscausedbystrainsofmicroorganismssusceptibleto

marbofloxacin.

Skinandsofttissueinfections(skinfoldpyoderma,impetigo,folliculitis,

furunculosis,cellulitis);

Urinarytractinfections(UTI)associatedornotwithprostatitis;

Respiratorytractinfections.

Seesection5.1,Pharmcodynamicpropertiesforfurtherinformationonspecifictarget

pathogens.

Issued:March2013

AN:01689/2011

Page2of6

4.3 Contraindications

Marbofloxacinshouldnotbeusedindogsagedlessthan12months,orlessthan18

monthsforexceptionallylargebreedsofdogs,suchasGreatDanes,Briard,Bernese

BonvierandMastiffs,withalongergrowthperiod.

Notsuitableforinfectionsresultingfromstrictanaerobes,yeastorfungi.

Donotuseincasesofhypersensitivitytofluoroquinolonesoranyoftheexcipientsof

theproduct.

Donotuseincaseofresistanceagainstquinolones,since(almost)completecross-

resistanceexistsagainstandotherfluoroquinolones.

DonotuseMarbotabP80mgtabletsincats.Forthetreatmentofthisspecies,a

divisible20mgtabletisavailable(MarbotabP20mgtablets).

4.4Specialwarnings

None.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Thefluoroquinoloneshavebeenshowntoinduceerosionofarticularcartilagein

juveniledogsandcareshouldbetakentodoseaccuratelyespeciallyinyoung

animals.

Thefluoroquinolonesarealsoknownfortheirpotentialneurologicalsideeffects.

Cautioususeisrecommendedindogsdiagnosedassufferingfromepilepsy.

AlowurinarypHcouldhaveaninhibitoryeffectontheactivityofmarbofloxacin.

Officialandlocalantimicrobialpoliciesshouldbetakenintoaccountwhentheproduct

isused.

Fluoroquinolonesshouldbereservedforthetreatmentofclinicalconditionswhich

haverespondedpoorly,orareexpectedtorespondpoorly,tootherclassesof

antimicrobials.

Wheneverpossible,fluoroquinolonesshouldonlybeusedbasedonsusceptibility

testing.

UseoftheproductdeviatingfromtheinstructionsgivenintheSmPCmayincrease

theprevalenceofbacteriaresistanttothefluoroquinolonesandmaydecreasethe

effectivenessoftreatmentwithotherquinolonesduetothepotentialforcross

resistance.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Incaseofaccidentalingestionseekmedicaladviceimmediatelyandshowthe

packageleafletorthelabeltothephysician.Weargloveswhenhandlingordividing

tablets.Washhandsafteruse.

Issued:March2013

AN:01689/2011

Page3of6

Peoplewithknownhypersensitivitytofluoroquinolonesshouldavoidusingthis

product.

4.6Adversereactions(frequencyandseriousness)

Atthetherapeuticrecommendeddosage,nosevereside-effectsaretobeexpected.

Mildsideeffectssuchasvomiting,allergicreactions,softeningoffaeces,modification

ofthirstortransientincreaseinactivitymayoccasionallyoccur.Thesesignscease

spontaneouslyaftertreatmentanddonotnecessitatecessationoftreatment.

Nolesionsoftheparticularjointswereencounteredinclinicalstudiesatthe

recommendeddoserate.However,jointpainand/orneurologicalsymptoms(ataxia,

aggressiveness,convulsion,depression)mayoccurinrareoccasions.

Allergicreactionshavebeenobserved(temporaryskinreactions)duetothe

histaminereleasethatmayoccur.

4.7Useduringpregnancy,lactationorlay

Safetyinpregnantandlactatingdogsandcatshavenotbeenestablished.Studiesin

pregnantratsandrabbitsshowednosideeffectsonpregnancy.

Useinpregnantandlactatinganimalsshouldbeinaccordancewiththebenefit/risk

assessmentperformedbytheresponsibleveterinarian.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Fluoroquinolonesareknowntointeractwithorallyadministeredcations(aluminium,

calcium,magnesium,iron).Insuchcases,thebioavailabilitymaybereduced.

Donotuseincombinationwithtetracyclines,macrolidesbecauseofthe

potentialantagonisteffect.

Whenadministeredtogetherwiththeophylline,thehalf-lifeandthustheplasma

concentrationoftheophyllineincrease.Hence,thedoseoftheophyllineshouldbe

reduced.

4.9 Amountstobeadministeredandadministrationroute

Fororaladministration.Therecommendeddoserateis2mg/kg/dinasingledaily

administration.Toensureacorrectdosagebodyweightshouldbedeterminedas

accuratelyaspossibletoavoidunderdosing.

Durationoftreatment:

Inskinandsofttissueinfections,treatmentdurationisatleast5days.Dependingon

thecourseofthedisease,itmaybeextendedupto40days.

Inurinarytractinfectionsnotrelatedtoprostatitisorepididymitis,treatmentduration

isatleast10days.Inothercases,dependingonthecourseofthedisease,itmaybe

extendedupto28days.

Issued:March2013

AN:01689/2011

Page4of6

Inrespiratoryinfections,treatmentdurationisatleast7days.Dependingonthe

courseofthedisease,itmaybeextendedupto21days.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Overdosagemaycausecartilagedamageinthejointsandacutesignsintheformof

neurologicaldisorders,whichshouldbetreatedsymptomatically.

4.11Withdrawalperiod(s)

Notapplicable

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antibacterialsforsystemicuse,Fluoroquinolone

ATCvetcode:QJ01MA93

5.1 Pharmacodynamicproperties

Marbofloxacinisasynthetic,bactericidalantimicrobial,belongingtothe

fluoroquinolonegroup,whichactsbyinhibitionofDNAgyrase.Itiseffectiveagainsta

widerangeofGrampositivebacteria(Staphylococci(S.aureusandS.intermedius)

andStreptococci)andGramnegativebacteria(Escherichiacoli,Citrobacterfreundii,

Enterobactercloacae,Proteusspp,Klebsiellapneuminiae,Pasteurellamulticida,

Pseudomonasaeruginosa,Bordetellabronchiseptica)aswellasMycoplasmaspp.

CasesofresistancehavebeenobservedinStreptococcus.

StrainswithMIC≤1µg/mlaresensitivetomarbofloxacinwhereasstrainswithMIC≥

4µg/mlareresistanttomarbofloxacin.

Resistancetofluoroquinolonesoccursbychromosomalmutationwiththree

mechanisms:decreaseofthebacterialwallpermeability,expressionofeffluxpump

ormutationofenzymesresponsibleformoleculebinding.

Marbofloxacinisnotactiveagainstanaerobes,yeastsorfungi.

5.2Pharmacokineticparticulars

Afteroraladministrationindogsandcatsattherecommendeddoseof2mg/kg,

marbofloxacinisreadilyabsorbedandreachesmaximalplasmaconcentrationsof1.5

µg/mlwithin2hours.

Itsbioavailabilityiscloseto100%.

Itisweaklyboundtoplasmaproteins(lessthan10%),extensivelydistributedandin

mosttissues(liver,kidney,skin,lung,bladder,digestivetract)itachieveshigher

concentrationsthaninplasma.Marbofloxaciniseliminatedslowly(eliminationhalf-life

is14hoursindogsand10hoursincats)predominantlyintheactiveforminurine

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

Issued:March2013

AN:01689/2011

Page5of6

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Lactosemonohydrate

Cellulose,powdered

Crospovidone

Colloidalanhydroussilica

Calciumbehenate

Yeast,deactivated

Artificialbeefflavour(PC-0125)

6.2Incompatibilities

Noneknown

6.3Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:2years.

Shelflifeofhalvedtablets:24hours.

6.4.Specialprecautionsforstorage

Storetheblisterintheoriginalcontainer.

Ifthetabletsaredivided,theremainighalfshouldbekeptintheblisterpack.Any

halvedtabletsremainingafter24hoursshouldbediscarded.

6.5Natureandcompositionofimmediatepackaging

Aluminium-Polyamide/Aluminium/PVCblisterpackscontaining10tablets.

Theblisterpacksareavailableincartonsof20,50,100and200tablets.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

7. MARKETINGAUTHORISATIONHOLDER

CP-PharmaHandelsgesellschaftmbH

Ostlandring13

31303Burgdorf

Germany

Issued:March2013

AN:01689/2011

Page6of6

8. MARKETINGAUTHORISATIONNUMBER

Vm20916/4019

9. DATEOFFIRSTAUTHORISATION

27March2013

10.DATEOFREVISIONOFTHETEXT

March2013

PROHIBITIONORSUPPLYSALEANDORUSE

Tobesuppliedonlyonveterinaryprescription.

Approved:27/03/2013

7-12-2018

Re‐evaluation of propane‐1,2‐diol esters of fatty acids (E 477) as a food additive

Re‐evaluation of propane‐1,2‐diol esters of fatty acids (E 477) as a food additive

Published on: Thu, 06 Dec 2018 The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of propane‐1,2‐diol esters of fatty acids (E 477) when used as a food additive. The Scientific Committee on Food (SCF) in 1978 endorsed the acceptable daily intake (ADI) of 25 mg/kg body weight (bw) per day, expressed as propane‐1,2‐diol, established by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1974. No adverse effects were observed in short‐t...

Europe - EFSA - European Food Safety Authority Publications

4-12-2018

Mylan Expands Its Voluntary Nationwide Recall of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, to all Lots Within Expiry Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylam

Mylan Expands Its Voluntary Nationwide Recall of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, to all Lots Within Expiry Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylam

– Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is expanding its consumer-level voluntary nationwide recall to include all lots of Valsartan-containing products within expiry. The 104 additional lots include 26 lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, 5mg/320mg and 10mg/320mg strengths), 51 lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg and 320 mg strengths), and 27 lots of Valsartan and Hydrochloroth...

FDA - U.S. Food and Drug Administration

28-11-2018

Information Update - Mylan-Valsartan medications voluntarily recalled as a precaution due to an impurity

Information Update - Mylan-Valsartan medications voluntarily recalled as a precaution due to an impurity

Mylan Pharmaceuticals ULC is voluntarily recalling four lots of Mylan-Valsartan tablets (40 mg, 80 mg, 160 mg and 320 mg strength) after testing found low levels of an impurity, N-nitrosodiethylamine (NDEA).

Health Canada

21-11-2018

Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Fou

Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Fou

Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is conducting a voluntary nationwide recall to the consumer level of select lots of Valsartan-containing products, including six lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, and 10mg/320mg strengths), seven lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg, and 320 mg strengths), and two lots of Valsartan and Hydrochlorothiazide Tablets, USP 320mg/25mg strength. ...

FDA - U.S. Food and Drug Administration

17-10-2018

Pest categorisation of Stagonosporopsis andigena

Pest categorisation of Stagonosporopsis andigena

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The Panel on Plant Health performed a pest categorisation of Stagonosporopsis andigena, the causal agent of black blight of potato, for the EU. The pest is a well‐defined fungal species and reliable methods exist for its detection and identification. S. andigena is present in Bolivia and Peru. The pest is not known to occur in the EU and is listed in Annex IAI of Directive 2000/29/EC as Phoma andina, meaning its introduction into the EU is prohibited. The ma...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The duration of the vaccination campaign sufficient to eliminate lumpy skin disease (LSD) mainly depends on the vaccination effectiveness and coverage achieved. By using a spread epidemiological model, assuming a vaccination effectiveness of 65%, with 50% and 90% coverage, 3 and 4 years campaigns, respectively, are needed to eliminate LSD. When vaccination effectiveness is 80% to 95%, 2 years of vaccination at coverage of 90% is sufficient to eliminate LSD vir...

Europe - EFSA - European Food Safety Authority Publications

9-8-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg Due to The Detection of Trace Amounts of N-Nitrosodimethylamine (NDMA) Impurity, Found in an Active Pharmaceutical Ingredient (API)

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg Due to The Detection of Trace Amounts of N-Nitrosodimethylamine (NDMA) Impurity, Found in an Active Pharmaceutical Ingredient (API)

As a precautionary measure, Camber Pharmaceuticals, Inc. is voluntarily recalling all unexpired lots of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg to the hospital, retail and consumer level. This recall of multiple batches of Valsartan Tablets was prompted due to the detection of trace amounts of N-Nitrosodimethylamine (NDMA), a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, Unit – I (API manufacturer).

FDA - U.S. Food and Drug Administration

13-7-2018

Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products

Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products

Prinston Pharmaceutical Inc. dba Solco Healthcare LLC. is recalling all lots of Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-Hydrochlorothiazide Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg to the retail level. This product recall is due to the detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA), made by the manufacturer – Zhejiang Huahai Pharmaceutical Co. Ltd. -- that is used in the manufacture of the subject product ...

FDA - U.S. Food and Drug Administration

12-7-2018

Minister Bruno Bruins bereikt akkoord over vergoeding Spinraza

Minister Bruno Bruins bereikt akkoord over vergoeding Spinraza

Minister Bruno Bruins (Medische Zorg) heeft  een akkoord bereikt met fabrikant Biogen. Hierdoor komt het middel Spinraza voor circa 80 jonge kinderen met de spierziekte Spinale Musculaire Atrofie (SMA) vanaf 1 augustus in het basispakket.  

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

1-8-2018

Nimenrix (Pfizer Europe MA EEIG)

Nimenrix (Pfizer Europe MA EEIG)

Nimenrix (Active substance: Meningococcal group A, C, W-135 and Y conjugate vaccine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5220 of Wed, 01 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2226/T/80

Europe -DG Health and Food Safety