Marbocare Flavour 20 mg Tablet for Dogs

Main information

  • Trade name:
  • Marbocare Flavour 20 mg Tablet for Dogs
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Marbocare Flavour 20 mg Tablet for Dogs
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Fluoroquinolones
  • Therapeutic area:
  • Dogs Non Food

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0470/002
  • Authorization date:
  • 26-06-2013
  • EU code:
  • UK/V/0470/002
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Issued:September2013

AN:00539/2012

Page1of6

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Marbocareflavour20mgtabletsfordogs(UKandIE)

MarbocareF20mgtabletsfordogs(FR)

Odimar20mgtabletsfordogs(BE,LU,NL)

MarbofloxacinWDT20mgflavouredtabletsfordogs(AT,DE)

MarbofloxacinoEmdoka20mgtabletsfordogs(ES)

MarbofloxacinaEmdoka20mgtabletsfordogs(PT)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains:

Activesubstance:

Marbofloxacin20.0mg

Excipients:

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Tablet.

Beigebrownspottedroundtabletswithacross-snaptabononeside.

Thetabletcanbedividedintohalvesorquarters.

4. CLINICALPARTICULARS

4.1Targetspecies

Dogs

4.2Indicationsforuse,specifyingthetargetspecies

Marbofloxacinisindicatedinthetreatmentofthefollowinginfectionscausedby

susceptiblestrainsoforganisms(seesection5.1);

Skinandsofttissueinfections(skinfoldpyoderma,impetigo,folliculitis,

furunculosis,cellulitis).

Urinarytractinfections(UTI)associatedornotwithprostatitisorepididymitis.

Respiratorytractinfections.

Issued:September2013

AN:00539/2012

Page2of6

4.3Contraindications

Donotuseindogsagedlessthan12months,orlessthan18monthsforexceptionally

largebreedsofdogs,suchasGreatDanes,Briard,Bernese,BouvierandMastiffs,with

alongergrowthperiod.

Donotuseincats.Forthetreatmentofthisspecies,a5mgtabletisavailable.

Donotuseinanimalswithknownhypersensitivitytomarbofloxacinorother

(fluoro)quinolonesortoanyoftheexcipients.

Donotuseincaseofconfirmedorsuspectedresistancetofluoroquinolones(cross

resistance).

4.4Specialwarnings

AlowurinarypHcouldhaveaninhibitoryeffectontheactivityofmarbofloxacin.

4.5Specialprecautionsforuse

Specialprecautionsforuseinanimals

Thefluoroquinoloneshavebeenshowntoinduceerosionofarticularcartilageinjuvenile

dogsandcareshouldbetakentodoseaccuratelyespeciallyinyounganimals.However

atthetherapeuticrecommendeddosage,noseveresideeffectsaretobeexpectedin

dogs.

Somefluoroquinolonesathighdosesmayhaveanepileptogenicpotential.Cautious

useisrecommendedindogsdiagnosedassufferingfromepilepsy.

Fluoroquinolonesshouldbereservedforthetreatmentofclinicalconditionswhichhave

respondedpoorly,orareexpectedtorespondpoorlytootherclassesofantimicrobials.

Wheneverpossible,useoffluoroquinolonesshouldbebasedonsusceptibilitytesting.

UseoftheproductdeviatingfromtheinstructionsgivenintheSPCmayincreasethe

prevalenceofbacteriaresistanttothefluoroquinolonesandmaydecrease

effectivenessoftreatmentwithotherquinolonesduetothepotentialforcross-

resistance.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Peoplewithknownhypersensitivityto(fluoro)quinolonesshouldavoidusingthisproduct.

Incaseofaccidentalingestionseekmedicalattentionandshowproductlabeland/or

packageleaflettothedoctor.Washhandsafteruse.

Issued:September2013

AN:00539/2012

Page3of6

4.6Adversereactions(frequencyandseriousness)

Mildsideeffectssuchasvomiting,softeningoffaeces,modificationofthirstortransient

increaseinactivitymayoccasionallyoccur.Thesesignsceasespontaneouslyafter

treatmentanddonotnecessitatecessationoftreatment.

4.7Useduringpregnancy,lactationorlay

Studiesinlaboratoryanimals(rats,rabbits)showednoteratogenicity,embryotoxicity

andmaternotoxicitywithmarbofloxacinattherapeuticdoses.

Thesafetyofmarbofloxacinhasnotbeenassessedinpregnantandlactatingdogs.Use

onlyaccordinglytothebenefit/riskassessmentbytheresponsibleveterinarianin

pregnantandlactatinganimals.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Fluoroquinolonesareknowntointeractwithorallyadministeredcations(Aluminium,

Calcium,Magnesium,Iron).Insuchcases,thebioavailabilitymaybereduced.

Whenadministeredtogetherwiththeophylline,thehalf-lifeandthustheplasma

concentrationoftheophyllineincrease.Hence,incaseofconcurrentadministrationthe

doseoftheophyllineshouldbereduced.

4.9Amountstobeadministeredandadministrationroute

Fororaladministration.

Therecommendeddoserateis2mg/kg/dayinasingledailyadministration(seetable

below).Thetabletcanbedividedintohalvesorquartersasfollows;

Placethetabletonaflatsurfacewiththescoredsidefacingup

Breakthetabletintofourequalpartsbypressingdownwithyourthumbor

fingerontothescoredside

.

BodyWeight Tablets

1.3 –2.5 ¼

2.6 –5kg

½

5.1 –7.5kg ¾

7.6 –10kg 1

10.1 –12.5kg 1¼

12.6 –15kg 1½

15.1 –20kg 2

Issued:September2013

AN:00539/2012

Page4of6

Toensureacorrectdosagebodyweightshouldbedeterminedasaccuratelyas

possibletoavoidunderdosing.

 Inskinandsofttissueinfections,treatmentdurationisatleast5days.Depending

onthecourseofthedisease,itmaybeextendedupto40days.

 Inurinarytractinfections,treatmentdurationisatleast10days.Dependingonthe

courseofthedisease,itmaybeextendedupto28days.

 Inrespiratoryinfections,treatmentdurationisatleast7daysanddependingonthe

courseofthedisease,itmaybeextendedupto21days.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Overdosagemaycauseacutesignsintheformofneurologicaldisorders,whichshould

betreatedsymptomatically.

4.11Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antibacterialsforsystemicuse;

Fluoroquinolones;Marbofloxacin.

ATCvetcode:QJ01MA93

5.1Pharmacodynamicproperties

Marbofloxacinisasynthetic,bactericidalantimicrobial,belongingtothefluoroquinolone

groupwhichactsbyinhibitionofDNAgyrase.Itiseffectiveagainstawiderangeof

Grampositivebacteria(inparticularStaphylococci,Streptococci)andGramnegative

bacteria(Escherichiacoli,Salmonellatyphimurium,Citrobacterfreundii,Enterobacter

cloacae,Serratiamarcescens,Morganellamorganii,Proteusspp,Klebsiellaspp,

Shigellaspp,Pasteurellaspp,Haemophilusspp,Moraxellaspp,Pseudomonasspp,

Brucellacanis)aswellasMycoplasmaspp.

Bacterialst rainswithaMIC≤1µg/mlaresusceptible,strainswithaMICof2µg/mlare

intermediatelysusceptibleandstrainswithaMIC≥4µg/mlareresistantto

marbofloxacin(CLSI,2004).MIC

90 valuesofmarbofloxacinforstrainsof

Staphylococcus(pseudo)intermedius,EscherichiacoliandPasteurellamultocida

isolatedfromdiseasedcatsanddogsinGermanywere0.5µg/ml,0.5µg/mland0.06

µg/ml,respectively.

Resistancetofluoroquinolonesoccursmostlybychromosomalmutationwiththree

mechanisms:decreaseofthebacterialwallpermeability,expressionofeffluxpumpor

mutationofenzymesresponsibleformoleculebinding.

Marbofloxacinisnotactiveagainstanaerobes,yeastsorfungi.

Issued:September2013

AN:00539/2012

Page5of6

5.2Pharmacokineticparticulars

Afteroraladministrationindogsattherecommendeddoseof2mg/kg,marbofloxacinis

readilyabsorbedandreachesmaximalplasmaconcentrationsof1.5µg/mlwithin2

hours.

Itsbioavailabilityiscloseto100%.

Itisweaklyboundtoplasmaproteins(lessthan10%),extensivelydistributedandin

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

concentrationsthaninplasma.Marbofloxaciniseliminatedslowly(t½ß=14hindogs)

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

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Lactosemonohydrate

Povidone(K90)

Silica,colloidalhydrated

Crospovidone(TypeA)

CastorOil,Hydrogenated

Dessicatedporkliverpowder

Driedyeast

Magnesiumstearate

6.2Incompatibilities

Notapplicable.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:3years

Shelflifeoftabletportions:96hours

6.4.Specialprecautionsforstorage

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

Unuseddividedtabletsshouldbereturnedtotheblisterpackandanydividedtablet

portionsremainingafter96hours(4days)shouldbediscarded.

6.5Natureandcompositionofimmediatepackaging

TheproductispackagedinAluminium-PVC/aluminium/polyamideblister

Boxcontaining1blisterof10tablets(10tablets)

Boxcontaining2blistersof10tablets(20tablets)

Issued:September2013

AN:00539/2012

Page6of6

Boxcontaining10blistersof10tablets(100tablets)

.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

EmdokaBvba

JohnLijsenstraat16

B-2321Hoogstraten

Belgium

8. MARKETINGAUTHORISATIONNUMBER

Vm34534/4004

9. DATEOFFIRSTAUTHORISATION

04September2013

10.DATEOFREVISIONOFTHETEXT

September2013

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable.

Approved: 04/09/2013

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

FDA Approves Pexion for Treating Noise Aversion in Dogs

FDA Approves Pexion for Treating Noise Aversion in Dogs

The U.S. Food and Drug Administration announced today that its Center for Veterinary Medicine has approved Pexion (imepitoin tablets) to treat noise aversion in dogs. Dogs with noise aversion are sensitive to loud noises such as fireworks, street/traffic noises, and gun shots.

FDA - U.S. Food and Drug Administration

21-11-2018

Fresenius Kabi Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9% Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex

Fresenius Kabi Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9% Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex

Fresenius Kabi USA is voluntarily recalling 163 lots of Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial and Sodium Chloride Injection, USP, 0.9%, 20 mL fill in a 20 mL vial to the user level. The product insert states that stoppers for both the 10mL and the 20mL vials do not contain natural rubber latex; the tray label for the two vial sizes and the vial label for the 20mL vial also state that the stoppers do not contain latex. The product is being recalled because the stoppers contain n...

FDA - U.S. Food and Drug Administration

20-11-2018

November 20, 2018: Rochester Man Pleads Guilty to Smuggling Counterfeit Cialis and Viagra into the United States

November 20, 2018: Rochester Man Pleads Guilty to Smuggling Counterfeit Cialis and Viagra into the United States

November 20, 2018: Rochester Man Pleads Guilty to Smuggling Counterfeit Cialis and Viagra into the United States

FDA - U.S. Food and Drug Administration

24-10-2018

G & C Raw, LLC is Expanding Recall to Include All Product Lots Manufactured from February 27, 2018 Through July 20, 2018, Because of Possible Listeria Monocytogenes Health Risk

G & C Raw, LLC is Expanding Recall to Include All Product Lots Manufactured from February 27, 2018 Through July 20, 2018, Because of Possible Listeria Monocytogenes Health Risk

G & C Raw, of Versailles, OH is recalling all products lots manufactured from February 27, 2018 through July 20, 2018, as a precaution because they have the potential to be contaminated with Listeria monocytogenes

FDA - U.S. Food and Drug Administration

18-7-2018

FDA Approves NexGard for prevention of infections that cause Lyme disease in dogs

FDA Approves NexGard for prevention of infections that cause Lyme disease in dogs

FDA has approved NexGard (afoxolaner), a chewable tablet administered once monthly to dogs, for the prevention of Borrelia burgdorferi (B. burgdorferi) infections by killing Black-legged ticks (Ixodes scapularis), which carry the bacterium.

FDA - U.S. Food and Drug Administration

22-6-2018

June 20, 2018: Fitchburg Woman and Saugus Man Sentenced for Roles in Counterfeit Steroid Conspiracy

June 20, 2018: Fitchburg Woman and Saugus Man Sentenced for Roles in Counterfeit Steroid Conspiracy

June 20, 2018: Fitchburg Woman and Saugus Man Sentenced for Roles in Counterfeit Steroid Conspiracy

FDA - U.S. Food and Drug Administration

2-5-2018

April 17, 2018: Tampa Resident Sentenced to More Than 20 Years in Federal Prison for Tricare Health Care Fraud Scheme

April 17, 2018: Tampa Resident Sentenced to More Than 20 Years in Federal Prison for Tricare Health Care Fraud Scheme

April 17, 2018: Tampa Resident Sentenced to More Than 20 Years in Federal Prison for Tricare Health Care Fraud Scheme

FDA - U.S. Food and Drug Administration

26-11-2018

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health technologies.

FDA - U.S. Food and Drug Administration

4-9-2018

Agenda:  Agenda - CHMP agenda of the 20-23 August 2018 written procedure

Agenda: Agenda - CHMP agenda of the 20-23 August 2018 written procedure

Agenda of CHMP written procedure*20-23 August 2018

Europe - EMA - European Medicines Agency

22-8-2018

After over 20 years of wearing contact lenses, this freelance blogger had an unexpected diagnosis in her left eye:  http://bit.ly/2h2NcHz .pic.twitter.com/ecJErFeiSH

After over 20 years of wearing contact lenses, this freelance blogger had an unexpected diagnosis in her left eye: http://bit.ly/2h2NcHz .pic.twitter.com/ecJErFeiSH

After over 20 years of wearing contact lenses, this freelance blogger had an unexpected diagnosis in her left eye: http://bit.ly/2h2NcHz . pic.twitter.com/ecJErFeiSH

FDA - U.S. Food and Drug Administration

20-7-2018

Agenda:  Agenda - CAT agenda of the 18-20 July 2018 meeting

Agenda: Agenda - CAT agenda of the 18-20 July 2018 meeting

Committee for Advanced Therapies (CAT) agenda for the meeting on 18-20 July 2018

Europe - EMA - European Medicines Agency

29-6-2018

A past diagnosis of asthma is also associated with #COPD in 20% of the cases. Visit  https://bit.ly/1xErH2t  to learn more. #FactFridaypic.twitter.com/JWK672XtdI

A past diagnosis of asthma is also associated with #COPD in 20% of the cases. Visit https://bit.ly/1xErH2t  to learn more. #FactFridaypic.twitter.com/JWK672XtdI

A past diagnosis of asthma is also associated with #COPD in 20% of the cases. Visit https://bit.ly/1xErH2t  to learn more. #FactFriday pic.twitter.com/JWK672XtdI

FDA - U.S. Food and Drug Administration