Marfloquin 80 mg Tablets for Dogs

Main information

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

Documents

Localization

  • Available in:
  • Marfloquin 80 mg Tablets for Dogs
    Austria
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0433/003
  • Authorization date:
  • 21-11-2012
  • EU code:
  • UK/V/0433/003
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Issued:March2013

AN:01884/2011

Page1of6

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Marfloquin80mgtabletsfordogs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains:

Activesubstance:

Marbofloxacin …….80mg

Excipients:

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Tablets.

Lightbrownishyellow,capsuleshaped,biconvex,marbletabletswithpossibledark

andwhitespotsandscoredonthebothsides.

Thetabletscanbedividedintohalves.

4. CLINICALPARTICULARS

4.1 Targetspecies

Dogs.

4.2 Indicationsforuse,specifyingthetargetspecies

Treatmentofinfectionscausedbystrainsofmicroorganismssusceptibleto

marbofloxacinindogs:

skinandsofttissueinfections(skinfoldpyoderma,impetigo,folliculitis,

furunculosis,cellulitis);

urinarytractinfections(UTI)associatedornotwithprostatitisorepididymitis;

respiratorytractinfections.

4.3 Contraindications

Donotuseindogsagedlessthan12months,orlessthan18monthsfor

exceptionallylargebreedsofdogs,suchasGreatDanes,Briard,Bernese,Bouvier

andMastiffs,withalongergrowthperiod.

Donotuseincats.Forthetreatmentofthisspecies,a5mgtabletisavailable.

Donotuseinanimalswithknownhypersensitivitytomarbofloxacinorother

(fluoro)quinolonesortoanyoftheexcipientsoftheproduct.

Issued:March2013

AN:01884/2011

Page2of6

4.4 Specialwarningsforeachtargetspecies

AlowurinarypHcouldhaveaninhibitoryeffectontheactivityofmarbofloxacin.

Pyodermaoccursmostlysecondarytoanunderlyingdisease,thus,itisadvisableto

determinetheunderlyingcauseandtotreattheanimalaccordingly.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Highdosesofsomefluoroquinolonesmayhaveepileptogenicpotential.Cautioususe

isrecommendedindogsdiagnosedassufferingfromepilepsy.However,atthe

therapeuticrecommendeddosage,nosevereside-effectsaretobeexpectedin

dogs.Inparticular,nolesionsofthearticularjointswereencounteredinclinical

studiesattherecommendeddoserate.

Officialandlocalantimicrobialpoliciesshouldbetakenintoaccountwhenthe

veterinarymedicinalproductisused.Fluoroquinolonesshouldbereservedforthe

treatmentofclinicalconditionswhichhaverespondedpoorly,orareexpectedto

respondpoorlytootherclassesofantimicrobials.Wheneverpossible,useof

fluoroquinolonesshouldbebasedonsusceptibilitytesting.Useoftheproduct

deviatingfromtheinstructionsgivenintheSPCmayincreasetheprevalenceof

bacteriaresistanttothe(fluoro)quinolonesandmaydecreaseeffectivenessof

treatmentwithotherquinolonesduetothepotentialforcross-resistance.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Peoplewithknownhypersensitivityto(fluoro)quinolonesshouldavoidusingthis

product.

Incaseofaccidentalingestionseekmedicalattentionandshowproductlabeland/or

packageleaflettothedoctor.

Washhandsafteruse.

4.6Adversereactions(frequencyandseriousness)

Mildsideeffectssuchasvomiting,softeningoffaeces,modificationofthirstor

transientincreaseinactivitymayoccasionallyoccur.Thesesignscease

spontaneouslyaftertreatmentanddonotnecessitatecessationoftreatment.

4.7Useduringpregnancy,lactationorlay

Studiesinlaboratoryanimals(rat,rabbit)showednoembryotoxicity,teratogenicity

andmaternotoxicitywithmarbofloxacinattherapeuticdoses.Howevernospecific

studieshavebeencarriedoutinpregnantorlactatingcatsanddogs.Therefore,in

theseclassesofanimals,useonlyaccordingtothebenefit/riskassessmentbythe

responsibleveterinarian.

Issued:March2013

AN:01884/2011

Page3of6

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Fluoroquinolonesareknowntointeractwithorallyadministeredcations(Aluminium,

Calcium,Magnesium,Iron).Insuchcases,thebioavailabilityofmarbofloxacinmay

bereduced.Concurrentadministrationoftheophyllineproductsmaybefollowedby

inhibitedtheophyllineclearance.

4.9 Amountstobeadministeredandadministrationroute

Fororaladministration.

Therecommendeddoserateis2mg/kg/day(1tabletfor40kgperday)insingle

dailyadministration.

Whereappropriate,theuseofcombinationsofwholeorhalftabletsofdifferent

strengths(80mg,20mgor5mg)willallowaccuratedosing.

Animalbodyweight

(kg) Numberoftablets

(80mg+20mg

strengths) Approx.dosagerange

(mg/kg)

17 –20 0.5 2.0 –2.4

>20 –25 0.5+0.5 2.0 –2.5

>25 –30 0.5+1 2.0 –2.4

>30 –40

1 2.0 –2.7

>40 –50 1+1 2.0 –2.5

>50 1.5 ≤2.4

Toensureacorrectdosagebodyweightshouldbedeterminedasaccuratelyas

possibletoavoidunderdosing.

Durationoftreatment:

inskinandsofttissueinfections,treatmentdurationisatleast5daysand

dependingonthecourseofthedisease,itmaybeextendedupto40days.

inurinarytractinfections,treatmentdurationisatleast10daysanddepending

onthecourseofthedisease,itmaybeextendedupto28days.

inrespiratoryinfections,treatmentdurationisatleast7daysanddepending

onthecourseofthedisease,itmaybeextendedupto21days.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Overdosagemaycauseacutesignsintheformofneurologicaldisorders,which

shouldbetreatedsymptomatically.

4.11Withdrawalperiod(s)

Notapplicable.

Issued:March2013

AN:01884/2011

Page4of6

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antibacterialsforsystemicuse,Fluoroquinolones,

ATCvetcode:QJ01MA93

5.1 Pharmacodynamicproperties

Marbofloxacinisasynthetic,bactericidalantimicrobial,belongingtothe

fluoroquinolonegroupwhichactsbyinhibitionofDNAgyraseandoftopoisomerase

IV.ItiseffectiveagainstawiderangeofGrampositivebacteria(including

StreptococciandinparticularStaphylococci)andGramnegativebacteria

(Escherichiacoli,Citrobacterfreundii,Proteusspp.,Klebsiellaspp,Shigellaspp.,

Pasteurellaspp.,Pseudomonasspp.)aswellasMycoplasmaspp.

Asecondaryliteraturereportofmicrobiologicalsusceptibilitydatawhosesource

includedtwoEuropeanfieldsurveys,eachinvolvinghundredsofcanineandfeline

pathogenssusceptibletomarbofloxacin,waspublishedin2009.

Microorganism MIC

(µg/ml)

Staphylococcus

intermedius 0.23-0.25

Escherichiacoli 0.125-0.25

Pasteurellamultocida 0.04

Pseudomonas

aeruginosa 0.94

Susceptibilitybreakpointshavebeendeterminedas ≤1µg/mlforsensitive,2µg/ml

forintermediateand≥4µg/mlforresistantbacterialstrains.

Marbofloxacinisnotactiveagainstanaerobes,yeastorfungi.Casesofresistance

havebeenobservedinStreptococcus.

Resistancetofluoroquinolonesoccursbychromosomalmutationwiththree

mechanisms:decreaseofthebacterialwallpermeability,expressionofeffluxpump

ormutationofenzymesresponsibleformoleculebinding.

5.2 Pharmacokineticparticulars

Afteroraladministrationindogsattherecommendeddoseof2mg/kg,marbofloxacin

isreadilyabsorbedandreachesmaximalplasmaconcentrationsof1.5µg/mlwithin2

hours

Itsbioavailabilityiscloseto100%.

Itisweaklyboundtoplasmaproteins(lessthan10%),extensivelydistributedandin

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

concentrationsthaninplasma.Marbofloxaciniseliminatedslowly(t½ß=14hin

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

Issued:March2013

AN:01884/2011

Page5of6

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Lactosemonohydrate

Povidone(K90)

Yeastpowder

Meatflavour

Crospovidone

Castoroil,hydrogenated

Silica,ColloidalAnhydrous

Magnesiumstearate

6.2Incompatibilities

Notapplicable.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years

Shelflifeofhalf-tablets:5days.

6.4.Specialprecautionsforstorage

Storeintheoriginalpackageinordertoprotectfromlight.

Thisveterinarymedicinalproductdoesnotrequireanyspecialtemperaturestorage

conditions.

6.5Natureandcompositionofimmediatepackaging

Polyvinylchloride-aluminium-orientedpolyamide/Aluminiumcoldformedblister

containing6tablets.

Boxeswiththeinstructionleafletwith12tabletsand72tablets.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

7. MARKETINGAUTHORISATIONHOLDER

KRKA,d.d.,Novomesto

Šmarješkacesta6

8501Novomesto

Slovenia

Issued:March2013

AN:01884/2011

Page6of6

8. MARKETINGAUTHORISATIONNUMBER

Vm01656/4049

9. DATEOFFIRSTAUTHORISATION

06March2013

10. DATEOFREVISIONOFTHETEXT

March2013

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable.

Approved: 06/03/2013

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Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan / Amlodipine / HCTZ Tablets

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan / Amlodipine / HCTZ Tablets

Torrent Pharmaceuticals Limited is voluntarily recalling 14 lots of Valsartan/Amlodipine/HCTZ tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probabl...

FDA - U.S. Food and Drug Administration

15-8-2018

G Female Oral Tablets

G Female Oral Tablets

G Female Oral Tablets pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

10-8-2018

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Westminster Pharmaceuticals, LLC is voluntarily recalling all lots, within expiry, of Levothyroxine and Liothyronine (Thyroid Tablets, USP) 15 mg, 30 mg, 60 mg, 90 mg, & 120 mg to the wholesale level. These products are being recalled as a precaution because they were manufactured using active pharmaceutical ingredients that were sourced prior to the FDA’s Import Alert of Sichuan Friendly Pharmaceutical Co., Ltd., which as a result of a 2017 inspection were found to have deficiencies with Current Good Ma...

FDA - U.S. Food and Drug Administration

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

24-7-2018

FDA Advises Vets of Percorten™-V Shortage and Alternative Drug Option for Treatment of Canine Addison’s Disease

FDA Advises Vets of Percorten™-V Shortage and Alternative Drug Option for Treatment of Canine Addison’s Disease

FDA is aware of a shortage of Percorten™-V (desoxycorticosterone pivalate injectable suspension), which is approved for use as replacement therapy for mineralocorticoid deficit in dogs with primary adrenocortical insufficiency, more commonly known as Addison’s Disease.

FDA - U.S. Food and Drug Administration

23-7-2018

FDA Awards Grants to Fund Studies for Drugs for Minor Uses/Minor Species

FDA Awards Grants to Fund Studies for Drugs for Minor Uses/Minor Species

FDA has awarded five grants totaling $650,000 to provide funding for studies to support the approval or conditional approval of three different products, including a cancer drug for dogs.

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

17-7-2018

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of Valsartan and Valsartan Hydrochlorothiazide Tablets

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of Valsartan and Valsartan Hydrochlorothiazide Tablets

Teva Pharmaceuticals USA today confirmed a voluntary recall to the consumer / user level of 29 lots of single and 51 lots of combination valsartan medicines distributed under the Actavis label in the U.S. due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceutical. The impurity detected in the API is N- nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking wat...

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

FDA Investigating Potential Connection Between Diet and Cases of Canine Heart Disease

FDA Investigating Potential Connection Between Diet and Cases of Canine Heart Disease

FDA is alerting pet owners and veterinary professionals about reports of canine dilated cardiomyopathy (DCM) in dogs eating certain pet foods containing peas, lentils, other legume seeds, or potatoes as main ingredients.

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

29-6-2018

UPDATE: FDA Animal Drug Safety Communication: FDA continues to warn about risk of accidental overdosing of dogs with the noise aversion drug Sileo

UPDATE: FDA Animal Drug Safety Communication: FDA continues to warn about risk of accidental overdosing of dogs with the noise aversion drug Sileo

FDA is alerting dog owners and veterinarians about the risk of accidental overdose to dogs treated with the drug Sileo, a prescription gel that is given to dogs by mouth to treat noise aversion.

FDA - U.S. Food and Drug Administration

28-6-2018

Need for Seal tablets

Need for Seal tablets

Need for Seal tablets pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

28-6-2018

Gold Maka tablets

Gold Maka tablets

Gold Maka tablets pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

28-6-2018

One Night Lover tablets

One Night Lover tablets

One Night Lover tablets pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

19-6-2018

Bulbao Male Enhancer tablets

Bulbao Male Enhancer tablets

Bulbao Male Enhancer tablets pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

19-6-2018

Meltz – Instant Energy For Males tablets

Meltz – Instant Energy For Males tablets

Meltz Instant Energy For Males tablets pose a serious risk to your health and should not be taken.

Therapeutic Goods Administration - Australia

7-6-2018

Prevent Heartworms in Dogs, Cats, and Ferrets Year-Round

Prevent Heartworms in Dogs, Cats, and Ferrets Year-Round

Heartworm disease can be fatal to pets, but it is also preventable. Learn more about the dangers of heartworm disease and the importance of year-round prevention.

FDA - U.S. Food and Drug Administration

5-6-2018

Valpam 5 (diazepam) 5 mg tablets

Valpam 5 (diazepam) 5 mg tablets

Product defect alert - potential for blister strip to contain lower strength tablets

Therapeutic Goods Administration - Australia

23-5-2018

The FDA is Seeking Input on the Evaluation of Approaches to Demonstrate Effectiveness of Heartworm Preventatives for Dogs

The FDA is Seeking Input on the Evaluation of Approaches to Demonstrate Effectiveness of Heartworm Preventatives for Dogs

FDA’s CVM is evaluating the design of studies intended to support the standard of effectiveness for new animal drugs to prevent heartworm disease in dogs. The FDA is requesting public input on evaluating these products to assist in the potential development of alternative study designs.

FDA - U.S. Food and Drug Administration

10-4-2018

Stree Overlord Strong tablets (pills)

Stree Overlord Strong tablets (pills)

Safety alert - stree overlord tablets pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

9-4-2018

Black Ant King tablets

Black Ant King tablets

Safety advisory

Therapeutic Goods Administration - Australia

6-4-2018

Two lots of the epilepsy drug Primidone recalled because of high levels of lead, which may pose serious health risks

Two lots of the epilepsy drug Primidone recalled because of high levels of lead, which may pose serious health risks

Health Canada is advising Canadians that AA Pharma Inc. is voluntarily recalling two lots of Primidone tablets because they contain high levels of lead. The company has indicated that only the lots identified below are affected by this issue.

Health Canada

15-3-2018

Duro-K 600 mg potassium chloride tablets

Duro-K 600 mg potassium chloride tablets

Advisory – lead content may exceed regulatory guidelines

Therapeutic Goods Administration - Australia

12-12-2017

Keep Your Dogs and Cats Safe From Holiday Hazards

Keep Your Dogs and Cats Safe From Holiday Hazards

From tinsel to table scraps, holiday hazards for pets abound. Here are some tips to help you keep them safe.

FDA - U.S. Food and Drug Administration

10-8-2017

Bravecto® may cause convulsions in dogs on rare occasions

Bravecto® may cause convulsions in dogs on rare occasions

The European Medicines Agency has reviewed the adverse events of Bravecto®, a veterinary medicine used to treat flea and tick infestations in dogs. The conclusion is that the medicine may on very rare occasions cause convulsions in dogs – primarily in dogs with pre-existing epilepsy.

Danish Medicines Agency

21-2-2017

Takeda Pharma A/S recalls batch of Pamol® in packs of 300 film-coated tablets

Takeda Pharma A/S recalls batch of Pamol® in packs of 300 film-coated tablets

Takeda Pharma A/S recalls a batch of Pamol® in packs of 300 film-coated tablets after the discovery of Ibumetin 600 mg containing ibuprofen in some packs. Both types of medicine are used for the treatment of mild pain, but they work in different ways and may cause different adverse reactions.

Danish Medicines Agency

4-7-2012

Danish Pharmacovigilance Update, 19 April 2012

Danish Pharmacovigilance Update, 19 April 2012

Among the topics covered in this issue of Danish Pharmacovigilance Update are: Split and crushed tablets containing finasteride may pose a risk for pregnant and fertile women.

Danish Medicines Agency

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