XEDEN 200 mg Tablet for dogs

Main information

  • Trade name:
  • XEDEN 200 mg Tablet for dogs
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • XEDEN 200 mg Tablet for dogs
    Greece
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • enrofloxacin
  • Therapeutic area:
  • Dogs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0186/004
  • Authorization date:
  • 20-01-2012
  • EU code:
  • FR/V/0186/004
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

VETERINARYMEDICINALPRODUCT

XEDEN200mgtabletfordogs

PARTIB

SUMMARYOFPRODUCTCHARACTERISTICS

PharmaceuticalForm

Tablet

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

XEDEN200mgtabletfordogs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Activesubstance:

Onetabletcontains:

Enrofloxacin...........................................................200.0mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Tablet

Clover-shapedscoredbeigetablet

Thetabletcanbedividedintofourequalparts.

4. CLINICALPARTICULARS

4.1Targetspecies

Dogs

4.2Indicationsforuse,specifyingthetargetspecies

Indogs:

-Treatmentoflowerurinarytractinfections(associatedornotwithprostatitis)andupper

urinarytractinfectionscausedbyEscherichiaColiorProteusmirabilis.

-Treatmentofsuperficialanddeeppyoderma.

4.3Contraindications

Donotuseinyoungorgrowingdogs(dogsagedlessthan12months(smallbreed)orless

than18months(largebreed))astheproductmaycauseepiphysealcartilagealterationsin

growingpuppies.

Donotuseindogshavingseizuredisorders,sinceenrofloxacinmaycauseCNSstimulation.

Donotuseindogswithknownhypersensitivitytofluoroquinolonesortoanyoftheexcipients

oftheproduct.

Donotuseincaseofresistancetoquinolones,asthereexistsalmostcompletecross

resistancetootherquinolonesandcompletecrossresistancetootherfluoroquinolones.

Donotusewithtetracyclines,phenicolsormacrolidesbecauseofpotentialantagonistic

effects.

Seealsosection4.7.

4.4Specialwarningsforeachtargetspecies

None

4.5Specialprecautionsforuse

i)Specialprecautionsforuseinanimals

Fluoroquinolonesshouldbereservedforthetreatmentofclinicalconditionswhichhave

respondedpoorly,orareexpectedtorespondpoorly,tootherclassesofantimicrobials.

Whereverpossible,fluoroquinolonesshouldbeusedbasedonsusceptibilitytesting.

UseoftheproductdeviatingfrominstructionsgivenintheSPCmayincreasetheprevalence

ofbacteriaresistanttofluoroquinolonesandmaydecreasetheeffectivenessoftreatmentwith

otherquinolonesduetothepotentialforcrossresistance.

Officialandlocalantimicrobialpoliciesshouldbetakenintoaccountwhentheproductis

used.

Usetheproductwithcautionindogswithsevererenalorhepaticimpairment.

Pyodermaismostlysecondarytoanunderlyingdisease.Itisadvisabletodeterminethe

underlyingcauseandtotreattheanimalaccordingly.

ii)Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Personswithaknownhypersensitivityto(fluoro)quinolonesshouldavoidanycontactwiththe

product.

Incaseofaccidentalingestion,seekmedicaladviceimmediatelyandshowthepackage

leaflettothephysician.

Washhandsafterhandlingtheproduct

Incaseofcontactwitheyes,rinseimmediatelywithplentyofwater.

4.6Adversereactions(frequencyandseriousness)

Possiblejointcartilagealterationsingrowingpuppies(see4.3contra-indications).

Inrarecasesvomitingandanorexiaareobserved.

4.7 Useduringpregnancy,lactationorlay

Useduringpregnancy:Laboratorystudiesinlaboratoryanimals(rat,chinchilla)havenot

producedanyevidenceofateratogenic,foetotoxic,maternototoxiceffect.Useonlyaccording

tothebenefit/riskassessmentbytheresponsibleveterinarian.

Useduringlactation:Asenrofloxacinpassesintothematernalmilk,theuseisnot

recommendedduringlactation.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Concurrentuseofflunixinshouldbeundercarefulveterinarymonitoring,astheinteractions

betweenthesedrugsmayleadtoadverseeventsrelatedtodelayedelimination.

Concomitantadministrationoftheophyllinerequirescarefulmonitoringasserumlevelsof

theophyllinemayincrease.

Concurrentuseofmagnesiumoraluminumcontainingsubstances(suchasantacidsor

sucralfate)mayreduceabsorptionofenrofloxacin.Thesedrugsshouldbeadministeredtwo

hoursapart.

4.9Amountstobeadministeredandadministrationroute

Oraluse

5mgofenrofloxacin/kg/dayasasingledailydosing,i.e.onetabletfor40kgdailyfor:

- 10daysinlowerurinarytractinfections

- 15daysinupperurinarytractinfectionsandlowerurinarytractinfectionsassociated

withprostatitis

- Upto21daysinsuperficialpyodermadependingonclinicalresponse

- Upto49daysindeeppyodermadependingonclinicalresponse

Thetreatmentshouldbereconsideredincaseoflackofclinicalimprovementathalfofthe

treatmentduration.

XEDEN50mg

Numberoftabletsper

day XEDEN150mg

Numberoftablets

perday XEDEN200mg

Numberoftablets

perday Dogweight(kg)

¼ ≥2 - <4

½ ≥4 - <6.5

¾ ¼ ≥6.5 - <8.5

1 ¼ ≥8.5 - <11

1¼ ½ ≥11 - <13.5

1½ ½ ≥13.5- <17

¾ ½ ≥17 - <25

1 ¾ ≥25 - <35

1¼ 1 ≥35 - <40

1½ 1 ≥40 <45

1½ 1¼ ≥45 - <50

1¾ 1¼ ≥50 - <55

2 1½ ≥55 - <65

1¾ ≥65

- <80

Thetabletsareflavoured,andarewellacceptedbydogs.Thetabletsmaybeadministered

directlyinthemouthofthedogorsimultaneouslywithfoodifnecessary.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Overdosingcancausevomitingandnervoussigns(muscletremor,incoordinationand

convulsions)whichmayrequiretreatmentdiscontinuation.

Intheabsenceofanyknownantidote,applydrugeliminationmethodsandsymptomatic

treatment.

Ifnecessary,administrationofaluminium-ormagnesium-containingantacidsoractivated

carboncanbeusedtoreduceabsorptionofenrofloxacin.

Accordingtoliterature,signsofoverdosagewithenrofloxacinindogssuchasinappetence

andgastrointestinaldisturbancewereobservedatapproximately10timestherecommended

dosewhenadministeredfortwoweeks.Nosignsofintolerancewereobservedindogs

administered5timestherecommendeddoseforamonth.

4.11Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

ATCvetcode:QJ01MA90

Pharmacotherapeuticgroup:Fluoroquinolones

5.1Pharmacodynamicproperties

Enrofloxacinisasyntheticfluoroquinoloneantibioticthatexertsitsactivitybyinhibiting

topoisomeraseII,anenzymeinvolvedinthemechanismofbacterialreplication.

Enrofloxacinexertsbactericidalactivityconcentration-dependantwithsimilarvaluesof

minimalinhibitconcentrationandminimalbactericideconcentrations.Italsopossesses

activityagainstbacteriainthestationaryphasebyanalterationofthepermeabilityoftheouter

membranephospholipidcellwall.

Ingeneral,enrofloxacinexhibitsgoodactivityagainstmostgram-negativebacteria,especially

thoseoftheEnterobacteriacea.Escherichiacoli,Klebsiellaspp.,Proteusspp.,and

Enterobacterspp.aregenerallysusceptible.

Pseudomonasaeruginosaisvariablysusceptibleand,whenitissusceptible,usuallyhasa

higherMICthanothersusceptibleorganisms.

StaphylococcusaureusandStaphylococcusintermediususuallyaresusceptible.

Streptococci,enterococci,anaerobicbacteriacangenerallybeconsideredresistant.

Inductionofresistanceagainstquinolonescandevelopbymutationsinthegyrasegeneof

bacteriaandbychangesincellpermeabilitytowardsquinolones.

5.2Pharmacokineticparticulars

Enrofloxacinisrapidlymetabolisedtoformanactivecompound,ciprofloxacin.

AfteroraladministrationofXEDEN200(5mg/kg)indogs:

- Themaximalplasmaconcentrationofenrofloxacinof1.72µg/mLwasobservedone

hourfollowingadministration.

- Themaximalplasmaconcentrationofciprofloxacin(0.32µg/mL)wasobservedtwo

hoursfollowingadministration.

Enrofloxacinisprimarilyexcretedviathekidneys.Amajorportionoftheparentdrugandits

metabolitesisrecoveredinurine.

Enrofloxaciniswidelydistributedinthebody.Thetissueconcentrationsareoftenhigherthan

theserumconcentrations.Enrofloxacincrossestheblood-brainbarrier.Thedegreeofprotein

bindinginserumis14%indogs.Thehalf-lifeinserumis3-5hoursindogs(5mg/kg).

Approximately60%ofthedoseisexcretedasunchangedenrofloxacinandtheremainderas

metabolites,amongstothersciprofloxacin.Thetotalclearanceisapproximately9

ml/minute/kgbodyweightindogs.

Environmentalproperties

Notapplicable

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Pigliverpowder

Yeast

Cellulosemicrocrystalline

Croscarmellosesodium

Copovidone

Silicacolloidalanhydrous

Hydrogenatedcastoroil

Lactosemonohydrate

6.2Incompatibilities

Notknown.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:

3years

Shelf-lifeofdivisionsofthetablets:

3days

6.4.Specialprecautionsforstorage

Storeintheoriginalcontainer

Protectfromlight

Dividedtabletsshouldbestoredintheblisterpack.Anydividedtabletportionsremainingafter

3daysshouldbediscarded.

Thismedicinalproductdoesnotrequireanyspecialtemperaturestorageconditions.

6.5Natureandcompositionofimmediatepackaging

Blistercomplex:PVDC-TE-PVC/Aluminiumheatsealedblisterswith6tablets/blister

Cardboardboxwith2blistersof6tablets

Cardboardboxwith20blistersof6tablets

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproductor

wastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

LaboratoriesSOGEVAL

RoutedeMayenne

ZIdestouches

53000LAVAL

France

Tel:33.2.43.49.51.51

Fax:33.2.43.53.97.00

E-mail: sogeval@sogeval.fr

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10 DATEOFREVISIONOFTHETEXT

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Tobecompletedinaccordancewithnationalrequirements.

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Danish Medicines Agency

26-11-2018

Today’s statement highlights increased expectations for information required in 510(k) submissions; each averages 1,185 pages, compared to 475 pages in 2009. Reviewers spend more time reviewing applications, but time to decision has become more efficient

Today’s statement highlights increased expectations for information required in 510(k) submissions; each averages 1,185 pages, compared to 475 pages in 2009. Reviewers spend more time reviewing applications, but time to decision has become more efficient

Today’s statement highlights increased expectations for information required in 510(k) submissions; each averages 1,185 pages, compared to 475 pages in 2009. Reviewers spend more time reviewing applications, but time to decision has become more efficient https://go.usa.gov/xPHdE 

FDA - U.S. Food and Drug Administration

26-11-2018

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009.  https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https://go.usa.gov/xPHdn 

FDA - U.S. Food and Drug Administration

17-9-2018

Scientific guideline:  Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1, draft: consultation open

Scientific guideline: Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1, draft: consultation open

The Guideline on the investigation of medicinal products in the term and preterm neonates was prepared during the period from 2007 to 2009 and came into effect in 2010 (EMEA/536810/2008). Considerable experience of assessing PIP applications covering neonatal age subset has been gained since then and it has become apparent that some essential questions arise repeatedly during the assessment of Paediatric Investigation Plans (PIP) applications for products intended to be investigated and used in neonates....

Europe - EMA - European Medicines Agency

18-4-2018

EU/3/18/2009 (SOTIO a.s)

EU/3/18/2009 (SOTIO a.s)

EU/3/18/2009 (Active substance: Autologous dendritic cells pulsed with killed ovarian cancer cells and matured by TLR3 ligand ex vivo) - Orphan designation - Commission Decision (2018)2405 of Wed, 18 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/246/17

Europe -DG Health and Food Safety

18-4-2018

EU/3/18/2008 (StolmAr and Partner PatentanwAlte PartG mbB)

EU/3/18/2008 (StolmAr and Partner PatentanwAlte PartG mbB)

EU/3/18/2008 (Active substance: Adeno-associated viral vector serotype 9 encoding miRNA against human superoxide dismutase 1) - Orphan designation - Commission Decision (2018)2404 of Wed, 18 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/254/17

Europe -DG Health and Food Safety

18-4-2018

EU/3/18/2007 (Dr Philippe Moullier)

EU/3/18/2007 (Dr Philippe Moullier)

EU/3/18/2007 (Active substance: Adeno-associated viral vector serotype 8 containing the human acid alpha-glucosidase gene) - Orphan designation - Commission Decision (2018)2403 of Wed, 18 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/255/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2005 (IQVIA RDS Ireland Limited)

EU/3/18/2005 (IQVIA RDS Ireland Limited)

EU/3/18/2005 (Active substance: Tazemetostat) - Orphan designation - Commission Decision (2018)1893 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/222/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2004 (IQVIA RDS Ireland Limited)

EU/3/18/2004 (IQVIA RDS Ireland Limited)

EU/3/18/2004 (Active substance: Tazemetostat) - Orphan designation - Commission Decision (2018)1892 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/217/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2003 (Pharmadev Healthcare Ltd)

EU/3/18/2003 (Pharmadev Healthcare Ltd)

EU/3/18/2003 (Active substance: Ribavirin) - Orphan designation - Commission Decision (2018)1891 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/225/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2002 (Pharmadev Healthcare Ltd)

EU/3/18/2002 (Pharmadev Healthcare Ltd)

EU/3/18/2002 (Active substance: Ribavirin) - Orphan designation - Commission Decision (2018)1890 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/224/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2001 (Soligenix UK Ltd)

EU/3/18/2001 (Soligenix UK Ltd)

EU/3/18/2001 (Active substance: Recombinant modified ricin toxin A-chain subunit) - Orphan designation - Commission Decision (2018)1889 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/242/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2006 (IQVIA RDS Ireland Limited)

EU/3/18/2006 (IQVIA RDS Ireland Limited)

EU/3/18/2006 (Active substance: Tazemetostat) - Orphan designation - Commission Decision (2018)1894 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/234/17

Europe -DG Health and Food Safety