Cephorum 250mg Film Coated Tablets

Main information

  • Trade name:
  • CEPHORUM 250 MG COMPRIMIDOS RECUBIERTOS CON PELICULA PARA PERROS
  • Pharmaceutical form:
  • Film coated tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CEPHORUM 250 MG COMPRIMIDOS RECUBIERTOS CON PELICULA PARA PERROS
    Spain
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Cefalexin
  • Therapeutic area:
  • Dogs

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0411/001
  • Authorization date:
  • 21-12-2011
  • EU code:
  • UK/V/0411/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Revised:February2012

AN:00045/2011

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SUMMARYOFPRODUCTSCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Cephorum250mgfilm-coatedtabletsfordogs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains:

Activeingredient:

Cefalexin 250mg

ascefalexinmonohydrate 263mg

Excipients:

Titaniumdioxide(E171) 0.55mg

Excipientqsp1tabletof355mg

Forafulllistofexcipients,seesection6.1

3. PHARMACEUTICALFORM

Film-coatedtablet

Round,whitetoyellowish,biconvextablet,scoredononeside.‘CX’is

imprintedabovethescoreline,‘250’isimprintedbelowthescoreline.

Thetabletsarenotdivisible.

4. CLINICALPARTICULARS

4.1 Targetspecies

Dogs

4.2 Indicationsforuse,specifyingthetargetspecies

Theproductisindicatedforthetreatmentofurinarytractinfectionsindogs

causedbyKlebsiellapneumoniaeandforthetreatmentofbacterialskin

infectionsindogs,whensusceptibleorganismsarepresent.

4.3 Contra-indications

Donotuseincasesofknownhypersensitivitytotheactivesubstance,to

othercephalosporins,toothersubstancesoftheβ-lactamgrouportoanyof

theexcipients.

Donotuseinrabbits,gerbils,guineapigsandhamsters.

4.4 Specialwarningsforeachtargetspecies

None

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AN:00045/2011

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4.5 Specialprecautionsforuse

i. Specialprecautionsforuseinanimals

Useoftheproductshouldbebasedonsusceptibilitytestingandtake

intoaccountofficialandlocalantimicrobialpolicies.

UseoftheproductdeviatingfromtheinstructionsgivenintheSPC

mayincreasetheprevalenceofbacteriaresistanttocefalexinandmay

decreasetheeffectivenessoftreatmentwithpenicillins,dueto

potentialcross-resistance.

Incaseofanallergicreaction,treatmentshouldbewithdrawn.

Aswithotherantibioticswhichareexcretedmainlybythekidneys,

unnecessaryaccumulationmayoccurinthebodywhenrenalfunction

isimpaired.Incasesofknownrenalinsufficiencythedoseshouldbe

reduced,antimicrobialsknowntobenephrotoxicshouldnotbe

administeredconcurrentlyandtheproductshouldbeusedonly

accordingtoarisk/benefitassessmentbytheresponsibleveterinarian.

ii. Specialprecautionsforthepersonadministeringtheveterinary

medicinalproducttoanimals

Penicillinsandcephalosporinsmaycausehypersensitivity(allergy)

followinginjection,inhalation,ingestionorskincontact.

Hypersensitivitytopenicillinsmayleadtocross-reactionsto

cephalosporinsandviceversa.Allergicreactiontothesesubstances

mayoccasionallybeserious.

1.Donothandlethisproductifyouknowyouaresensitised,orif

youhavebeenadvisednottobeincontactwithsuch

preparations.

2.Handlethisproductwithgreatcaretoavoidexposuretakingall

recommendedprecautions.

3.Ifyoudevelopsymptomsfollowingexposure,suchasaskin

rash,youshouldseekmedicaladviceandshowthedoctorthis

warning.Swellingoftheface,lipsoreyesordifficultyin

breathingaremoreserioussymptomsandrequireurgent

medicalattention.Incaseofaccidentalingestion,seekmedical

attentionimmediatelyshowingthephysicianthisinformation.

Washhandsafteruse.

4.6 Adversereactions(frequencyandseriousness)

Vomitingand/ordiarrhoeahavebeenobservedindogs.Inrarecases

hypersensitivitycanoccur.Incasesofhypersensitivityreactionsthe

treatmentshouldbestopped.

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4.7 Useduringpregnancy,lactationorlay

Thesafetyoftheveterinarymedicinalproducthasnotbeenestablishedin

bitchesduringpregnancyandlactation.Useonlyaccordinglytothe

benefit/riskassessmentbytheresponsibleveterinarian.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Thebactericidalactivityofcephalosporinsisreducedbyconcomitant

administrationofbacteriostaticactingcompounds(macrolides,

sulphonamidesandtetracyclines).

Nephrotoxicitycanbeincreasedwhen1 st

generationcephalosporinsare

combinedwithpolypeptideantibiotics,aminoglycosidesandsomediuretics

(furosemide).

Concomitantusewithsuchactivesubstancesshouldbeavoided.

4.9 Amount(s)tobeadministeredandadministrationroute

Fororaluse.

Therecommendeddoserateis15mgcefalexin/kgbodyweighttwicedaily.

Insevereoracuteconditionstheabovedosemaybesafelydoubledto30

mg/kgorgivenatmorefrequentintervals.

Thetablebelowisintendedasaguidefortherecommendeddoseof15mg

cefalexinperkgbodyweight.Anyincreaseinthedoseshouldbecalculated

case-by-casefortheindividualanimalconcerned.

Bodyweightinkg Numberoftablets

perdose*

12to18 1tablet

19to32 2tablets

33to50 3tablets

*Twodosesperdayshouldbegiven

Toensureacorrectdosagebodyweightshouldbedeterminedasaccurately

aspossibletoavoidunderdosing.

Treatmentforfivedaysisrecommendedbutthismaybeextendedor

shortenedatthediscretionoftheveterinarysurgeon.

Anyincreaseindoseordurationofuse,andanyuseindogslessthan12kg

bodyweight,shouldbeinaccordancewitharisk/benefitassessmentbythe

responsibleveterinarian.

4.10 Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Symptomsofoverdoseincludenausea,vomiting,epigastricdistress,

diarrhoeaandhaematuria.Treatmentshouldbesymptomatic.

4.11 Withdrawalperiod(s)

Notapplicable.

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5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:

Antibacterialsforsystemicuse,Otherbeta-lactamantibacterials,First-

generationcephalosporins

ATCVetCode:QJ01DB01

5.1 Pharmacodynamicproperties

Cefalexin,firstgenerationcephalosporin,inhibitsbacterialcellwallsynthesis

inamannersimilartothepenicillins,andiswidelyconsideredtobe

bactericidalinaction.Itisthoughtthatcefalexinactsbybindingtoand

inactivatinganumberofdifferentpenicillin-bindingproteins(PBPs)located

ontheinneraspectsofthebacterialcellmembrane.Cephalosporinsare

essentiallytime-dependentantibiotics.

Cefalexinisactiveagainstalargespectrumofgram-positiveandgram-

negativebacteria.Thebreakpointsforcefalexi nareusuallydefinedasS≤8

μg/ml,R>32μg/ml.

Theinvitroactivityofcefalexinagainstbacterialisolatesfromskininfections

indogsisasfollows:

Pathogen

MIC

90 (µg/ml)

S.intermedius 0.5to8

S.aureus 2to8

E.coli 2to16

BetahaemolyticStreptococcusspp.(86) 2

TheMIC

valueofcefalexinagainstKlebsiellapneumoniaeisolatedfrom

urinarytractinfectionsindogsis4µg/ml.

Themostprevalentresistancemechanismamonggram-negativebacteriato

cefalexinisduetotheproductionofvariousbeta-lactamases

(cephalosporinase)thatcauseinactivation.Resistanceingram-positive

bacteriaofteninvolvesadecreasedaffinityofthePBPs(penicillin-binding

proteins)forbeta-lactamdrugs.Effluxpumps,extrudingtheantibioticfrom

thebacterialcell,andstructuralchangesinporins(reducingpassivediffusion

ofthedrugthroughthecellwall),maycontributetobacterialresistance.

Cross-resistance(involvingthesameresistancemechanism)existsbetween

antibioticsbelongingtothebeta-lactamgroupduetotheirsimilarstructures.

Thisoccurswithbeta-lactamaseenzymes,structuralchangesinporinsor

variationsineffluxpumps.Co-resistance(involvingdifferentresistance

mechanisms)hasbeenreportedinE.coliduetoaplasmidwithresistance

genes.

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5.2 Pharmacokineticproperties

Afteroraladministration,60to80%ofcefalexinisabsorbedfromthesmall

intestine.Thedelayreportedbetweenadministrationandbeginningof

absorptionisapproximately20minutesanddifferencesinmeanAUC,Cmax,

andTmaxarenotsignificantlyaffectedbyfoodadministrationconcomitantto

treatmentwithcefalexin.

Doseadministered

(mg/kg) 15

Cmax(µg/ml) 17.6

Tmax(min) 158

AUC(µg.h/ml) 73.5

Halflife(min) 107

Proteinbindingislowat18%.Cefalexiniswidelydistributedintoavarietyof

tissuefluids,includingbile,synovialandpericardialfluid.Thepassageinto

interstitialtissue,asdemonstratedinwoundfluidconcentration,peritoneal

fluidandskinblistersisgenerallygood.

Cefalexinisminimallymetabolizedandprimarilyexcretedviatherenalroute,

around70%ofanoraldoseisexcretedintotheurinein24hoursinthedog.

Itisimportanttonotethatcefalexinconcentrationsobtainedinurinearewell

aboveplasmaconcentrations,andsimilarlyconcentrationsinbilemaybeup

tofourtimeshigher.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Titaniumdioxide(E171)

PovidoneK25

Sodiumstarchglycolate(TypeA)

Magnesiumstearate

Macrogol6000

Lactosemonohydrate

Hypromellose

Talc

Peppermintoil

Saccharinsodiumdihydrate

6.2 Incompatibilities

Noneknown.

6.3 Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsalein

polypropylenesecuritainers:4years

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AN:00045/2011

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Shelflifeoftheveterinarymedicinalproductaspackagedforsaleinblister

packs:4years

6.4 Specialprecautionsforstorage

Donotstoreabove30°C.

Protectfromlight.

6.5 Natureandcompositionofimmediatepackaging

Whitepolypropylenesecuritainerswithwhitepolyethylenesnaponcaps

containing50,100or250tablets.

PVC/PVDC –Aluminiumfoilblisterpackscontaining10stripsof10tablets

eachor8stripsof14tabletseach.

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts,if

appropriate

Anyunusedveterinarymedicinalproductorwastematerialsderivedfrom

suchveterinarymedicinalproductsshouldbedisposedofinaccordancewith

localrequirements.

7. MARKETINGAUTHORISATIONHOLDER

ForumProductsLimited

BetchworthHouse

57-65StationRoad

Redhill

Surrey

RH11DL

UnitedKingdom

8. MARKETINGAUTHORISATIONNUMBER

Vm05928/4004

9. DATEOFFIRSTAUTHORISATION

11June1999

10. DATEOFREVISIONOFTHETEXT

February2012