Therios 300 mg Palatable Tablets for Dogs

Main information

  • Trade name:
  • Therios 300 mg Palatable Tablets for Dogs
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Therios 300 mg Palatable Tablets for Dogs
    Austria
  • Language:
  • English

Therapeutic information

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

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0347/001
  • Authorization date:
  • 25-11-2009
  • EU code:
  • UK/V/0347/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Revised29/03/2010 –AN02535/2008

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

UK,AT,IE,PL,CZ,

BE,HU,GK,LUX,NL,

PT Therios300mgpalatabletabletsfordogs

IT,ES,FI Therios300mgflavouredtabletsfordogs

DE Therios300mgaromatisierteTablettenfürHunde

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Activesubstance:

Eachtabletcontains:

Cefalexin(ascefalexinmonohydrate).300mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Tablet

Roundscoredbeigepalatabletablet

Thetabletcanbedividedintoequalhalvesandquarters

4. CLINICALPARTICULARS

4.1 Targetspecies

Dogs.

4.2 Indicationsforuse,specifyingthetargetspecies

Forthetreatmentofbacterialskininfectionsindogs(includingdeepandsuperficial

pyoderma)causedbyorganismssensitivetocefalexin.

Forthetreatmentofurinarytractinfectionsindogs(includingnephritisandcystitis)causedby

organismssensitivetocefalexin.

4.3 Contraindications

Donotuseinanimalswhichareknowntobehypersensitivetopenicillins.

Donotuseincaseofsevererenalfailure

Donotuseinrabbits,guineapigs,hamstersandgerbils.

4.4Specialwarningsforeachtargetspecies

None.

4.5 Specialprecautionsforuse

i)Specialprecautionsforuseinanimals

Aswithotherantibioticswhichareexcretedmainlybythekidneys,systemicaccumulation

mayoccurwhenrenalfunctionisimpaired.Incaseofknownrenalinsufficiencythedose

shouldbereduced.

Theproductisnotrecommendedforuseindogslessthan2.5kgbodyweight.

Whereverpossible,theuseoftheproductshouldbebasedonsusceptibilitytestingandtake

intoaccountofficialandlocalantimicrobialpolicies

Revised29/03/2010 –AN02535/2008

Safetyoftheexcipient,ammoniumglycyrrhizate,hasnotbeenestablishedindogslessthan

1yearold.

ii)Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Cephalosporinsmaycausesensitization(allergy)followinginjection,inhalation,ingestionor

skincontact.Sensitivitytopenicillinsmayleadtocrosssensitivitytocephalosporinandvice

versa.Allergicreactionstothesesubstancesmayoccasionallybeserious.

1.Donothandlethisproductifyouknowyouaresensitizedorifyouhavebeenadvisednotto

workwithsuchpreparations.

2.Handlethisproductwithgreatcaretoavoidexposure,takingallrecommended

precautions.Washhandsafteruse.

3.Ifyoudevelopsymptomsfollowingexposuresuchasskinrashyoushouldseekmedical

adviceandshowthedoctorthiswarning.Swellingsoftheface,lipsoreyesordifficulty

breathingaremoreserioussymptomsandrequireurgentmedicalattention.

Intheeventofaccidentalingestion,particularlybyachild,seekmedialattentionandshowthe

doctortheleaflet

4.6Adversereactions(frequencyandseriousness)

Vomitinganddiarrhoeahavebeenobservedindogs.Inrarecaseshypersensitivitycanoccur.

4.7Useduringpregnancy,lactationorlay

Donotuseinpregnantorlactatingbitches.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Inordertoensureefficacy,theproductshouldnotbeusedincombinationwithbacteriostatic

antibiotics.

Concurrentuseoffirstgenerationcephalosporinswithaminoglycosideantibioticsorsome

diureticssuchasfurosemidecanenhancenephrotoxicityrisks

4.9 Amountstobeadministeredandadministrationroute

Fororaladministration.

15mgcefalexinperkgbodyweighttwicedaily(equivalentto30mgperkgbodyweightper

day)fordurationof:

-14daysincasesofurinarytractinfection

-Atleast15daysincasesofsuperficialinfectiousdermatitis

-Atleast28daysincasesofdeepinfectiousdermatitis

Insevereoracuteconditionsthedosemaybesafelydoubledto30mg/kgtwicedaily.To

allowforaccuracyofdosing,tabletscanbehalvedorquartered.

Toensureacorrectdosagebodyweightshouldbedeterminedasaccuratelyaspossibleto

avoidunderdosing.

Theriostabletsarewellacceptedbydogsbutmaybecrushedoraddedtoasmallquantityof

foodimmediatelypriortofeedingifnecessary

Revised29/03/2010 –AN02535/2008

4.10 Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Trialsperformedonanimalswithupto5timestherecommendedtwicedailydosageof15

mg/kgdemonstratedthatcefalexinwaswelltolerated.

4.11Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Cefalexinmonohydrate,theactiveingredientoftheTheriostablets,isabactericidalantibiotic

ofthecephalosporinfamily,obtainedbyhemi-synthesisofthe7amino-cephalosporanic

nucleus.

ATCvetcode:QJ01DB01

Pharmacotherapeuticgroup:Antibacterialforsystemicuse,first-generationcephalosporin

5.1 Pharmacodynamicproperties

Cefalexinactsbyinhibitingthenucleopeptidesynthesisofthebacterialwall.Cephalosporins

interferewithtranspeptidationbyacylatingtheenzymemakingitunabletocross-linkmuramic

acid-containingpeptidoglycanstrands.Theinhibitionofthebiosynthesisofthematerial

requiredtobuildthecellwallresultsinadefectivecellwallandconsequentlyosmotically

unstabletoprotoplasts.Thecombinedactionresultsincelllysisandfilamentformation.

CefalexinisactiveagainstGrampositiveandGramnegativebacteriasuchas

Staphylococcusspp(includingpenicillin-resistantstrains),Streptococcusspp.,.,Escherichia

.coli,andKlebsiellaspp,.Cefalexinisnotinactivatedbybeta-lactamasesproducedbyGram

positivebacteria.However,beta-lactamasesproducedbygram-negativebacteriacaninhibit

cefalexinbyhydrolysisofthebeta-lactamcycle.Resistanceistransmittedbyplasmidicor

chromosomicroute.

Cefalexinisnotinactivatedbythestaphylococcalbeta-lactamasesbuthasamoderate

activityagainstnon-transferable(chromosomal)beta-lactamaseproducinggram-negative

enterobacteriacceaeandfastidiousgram-negatives.Noantibacterialactivityisobtained

againstEnterobacterspp.,P.aeruginosaandSerratiaspp.

Cefalexinhasatime-dependentbactericidalactivityagainstStaphylococcussppand

Pasteurellamultocida.

Thecefalexincriticalbreakpoints(MICvalue)forpathogensofveterinaryimportancewereset

upat:

- Susceptible:≤8mg/L

- Resistant:>32mg/L

Staphylococcusspp,Streptococcusspp,E.coliandKlebsiellasppandP.multocidaare

susceptibletocefalexin.MIC90valuesforcefalexindeterminedintargetbacterialstrains

isolatedfromdiseaseddogsinEuropeandintheUSAare:

- S.pseudintermedius:2µg/mL

- S.aureus:8µg/mL

- S.canis ≤0.5µg/mL

- Beta-hemolyticStreptococcusspp:2µg/mL

Revised29/03/2010 –AN02535/2008

- E.coli:16µg/mL

- P.multocida:2µg/mL

- Klebsiella.spp:4µg/mL

Resistancetocefalexinmaybeduetooneofthefollowingmechanismsofresistance.Firstly,

theproductionofvariousbeta-lactamases(cephalosporinase),thatinactivatetheantibiotic,is

themostprevalentmechanismamonggram-negativebacteria.Secondly,adecreasedaffinity

ofthePBPs(penicillin-bindingproteins)forbeta-lactamdrugsisfrequentlyinvolvedforbeta-

lactamresistantgram-positivebacteria.Lastly,effluxpumps,extrudingtheantibioticfromthe

bacterialcell,andstructuralchangesinporins,reducingpassivediffusionofthedrugthrough

thecellwall,maycontributetoimprovetheresistantphenotypeofabacterium.

Well-knowncross-resistance(involvingthesameresistancemechanism)existsbetween

antibioticsbelongingtothebeta-lactamgroupduetostructuralsimilarities.Itoccurswithb-

lactamasesenzymes,structuralchangesinporinsorvariationsineffluxpumps.Co-

resistance(differentresistancemechanismsinvolved)hasbeendescribedinE.coliduetoa

plasmidharbouringvariousresistancegenes.

5.2Pharmacokineticparticulars

Aftersingleoraladministrationoftherecommendeddosageof15mgcefalexinperkg

bodyweighttoBeagledogs,plasmaconcentrationswereobservedwithin30minutes.The

plasmapeakwasobservedat1.33hwithaplasmaconcentrationof21.2µg/ml.The

bioavailabilityoftheactivewasover90%.Cefalexinwasdetecteduntil24hoursafterthe

administration.Thefirsturinespecimenwascollectedwithin2to12hourswithpeak

concentrationsofcefalexinmeasuredat430to2758µg/mlwithin12hours.

Afterrepeatedoraladministrationofthesamedosage,twiceadayfor7days,plasmapeaks

occurred2hourslaterwithaconcentrationof20µg/ml.Overthetreatmentperiod

concentrationsweremaintainedabove1µg/ml.Themeaneliminationhalflifeis2hours.Skin

levelswerearound5.8to6.6µg/g2hoursaftertreatment.

5.3Environmentalproperties

Notapplicable.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Croscarmellosesodium

Silica,colloidalanhydrous

Magnesiumstearate

Yeastdried

BiscuitflavourF07012

Ammoniumglycyrrhizate

Macrogol6000

6.2Incompatibilities

Noneknown

Revised29/03/2010 –AN02535/2008

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:3years

Shelf-lifeafterfirstopeningtheimmediatepackaging:48hours.

Anydividedtabletportionsremainingafter48hoursshouldbediscarded.

6.4.Specialprecautionsforstorage

Donotstoreabove25

C

Dividedtabletsshouldbestoredintheblisterpack.

6.5Natureandcompositionofimmediatepackaging

Polyvinylchlorideblisterheatsealedwithanaluminiumcoverfoil.

Packsizes:

Cardboardboxwith1blisterof10tablets

Cardboardboxwith20blistersof10tablets

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproductor

wastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductshouldbedisposedofinaccordancewithlocalrequirements

7. MARKETINGAUTHORISATIONHOLDER

SogevalSA

200avenuedeMayenne –BP2227

53022LAVALCedex9

France

Tel:33.2.43.49.51.51

Fax:33.2.43.53.97.00

E-mail: sogeval@sogeval.fr

8. MARKETINGAUTHORISATIONNUMBER

Vm20749/4004

9. DATEOFFIRSTAUTHORISATION

27February2009

10 DATEOFREVISIONOFTHETEXT

29March2010

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable