Therios

Main information

  • Trade name:
  • Therios 75
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Therios 75
    Ireland
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0213/001
  • Authorization date:
  • 09-06-2011
  • EU code:
  • FR/V/0213/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

VeterinaryMedicinalProduct

Therios75mgChewableTabletsforCats

PARTIB

SUMMARYOFTHEPRODUCT

CHARACTERISTICS

PharmaceuticalForm

ChewableTablet

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Therios75mgChewableTabletsforCats

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Each250mgtabletcontains

Activesubstance:

Cefalexin(ascefalexinmonohydrate)...........................................75mg

Excipient(s):

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Chewabletablet

Oblongscoredbeigetablet.Thetabletscanbedividedintoequalhalves

4. CLINICALPARTICULARS

4.1Targetspecies

Cats

4.2Indicationsforuse,specifyingthetargetspecies

Incats:

Infectionscausedbybacteriasusceptibletocefalexin

.LowerurinarytractinfectionsduetoE.coliandProteusmirabilis,

.Treatmentofcutaneousandsubcutaneousinfections:pyodermaduetoStaphylococcus.spp

andwoundsandabscessesduetoPasteurellaspp.

4.3Contraindications

Donotuseincaseofseverekidneyfailure

Donotuseinanimalswhichareknowntobehypersensitivetocephalosporinsoranyother

substancefromthe 

-lactamgroup.

Donotuseinrabbits,guineapigs,hamstersandgerbilsandothersmallrodents.

Theproductiscontra-indicatedincaseofaknownresistancetocefalexin.

4.4Specialwarningsforeachtargetspecies

None

4.5Specialprecautionsforuse

i)Specialprecautionsforuseinanimals

Aswithotherantibioticswhichareexcretedmainlybythekidneys,unnecessaryaccumulation

mayoccurinthebodywhenrenalfunctionisimpaired.Incasesofknownrenalinsufficiency,

thedoseshouldbereducedand/ortheintervalofadministrationincreased andnephrotoxic

drugsshouldnotbeadministeredconcurrently.

Whereverpossible,theuseoftheproductshouldbebasedonsusceptibilitytesting.

Officialandlocalantimicrobialpoliciesonantibiotherapyshouldbetakenintoaccountwhen

theproductisused.

UseoftheproductdeviatingfromtheinstructionsgivenintheSPCmayincreasethe

prevalenceofbacteriaresistanttothecefalexinandmaydecreasetheeffectivenessof

treatmentwithpenicillinsduetothepotentialforcrossresistance.

Thisproductshouldnotbeusedtotreatkittenslessthan9weeksofage.

Useoftheproductincatsweighinglessthan2.5kgshouldbeinaccordancewiththe

benefit/riskassessmentperformedbytheresponsibleveterinarian.

ii)Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Cephalosporinsmaycausesensitisation(allergy)followinginjection,inhalation,ingestionor

skincontact.Sensitivitytopenicillinsmayleadtocrosssensitivitytocephalosporinsandvice

versa.Allergicreactionstothesesubstancesmayoccasionallybeserious.

Donothandlethisproductifyouknowyouaresensitised,orifyouhavebeen

advisednottoworkwithsuchpreparations.

Handlethisproductwithgreatcaretoavoidexposuretakingallrecommended

precautions.Washhandsafteruse.

Ifyoudevelopsymptomsfollowingexposure,suchasskinrash,youshould

seekmedicaladviceandshowthedoctorthiswarning.Swellingoftheface,lips

oreyesordifficultyinbreathingaremoreserioussymptomsandrequireurgent

medicalattention.

Incaseofaccidentalingestion,seekmedicalattentionandshowthepackage

leafletorthelabeltothedoctor.

4.6Adversereactions(frequencyandseriousness)

Vomitingand/ordiarrhoeahavebeenobservedincats.Incaseofrecurringvomitingand/or

diarrhoea,thetreatmentshouldbediscontinuedandtheadviceoftheattendingveterinarian

sought.

Allergicreactionsarepossiblewithcefalexinandallergiccross- reactivitywithotherβ-lactams

mayoccur..

4.7 Useduringpregnancy,lactationorlay

Laboratorystudiesinmouse,ratandrabbithavenotproducedanyevidenceofteratogenic

effects.Thesafetyoftheproducthasnotbeeninvestigatedinpregnantorlactatingcatsand

shouldonlybeusedaccordingtothebenefit/riskassessmentbytheresponsibleveterinarian.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Thebactericidalactivityofcephalosporinsisreducedbyconcomitantadministrationof

bacteriostaticactingcompounds(macrolides,sulfonamidesandtetracyclines).

Nephrotoxicitycanbeincreasedwhen1 st

generationcephalosporinsarecombinedwith

polypeptideantibiotics,aminoglycosidesorsomediuretics(furosemide).

Concomitantusewithsuchactivesubstancesshouldbeavoided.

4.9Amountstobeadministeredandadministrationroute

Oraluse.

15mgcefalexinperkgbodyweighttwicedaily,equivalentto1tabletfor5kgbodyweightfor:

-5daysforwoundsandabscesses

-10to14daysincaseofurinarytractinfections,

-14daysatleastincaseofpyoderma.Thetreatmentmustbecontinuedfor10daysonce

thelesionshavedisappeared.

Toensureacorrectdosagebodyweightshouldbedeterminedasaccuratelyaspossibleto

avoidunderdosing

Incaseofuseofhalftablets, puttheremainingquantityofthetabletbackintotheblister

pocketanduseitforthenextadministration.

Thetabletsareflavoured.Theycanbeadministeredwithfoodordirectlyintothemouthofthe

animal.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Notapplicable

4.11Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Cefalexinmonohydrateisabactericidalantibioticofthecephalosporinfamily,obtainedby

hemi-synthesisofthe7-aminocephalosporanicnucleus.

Pharmacotherapeuticgroup:Antibacterialforsystemicuse,first-generationcephalosporin

ATCvetcode:QJ01DB01

5.1Pharmacodynamicproperties

Cefalexinactsbyinhibitingthenucleopeptidesynthesisofthebacterialwall.Cephalosporins

interferewithtranspeptidationbyacylatingtheenzymemakingitunabletocross-linkmuramic

acid-containingpeptidoglycanstrands.Theinhibitionofthebiosynthesisofthematerial

requiredtobuildthecellwallresultsinadefectivecellwallandconsequentlyosmotically

unstabletoprotoplasts.Thecombinedactionresultsincelllysisandfilamentformation.

CefalexinisactiveagainstGrampositiveandGramnegativebacteriasuchas

Staphylococcusspp(includingpenicillin-resistantstrains),Streptococcusspp.,and

EscherichiaColi.Cefalexinisnotinactivatedbyβ-lactamasesproducedbyGrampositive

bacteria.However,beta-lactamasesproducedbygram-negativebacteriacaninhibitcefalexin

byhydrolysisofthebeta-lactamcycle.

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

Incats,thebioavailabilityafteroraladministrationisaround56%.

Incats,afterasingleoraladministrationof18.5mg/kgofcefalexin,theplasmaticpeakwas

reachedafter1.6hwithaconcentrationof22µg/ml.

Cefalexinwasdetectedinplasmatill24hoursafteradministration.

Thediffusionofcefalexinintissueishigh.Cefalexinismainlyeliminatedbyurinaryroute

(85%)underactiveform,urinaryconcentrationpeaksaresignificantlyhigherthanplasmatic

concentrationpeaks.

Environmentalproperties

Notapplicable

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Pigliverpowder

Yeast

Croscarmellosesodium

Magnesiumstearate

Anhydrouscolloidalsilica

Calciumhydrogenphosphatedihydrate

6.2Incompatibilities

None

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:

Polyvinylchloride/thermo-elast/polyvinylidenechloride –aluminiumheatsealedblister: 3years

Polyamide/aluminium/polyvinylchloride –aluminiumheatsealedblister:30months

Anydividedtabletportionsremainingafter24hoursshouldbediscarded

6.4.Specialprecautionsforstorage

Donotstoreabove25°C

Storeintheoriginalpackage

Returnanyhalvedtablettotheopenedblisterpack

6.5Natureandcompositionofimmediatepackaging

Blister:

Polyvinylchloride/thermo-elast/polyvinylidenechloride –aluminiumheatsealed

containing10tabletsperblister

Polyamide/aluminium/polyvinylchloride –aluminiumheatsealedcontaining10

tabletsperblister

Cardboardboxwith1blisterof10tablets

Cardboardboxwith2blistersof10tablets

Cardboardboxwith10blistersof10tablets

Cardboardboxwith15blistersof10tablets

Cardboardboxwith20blistersof10tablets

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproductor

wastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

LaboratoiresSOGEVAL

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(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10 DATEOFREVISIONOFTHETEXT

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Tobecompletedinaccordancewithnationalrequirements

1-10-2018

Public Notification: FX75000 contains hidden drug ingredient

Public Notification: FX75000 contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use FX75000, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

28-9-2018

Endo Pharmaceuticals Issues Voluntary Nationwide Recall for Two Lots of Robaxin® 750mg Tablets 100 Count Bottle Packs Due to Incorrect Daily Dosing Information on Label

Endo Pharmaceuticals Issues Voluntary Nationwide Recall for Two Lots of Robaxin® 750mg Tablets 100 Count Bottle Packs Due to Incorrect Daily Dosing Information on Label

Endo International plc (NASDAQ: ENDP) today announced that one of its operating companies, Endo Pharmaceuticals Inc., is voluntarily recalling two lots of Robaxin® (methocarbamol tablets, USP) 750mg Tablets 100 Count Bottle pack to the consumer level. The products have been found to have incorrect daily dosing information on the label due to a labeling error which misstates the daily dose as "two to four tablets four times daily" rather than the correct dosage of "two tablets three times daily." (see pic...

FDA - U.S. Food and Drug Administration

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