Therios

Main information

  • Trade name:
  • Therios 750 mg Palatable Tablets for Dogs
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Therios 750 mg Palatable Tablets for Dogs
    Ireland
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0347/002
  • Authorization date:
  • 04-01-2011
  • EU code:
  • UK/V/0347/002
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:May2012

AN:00601/2011

Page-1-of6

SUMMARYOFPRODUCTCHACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

UK,AT,IE,PL,CZ,BE,

HU,GK,LUX,NL,PT Therios750mgpalatabletabletsfordogs

IT,ES,FI Therios750mgflavouredtabletsfordogs

Therios750mgaromatisierteTablettenfürHunde

NO Therios750mg,tyggetabletttilhund.

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Activesubstance:

Eachtabletcontains:

Cefalexin(ascefalexinmonohydrate)...........................750mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Tablet

Roundscoredbeigepalatabletablet

Thetabletcanbedividedintoequalhalvesandquarters

4. CLINICALPARTICULARS

4.1Targetspecies

Dogs

4.2Indicationsforuse,specifyingthetargetspecies

Forthetreatmentofbacterialskininfectionsindogs(includingdeepand

superficialpyoderma)causedbyorganismssensitivetocefalexin.

Forthetreatmentofurinarytractinfectionsindogs(includingnephritisandcystitis)

causedbyorganismssensitivetocefalexin.

4.3Contraindications

Donotuseinanimalswhichareknowntobehypersensitivetopenicillins.

Donotuseincaseofsevererenalfailure

Donotuseinrabbits,guineapigs,hamstersandgerbils.

4.4Specialwarningsforeachtargetspecies

None.

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4.5Specialprecautionsforuse

i. Specialprecautionsforuseinanimals

Aswithotherantibioticswhichareexcretedmainlybythekidneys,systemic

accumulationmayoccurwhenrenalfunctionisimpaired.Incaseofknown

renalinsufficiencythedoseshouldbereduced.

Theproductisnotrecommendedforuseindogslessthan6kgbodyweight.

Whereverpossible,theuseoftheproductshouldbebasedonsusceptibility

testingandtakeintoaccountofficialandlocalantimicrobialpolicies.

Safetyoftheexcipient,ammoniumglycyrrhizate,hasnotbeenestablishedin

dogslessthan1yearold.

ii. Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Cephalosporinsmaycausesensitization(allergy)followinginjection,

inhalation,ingestionorskincontact.Sensitivitytopenicillinsmayleadto

crosssensitivitytocephalosporinandviceversa.Allergicreactionstothese

substancesmayoccasionallybeserious.

1.Donothandlethisproductifyouknowyouaresensitizedorifyouhave

beenadvisednottoworkwithsuchpreparations.

2.Handlethisproductwithgreatcaretoavoidexposure,takingall

recommendedprecautions.Washhandsafteruse.

3.Ifyoudevelopsymptomsfollowingexposuresuchasskinrashyoushould

seekmedicaladviceandshowthedoctorthiswarning.Swellingsoftheface,

lipsoreyesordifficultybreathingaremoreserioussymptomsandrequire

urgentmedicalattention.

Intheeventofaccidentalingestion,particularlybyachild,seekmedial

attentionandshowthedoctortheleaflet

4.6Adversereactions(frequencyandseriousness)

Vomitinganddiarrhoeahavebeenobservedindogs.Inrarecases

hypersensitivitycanoccur.

4.7Useduringpregnancy,lactationorlay

Donotuseinpregnantorlactatingbitches.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Inordertoensureefficacy,theproductshouldnotbeusedincombinationwith

bacteriostaticantibiotics.

Revised:May2012

AN:00601/2011

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Concurrentuseoffirstgenerationcephalosporinswithaminoglycosideantibiotics

orsomediureticssuchasfurosemidecanenhancenephrotoxicityrisks

4.9Amountstobeadministeredandadministrationroute

Fororaladministration.

15mgcefalexinperkgbodyweighttwicedaily(equivalentto30mgperkg

bodyweightperday)fordurationof:

-14daysincasesofurinarytractinfection

-Atleast15daysincasesofsuperficialinfectiousdermatitis

-Atleast28daysincasesofdeepinfectiousdermatitis

Insevereoracuteconditionsthedosemaybesafelydoubledto30mg/kgtwice

daily.Toallowforaccuracyofdosing,tabletscanbehalvedorquartered.

Toensureacorrectdosagebodyweightshouldbedeterminedasaccuratelyas

possibletoavoidunderdosing.

Theriostabletsarewellacceptedbydogsbutmaybecrushedoraddedtoasmall

quantityoffoodimmediatelypriortofeedingifnecessary

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Trialsperformedonanimalswithupto5timestherecommendedtwicedaily

dosageof15mg/kgdemonstratedthatcefalexinwaswelltolerated.

4.11Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antibacterialforsystemicuse,first-generation

cephalosporin

ATCvetcode:QJ01DB01

Cefalexinmonohydrate,theactiveingredientoftheTheriostablets,isa

bactericidalantibioticofthecephalosporinfamily,obtainedbyhemi-synthesisof

the7amino-cephalosporanicnucleus.

5.1Pharmacodynamicproperties

Cefalexinactsbyinhibitingthenucleopeptidesynthesisofthebacterialwall.

Cephalosporinsinterferewithtranspeptidationbyacylatingtheenzymemakingit

unabletocross-linkmuramicacid-containingpeptidoglycanstrands.Theinhibition

ofthebiosynthesisofthematerialrequiredtobuildthecellwallresultsina

defectivecellwallandconsequentlyosmoticallyunstabletoprotoplasts.The

combinedactionresultsincelllysisandfilamentformation.Cefalexinisactive

Revised:May2012

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againstGrampositiveandGramnegativebacteriasuchasStaphylococcusspp

(includingpenicillin-resistantstrains),Streptococcusspp.,.,Escherichia.coli,and

Klebsiellaspp,.Cefalexinisnotinactivatedbybeta-lactamasesproducedby

Grampositivebacteria.However,beta-lactamasesproducedbygram-negative

bacteriacaninhibitcefalexinbyhydrolysisofthebeta-lactamcycle.Resistanceis

transmittedbyplasmidicorchromosomicroute.

Cefalexinisnotinactivatedbythestaphylococcalbeta-lactamasesbuthasa

moderateactivityagainstnon-transferable(chromosomal)beta-lactamase

producinggram-negativeenterobacteriacceaeandfastidiousgram-negatives.No

antibacterialactivityisobtainedagainstEnterobacterspp.,P.aeruginosaand

Serratiaspp.

Cefalexinhasatime-dependentbactericidalactivityagainstStaphylococcusspp

andPasteurellamultocida.

Thecefalexincriticalbreakpoints(MICvalue)forpathogensofveterinary

importanceweresetupat:

- Susceptible:≤8mg/L

-Resistant:>32mg/L

Staphylococcusspp,Streptococcusspp,E.coliandKlebsiellasppandP.

multocidaaresusceptibletocefalexin.MIC90valuesforcefalexindeterminedin

targetbacterialstrainsisolatedfromdiseaseddogsinEuropeandintheUSAare:

-S.pseudintermedius:2µg/mL

-S.aureus:8µg/mL

-S.canis ≤0.5µg/mL

-Beta-hemolyticStreptococcusspp:2µg/mL

-E.coli:16µg/mL

-P.multocida:2µg/mL

-Klebsiella.spp:4µg/mL

Resistancetocefalexinmaybeduetooneofthefollowingmechanismsof

resistance.Firstly,theproductionofvariousbeta-lactamases(cephalosporinase),

thatinactivatetheantibiotic,isthemostprevalentmechanismamonggram-

negativebacteria.Secondly,adecreasedaffinityofthePBPs(penicillin-binding

proteins)forbeta-lactamdrugsisfrequentlyinvolvedforbeta-lactamresistant

gram-positivebacteria.Lastly,effluxpumps,extrudingtheantibioticfromthe

bacterialcell,andstructuralchangesinporins,reducingpassivediffusionofthe

drugthroughthecellwall,maycontributetoimprovetheresistantphenotypeofa

bacterium.

Well-knowncross-resistance(involvingthesameresistancemechanism)exists

betweenantibioticsbelongingtothebeta-lactamgroupduetostructural

similarities.Itoccurswithb-lactamasesenzymes,structuralchangesinporinsor

variationsineffluxpumps.Co-resistance(differentresistancemechanisms

involved)hasbeendescribedinE.coliduetoaplasmidharbouringvarious

resistancegenes.

5.2Pharmacokineticparticulars

Aftersingleoraladministrationoftherecommendeddosageof15mgcefalexin

perkgbodyweighttoBeagledogs,plasmaconcentrationswereobservedwithin

30minutes.Theplasmapeakwasobservedat1.33hwithaplasmaconcentration

of21.2µg/ml.Thebioavailabilityoftheactivewasover90%.Cefalexinwas

Revised:May2012

AN:00601/2011

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detecteduntil24hoursaftertheadministration.Thefirsturinespecimenwas

collectedwithin2to12hourswithpeakconcentrationsofcefalexinmeasuredat

430to2758µg/mlwithin12hours.

Afterrepeatedoraladministrationofthesamedosage,twiceadayfor7days,

plasmapeaksoccurred2hourslaterwithaconcentrationof20µg/ml.Overthe

treatmentperiodconcentrationsweremaintainedabove1µg/ml.Themean

eliminationhalflifeis2hours.Skinlevelswerearound5.8to6.6µg/g2hours

aftertreatment.

5.3Environmentalproperties

Notapplicable.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Croscarmellosesodium

Silica,colloidalanhydrous

Magnesiumstearate

Yeastdried

BiscuitflavourF07012

Ammoniumglycyrrhizate

Macrogol6000

6.2Incompatibilities

Noneknown

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:3years

Shelf-lifeafterfirstopeningtheimmediatepackaging:48hours.

Anydividedtabletportionsremainingafter48hoursshouldbediscarded.

6.4.Specialprecautionsforstorage

Donotstoreabove25

C

Dividedtabletsshouldbestoredintheblisterpack.

6.5Natureandcompositionofimmediatepackaging

Polyvinylchlorideblisterheatsealedwithanaluminiumcoverfoil.

Packsizes:

Cardboardboxwith1blisterof10tablets

Cardboardboxwith3blistersof10tablets

Cardboardboxwith20blistersof10tablets

Revised:May2012

AN:00601/2011

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Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductshouldbedisposedofinaccordancewithlocal

requirements

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

Vm 20749/4013

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Date:27 th

February2009

10.DATEOFREVISIONOFTHETEXT

Date:May2012

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable

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

30-10-2018

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Active substance: Glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-cystine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine) - Orphan designation - Commission Decision (2018)7277 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/100/18

Europe -DG Health and Food Safety

27-7-2018

EU/3/16/1635 (Leadiant GmbH)

EU/3/16/1635 (Leadiant GmbH)

EU/3/16/1635 (Active substance: N-acetyl-D-mannosamine monohydrate) - Transfer of orphan designation - Commission Decision (2018)5053 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/228/15/T/01

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/811 (Celgene Europe B.V.)

EU/3/10/811 (Celgene Europe B.V.)

EU/3/10/811 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3809 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/092/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/810 (Celgene Europe B.V.)

EU/3/10/810 (Celgene Europe B.V.)

EU/3/10/810 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3808 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/084/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3803 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/069/10/T/03

Europe -DG Health and Food Safety