Therios 300 mg Palatable Tablets for Dogs

Main information

  • Trade name:
  • THERIOS 300 MG COMPRIMIDOS SABOR PARA PERROS
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • THERIOS 300 MG COMPRIMIDOS SABOR PARA PERROS
    Spain
  • Language:
  • English

Therapeutic information

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

Other information

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

4-12-2018

FDA Approves Pexion for Treating Noise Aversion in Dogs

FDA Approves Pexion for Treating Noise Aversion in Dogs

The U.S. Food and Drug Administration announced today that its Center for Veterinary Medicine has approved Pexion (imepitoin tablets) to treat noise aversion in dogs. Dogs with noise aversion are sensitive to loud noises such as fireworks, street/traffic noises, and gun shots.

FDA - U.S. Food and Drug Administration

30-10-2018

Sciegen Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Irbesartan Tablets, USP  75 Mg, 150 Mg, and 300 Mg Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in The Active Pharmaceutical Ingredient (API)

Sciegen Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Irbesartan Tablets, USP 75 Mg, 150 Mg, and 300 Mg Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in The Active Pharmaceutical Ingredient (API)

ScieGen Pharmaceuticals, Inc. is voluntarily recalling listed lots, within expiry, of Irbesartan Tablets, USP 75 mg, 150 mg, and 300 mg dosage forms to the consumer level. These products are being recalled due to the presence of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Irbesartan, USP manufactured by Aurobindo Pharma Limited. This impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a...

FDA - U.S. Food and Drug Administration

12-9-2018

FDA takes new steps to address epidemic of youth e-cigarette use, including a historic action against more than 1,300 retailers and 5 major manufacturers for their roles perpetuating youth access

FDA takes new steps to address epidemic of youth e-cigarette use, including a historic action against more than 1,300 retailers and 5 major manufacturers for their roles perpetuating youth access

FDA takes new steps to address epidemic of youth e-cigarette use, including a historic action against more than 1,300 retailers and 5 major manufacturers for their roles perpetuating youth access

FDA - U.S. Food and Drug Administration

19-7-2018

Openfoodtox: over 300 substances added to EFSA chemical hazards database

Openfoodtox: over 300 substances added to EFSA chemical hazards database

Openfoodtox: over 300 substances added to EFSA chemical hazards database

Europe - EFSA - European Food Safety Authority Press Releases & News Stories

17-3-2017

Withdrawal of a batch of EpiPen® 300 micrograms

Withdrawal of a batch of EpiPen® 300 micrograms

MEDA recalls a batch of the adrenaline product EpiPen® 300 micrograms/dose, which is used for sudden allergic reactions. There is a risk that the auto-injector does not work. The withdrawal concerns product number 578818 with batch number: 5FA665B and expiry date 03/2017.

Danish Medicines Agency

21-2-2017

Takeda Pharma A/S recalls batch of Pamol® in packs of 300 film-coated tablets

Takeda Pharma A/S recalls batch of Pamol® in packs of 300 film-coated tablets

Takeda Pharma A/S recalls a batch of Pamol® in packs of 300 film-coated tablets after the discovery of Ibumetin 600 mg containing ibuprofen in some packs. Both types of medicine are used for the treatment of mild pain, but they work in different ways and may cause different adverse reactions.

Danish Medicines Agency

There are no news related to this product.