CLINDASEPTIN 25 MG/ML ORAL SOLUTION FOR CATS AND DOGS

Main information

  • Trade name:
  • CLINDASEPTIN 25 MG/ML ORAL SOLUTION FOR CATS AND DOGS
  • Pharmaceutical form:
  • Oral solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CLINDASEPTIN 25 MG/ML ORAL SOLUTION FOR CATS AND DOGS
    Netherlands
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • clindamycin
  • Therapeutic area:
  • Cats, Dogs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0236/001
  • Authorization date:
  • 23-02-2012
  • EU code:
  • FR/V/0236/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Clindaseptin25mg/mlOralSolutionforCatsandDogs.

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Onemlcontains:

Activesubstance:

Clindamycin 25mg

(asClindamycinhydrochloride27.15mg)

Excipients

Ethanol96% 90.56mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Oralsolution.

Clear,colourlesssolution.

4. CLINICALPARTICULARS

4.1 Targetspecies

Catsanddogs.

4.2 Indicationsforuse,specifyingthetargetspecies

Cats:

Forthetreatmentofinfectedwoundsandabscessescausedbyclindamycin-sensitivespeciesof

StaphylococcussppandStreptococcusspp.

Dogs:

Forthetreatmentofinfectedwounds,abscessesandoralcavity/dentalinfectionscausedbyor

associatedwithclindamycin-sensitivespeciesofStaphylococcusspp,Streptococcusspp,

Bacteroidesspp,Fusobacteriumnecrophorum,Clostridiumperfringens

Adjunctivetreatmentofmechanicalorsurgicalperiodontaltherapyinthetreatmentof

infectionsofthegingivalandperiodontaltissues

ForthetreatmentofosteomyelitiscausedbyStaphylococcusaureus

4.3 Contraindications

Donotuseinrabbits,hamsters,guineapigs,chinchillas,horsesorruminantsbecauseingestionof

clindamycinbythesespeciesmaycauseseveregastrointestinaldisorders.

Donotuseincasesofhypersensitivitytoeitherclindamycinorlincomycin,ortoanyofthe

excipients.

4.4 Specialwarnings<foreachtargetspecies>

None.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Inappropriateuseoftheproductmayincreasetheprevalenceofbacteriaresistanttoclindamycin.

Wheneverpossible,clindamycinshouldonlybeusedbasedonsusceptibilitytesting.

Officialnationalandlocalantimicrobialpoliciesshouldbetakenintoaccountwhentheproductis

used.

Clindamycinshowsparallel-resistancewithlincomycinandco-resistancewitherythromycin.Thereis

apartialcross-resistancetoerythromycinandothermacrolides.

Incaseofadministrationofhighdosesofclindamycinorduringprolongedtherapyofonemonthor

greater,testsforliverandrenalfunctionsandbloodcountsshouldbeperformedperiodically.

Indogsandcatswithkidneyproblemsand/orliverproblems,accompaniedbyseveremetabolic

aberrations,thedosetobeadministeredshouldbecarefullydeterminedandtheirconditionshouldbe

monitoredbyperformingserumtestsduringtreatment.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproduct

toanimals

Washhandsafteradministration.

Peoplewithknownhypersensitivitytolincosamides(lincomycinandclindamycin)shouldavoid

contactwiththeveterinarymedicinalproduct.

Incaseofaccidentalingestion,seekmedicaladviceimmediatelyandshowthepackageleafletorthe

labeltothephysician.

Otherprecautions:

None.

4.6 Adversereactions(frequencyandseriousness)

Vomitinganddiarrhoeaareoccasionallyobserved.

Clindamycinsometimescausestheovergrowthofnon-sensitiveorganismssuchasresistantclostridia

andyeasts.Ifsuperinfectionoccurs,thetreatmentshouldbestoppedandappropriatemeasuresshould

betakenbasedontheclinicalsituation.

4.7 Useduringpregnancy,lactationorlay

Whilehighdosestudiesinratssuggeststhatclindamycinisnotateratogenanddoesnotsignificantly

affectthebreedingperformanceofmalesandfemales,thesafetyoftheveterinarymedicinalproduct

ingestatingbitches/queensorbreedingmaledogs/catshasnotbeenestablished.

Useonlyaccordingtothebenefit/riskassessmentbytheresponsibleveterinarian.

Clindamycincanpasstheblood-milkbarrier.Asaconsequence,treatmentoflactatingfemalescan

causediarrhoeainpuppies.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Neuromuscularblockingeffectswereobservedwithclindamycin,whichmaypossiblyenhancethe

activityofotherneuromuscularblockingagents.Thesimultaneoususeofsuchproductsmustbe

madewithcaution.

Donotuseclindamycintogetherwithchloramphenicolormacrolidesastheysharethesamebinding

siteontheribosomes.

Duringthesimultaneoususeofclindamycinandaminoglycosides(eggentamicin),theriskofadverse

interactions(acuterenalfailure)cannotbeexcluded.

Clindamycinmayreducethelevelsofcyclosporine,concomitantuseshouldbeavoided.

4.9 Amountstobeadministeredandadministrationroute

Fororaladministrationonly.

Recommendeddosage:

Cats:

-infectedwounds,abscesses:11 mgclindamycinperkgofbodyweightper24hor5.5 mg

/kgper12hfor7 to 10 days

Thetreatmentshouldbestoppedifnotherapeuticeffectisobservedafter4 days.

Dogs:

-Infectedwounds,abscessesandoralcavity/dentalinfections:11 mgclindamycinperkgof

bodyweightper24hor5.5 mg/kgper12hfor7 to10 days.

Thetreatmentshouldbestoppedifnotherapeuticeffectisobservedafter4 days.

-Treatmentofboneinfections(osteomyelitis):11 mgclindamycinperkgofbodyweight

every12 hoursduringaperiodof28 daysminimum.Thetreatmentshouldbediscontinuedif

notherapeuticeffectisobservedinthefirst14 days.

Dosage Volumetobeadministeredperkgbodyweight

5.5mg/kg Correspondingapproximatelyto0.25mlperkg

11mg/kg Correspondingapproximatelyto0.5mlperkg

A3mlgraduatedsyringeisprovidedtofacilitatetheadministrationoftheveterinarymedicinal

product.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Dosesof300mg/kgweretoleratedbydogswithouthavingadverseeffects.Vomiting,lossof

appetite,diarrhoea,leukocytosisandelevationsinliverenzymes(AST,ALT)wereobserved

occasionally.Insuchcases,discontinuetreatmentimmediatelyandestablishasymptomatic

treatment.

4.11Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup: Anti-infectivesforsystemicuse, lincosamides.

ATCvet-code:QJ01FF01.

5.1 Pharmacodynamicproperties

Clindamycinismainlyabacteriostaticantibioticbelongingtothegroupoflincosamides.

Clindamycinisachlorinatedanalogueoflincomycin. Itworksbyinhibitingbacterialprotein

synthesis.Thereversiblecouplingtothesub-unit50-Sbacterialribosomeinhibitstranslationof

aminoacidslinkedtothetRNA,therebypreventingelongationofthepeptidechain.Thatiswhythe

modeofactionofclindamycinispredominantlybacteriostatic.

Clindamycinandlincomycinhavecross-resistance,whichisalsocommonbetweenerythromycinand

othermacrolides.

Acquiredresistancecanoccur,bymethylationoftheribosomalbindingsiteviachromosomal

mutationingrampositiveorganisms,orbyplasmid-mediatedmechanismsingramnegative

organisms

ClindamycinisactiveinvitroagainstmanyGram-positivebacteria,Grampositiveand

Gram-negativeanaerobicbacteria.MostaerobicorfacultativeGram-negativebacteriaare

resistanttoclindamycin.

CLSIclindamycinveterinarybreakpointsareavailablefordogsinStaphylococcusspp.inskinand

softtissueinfections:S≤0.5µg/ml;I=1-2µg/ml;R≥4µg/ml(CLSIJanuary2010).

5.2 Pharmacokineticparticulars

Clindamycinisalmostcompletelyabsorbedafteroraladministration.Maximumserumconcentrations

of8µg/ml(withoutinfluenceofthebolus)wereobtained1hourafteradoseof11mgperkg.

Clindamyciniswidelydistributedandcanconcentrateincertaintissues.

Thehalf-lifeofclindamycinisabout4hours.Approximately70%ofclindamycinisexcretedin

faecesandabout30%inurine.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Ethanol96%

Sorbitol,liquid(non-crystallising)

DisodiumEdetate

PropyleneGlycol

SodiumSaccharin

CitricAcidMonohydrate

Purifiedwater

6.2 Incompatibilities

Donotmixthisproductwithanyotherveterinarymedicinalproducts.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:1year

Shelf-lifeafterfirstopeningtheimmediatepackaging:28days

6.4.Specialprecautionsforstorage

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

6.5 Natureandcompositionofimmediatepackaging

Cartonboxcontainingclearpolyethyleneterephthalate(PET)bottleof22mlwithHDPE/LDPE

tamperproofclosuresuppliedwithalowdensitypolyethylenemeasuringsyringe.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

ChanellePharmaceuticalManufacturingLimited

Loughrea,Co.Galway

Ireland

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10 DATEOFREVISIONOFTHETEXT

Tobesuppliedonlyonveterinaryprescription.

Administrationbyaveterinarysurgeonorundertheirdirectresponsibility.

<PARTICULARSTOAPPEARONTHEOUTERPACKAGE>

{Carton}

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Clindaseptin25mg/mlOralSolutionforCats&Dogs

Clindamycin

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Eachmlcontainsclindamycin25mg(ashydrochloride)andethanol(96%)90.6mg

3. PHARMACEUTICALFORM

OralSolution

4. PACKAGESIZE

22ml

5. TARGETSPECIES

CatsandDogs.

6. INDICATIONS

7. METHODANDROUTEOFADMINISTRATION

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

NotApplicable

9. SPECIALWARNINGS,IFNECESSARY

Readthepackageleafletbeforeuse.

10. EXPIRYDATE

EXP

Shelflifeafterfirstopeningthecontainer:28days.

Onceopened,useby:

11. SPECIALSTORAGECONDITIONS

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Disposal:Readpackageleaflet;

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly

Tobesuppliedonlyonveterinaryprescription.

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

ChanellePharmaceuticalsManufacturingLtd.,Loughrea,Co.Galway.

16. MARKETINGAUTHORISATIONNUMBER(S)

17. MANUFACTURER’SBATCHNUMBER

Lot

MINIMUMPARTICULARSTOAPPEARONSMALLIMMEDIATEPACKAGINGUNITS

{Label}

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Clindaseptin25mg/mlOralSolutionforCats&Dogs.

Clindamycin

2. QUANTITYOFTHEACTIVESUBSTANCE(S)

Clindamycin25mg/ml

3. CONTENTSBYWEIGHT,BYVOLUMEORBYNUMBEROFDOSES

22ml

4. ROUTEOFADMINISTRATION

Oraluse

5. WITHDRAWALPERIOD

NotApplicable

6. BATCHNUMBER

Lot

7. EXPIRYDATE

EXP

Onceopened,useby:

8. THEWORDS“FORANIMALTREATMENTONLY”

Foranimaltreatmentonly.

PACKAGELEAFLET

Clindamycin25mg/mlOralSolutionforCats&Dogs

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERAND

OFTHEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFOR

BATCHRELEASE,IFDIFFERENT

ChanellePharmaceuticalsManufacturingLtd.,Loughrea,Co.Galway,Ireland.

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Clindaseptin25mg/mlOralSolutionforCats&Dogs.

Clindamycin

3. STATEMENTOFTHEACTIVESUBSTANCESANDOTHERINGREDIENT

Onemlcontains:

Activesubstance:

Clindamycin 25mg

(asClindamycinhydrochloride27.15mg)

Excipients

Ethanol 96 % 90.56mg

Clear,colourlesssolution.

4. INDICATIONS

Cats:

Forthetreatmentofinfectedwoundsandabscessescausedbyclindamycin-sensitivespeciesof

StaphylococcussppandStreptococcusspp.

Dogs:

Forthetreatmentofinfectedwounds,abscessesandoralcavity/dentalinfectionscausedbyor

associatedwithclindamycin-sensitivespeciesofStaphylococcusspp,Streptococcusspp,

Bacteroidesspp,Fusobacteriumnecrophorum,Clostridiumperfringens

Adjunctivetreatmentofmechanicalorsurgicalperiodontaltherapyinthetreatmentof

infectionsofthegingivalandperiodontaltissues

ForthetreatmentofosteomyelitiscausedbyStaphylococcusaureus

5. CONTRAINDICATIONS

Donotuseinrabbits,hamsters,guineapigs,chinchillas,horsesorruminantsbecause

ingestionofclindamycinbythesespeciesmaycauseseveregastrointestinaldisorders.

Donotuseincasesofhypersensitivitytoeitherclindamycinorlincomycin,orto anyofthe

excipients.

6. ADVERSEREACTIONS

Vomitinganddiarrhoeaareoccasionallyobserved.

Clindamycinsometimescausestheovergrowthofnon-sensitiveorganismssuchasresistantclostridia

andyeasts.Ifsuperinfectionoccurs,thetreatmentshouldbestoppedandappropriatemeasures

shouldbetakenbasedontheclinicalsituation.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinformyour

veterinarysurgeon.

7. TARGETSPECIES

Cats&Dogs

8. DOSAGEFOREACHSPECIES,ROUTEANDMETHODOFADMINISTRATION

Fororaladministrationonly.

Recommendeddosage:

Cats:

-infectedwounds,abscesses:11mgclindamycinperkgofbodyweightper24hor5.5mg/kgper

12hfor7to10days

Thetreatmentshouldbestoppedifnotherapeuticeffectisobservedafter4days.

Dogs:

-Infectedwounds,abscessesandoralcavity/dentalinfections:11mgclindamycinperkgofbody

weightper24hor5.5mg/kgper12hfor7to10days.

Thetreatmentshouldbestoppedifnotherapeuticeffectisobservedafter4days.

-Treatmentofboneinfections(osteomyelitis):11mgclindamycinperkgofbodyweightevery12

hoursduringaperiodof28daysminimum.Thetreatmentshouldbediscontinuedifnotherapeutic

effectisobservedinthefirst14days.

Dosage Volumetobeadministeredperkgbodyweight

5.5mg/kg Correspondingapproximatelyto0.25mlperkg

11mg/kg Correspondingapproximatelyto0.5mlperkg

9. ADVICEONCORRECTADMINISTRATION

A3mlgraduatedsyringeisprovidedtofacilitatetheadministrationoftheveterinarymedicinal

product.

10.WITHDRAWALPERIOD

NotApplicable.

11. SPECIALSTORAGEPRECAUTIONS

Keepoutofthereachandsightofchildren.

DonotuseaftertheexpirydatestatedonthelabelandcartonafterEXP.

Shelf-lifeafterfirstopeningthecontainer:28days

12. SPECIALWARNINGS

Specialprecautionsforuseinanimals

Inappropriateuseoftheproductmayincreasetheprevalenceofbacteriaresistanttoclindamycin.

Wheneverpossible,clindamycinshouldonlybeusedbasedonsusceptibilitytesting.SeeSection15

forinformationonclinicalbreakpointsforclindamycin.

Officialnationalandlocalantimicrobialpoliciesshouldbetakenintoaccountwhentheproductis

used.

Clindamycinshowsparallel-resistancewithlincomycinandco-resistancewitherythromycin.There

isapartialcross-resistancetoerythromycinandothermacrolides.

Incaseofadministrationofhighdosesofclindamycinorduring prolongedtherapyofone

monthorgreater,testsforliverandrenalfunctionsandbloodcountsshouldbeperformed

periodically.

Indogsandcatswithkidneyproblemsand/orliverproblems,accompaniedbyseveremetabolic

aberrations,thedosetobeadministeredshouldbecarefullydeterminedandtheirconditionshouldbe

monitoredbyperformingserumtestsduringtreatment.

Specialprecautionstobetakenbythepersonadministeringthemedicinalproducttoanimals

Washhandsafteradministration.

Peoplewithknownhypersensitivitytolincosamides(lincomycinandclindamycin)shouldavoid

contactwiththeveterinarymedicinalproduct.

Incaseofaccidentalingestion,seekmedicaladviceimmediatelyandshowthepackageleafletorthe

labeltothephysician.

Useduringpregnancy,lactationorlay

Whilehighdosestudiesinratssuggeststhatclindamycinisnotateratogenanddoesnotsignificantly

affectthebreedingperformanceofmalesandfemales,thesafetyoftheveterinarymedicinalproduct

ingestatingbitches/queensorbreedingmaledogs/catshasnotbeenestablished.Useonlyaccording

tothebenefit/riskassessmentbytheresponsibleveterinarian.

Clindamycincanpasstheblood-milkbarrier.Asaconsequence,treatmentoflactatingfemalescan

causediarrhoeainpuppies.

Interactionwithothermedicinalproductsandotherformsofinteraction

Neuromuscularblockingeffectswereobservedwithclindamycin,whichmaypossiblyenhancethe

activityofotherneuromuscularblockingagents.Thesimultaneoususeofsuchproductsmustbe

madewithcaution.

Donotuseclindamycintogetherwithchloramphenicolormacrolidesastheysharethesamebinding

siteontheribosomes.

Duringthesimultaneoususeofclindamycinandaminoglycosides(eggentamicin),theriskof

adverseinteractions(acuterenalfailure)cannotbeexcluded.

Clindamycinmayreducethelevelsofcyclosporine,concomitantuseshouldbeavoided.

Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Dosesof300mg/kgweretoleratedbydogswithouthavingadverseeffects.Vomiting,lossof

appetite,diarrhoea,leukocytosisandelevationsinliverenzymes(AST,ALT)wereobserved

occasionally.Insuchcases,discontinuetreatmentimmediatelyandestablishasymptomatic

treatment.

Incompatibilities

Donotmixthisproductwithanyotherveterinarymedicinalproducts.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIALS,IFANY

Medicinesshouldnotbedisposedofviawastewaterorhouseholdwaste.

Askyourveterinarysurgeonhowtodisposeofmedicinesnolongerrequired.Thesemeasuresshould

helptoprotecttheenvironment.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

MM/YYYY

15. OTHERINFORMATION

Packsize:

Cartonboxofonebottleof22ml

CLSIclindamycinveterinarybreakpointsareavailablefordogsinStaphylococcusspp.inskinand

softtissueinfections:S≤0.5µg/ml;I=1-2µg/ml;R≥4µg/ml(CLSIJanuary2010).

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