DFV Coliplus

Main information

  • Trade name:
  • Coliplus
  • Pharmaceutical form:
  • Oral solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Coliplus
    Germany
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • colistin
  • Therapeutic area:
  • Cattle Young, Chicken, Other Young, Pigs

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0313/001
  • Authorization date:
  • 28-10-2010
  • EU code:
  • UK/V/0313/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Revised:December2010

AN:00921/2010

Page1of6

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Coliplus2,000,000IU/mlConcentrateforOralSolutionforuseindrinking

waterforCattle,Sheep,SwineandChickens

ES:ColistinaDivasa2,000,000IU/mlConcentrateforOralSolutionforusein

drinkingwaterforCattle,Sheep,SwineandChickens

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Compositionfor1ml:

Activesubstance:

Colistin(asColistinsulfate) 2MIU(equivalentto83.33mg)

Excipient(s):

BenzylAlcohol 10mg

Disodiumedetate 0.1mg

Excipientsqs 1ml

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Concentratefororalsolutionforuseindrinkingwater.

Clearyellow-brownsolution.

4. CLINICALPARTICULARS

4.1 Targetspecies

Cattle(calves),sheep(lambs),swineandchickens

4.2 Indicationsforuse,specifyingthetargetspecies

Treatmentofgastrointestinalinfectionscausedbynon-invasiveEscherichiacoli

susceptibletocolistin.

4.3 Contraindications

Donotuseincaseofhypersensitivitytopolypeptideantibioticsortoanyofthe

excipients.

Donotuseincaseofresistancetothepolymyxin.

4.4 Specialwarningsforeachtargetspecies

Useoftheproductshouldbebasedonsusceptibilitytestingandtakeinto

accountofficialandlocalantimicrobialspolicies.

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4.5 Specialprecautionsforuse

i.Specialprecautionsforuseinanimals

Usingtheveterinarymedicinalproduct(antimicrobials)inpoultryshouldbein

accordancewithCommissionRegulationEC1177/2006andsubsequent

nationalrequirements.

Inthecaseofnewbornanimalsandofanimalswithseveregastrointestinaland

renaldisorderstheabsorptionofcolistinmaybeincreased.Neuro-and

nephrotoxicalterationsmayoccur.

ii.Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Peoplewithknownhypersensitivitytopolymyxinsshouldavoidcontactwiththe

veterinarymedicinalproduct.

Itisrecommendedtoweargloveswhenhandlingoradministeringthe

product.

Donoteat,drinkorsmokewhilehandlingtheproduct.

Incaseofaccidentaleyeexposure,washwithplentyofwaterandseekmedical

adviceimmediatelyandshowthelabeltothephysician.

Washhandsafteruse.

4.6Adversereactions(frequencyandseriousness)

Noneknown.

4.7Useduringpregnancy,lactationorlay

Thesafetyoftheveterinarymedicinalproducthasnotbeenestablishedduring

pregnancy,lactationorlayinthetargetspecies.Useonlyaccordinglytothe

risk/benefitoftheveterinarian.

Usingtheveterinarymedicinalproduct(antimicrobials)inpoultryshouldbein

accordancewithCommissionRegulationEC1177/2006andsubsequent

nationalrequirements.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Afteroraladministrationofcolistinsulphateinteractionwithanaestheticsand

myorelaxantsmaynotbeexcludedinindividualcases.Thecombinationwith

aminoglycosidesandlevamisoleshouldbeavoided.Theeffectsofcolistin

sulphatemaybeantagonizedbybinarycations(iron,calcium,magnesium)and

byunsaturatedfattyacidsandpolyphosphates.

4.9 Amountstobeadministeredandadministrationroute

Dosage:

Tobeadministeredorally:

Forcalves,lambsandpigstherecommendeddoseis100000IUofcolistinper

kilogrambodyweightdailyfor3-5consecutivedays.Therecommendeddaily

Revised:December2010

AN:00921/2010

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doseshouldbedividedintotwoiftheproductistobeadministereddirectlyinto

themouthoftheanimal.

Forpoultrytherecommendeddoseis75000IUofcolistinperkilogrambody

weightdailyfor3-5consecutivedays.

Administrationviadrinkingwater

Theuptakeofmedicatedwaterdependsonthephysiologicalandclinical

conditionsoftheanimals.Inordertoobtainthecorrectdosage,theconcentration

ofcolistinhastobeadjustedaccordingly.Carefullycalculatethetotalbodymass

tobetreatedandthetotaldailywaterconsumptionbeforeeachtreatment.

Medicatedwatershouldbemadeeveryday,immediatelypriortoprovision

Themedicatedwatershouldbetheonlysourceofdrinkingwaterfortheanimals

fortheentiredurationofthetreatmentperiod.

Withthefollowingformulawecancalculateanexactdosage:

.mlColiplus

perkgbody

weightandday

x Average

body

weight(kg)

=.mlColiplus

perlitreof

drinkingwater

Averagedailywaterintake(l/animal)

Administrationwithoutadosingpump:

Thetreatmentisdistributedinatankoveraperiodof24hours,for3consecutive

days.

Coliplusisaddedtoavolumeofthedrinkingwatercorrespondingtothevolume

consumedbytheanimalsoverthetreatmentperiod(24hours)toachieveadose

ofIUofcolistinperkgbodyweight.Thefollowingsequentialstepsshouldbe

followed:

Fromthedosageregimenandthetotalweightofanimalstobetreated,

determinethenecessaryquantityofactiveingredient,anddeducethenecessary

quantityofcommercialproduct.

Determinethemeanwaterconsumptionoftheanimalstobetreatedover24

hours.

Thefollowingformulacanbeapplied:

1) Calculationofproductsolutionvolumeateachday(V):

V(ml)=(DosageperdayinIU/kgb.w.xTotalweightofanimalstotreat)/

2,000,000IU.

2) Calculationofthequantityofdrinkingwatertoprepare(Q

water ):

water (L):(Meanindividualwaterconsumption/day)x(Numberofanimalstobe

treated)

Administrationviaadosingpump

Thetreatmentisdistributedoveraperiodof24hours,for3consecutivedays.

Revised:December2010

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Adosingpumpisusedtoaddastocksolutionatapre-determinedconcentration

tothedrinkingwater.Thepumpedvolumeisconstant,butthedrinkingfrequency

dependsontheflowrateofthecircuit.Theflowrate(F)throughthepumpisa

percentage.

Iftheproductisadministeredwithanautomateddrinkingwatersystem,wehave

tocalculatethevolumeandtheconcentrationofthestocksolution.Thefollowing

sequentialstepsshouldbefollowed:

1)Calculationofproductsolutionvolumeateachdistribution(V):

V(ml)=(DosageperdayinIU/kgb.w.xTotalweightofanimalstotreat)/

2,000,000IU

2)Calculationofthedrinkingwaterconcentration(C):

C(ml/L)=V/Totalvolumeofwaterconsumedbytheanimalsin24hours.

3)Calculationofthestocksolutionvolume(V

stock )

stock (L)=Totalvolumeofwaterconsumedbytheanimalsin24hoursxF

4)Calculationofthestocksolutionconcentration(Cstock):

stock (ml/L)=C/F”

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

None.

4.11Withdrawalperiod(s)

Meatandoffal:Calves,Lambs,PigandPoultry:1day

Eggs:Zerodays

Notpermittedforuseinanimalsproducingmilkforhumanconsumption.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:intestinalanti-infectives,antibiotics.

ATCvetcode:QA07AA10

Revised:December2010

AN:00921/2010

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5.1 Pharmacodynamicproperties

Colistinisapolypeptideantibioticbelongingtothepolymyxinclass.

Colistinexertsabactericidalactiononsusceptiblebacteriastrainsbydisruption

ofthebacteriacytoplasmicmembraneleadingtoanalterationofcellpermeability

andthenaleakageofintracellularmaterials.Colistinisbactericidalandis

primarilyeffectiveagainstarangeofgramnegativebacteria,suchas

enterobacteriaceaeandinparticularEscherichiacoli.Colistinpossesses

virtuallynoactivityagainstgram-positivebacteriaandfungi.

Gram-positivebacteriaarenaturallyresistanttocolistin,asaresomespeciesof

gram-negativebacteriasuchasProteusandSerrati.However,acquired

resistanceofgram-negativeentericbacteriatocolistinisrareandexplainedbya

singlestepmutation.

InvitrosensibilityofColistinagainstEscherichiacoliandSalmonella

typhimuriumstrainsisolatedfrompigsandEscherichiacoli,Salmonella

enteritidisandSalmonellatyphimuriumstrainsisolatedfrompoultryhavebeen

determined,withthefollowingMIC

50 andMIC

values:

50 MIC

90

Escherichiacolifrompigs 0,19µg/ml 4,0µg/ml

Salmonellatyphimuriumfrompigs 3,0µg/ml 4,0µg/ml

Escherichiacolifrompoultry 0,25µg/ml 0,38µg/ml

Salmonellatyphimuriumfrompoultry 3,0µg/ml 4,20µg/ml

Salmonellaenteritidisfrompoultry 3,0µg/ml 4,20µg/ml

AccordingtotheNCCLSstandard,thecriticalconcentrationforresistanceof

colistinis16µg/ml.ThesensitivityofEscherichiacoliandSalmonellaspeciesin

cattleandsheepissimilartothesensitivityofpigsandpoultrypathogens.These

valueswereobtainedin2006.

5.2 Pharmacokineticparticulars

Colistinispoorlyabsorbedfromthegastro-intestinaltract.Incontrasttoverylow

concentrationofcolistininserumandtissues,highandpersistentamountsare

presentwithinthedifferentsectionsofthegastro-intestinaltract.

Nosignificantmetabolismisobserved.

Colistinisalmostexclusivelyeliminatedviathefaeces.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Benzylalcohol

EDTAdisodiumsalt

Purifiedwater

6.2 Incompatibilities

Noneknown.

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6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years

Shelf-lifeafterfirstopeningtheimmediatepackaging:60days

Shelf-lifeafterdilutionorreconstitutionaccordingtodirections:24hoursafter

dilutioninwater.

6.4.Specialprecautionsforstorage

Storebelow25°C

6.5Natureandcompositionofimmediatepackaging

Natureofcontainer:

WhiteHDPEcontainerwithtamper-evidentaluminiumsealandHDPEscrew

cap

Packagesizes:250ml,1litreand5litres.

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfrom

suchveterinarymedicinalproductsshouldbedisposedofinaccordancewith

localrequirements.

7. MARKETINGAUTHORISATIONHOLDER

DIVASA-FARMAVIC,S.A.

Ctra.SantHipòlit,km71

08503GURB-VIC

Barcelona(Spain)

Tel:+34938860100

Fax:+34938860131

8. MARKETINGAUTHORISATIONNUMBER

Vm33229/4000

9. DATEOFFIRSTAUTHORISATION

8December2010

10. DATEOFREVISIONOFTHETEXT

December2010