Colfen

Main information

  • Trade name:
  • Colfen 200 SP, 200 mg/g granules for use in drinking water for pigs
  • Pharmaceutical form:
  • Granules for oral solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Colfen 200 SP, 200 mg/g granules for use in drinking water for pigs
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • florfenicol
  • Therapeutic area:
  • Pigs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0456/001
  • Authorization date:
  • 29-05-2013
  • EU code:
  • UK/V/0456/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Issued:June2013

AN:02085/2011

Page1of6

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

COLFEN200SP,200mg/ggranulesforuseindrinkingwaterforpigs.

(Denmark:ColfenSP)

(Spain:COLFEN200,200mg/ggranulesforuseindrinkingwaterforpigs)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachgcontains:

Activesubstance:

Florfenicol 200.0mg

Excipient(s):

Butylhydroxytoluene(E321) 1.0mg

Forafulllistofexcipients,seesection6.1

3. PHARMACEUTICALFORM

Granulesforuseindrinkingwater.

Whitetocreamwaxygranules.

4. CLINICALPARTICULARS

4.1Targetspecies

Pigs

4.2Indicationsforuse,specifyingthetargetspecies

ForthetreatmentofswinerespiratorydiseaseassociatedwithPasteurella

multocidasusceptibletoflorfenicol.

4.3Contraindications

Donotadministertoboarsintendedforbreedingpurposes.

Donotadministerincasesofpreviousallergicreactionstoflorfenicoloranyofthe

excipients.

Donotuseinpigletslessthan6weeksold.

4.4Specialwarningsforeachtargetspecies

Ifthereisnosignificantimprovementafter3daysoftreatment,thediagnosis

shouldbereviewedandifnecessarythetreatmentshouldbechanged.

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4.5Specialprecautionsforuse

i)Specialprecautionsforuseinanimals

Theveterinarymedicinalproductshouldbeusedinconjunctionwith

susceptibilitytesting.Official,nationalandregionalantimicrobialpolicies

shouldbetakenintoaccountwhentheproductisused.

Inappropriateuseoftheveterinarymedicinalproductmayincreasethe

prevalenceofbacteriaresistanttoflorfenicol.

Treatmentshouldnotexceed5days.

ii)Specialprecautionsforthepersonadministeringtheveterinarymedicinal

producttoanimals

Avoidskinandeyecontactwithproduct.

Donoteat,drinkorsmokewhenhandlingtheproductormixingitwith

water.

Donotuseinknowncasesofsensitivitytopolyethyleneglycols.

Incaseofaccidentalspillageontoskinrinsewithwater.

4.6Adversereactions(frequencyandseriousness)

Diarrhoeahasbeenverycommonlyreported(upto30%ofanimals)and

inflammationoftheperianalarea(upto5%ofanimals)hasbeencommonly

reportedintreatedanimals.Theseeffectsaretransientandnormallyresolve

within5days.Rectalprolapsehasbeenuncommonlyreported.

Aslightreductioninfoodconsumptionmaybeobservedduringtreatment.

4.7Useduringpregnancy,lactationorlay

Thesafetyoftheproductduringpregnancyandlactationhasnotbeen

demonstrated.Useoftheproductduringpregnancyandlactationisthereforenot

recommended.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9Amount(s)tobeadministeredandadministrationroute

Oralrouteindrinkingwater.

10mgflorfenicol/kgbodyweightperdayindrinkingwaterfor5consecutivedays.

Thedailyamountofproducttobemixedwithdrinkingwatercanbecalculated

basedontheTotalBodyWeight(TBW)oftheherdtobetreatedwiththefollowing

formula:

Amountofproduct(in

grams)perday* = TotalBodyWeightoftheherd(TBW)inKg

20

*tobemixedwiththeestimatedtotalwaterconsumptionoftheherdin24hr

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AN:02085/2011

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Theexamplesofmedicateddrinkingwaterinthetablebelowarecalculatedby

applyingtheformulaandbyassumingthatpigsdrink8%or10%oftheir

bodyweight.

TBWofthe

herd(Kg) Product(g) Estimateddaily

water

consumption(L) Productgrams

per10litresof

water

Pigsdrinking

8%oftheir

bodyweight 500kg 25g 40L

6.25g/10L 1000kg 50g 80L

5000kg 250g 400L

Pigsdrinking

10%oftheir

bodyweight 500kg 25g 50L

5g/10L 1000kg 50g 100L

5000Kg 250g 500L

FORBULKTANK:Totreatpigsdrinking10%oftheirbodyweight,atthedoseof

10mg/kg:add5gproductper10Ldrinkingwaterinthebulktankandmix

thoroughlyuntilvisuallydissolved.

Forpigsdrinking8%oftheirbodyweight,atadoseof10mg/kg:add6,25gproduct

toevery10Ldrinkingwaterinthetankandmixthoroughlyuntilvisuallydissolved.

Anysolutionsforuseinaheadertankmustbelimitedtonomorethan2.5g/L.

Dissolutionmaytakeupto30minutesandsolutionsshouldbecheckedvisually

forcompletedissolution.

FORPROPORTIONER:Convenientproportionersettingsfortheuseof

florfenicolinthedrinkingwateris20%

Totreat5,000kgofpigs,drinking10%oftheirbodyweight,atthedoserateof

10mg/kg:

1. Filltheproportionerwith100Ldrinkingwater.

2. Add250gofproducttotheproportioner.

3. Mixthoroughlyuntilvisuallydissolved

4. Settheproportionerto20%.

5. Turnontheproportioner.

Inordertoensurerapiddissolution,solutionsshouldbepreparedinaccordance

withtheexamplesabove.Otherwise,solutionsshouldbevisuallyinspectedto

ensurethatdissolutioniscompletebeforetheproductisadministered.

Inordertoensurecorrectdosingandtopreventunderdosing,thebodyweightof

theherdshouldbecalculatedaspreciselyaspossibleandwaterconsumption

shouldbemonitored.Therequiredquantityofgranulesshouldbemeasuredby

suitablycalibratedweighingequipment.

Theuptakeofwaterdependsonseveralfactorsincludingtheage,theclinical

stateoftheanimalsandthelocalconditionssuchasambienttemperatureand

humidity.Thedailywaterconsumptioncanbeunderestimated(e.g.reducedto6%

ofbodyweight)inordertoensuretotalconsumptionofmedicatedwaterduringthe

day(freshdrinkingwatercanbemadeavailablefollowingtheconsumptionofthe

medicatedwater).Ifitisnotpossibletoobtainsufficientuptakeofmedicatedwater

animalsshouldbetreatedparenterally.Themaximumsolubilityoftheproduct

granulesis5g/Lat20°Cand2.5g/Lat9°C.

Medicateddrinkingwatershouldbereplacedevery24hours.

Issued:June2013

AN:02085/2011

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4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Afteradministrationat3timestherecommendeddoseareductioninfoodand

waterconsumption,togetherwithadecreaseinbodyweighthasbeenobserved.

Afteradministrationat3timesormoreoftherecommendeddose,depressionof

someanimalshavebeenobserved.

4.11Withdrawalperiod(s)

Meatandoffal:20days

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Amphenicols

ATCVetCode:QJ01BA90

5.1Pharmacodynamicproperties

Florfenicolisasynthetic,broad-spectrumantibioticinthephenicolgroupactive

againstmostGram-positiveandGram-negativeorganismsisolatedfromdomestic

animals.Florfenicolactsbyinhibitingproteinsynthesisattheribosomalleveland

maybeconsideredbacteriostatic.

However,bactericidalactivityhasbeendemonstratedinvitroagainststrainsof

Pasteurellamultocidaisolatedfrompigsandinvolvedinrespiratorydisease.

Amongclinicalisolatescollectedfromtherespiratorytractsofswinebetween

2008-2010intheEU,theobservedflorfenicolMIC

andMIC

were0.25 –1

µg/ml.ForP.multocidathefollowingbreakpointshavebeendeterminedfor

florfenicolinswinerespiratorydisease;susceptibe: ≤2µg/ml,intermediate:4

µg/mlandresistant: ≥8µg/ml(CLSIM31-A3,2008).

Acquiredresistancetoflorfenicolisassociatedwithseveralgenes,includingFloR

whichencodesaneffluxpump.Genesresponsibleforresistancearetransferable

bymobilegeneticelements.

5.2Pharmacokineticproperties

Followingadministrationofflorfenicolindrinkingwaterfor5consecutivedays,the

maximumplasmaconcentrationof3.92µg/mLoccurredatamedianof4hours.

Themeanplasmaconcentrationsremainedabove0.5µg/mLforthe5day

administrationperiod.Themeanterminalhalf-lifewas5.6hoursandmeanAUC

0-24

of44.7µg·h/mL.Themajorclearancemechanismisexcretioninurine.

5.3Environmentproperties

Florfenicoldegradesinpigmanureandinsoilandassuchwillnotpersistinthe

environment.

Issued:June2013

AN:02085/2011

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6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Butylhydroxytoluene(E321)

DisodiumEdetate

Macrogols(4000and400)

Maltodextrin

Polysorbate80

6.2Incompatibilities

Intheabsenceofcompatibilitystudiedthisveterinarymedicinalproductmustnot

bemixedwithotherveterinarymedicinalproducts.

6.3Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:4years

Shelflifeafterfirstopeningoftheimmediatepackaging:3months

Shelflifeafterdilutionorreconstitutionaccordingtodirections:24hours

6.4Specialprecautionsforstorage

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

Storeintheoriginalpackage.

6.5Natureandcompositionofimmediatepackaging

Polyester/aluminium/polythenebagscontaining0.5kg,1kgor5kgofgranules.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproduct

orwastematerialsderivedfromtheuseofsuchproducts,ifappropriate

Anyunusedveterinarymedicinalproductorwastematerialderivedfromsuch

veterinarymedicinalproductshouldbedisposedofinaccordancewithlocal

requirements.

7. MARKETINGAUTHORISATIONHOLDER

ZoetisUKLtd

Floor,6StAndrewStreet

London

EC4A3AE

8. MARKETINGAUTHORISATIONNUMBER

Vm42058/4178

Issued:June2013

AN:02085/2011

Page6of6

9. DATEOFFIRSTAUTHORISATION

Date:June2013

10.DATEOFREVISIONOFTHETEXT

Date:June2013

Prohibitionofsale,supplyand/oruse:

Notapplicable.

APPROVED 24/06/13

There are no safety alerts related to this product.

21-11-2018

Osurnia (Elanco GmbH)

Osurnia (Elanco GmbH)

Osurnia (Active substance: terbinafine / florfenicol / betamethasone acetate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7842 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/003753/T/0010

Europe -DG Health and Food Safety

29-5-2018

Osurnia (Elanco Europe Ltd)

Osurnia (Elanco Europe Ltd)

Osurnia (Active substance: terbinafine / florfenicol / betamethasone acetate) - Centralised - Yearly update - Commission Decision (2018)3406 of Tue, 29 May 2018

Europe -DG Health and Food Safety