Florvio

Main information

  • Trade name:
  • Florvio Drinking Water concentrate for oral solution
  • Pharmaceutical form:
  • Concentrate for oral solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Florvio Drinking Water concentrate for oral solution
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Amphenicols
  • Therapeutic area:
  • Pigs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0401/001
  • Authorization date:
  • 27-06-2012
  • EU code:
  • UK/V/0401/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Issued:December2012

AN:00715/2011

Page1of7

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Florvio23mg/mlsolutionforuseindrinkingwaterforpigs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontains:

Activesubstance:

Florfenicol23mg

Excipients:

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Solutionforuseindrinkingwater.

Clear,colourlesstoyellow,slightlyviscoussolution.

4. CLINICALPARTICULARS

4.1 Targetspecies

Pig

4.2 Indicationsforuse,specifyingthetargetspecies

Treatmentandpreventionatthegrouplevelwhereclinicalsignsarepresentofswine

respiratorydiseaseassociatedwithActinobacilluspleuropneumoniaeandPasteurella

multocidasusceptibletoflorfenicol.Thepresenceofthediseaseshouldbe

establishedintheherdbeforeinitiatingtreatment.

4.3 Contraindications

Donotuseinboarsintendedforbreedingpurposes.

Donotadministerincasesofpreviousallergicreactionstoflorfenicol.

4.4 Specialwarningsforeachtargetspecies

Thetreatedpigsshouldbeplacedunderspecialobservation.Oneachofthefive

daysoftreatment,untreateddrinkingwatershouldnotbegivenuntilthefulldaily

amountofmedicateddrinkingwaterhasbeeningestedbythepigs.Ifthereisno

significantimprovementafter3treatmentdays,thediagnosisshouldbereviewed

andifnecessarythetreatmentshouldbechanged.

Issued:December2012

AN:00715/2011

Page2of7

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Theproductshouldbeusedinconjunctionwithsusceptibilitytestingandtakeinto

accountofficialandlocalantimicrobialpolicies.Inappropriateuseoftheproductmay

increasetheprevalenceofbacteriaresistanttoflorfenicolandmaydecreasethe

effectivenessoftreatmentwithflorfenicol,duetothepotentialforcross-resistance.

Treatmentshouldnotexceed5days.

Donotuseincaseofresistance.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Peoplewithknownhypersensitivitytopolyethyleneglycolsshouldavoidcontactwith

theveterinarymedicinalproduct.

Incaseofaccidentalspillageontoskinrinsewithwater.

Otherprecautions:

Manurefromtreatedpigsshouldbestoredfor27dayspriortospreadingand

incorporatingintoland.

4.6Adversereactions(frequencyandseriousness)

Aslightreductionofwaterconsumptionbytheanimals,darkbrownfaecesand

constipationmaybeobservedduringtreatment.

Commonlyobservedadverseeffectsarediarrhoeaand/orperi-analandrectal

erythema/oedemawhichmayaffectapproximately40%oftheanimals.Theseeffects

aretransient.Inafewoftheaffectedanimals,prolapseoftherectum,thatresolves

withouttreatment,maybeobserved.

4.7Useduringpregnancy,lactationorlay

Laboratorystudiesinpigshavenotproducedanyevidenceoffoetotoxic effects.

Thesafetyoftheveterinarymedicinalproductinsowshasnotbeenestablished

duringpregnancyandlactation.

Theuseisnotrecommendedduringpregnancyandlactation.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Nodataavailable.

4.9 Amountstobeadministeredandadministrationroute

Oralrouteindrinkingwater.

Pigs:10mgflorfenicolperkgbodyweightperdayfor5consecutivedays.Thisdose

isequivalentto0.44mloftheproductperkgbodyweightperday.

Issued:December2012

AN:00715/2011

Page3of7

TheamountoftheproductcanbecalculatedbasedontheTotalBodyWeightofherd

tobetreated(TBW)andtheTotalWaterConsumptionoftheherdin24hr(TWC)

withthefollowingformula:

Theproduct(litre)= 10xTBW(kg) per1000litreofmedicatedwaterin

23xTWC(litre) the tank

IfaproportionersetatP%isused,thentheformulais

Theproduct(litre)= 10xTBW(kg)x__1__per10litreofpre-diluted

23xTWC(litre)P(%)medicatedwaterinthe

proportioner

Dilutethecalculatedvolumeoftheproductwithwatertoatotalvolumeof10litrein

theproportioner.Donotusethisproductatanyotherproportionersetting.

Theappropriatequantityofmedicatedwaterorpre-dilutedmedicatedwatershould

bepreparedbasedonthedailywaterconsumption.

Medicateddrinkingwatershouldbereplacedevery24hours.

Checkforcompletenessofsolutionbeforeadministration.

Specificexamplesaregivenbelow:

FORBULKTANK:Totreatpigsdrinking10%oftheirbodyweight,atthedoseof10

mg/kg:addtheproducttothedrinkingwaterinthebulktank.Useonebottle(2.17

litre)ofproductforevery500litreofwaterandmixthoroughly.Thiscorrespondstoa

100mg/litredrinkingwaterconcentration.

FORPROPORTIONER(2.17litre):Twoconvenientproportionersettingsfortheuse

offlorfenicolinthedrinkingwaterare10%and1%.

A. Tenpercentsetting:

Totreat5,000kgofpigs,drinking10%oftheirbodyweight,atthedoserateof

10mg/kg:

1. Dilutethecontentofthebottleto4litrewithdrinkingwater.

2. Mixthoroughly.

3. Emptythedilutedproductintheproportioner.

4. Diluteto50litrewithdrinkingwater.

5. Mixthoroughly.

6. Settheproportioneron10%.

7. Turnontheproportioner.

B. Onepercentsetting:

Issued:December2012

AN:00715/2011

Page4of7

Totreat5,000kgofpigs,drinking8%oftheirbodyweight,atthedoserateof

10mg/kg:

1. Dilutethecontentofthebottleto4litrewithdrinkingwater.

2. Mixthoroughly.

3. Emptythedilutedproductintheproportioner.

4. Mixthoroughly.

5. Settheproportioneron1%.

6. Turnontheproportioner.

FORPROPORTIONER(0.54litre):Twoconvenientproportionersettingsfortheuse

offlorfenicolinthedrinkingwaterare10%and1%.

A. Tenpercentsetting:

Totreat1,250kgofpigs,drinking10%oftheirbodyweight,atthedoserateof

10mg/kg:

1. Dilutethecontentofthebottleto1litrewithdrinkingwater.

2. Mixthoroughly.

3. Emptythedilutedproductintheproportioner.

4. Diluteto12,5litrewithdrinkingwater.

5. Mixthoroughly.

6. Settheproportioneron10%.

7. Turnontheproportioner.

B. Onepercentsetting:

Totreat1,250kgofpigs,drinking8%oftheirbodyweight,atthedoserateof

10mg/kg:

1. Dilutethecontentofthebottleto1litrewithdrinkingwater.

2. Mixthoroughly.

3. Emptythedilutedproductintheproportioner.

4. Mixthoroughly.

5. Settheproportioneron1%.

6. Turnontheproportioner.

Solutionsshouldnotbepreparedatconcentrationsbetween1.2gand12g

florfenicolperlitre.

Theuptakeofmedicatedwaterdependsonseveralfactorsincludingtheclinicalstate

oftheanimalsandlocalconditionssuchasambienttemperatureandhumidity.In

ordertoobtainthecorrectdosagewateruptakehastobemonitoredandthe

concentrationofflorfenicolhastobeadjustedaccordingly.Ifhoweveritisnot

possibletoobtainsufficientuptakeofmedicatedwateranimalsshouldbetreated

parenterally.

Issued:December2012

AN:00715/2011

Page5of7

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Incaseofoverdosing,adecreaseinweightgain,foodandwaterconsumption,peri-

analerythemaandoedemaandmodificationofsomehaematologicaland

biochemicalparametersindicativeofdehydrationmaybeobserved.

4.11Withdrawalperiod(s)

Meatandoffal:20days

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup: Amphenicols

ATCVetCode: QJ01BA90

5.1 Pharmacodynamicproperties

Florfenicolisabroad-spectrumsyntheticantibioticinthephenicolgroupthatisactive

againstmostGram-positiveandGram-negativebacteriaisolatedfromdomestic

animals.Florfenicolactsbyinhibitionofproteinsynthesisattheribosomalleveland

isbacteriostatic.However,bactericidalactivityhasbeendemonstratedin-vitro

againstActinobacilluspleuropneumoniaeandPasteurellamultocidawhenflorfenicol

ispresentatconcentrationsabovetheMIC(µg/ml)forupto12hours.

In-vitrotestinghasshownthatflorfenicolisactiveagainstthebacterialpathogens

mostcommonlyisolatedinrespiratorydiseasesinpigs,includingActinobacillus

pleuropneumoniaeandPasteurellamultocida.

5.2 Pharmacokineticparticulars

Afteradministrationtopigsbygavageat15mg/kgunderexperimentalconditions,

absorptionofflorfenicolwasvariablebutpeakserumconcentrationsofapproximately

MIC5µg/mlwerereachedapproximately2hoursafterdosing.Theterminalhalf-life

wasbetween2and3hours.Whenpigsweregivenfreeaccess,for5days,towater

medicatedwithflorfenicolataconcentrationof100mgflorfenicolperlitreofwater,

serumconcentrationsofflorfenicolexceededMIC1µg/mlfortheentire5day

treatmentperiodexceptforacoupleofshortexcursionsbelowMIC1µg/ml.

Afterabsorptionanddistribution,florfenicolisextensivelymetabolisedbypigsand

rapidlyeliminated,primarilyinurine.

Afterparenteraldosingofflorfenicoltopigs,ithasbeenshownthatlung

concentrationsaresimilartoserumconcentrations.

Issued:December2012

AN:00715/2011

Page6of7

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Macrogol300

6.2Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbe

mixedwithotherveterinarymedicinalproducts.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2Years

Shelf-lifeafterdilutionorreconstitutionaccordingtodirections(in-use):24hours

Donotusetheveterinarymedicinalproductformorethan5hourswithproportioners,

ifgalvanisedpipingisused.

6.4.Specialprecautionsforstorage

Donotstoreabove25

C.

6.5Natureandcompositionofimmediatepackaging

PackSizes: 1litrebottlecontaining0.54litre

4litrebottlecontaining2.17litre

Containers: HDPEbottles

Closures: PolypropyleneScrewCapswithaliner.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

7. MARKETINGAUTHORISATIONHOLDER

NovartisAnimalHealthUKLimited

FrimleyBusinessPark

Frimley

Camberley

Surrey

GU167SR

8. MARKETINGAUTHORISATIONNUMBER

Vm12501/4182

Issued:December2012

AN:00715/2011

Page7of7

9. DATEOFFIRSTAUTHORISATION

11December2012

10. DATEOFREVISIONOFTHETEXT

December2012

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable.

Approved: 11/12/2012

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Europe -DG Health and Food Safety

23-7-2018

Trobalt (Glaxo Group Ltd)

Trobalt (Glaxo Group Ltd)

Trobalt (Active substance: retigabine) - Centralised - Withdrawal - Commission Decision (2018)4887 of Mon, 23 Jul 2018

Europe -DG Health and Food Safety

23-7-2018

Irbesartan Zentiva (Sanofi-Aventis groupe)

Irbesartan Zentiva (Sanofi-Aventis groupe)

Irbesartan Zentiva (Active substance: Irbesartan) - Centralised - Yearly update - Commission Decision (2018)4892 of Mon, 23 Jul 2018

Europe -DG Health and Food Safety

23-7-2018

SANCUSO (Kyowa Kirin Holdings B.V.)

SANCUSO (Kyowa Kirin Holdings B.V.)

SANCUSO (Active substance: granisetron) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4891 of Mon, 23 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2296/T/52

Europe -DG Health and Food Safety

23-7-2018

Rituzena (Celltrion Healthcare Hungary Kft.)

Rituzena (Celltrion Healthcare Hungary Kft.)

Rituzena (Active substance: rituximab) - Centralised - Yearly update - Commission Decision (2018)4884 of Mon, 23 Jul 2018

Europe -DG Health and Food Safety

23-7-2018

Carmustine Obvius (NovImmune B.V.)

Carmustine Obvius (NovImmune B.V.)

Carmustine Obvius (Active substance: carmustine) - New authorisation - Commission Decision (2018)4882 of Mon, 23 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4326

Europe -DG Health and Food Safety

27-6-2018

 Minutes of the CVMP meeting of 23-25 May 2018

Minutes of the CVMP meeting of 23-25 May 2018

Europe - EMA - European Medicines Agency

15-6-2018

 Minutes of the CHMP meeting 23-26 April 2018

Minutes of the CHMP meeting 23-26 April 2018

Committee for medicinal products for human use (CHMP) minutes of the meeting on 23-26 April 2018

Europe - EMA - European Medicines Agency