FML-NEO LIQUIFILM

Main information

  • Trade name:
  • FML-NEO LIQUIFILM
  • Dosage:
  • 1/5 Mg/Ml
  • Pharmaceutical form:
  • Eye Drops Suspension
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FML-NEO LIQUIFILM
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0148/020/001
  • Authorization date:
  • 18-05-1976
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0148/020/001

CaseNo:2053297

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

AllerganPharmaceuticalsIreland

CastlebarRoad,Westport,Co.Mayo,Ireland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

FML-NEOLiquifilm1mg/ml+5mg/mleyedrops,suspension

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom12/08/2008.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 12/08/2008 CRN 2053297 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

FML-NEOLiquifim1mg/ml+5mg/mleyedrops,suspension

2QUALITATIVEANDQUANTITATIVECOMPOSITION

3PHARMACEUTICALFORM

Eyedrops,suspension

Whitetoslightlystraw-colouredmicrofinesuspension.

4CLINICALPARTICULARS

4.1TherapeuticIndications

FML-NEOisindicatedforuseinthefollowingsituations:

Inthetreatmentofinfectiousconjunctivitisduetoorganismssensitivetoneomycin.

Forthetreatmentofcornealandanteriorsegmentinflammatorydisorderswhichmaybethreatenedwith,or

complicatedby,organismssensitivetoneomycin.

Prophylacticallyfollowingremovalofforeignbodies,aswellasbeforeandaftersurgerywherethepossibilityexistsof

infectionwithsusceptibleorganisms.

4.2Posologyandmethodofadministration

Onetotwodropsintheconjunctivalsactwotofourtimesdaily.Duringtheinitial24to48hours,thedosagemaybe

safelyincreasedtoonedropeveryhour.Careshouldbetakennottodiscontinuetreatmentprematurely.

4.3Contraindications

Acuteuntreatedpurulentocularinfections.Acutesuperficialherpessimplex(dendritic)keratitis,vaccinia,varicella,

andmostotherviraldiseasesoftheconjunctivaandcornea,oculartuberculosis.Fungaldiseasesoftheeye.

Hypersensitivitytoanyoftheconstituentsofthemedication.

4.4Specialwarningsandprecautionsforuse

Warnings:

Indiseasesduetomicro-organismsresistanttoneomycin,infectionmaybemasked,enhancedoractivatedbythe

steroid.Prolongedusemayresultinovergrowthofnonsusceptibleorganisms.

Percent(w/v) mg/ml

Fluorometholone 0.10 1.00

Neomycinsulphate 0.50 5.0

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Ifsensitivityorotheruntowardreactionsoccur,discontinuethemedication.

Asfungalinfectionsofthecorneahavebeenreportedcoincidentallywithlong-termsteroidapplications,fungal

invasionmaybesuspectedinanypersistentcornealulcerationwhereasteroidhasbeenused,orisinuse,overa

prolongedperiodoftime.

Useofsteroidmedicationinthepresenceofstromalherpessimplexrequiresgreatcaution;frequentslitlamp

microscopyisrequired.

Thispreparationcontainsbenzalkoniumchlorideandshouldnotbeusedbypatientscontinuingtowearsoft

(hydrophilic)contactlenses.

Precautions:

Patientswithahistoryofherpessimplexkeratitisshouldbetreatedwithcaution.

Useoftopicalsteroidsmayincreaseintraocularpressure.Eyedropscontainingcorticosteroidsshouldnotbeusedfor

morethanoneweekexceptunderstrictophthalmicsupervisionwithregulardeterminationofintraocularpressure.

Articlesincurrentmedicalliteratureindicateanincreaseintheprevalenceofpersonssensitivetoneomycin.The

possibilityofsuchareactionshouldbeborneinmind.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Corticosteroidsmayincreasetheactivityof:

Barbiturates

Sedativesandhypnotics

Tricyclicantidepressants

Corticosteroidsmaydecreasetheactivityof:

Anticholinesterases

Antiviraleyepreparations

Salicylates

Neomycinmayincreasetheactivityof:

EDTA(apnea)

Generalanesthetics(apnea)

Otherantibiotics(apnea)-Bacitracin,Colistin,Gentamicin,Kanamycin,

PolymyxinB,Streptomycin

Neomycinmaydecreasetheactivityof:

Oralpenicillins

OralvitaminB12

Anticholinesterases

NeomycincansharesynergisticactivitywithBacitracinandcrosssensitivitywith

Gentamicin,KanamycinandStreptomycin.

4.6Pregnancyandlactation

Thereisinadequateevidenceofsafetyinhumanpregnancy.Administrationofcorticosteroidstopregnantanimalscan

causeabnormalitiesoffoetaldevelopmentincludingcleftpalateandintrauterinegrowthretardation.Theremay

thereforebeaverysmallriskofsucheffectsinthehumanfoetus.

4.7Effectsonabilitytodriveandusemachines

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4.8Undesirableeffects

Inthosediseasescausingthinningofthecornea,perforationhasbeenknowntohaveoccurredwiththeuseoftopical

steroids.

Acutepurulentuntreatedinfectionsoftheeyemaybemasked,enhancedoractivatedbythepresenceofsteroid

medication.Secondaryocularinfectionmayoccurfrompathogensliberatedfromoculartissues.

Reportsintheliteratureindicatethatposteriorsubcapsularlenticularopacitieshaveoccurredafterheavyorprotracted

useoftopicalophthalmiccorticosteroids.

Localsideeffectsofsteroidtherapy,i.e.skinatrophy,striaeandtelangiectasia,areespeciallylikelytoeffectfacial

skin.

4.9Overdose

Overdosagewillnotordinarilycauseacuteproblems.Ifaccidentaloverdosageoccursintheeye,flushtheeyewith

waterornormalsaline.Ifaccidentallyingested,drinkfluidstodilute.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Fluorometholone,asyntheticcorticosteroid,haspotentanti-inflammatoryactivityandinhibitstheinflammatory

responsetoavarietyofincitingagentsofmechanical,chemicalorimmunologicalnature.Corticosteroidsinhibitthe

edema,fibrindeposition, capillarydilation,leukocytemigration,phagocyticactivity,capillaryproliferation,

fibroblastproliferation,depositionofcollagenandscarformationassociatedwithinflammation.Inhibitionofhistidine

decarboxylasebycorticosteroidsinhibitssynthesisofhistaminefromdegranulatedmastcells.Corticosteroidsalso

decreaseprostaglandinsynthesisandretardepithelialregeneration.Themechanismofactionofcorticosteroidshasnot

beenentirelyestablished;however,itisbelievedthatcorticosteroidsblocktheprogressionofinflammationby

increasingtheresistanceofcellstocytotoxicbreakdownproductsintheinflammatoryzone.

Neomycinsulphateisabroadspectrumbactericidalaminoglycosideantibioticeffectiveagainstavarietyofgram-

positiveandgram-negativeorganisms,suchasStaphylococcusaureus,S.epidermidis,Escherichiacoli,Moraxella

lacunata,Haemophilusinfluenzae,andProteusspecies.Itappearstoexertitsantibacterialactionprimarilythrough

inhibitionofproteinsynthesisbyirreversiblybindingwith30Sribosomalsubunits.Itsactivityisbroaderthanthatof

bacitracin,penicillinandstreptomycin.Neomycinexertsitseffectbyinhibitingtheproteinsynthesiswithinthecell

itself.Neomycinisnotinactivatedbybodyfluids,hasnostaphylococcalresistanceandisstableatroomtemperature.

5.2Pharmacokineticproperties

Referto5.1.

5.3Preclinicalsafetydata

Notapplicable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Polyvinylalcohol

Benzalkoniumchloride

Disodiumedetate

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6.1Listofexcipients(Cont/d)

Sodiumchloride

Sodiumthiosulfate,pentahydrate

Polysorbate80

Sodiumhydroxide(forpH-adjustment)

Hydrochloricacid(forpH-adjustment)

Purifiedwater

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

Unopened:2years

Opened:4weeks.

6.4Specialprecautionsforstorage

Donotstoreabove25 °

C.Donotfreeze.

6.5Natureandcontentsofcontainer

Theproductwillbemarketedina5mland10mlsize.Bottlewithdroppertip,containingawhitetoslightlystraw

colouredmicrofinesterileophthalmicsuspension.Bottlesandtipsaremadefromlowdensitypolyethylene.Thecaps

aremadeofpolystyrene.Asafetysealisplacedaroundthebottlecaptoinsureintegrityoftheproduct.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

AllerganPharmaceuticalsIreland

CastlebarRoad

Westport

CountyMayo

8MARKETINGAUTHORISATIONNUMBER

PA148/20/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:18 th

May1976

Dateoflastrenewal:18 th

May2006

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 12/08/2008 CRN 2053297 page number: 5