GENOPTIC LIQUIFILM

Main information

  • Trade name:
  • GENOPTIC LIQUIFILM
  • Dosage:
  • 0.30 %w/v
  • Pharmaceutical form:
  • Eye Drops Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • GENOPTIC LIQUIFILM
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0148/035/001
  • Authorization date:
  • 25-08-1982
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0148/035/001

CaseNo:2066571

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

AllerganPharmaceuticalsIreland

CastlebarRoad,Westport,Co.Mayo,Ireland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

GenopticLiquifilm0.30%w/vEyeDropsSolution

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom24/06/2009.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 24/06/2009 CRN 2066571 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

GenopticLiquifilm0.30%w/vEyeDropsSolution

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Genopticcontains0.30%w/v(3mg/ml)gentamicinsulphate(asgentamicinbase).

Excipients:contains0.004%w/vbenzalkoniumchloride.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Eyedropssolution

Clear,colourlesstoslightlyyellowsolution.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forthetopicaltreatmentofinfectionsoftheexternalportionsofeyeoradnexaduetoorganismssensitiveto

gentamicin.

4.2Posologyandmethodofadministration

Topicalbyinstillationintoconjunctivalsac.

Instill1to2dropsevery1to4hoursdependingupontheseverityoftheinfection.

4.3Contraindications

Useinpatientshypersensitivetogentamicin.

Usebyinjection.

4.4Specialwarningsandprecautionsforuse

1.Prolongeduseofananti-infectivemayresultinthedevelopmentofsuperinfectionduetoorganismsnot

sensitivetotheanti-infective.

2.Gentamicinmayinducetoxiceffectsifsignificantabsorptionoccursfromopensurfaces.Suchabsorptionis

minimalthroughtheeye.

3.Transientirritationhasbeenreportedduringuse.

ThepreservativeinGENOPTIC ®

,benzalkoniumchloride,maycauseeyeirritation.Contactwithsoftcontact

lensesshouldthereforebeavoided.Thecontactlensesshouldberemovedpriortoapplicationandreinsertedafter

Irish Medicines Board

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4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Nonestated.

4.6Pregnancyandlactation

Thisproductshouldbeusedbypregnantorlactatingwomenonlyifthepotentialbenefitjustifiesthepotentialrisk

tothefoetusornewborn.

4.7Effectsonabilitytodriveandusemachines

None.

4.8Undesirableeffects

Referto4.4.

4.9Overdose

Gentamicinispoorlyabsorbedorally.However,intheeventofaccidentalingestionof5mLofGenoptic,15mgof

gentamicinsulfateisingested.Sincethetotalrecommendeddailydosageforsystemicuseofgentamicinranges

from1.5to2mg/kg,theingestionof5mLofGenopticdoesnotappeartobeclinicallysignificant.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Gentamicin,apolaraminoglycoside,isanantimicrobialagenteffectiveagainstgram-negativeandsomegram-

positivebacteria.Themechanismofactionofgentamicinissimilartothatofotheraminoglycosideantibiotics

whichactdirectlyonthebacterialribosomewheretheyinhibitproteinsynthesisanddecreasethefidelityofthe

geneticcodeinsusceptibleorganisms.

5.2Pharmacokineticproperties

Referto5.1.

5.3Preclinicalsafetydata

Notapplicable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Polyvinylalcohol

Sodiumphosphate,dibasic,heptahydrate

Sodiumchloride

Disodiumedetate

Benzalkoniumchloride

Hydrochloricacid(forpHadjustment)or

Sodiumhydroxide(forpHadjustment)

Irish Medicines Board

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6.2Incompatibilities

Nodrugincompatibilitiesareknownfortheophthalmicdosageform.TheUSP,DrugInteractionshasanotefor

theinjectionformofthedrug.“Extemporaneousadmixturesofaminoglycosidesandbeta-lactamantibacterials

mayresultinsubstantialmutualinactivation”.

6.3ShelfLife

2yearsunopened.

Discardfourweeksafteropening.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

Thisproductwillbemarketedinthe5mlsize.Bottlesandtipsaremadefromlowdensitypolyethylene.Capsare

madefrompolystyrene.Asafetysealisplacedaroundthebottlecaptoensureintegrityoftheproduct.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

AllerganPharmaceuticalsIreland

CastlebarRoad

Westport

CountyMayo

8MARKETINGAUTHORISATIONNUMBER

PA148/35/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:25August1982

Dateoflastrenewal:25August2007

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 24/06/2009 CRN 2066571 page number: 4