BLEPH-10

Main information

  • Trade name:
  • BLEPH-10 Eye Drops Solution 10 %w/ v
  • Dosage:
  • 10 %w/ v
  • Pharmaceutical form:
  • Eye Drops Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BLEPH-10 Eye Drops Solution 10 %w/v
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0148/022/001
  • Authorization date:
  • 01-04-1977
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACT1995

MEDICINALPRODUCTS(LICENSINGANDSALE)REGULATIONS,1998

(S.I.No.142of1998)

PA0148/022/001

CaseNo:2028850

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

AllerganPharmaceuticalsIreland

CastlebarRoad,Westport,Co.Mayo,Ireland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Bleph-10LiquifilmTopicalOphthalmicSolution10.0%w/v,eyedropssolution

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom01/04/2007.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 18/04/2007 CRN 2028850 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Bleph-10LiquifilmTopicalOphthalmicSolution10.0%w/v,eyedropssolution

2QUALITATIVEANDQUANTITATIVECOMPOSITION

SulfacetamideSodium10.0%w/v

Excipient:Containsbenzalkoniumchloride0.005%w/v

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Eyedrops,solution.

Aclearcolourlesstoslightlystrawcolouredsolution.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forthetreatmentofconjunctivitis,cornealulcer,andothersuperficialocularinfectionsfromsusceptible

microorganism.

Asanadjuncttosystemicsulfonamidetherapyoftrachoma.

4.2Posologyandmethodofadministration

Topicalinstallationintoconjunctivalsac.

Applicationeverytwotothreehoursorasdirectedbythephysician.

4.3Contraindications

Useinpatientshypersensitivetoanyingredientoftheformulation,orothersulfonamidepreparation.

4.4Specialwarningsandprecautionsforuse

1.Thesolutionsareincompatiblewithsilverpreparations.

2.Prolongeduseofanti-infectivemayresultinthedevelopmentofsuperinfectionduetoorganisms,includingfungi,

resistanttothatanti-infective.

3.Theanti-infectivepresentmaybetoxicifabsorbedfromopensurfaces.

4.Sulfonamidesareinactivatedbytheaminobenzoicacidpresentinpurulentexudates.

5.Aswithallsulfonamidepreparations,severesensitivityreactions,e.g.Steven-Johnson’ssyndrome,fever,skinrash,

GIdisturbancesandbonemarrowdepressionhavebeenidentifiedinindividualswithnopriorhistoryof

sulfonamidehypersensitivity.Asignificantpercentageofstaphylococcalisolatesarecompletelyresistanttosulfa

drugs.

Irish Medicines Board

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Date Printed 18/04/2007 CRN 2028850 page number: 2

Bleph-10solutionisincompatiblewithsilverpreparations.

4.6Pregnancyandlactation

SafetyandeffectivenessofBleph-10duringpregnancyandlactationhasnotbeenestablished.Theproductshouldonly

beusedwherethebenefitsarejudgedtooutweighanyriskstothebaby.

4.7Effectsonabilitytodriveandusemachines

None.

4.8Undesirableeffects

Sodiumsulfacetamidemaycauselocalirritation,stingingandburning.Whiletheirritationmaybetransient,

occasionally,useofthemedicationhastobediscontinued.

4.9Overdose

Forknownsymptomsofoverdosageandparticularsofitstreatment:RefertoUndesirableEffects,SpecialPrecautions

andWarningsforUselistedabove.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Theactiveingredient,sulfacetamidesodium(asulfonamide),exertsabacteriostaticeffectagainstawiderangeof

gram-positiveandgram-negativemicroorganismsbyrestricting,throughcompetitionwithpara-aminobenzoicacid,the

synthesisoffolicacidwhichbacteriarequireforgrowth.

5.2Pharmacokineticproperties

Sulfacetamidesodiumisamemberofthesulfonamidegroupwhichcompetitivelyinhibitsthebacterialenzyme

responsiblefortheincorporationofparaminobenzoicacidintodihydropteroicacid,aprecursoroffolicacid.

Microorganismthatareaffectedarethosethatsynthesizetheirownfolicacid.Sulfacetamidesodiumhasawiderange

ofantibacterialactivityagainstgram-positiveandgram-negativemicroorganismssuchasStreptococcuspyogenes,

Sterptococcuspneumoniae,somestrainsofBacillusanthracisandCorynebacteriumdiphtheriae.Haemophilus

influenzae,H.ducrevi,Brucella,Vibriocholerae,Yersiniapestis,Nocardia,Actinomyces,Calymmatobacterium

granulomatis,andChlamydiatrachomatis.

5.3Preclinicalsafetydata

Irish Medicines Board

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Date Printed 18/04/2007 CRN 2028850 page number: 3

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Polyvinylalcohol

Benzalkoniumchloride

Disodiumedetate

SodiumDihydrogenPhosphateMonohydrate

Sodiumthiosulfate

Sodiumphosphate,dibasic,heptahydrate

Polysorbate80

Hydrochloricacid(forpHadjustment)

Sodiumhydroxide(forpHadjustment)

Purifiedwater

6.2Incompatibilities

Bleph-10Solutionisincompatiblewithsilverpreparations

6.3ShelfLife

18monthsunopened

Discardonemonthafteropening

6.4Specialprecautionsforstorage

Donotstoreabove25 o

Keepcontainerinoutercarton.

Donotuseifsolutionisdiscoloured(darkbrown)

6.5Natureandcontentsofcontainer

Bleph-10Solutionwillbemarketedin10mland15mldropperbottlesandtipsmadefromlowdensitypolyethylene.

Capsaremadefrommediumimpactpolystyrene.Asafetysealisplacedaroundthebottlecaptoinsureintegrityofthe

product.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

AllerganPharmaceuticalsIreland

CastlebarRoad,

Westport,

Co.Mayo,

Ireland.

8MARKETINGAUTHORISATIONNUMBER

Irish Medicines Board

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Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 18/04/2007 CRN 2028850 page number: 5

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:1 st

April1977

Dateoflastrenewal:1 st

April2007

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 18/04/2007 CRN 2028850 page number: 6