CELLUVISC 0.5 %w/v Eye Drops Solution

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
CARMELLOSE SODIUM
Available from:
LTT Pharma Limited
INN (International Name):
CARMELLOSE SODIUM
Dosage:
0.5 %w/v
Pharmaceutical form:
Eye Drops Solution
Prescription type:
Product not subject to medical prescription
Authorization status:
Withdrawn
Authorization number:
PPA1562/028/001
Authorization date:
2013-03-06

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Celluvisc0.5%w/v,eyedrops,solution,unitdose

2QUALITATIVEANDQUANTITATIVECOMPOSITION

1mlcontains5mgcarmellosesodium

Forafulllistofexcipients,seesection6.1

3PHARMACEUTICALFORM

Eyedrops,solutioninsingle-dosecontainer.

ProductimportedfromSpain

Clear,colourlesstoslightlyyellowsolution.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Tearsubstitute.Treatmentofthesymptomsofdryeye.

4.2Posologyandmethodofadministration

Instil1-2dropsintheaffectedeye/s4timesadayorasneeded.

Ensurethatthesingle-dosecontainerisintactbeforeuse.Theeyedropsolutionshouldbeusedimmediatelyafter

opening.

Toavoidcontaminationdonottouchthetiptotheeyeoranyothersurface.

IfCelluviscisconcomitantlyusedwithotheroculareyemedicationstheremustbeanintervalofatleast15minutes

betweenthetwomedications(asdisplacementofamedicationmayoccur).

Theeyedropsmaybeusedwithcontactlenses.

4.3Contraindications

Hypersensitivitytocarmellosesodiumortoanyoftheexcipients.

4.4Specialwarningsandprecautionsforuse

Ifirritation,pain,rednessorchangesinvisionoccurorifthepatient’sconditionisworsened,treatmentdiscontinuation

shouldbeconsideredandanewassessmentmade.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 12/10/2012 CRN 2117276 page number: 1

4.6Fertility,pregnancyandlactation

DuetothenegligiblesystemicexposureandthelackofpharmacologicalactivityCelluvisccanbeusedduring

pregnancyandlactation.

4.7Effectsonabilitytodriveandusemachines

Celluviscisnotexpectedtocauseblurredvision.Ifindividualpatientsexperiencetransientblurredvisiontheyshould

beadvisednottodriveoroperatemachineryuntilvisionhascleared.

4.8Undesirableeffects

Thefrequencyofadversereactionsdocumentedduringclinicaltrialsisgiven.Thefrequencyisdefinedasfollows:

VeryCommon(1/10);Common(1/100,<1/10);Uncommon(1/1,000,<1/100);Rare(1/10,000,<1/1,000);Very

Rare(<1/10,000),notknown(cannotbeestimatedfromtheavailabledata).

Eyedisorders:

Common:EyeIrritation

ThefollowingotheradversereactionshavereportedsinceCelluvischasbeenmarketed:

Eyepain,visionblurred,lacrimationincreased,ocularhyperaemia.

4.9Overdose

Accidentaloverdosewillpresentnohazard.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Otherophthalmologicals

ATCcode:S01XA20

Carmellosesodiumhasnopharmacologicaleffect.Carmellosesodiumhasahighviscosityresultinginanincreased

retentiontimeontheeye.

TheexcipientsinCelluviscwerechosentomimictheelectrolyteconstitutionoftears.

5.2Pharmacokineticproperties

Duetothehighmolecularweight(approx90,000Daltons)carmellosesodiumisunlikelytopenetratethecornea.

5.3Preclinicalsafetydata

TherearenopreclinicaldataconsideredrelevanttoclinicalsafetybeyonddataincludedinothersectionsoftheSPC.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Sodiumchloride

Sodiumlactate

Potassiumchloride

Calciumchloride

Irish Medicines Board

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Date Printed 12/10/2012 CRN 2117276 page number: 2

Purifiedwater

6.2Incompatibilities

Notapplicable.

6.3Shelflife

Theshelflifeexpirydateforthisproductshallbethedateshownoneachsingle-dosecontainer.

andouterpackageoftheproductonthemarketinthecountryoforigin.

Afterfirstopening:Useimmediately.

6.4Specialprecautionsforstorage

Donotstoreabove25ºC.

6.5Natureandcontentsofcontainer

0.4mlinLDPEsingle-dosecontainer.

Packsizes:30single-dosecontainers.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Discardanyunusedsolutioninopenedcontaineri.e.donotre-usecontainerforsubsequentdoses.

7PARALLELPRODUCTAUTHORISATIONHOLDER

LTTPharmaLimited

Unit18

OxleasowRoad

EastMoonMoat

Redditch

Worcestershire

B980RE

8PARALLELPRODUCTAUTHORISATIONNUMBER

PPA1562/28/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:12thNovember2010

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 12/10/2012 CRN 2117276 page number: 3

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