CELLUVISC

Main information

  • Trade name:
  • CELLUVISC Eye Drops Solution 0.5 %w/ v
  • Dosage:
  • 0.5 %w/ v
  • Pharmaceutical form:
  • Eye Drops Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CELLUVISC Eye Drops Solution 0.5 %w/v
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PPA1562/028/001
  • Authorization date:
  • 12-11-2010
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

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

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Date Printed 16/11/2010 CRN 2087372 page number: 1

4.6Fertility,pregnancyandlactation

DuetothenegligiblesystemicexposureandthelackofpharmacologicalactivityCelluvisccanbeusedduring

pregnancyandlactation.

4.7Effectsonabilitytodriveandusemachines

Celluviscisnotexpectedtocauseblurredvision.Ifindividualpatientsexperiencetransientblurredvisiontheyshould

beadvisednottodriveoroperatemachineryuntilvisionhascleared.

4.8Undesirableeffects

Temporaryburningmayoccur.

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

Magnesiumchloride

Purifiedwater

6.2Incompatibilities

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 16/11/2010 CRN 2087372 page number: 2

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

Irish Medicines Board

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Date Printed 16/11/2010 CRN 2087372 page number: 3