ELYZOL

Main information

  • Trade name:
  • ELYZOL Dental Gel 25 %w/w
  • Dosage:
  • 25 %w/w
  • Pharmaceutical form:
  • Dental Gel
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ELYZOL Dental Gel 25 %w/w
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0320/009/001
  • Authorization date:
  • 16-08-1998
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Elyzol25%w/wDentalGel

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each1gcontains:Metronidazolebenzoatecorrespondingto250mgmetronidazole.

Each0.3gcontains:Metronidazolebenzoatecorrespondingto75mgofmetronidazole.

3PHARMACEUTICALFORM

Awhitetooff-whitedentalgelinadisposableapplicatorcontaininganambercolouredTypeIglasscartridgewith

bromobutyl/chlorobutylorbromobutylrubberstoppersinbothends,thepierceableendbeingcoveredwithan

aluminiumcap.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Thetreatmentofadultperiodontitisinpatientsinwhomtheconditionhasrecurredafterconventionaltreatment.

4.2Posologyandmethodofadministration

Dosageisindividual,dependinguponthenumberofteethtobetreated.

Treatmentshouldnotnormallyberepeatedwithinsixmonthsofinitialtherapy.

Thegelisadministeredbymeansofadentalsyringeprovidedwithaflexibleandbluntedneedle.

4.3Contraindications

Knownhypersensitivitytometronidazole.

4.4Specialwarningsandprecautionsforuse

Insomepatients,metronidazolemayhaveaneffectsimilartothatofdisulfiramonthemetabolismofalcohol,resulting

inintolerancesymptoms.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Somepotentiationofanticoagulanttherapyhasbeenreportedwhenmetronidazolehasbeenusedwiththewarfarin

typeoralanticoagulants.Metronidazoleanddisulfiramtakenconcurrentlymaycauseaconfusionalcondition.

4.6Pregnancyandlactation

Pregnancy:

Metronidazoleshouldnotbegivenduringthefirsttrimesterofpregnancyunlessitisconsideredessential.

Lactation:

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4.7Effectsonabilitytodriveandusemachines

None.

4.8Undesirableeffects

Becauseofthelowplasmaconcentrationsafterlocalapplicationofthedentalgel,theriskofsystemicside-effectsis

low.Themostfrequentside-effectsarelocalandoccurdirectlyinconnectionwiththeapplication,suchasbittertaste

andtemporarylocaltenderness.Headachehasbeenreported.

4.9Overdose

Notapplicable.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Anantibioticactiveagainstthemicro-organismspredominantinginthesubgingivalflora

inadultperiodontitis.

Pharmacodynamicactions:MetronidazoleactsbactericidallyonBacteroidesspp.,Fusobacterium,Selenomonas,

Wolinella,Spirochetesandotherobligateanaerobes.Inaddition,certainfacultativeanaerobicbacteria,suchas

Actinobacillusactinomycetemcomitans,aresensitivetotheconcentrationsreachedlocallyinthegingivalpocket.

Aerobicbacterialfloraisnotaffected.

5.2Pharmacokineticproperties

Absorption:Thetotalbioavailabilityisabout70%.

Distribution:AfterapplicationofElyzoldentalgel,concentrationsofmetronidazoleabove100microgram/mlhave

beenmeasuredinthegingivalpocketforatleast8hours.Concentrationsabove1microgram/ml(theMIC

valuefor

mostobligateanaerobesisbelow1microgram/ml)werestillmeasurableat36hours.Theconcentrationexceeds

forActinobacillusactinomycetecomitansforatleast8hours.

Themaximumserumconcentrationisreachedafter4hours.Concentrationsabove1.3microgram/mlhavenotbeen

found.Proteinbinding:10-15%.Metronidazoleislipid-solubleandpenetrateswell;itcrossestheblood-brainbarrier.

Metabolism:Metronidazoleismetabolisedchieflyintheliverbyhydroxylationandoxidationandconjugateswith

glucuronicacid.Thebiologicallyactivemetabolite,hydroxymetronidazole,hasahalf-lifeof9-19hours.

Elimination:Metronidazoleisexcretedmainlywiththeurine,inwhich15-20%isrecoveredunchangedandthe

remainderasmetabolites.Theplasmahalf-lifeis6-8hours.Acertainamountiseliminatedinthebile.

5.3Preclinicalsafetydata

None.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Glycerolmono-oleate

Sesameoil

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6.2Incompatibilities

Notapplicable.

6.3ShelfLife

Threeyears.

6.4Specialprecautionsforstorage

Storebelow25 º C.

6.5Natureandcontentsofcontainer

Cartonsof2X0.3gor2X1gdisposableapplicatorscontainingElyzol25%DentalGel.Eachapplicatorcontainsan

ambercolouredTypeIglasscartridgewithbromobutyl/chlorobutylorbromobutylrubberstoppersinbothends,the

pierceableendbeingcoveredwithanaluminiumcap.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Useeachapplicatorononepatientduringonesessionoftreatmentonly.Ifonlypartisused,theremaindershouldbe

discarded.

7MARKETINGAUTHORISATIONHOLDER

Colgate-Palmolive(UK)Limited

GuildfordBusinessPark

MiddletonRoad

Guildford

SurreyGU28JZ

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA320/9/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:16August1993

Dateoflastrenewal:16August2003

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 09/12/2006 CRN 2030977 page number: 3