FLAMAZINE

Main information

  • Trade name:
  • FLAMAZINE Cream 1 %w/w
  • Dosage:
  • 1 %w/w
  • Pharmaceutical form:
  • Cream
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FLAMAZINE Cream 1 %w/w
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PPA1328/140/001
  • Authorization date:
  • 12-11-2010
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

FLAMAZINE1%w/wCream

2QUALITATIVEANDQUANTITATIVECOMPOSITION

ContainsSilversulfadiazine1%w/w

Excipients:Containscetylalcoholandpropyleneglycol.

Forafulllistexcipients.seesection6.1.

3PHARMACEUTICALFORM

Cream

ProductimportedfromSpain:

Whitetooff-white,sterilecream.

4CLINICALPARTICULARS

4.1TherapeuticIndications

FLAMAZINEcreamisindicatedfortheprophylaxisandtreatmentofinfectioninburnwounds,legulcersandpressure

soresduetomicro-organismssensitivetothisanti-infective.

FLAMAZINEcreamisalsoindicatedfortheconservativemanagementoffinger-tipinjurieswherepulp,nailloss

and/orpartiallossofthedistalphalanxhaveoccurred.

4.2Posologyandmethodofadministration

Tobeappliedtopically.

BurnsandLegUlcers/PressureSores:Alayerapproximately3to5mmthickshouldbeappliedtotheaffectedarea

usingasterilegloveorspatula.Theareashouldthenbecoveredbyanabsorbentgauzedressingandsupportbandage

wherenecessary.ThedressingshouldbechangedandFLAMAZINEcreamappliedatleastevery24hoursinburn

treatment,oratleastthreetimesweeklyotherwise,anddebridementcarriedoutasnecessary.

AsFlamazinecreamcancausemacerationofnormalskinonprolongedcontact;careshouldbetakentoavoidspread

ontonon-ulceratedareas.

Finger-TipInjuries:Haemostasisoftheinjuryshouldbeachievedpriortotheapplicationofa3-5mmlayerof

FLAMAZINEcream.Aconventionalfingerdressingmaybeused.Alternativelythefingerofaplasticorunsterile

surgicalglovecanbeusedandfixedinplacewithwaterproofadhesivetape.Dressingsshouldbechangedevery2-3

days.

4.3Contraindications

Assulphonamidesareknowntocausekernicterus,FLAMAZINEcreamshouldnotbeusedinlactatingwomenwho

arebreast-feedinginfants,onprematureinfantsoronnewborninfantsduringthefirstthreemonthsoflife.

FLAMAZINEcreamisalsocontraindicatedinpatientsknowntobehypersensitivetosulphonamidesandsilver

Irish Medicines Board

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Date Printed 16/11/2010 CRN 2086663 page number: 1

4.4Specialwarningsandprecautionsforuse

Prolongeduseofananti-infectivemayresultinthedevelopmentofsuperinfectionduetoorganismsresistanttothat

anti-infective.Fungalcolonizationmayoccur.

Theproductshouldonlybeusedwithextremecautioninpatientswithrespiratoryimpairmentorhepaticorrenal

functionimpairment.

Onecontainershouldbereservedforuseinasinglepatientandtheremainingcontentsdiscardedaftertreatmentis

completed.

Cautionofuseisrequiredinindividualsknowntohaveglucose-6-phosphatedeficiencyassulphonamidesareknownto

causehaemolyticanaemiainthesepatients.

UseofFlamazinecreammaydelayseparationofburnescharandmayaltertheappearanceofburnwounds.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Assilvermayinactivateenzymaticdebridingagents,theirconcomitantusemaybeinappropriate.

Inlarge-areaburnswhereserumsulfadiazinelevelsmayapproachtherapeuticlevels,itshouldbenotedthattheeffects

ofsystemicallyadministereddrugsmaybealtered.Thiscanespeciallyapplytooralhypoglycaemicagentsandto

phenytoin.Inthecaseofthesedrugs,itisrecommendedthatbloodlevelsshouldbemonitoredastheireffectscanbe

potentiated.

4.6Fertility,pregnancyandlactation

Studiesinsomeanimalspecieshaveshownateratogeniceffectwithsulphonamides.Asimilareffecthasnotbeen

clearlydemonstratedinhumanbeings.Nonethelesstheproductshouldonlybeusedduringpregnancyorlactationif

consideredessentialbythephysician.

Thesulphonamideconcentrationinbreastmilkis15-35%ofthatintheserum.Sinceallsulphonamidesincreasethe

possibilityofkernicterus,cautionisrequiredinnursingmothers.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Blood&lymphaticTissueDisorders

Common: Leukopenia

Leukopeniahasbeenreportedin3-5%ofburnspatientstreatedwithFlamazine.Thismaybeadrugrelatedeffect,and

oftenmanifestsitself2-3daysaftertreatmenthascommenced.Itisusuallyself-limitingandtherapywithFlamazine

creamdoesnotusuallyneedtobediscontinued,althoughthebloodcountmustbemonitoredtoensurethatitreturnsto

normalwithinafewdays.

GeneralDisorders&AdministrationSiteConditions

Irish Medicines Board

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Renal&UrinaryDisorders

Veryrare: Renalfailure

Skin&SubcutaneousTissueDisorders

Common: Pruritis

Common: Applicationsiterash(includingeczemaandcontactdermatitis).

Rare: Argyria

Thereisevidencethatinlargearewoundsand/orafterprolongedapplication,systemicabsorptionofsilvercanoccur

causingclinicalargyria.

4.9Overdose

Notlikelytooccurwithnormalusage.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

SilverSulfadiazinehasbacteriostaticandbactericidalproperties.Thiscombinationprovidesawidespectrumof

antimicrobialactivity.

5.2Pharmacokineticproperties

Thesilverisslowlyreleasedfromthesilversulfadiazinemoleculeandcanenterthesystemiccirculation.The

sulfadiazinereadilydiffusesacrosswoundsandentersthegeneralcirculation.Thedegreeofuptakewillsignificantly

dependuponthenatureofthewoundandthedosingregime.Sulfadiazineisexcretedintheurine.Anyabsorbedsilver

mayremaininthebodyforlongperiods,predominantlyinliver.Itisslowlyexcretedovertimeviathebile.

5.3Preclinicalsafetydata

NoData.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Polysorbate60

Polysorbate80

GlycerolMonostearate

CetylAlcohol

LiquidParaffin

PropyleneGlycol

PurifiedWater

6.2Incompatibilities

Irish Medicines Board

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6.3ShelfLife

Theshelf-lifeexpirydateofthisproductshallbethedateshownonthecontainerandouterpackageoftheproducton

themarketinthecountryoforigin.

Flamazineshouldbediscarded7daysafterfirstopening.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.Storeintheoriginalcontainerinordertoprotectfromlight.

6.5Natureandcontentsofcontainer

50gpre-printedcylindricalwhiteplastictubesfittedwithwhiteplasticcaps

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Thecontentsofonecontainerareforthetreatmentofoneperson.

7PARALLELPRODUCTAUTHORISATIONHOLDER

B&SHealthcare

Unit4,BradfieldRoad

Ruislip

Middlesex,HA40NU

UnitedKingdom

8PARALLELPRODUCTAUTHORISATIONNUMBER

PPA1328/140/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:12 th

November2010

Irish Medicines Board

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Date Printed 16/11/2010 CRN 2086663 page number: 4