FIBRO-VEIN

Main information

  • Trade name:
  • FIBRO-VEIN Solution for Injection 3 %w/v
  • Dosage:
  • 3 %w/v
  • Pharmaceutical form:
  • Solution for Injection
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FIBRO-VEIN Solution for Injection 3 %w/v
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0246/001/005A
  • Authorization date:
  • 04-05-2001
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Fibro-Vein3.0%w/vSolutionforInjection(2mlampoule).

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Containssodiumtetradecylsulphate3.0%w/v(equivalentto30mg/ml).

Excipients:Containsbenzylalcohol20mg/ml,sodium2.43mg/mlandpotassium0.29mg/ml.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Solutionforinjection.

Clear,colourlesssolution.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forthetreatmentofvaricoseveinsofthelegbyinjectionsclerotherapy.

4.2Posologyandmethodofadministration

RouteofAdministration

Forintravenousadministrationintothelumenofanisolatedsegmentofemptiedveinfollowedbyimmediate

continuouscompression.

Recommendeddosesanddosageschedules

Adults

0.25to1.0mlof3.0%fibro-veininjectedintravenouslyatamaximumof4sites(maximum4ml).

Children

Notrecommendedinchildren.

Elderly

Asforadults.

4.3Contraindications

Allergytosodiumtetradecylsulphateortoanycomponentofthepreparation.

Patientsunabletowalkduetoanycause.

Irish Medicines Board

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Date Printed 22/11/2007 CRN 2043579 page number: 1

Significantobesity.

Acutesuperficialthrombophlebitis.

Localorsystemicinfection.

Varicositiescausedbypelvicorabdominaltumours.

Uncontrolledsystemicdiseasee.g.diabetesmellitus.

Significantvalvularincompetencerequiringsurgicaltreatment.

4.4Specialwarningsandprecautionsforuse

Fibro-veinshouldonlybeadministeredbypractitionersfamiliarwithanacceptableinjectiontechnique.Thoroughpre-

injectionassessmentforvalvularcompetenceanddeepveinpatencymustbecarriedout.

Extremecareinneedleplacementandslowinjectionoftheminimaleffectivevolumeateachinjectionsiteareessential

forsafeandefficientuse.

Ahistoryofallergyshouldbetakenfromallpatientspriortotreatment.Wherespecialcautionisindicatedatestdose

of0.25to0.5mlfibro-veinshouldbegivenupto24hoursbeforeanyfurthertherapy.

Treatmentofanaphylaxismayrequire,dependingontheseverityofattack,someorallofthefollowing:injectionof

adrenaline,injectionofhydrocortisone,injectionofantihistamine,endotrachealintubationwithuseofalaryngoscope

andsuction.

Thetreatmentofvaricoseveinsbyfibro-veinshouldnotbeundertakeninclinicswheretheseitemsarenotreadily

available.

Extremecautioninuseisrequiredinpatientswitharterialdiseasesuchassevereperipheralatherosclerosisor

thromboangiitisobliterans(buerger’sdisease).

Specialcareisrequiredwheninjectionaboveandposteriortothemedialmalleoluswheretheposteriortibialartery

maybeatrisk.

Pigmentationmaybemorelikelytoresultifbloodisextravasatedattheinjectionsite(particularlywhentreating

smallersurfaceveins)andcompressionisnotused).

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Donotusewithheparininthesamesyringe.

4.6Pregnancyandlactation

Safetyforuseinpregnancyhasnotbeenestablished.Useonlywhenclearlyneededforsymptomaticreliefandwhen

thepotentialbenefitsoutweighthepotentialhazardstothefoetus.

Itisnotknownwhethersodiumtetradecylsulphateisexcretedinhumanmilk.Cautionshouldbeexercisedwhenused

innursingmothers.

4.7Effectsonabilitytodriveandusemachines

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Date Printed 22/11/2007 CRN 2043579 page number: 2

4.8Undesirableeffects

Local

Painorburning.Skinpigmentation.Tissuenecrosisandulcerationmayoccurwithextravasation.Paraesthesiaand

anaesthesiamayoccurifaninjectioneffectsacutaneaousnerve.

Vascular

superficialthrombophlebitis.Deepveinthrombosisandpulmonaryembolismareveryrare.Inadvertentintra-arterial

injectionisveryrarebutmayleadtogangrene.Mostcaseshaveinvolvedtheposteriortibialarteryabovethemedial

malleolus.

Systemicreactions

Allergicreactionsarerare,presentingaslocalorgeneralisedrash,urticaria,nauseaorvomiting,asthma,vascular

collapse.Anaphylacticshock,whichmaypotentiallybefatal,isextremelyrare.

4.9Overdose

Notapplicable.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Therapeuticgroup:Anti-varicosetherapy–sclerosantsforlocalaction

ATCCode:CO5BB04

Sodiumtetradecylsulphatedamagestheendotheliumcellswithinthelumenoftheinjectedvein.Theobjectof

compressionsclerotherapyisthentocompresstheveinsothattheresultingthrombusiskepttotheminimumandthe

subsequentformationofscartissuewithintheveinproducesafibrouscordandpermanentobliteration.Non-

compressedveinspermittheformationofalargethrombusandproducelessfibrosiswithinthevein.

5.2Pharmacokineticproperties

Notapplicable.

5.3Preclinicalsafetydata

Notapplicable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Benzylalcohol

Disodiumphosphate,anhydrous

Potassiumdihydrogenphosphate

Waterforinjection

Sodiumhydroxide(forpHadjustment)

6.2Incompatibilities

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Date Printed 22/11/2007 CRN 2043579 page number: 3

6.3ShelfLife

Unopened:3years.

Onceopened,useimmediatelyanddiscardanyremainingsolution.

6.4Specialprecautionsforstorage

Donotstoreabove25ºC.Keeptheampoulesintheoutercarton.

6.5Natureandcontentsofcontainer

Type1Ph.Eur.glassampoules.

Packsize:5x2mlampoules.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Eachglassampouleisforsingleuseonly.

Anyunusedcontentsmustbediscarded.

7MARKETINGAUTHORISATIONHOLDER

STDPharmaceuticalProductsLtd

FieldsYard

PloughLane

HerefordHR40EL

8MARKETINGAUTHORISATIONNUMBER

PA0246/001/005

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:4 th

May2001

Dateoflastrenewal:4 th

May2006

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 22/11/2007 CRN 2043579 page number: 4