DICYNENE 250MG/2ML SOLUTION FOR INJECTION

Main information

  • Trade name:
  • DICYNENE 250MG/2ML SOLUTION FOR INJECTION
  • Dosage:
  • 250/2
  • Pharmaceutical form:
  • Solution for Injection
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DICYNENE 250MG/2ML SOLUTION FOR INJECTION
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1108/001/001
  • Authorization date:
  • 01-04-1998
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Dicynene250mg/2mlSolutionforInjection.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Activeingredientisetamsylate125mg/mlofinjectionsolution.

(250mgper2mlampoule).

Excipients:Each2mlampoulealsocontains0.8mgofsodiummetabisulphite(E223)

Forafulllistofexcipients,seesection6.1

3PHARMACEUTICALFORM

Solutionforinjection(injection).

Aclear,colourless,aqueoussolutionforinjection(pH6.2to6.8).

4CLINICALPARTICULARS

4.1TherapeuticIndications

DICYNENEisusedclinicallyfortheprophylaxisandtreatmentofperiventricularhemorrhageinlowbirthweight

infants.

4.2Posologyandmethodofadministration

Neonatesonly:

Thenormaldosageis12.5mg/kggivenbyintravenousorintramuscularroutewithinanhourofbirthandeverysix

hoursforthefirst4daysoflife.

4.3Contraindications

Useinpatientswithaknownhypersensitivitytoetamsylateortoanyoftheexcipients.

4.4Specialwarningsandprecautionsforuse

Theproductcontainssulfiteswhichmaycauseananaphylacticreaction(see4.8UndesirableEffects).

Iftheinfantdevelopsafeverthentreatmentshouldbediscontinued.

DICYNENEinjectionisintendedforneonataluseonly.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

DICYNENEinjectionisincompatiblewithsolutionsofsodiumbicarbonateandcompoundsodiumlactate.

WhenDICYNENEinjectionismixedwithsalineitshouldbeusedimmediately.

4.6Fertility,pregnancyandlactation

Clinicaluseisnotrelevantforthisindication.

Irish Medicines Board

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Date Printed 31/03/2011 CRN 2056958 page number: 1

Nonestated.

4.8Undesirableeffects

Ininfantsnomajorside-effectshavebeenreported.

However,occasionalheadaches,skinrashes,feverandgastrointestinaldisturbancessuchasnausea,vomitingand

diarrhoeahaveoccurredinadults.

Duetothepresenceofsulfites,allergicreactionsmayoccurincludinganaphylacticsymptomsrangingfromrashto

anaphylacticshock(see4.4SpecialWarningsandPrecautionsforuse).

4.9Overdose

ThereisnoexperienceofoverdosagewithDICYNENE.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

DICYNENEisanon-hormonalagentwhichreducescapillaryexudationandbloodloss.DICYNENEdoesnotaffect

thenormalcoagulationmechanismsinceadministrationiswithouteffectonprothrombintimes,fibrinolysis,platelet

countorfunction.

DICYNENEisthoughttoactbyincreasingcapillaryvascularwallresistanceandplateletadhesiveness;inthepresence

ofavascularlesion,itinhibitsthebiosynthesisandactionofthoseprostaglandinswhichcauseplateletdisaggregation,

vasodilationandincreasedcapillarypermeability.DICYNENEdoesnothaveavasoconstrictingaction.

5.2Pharmacokineticproperties

Followingintravenousadministrationmaximumbloodlevelsofetamsylateareachievedin2-3minutes,whileafter

intramuscularinjection,maximumbloodlevelsofetamsylateareachievedafteraboutonehour.Etamsylateisexcreted

unchanged,largelybytheurinaryroute.

5.3Preclinicalsafetydata

Nofurtherinformationisavailable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Sodiummetabisulphite(E223)

Sodiumhydrogencarbonate(forpHadjustment)

Waterforinjections

6.2Incompatibilities

Dicyneneinjectionisincompatiblewithsolutionsofsodiumbicarbonateandcompoundsodiumlactate.

6.3ShelfLife

Unopened:3years

Onceopened:fromamicrobiologicalpointofviewtheproductshouldbeusedimmediately.Ifnotusedimmediately,

in-usestoragetimesandconditionspriortouseareresponsibilityoftheuserandwouldnormallynotbelongerthan24

hoursat2to8 o

Irish Medicines Board

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Date Printed 31/03/2011 CRN 2056958 page number: 2

6.4Specialprecautionsforstorage

Storebelow25°C.Keeptheampouleintheoutercarton.

6.5Natureandcontentsofcontainer

2mlclear,TypeIglassampoulescontainingacolourless,sterile,aqueoussolution.

Outercartonscontaining10X2mlampoules.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Discardifsolutioniscoloured.

Forsingleuseonly,anyremainingsolutionshouldbediscarded.

7MARKETINGAUTHORISATIONHOLDER

OMPHARMAS.A.

R.daIndustria2

QuintaGrande

2610-088Amadora

Lisboa

Portugal

8MARKETINGAUTHORISATIONNUMBER

PA1108/1/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: 1 st

April1983

Dateoflastrenewal: 1 st

April2008

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 31/03/2011 CRN 2056958 page number: 3