CERNEVIT BIO-SET

Main information

  • Trade name:
  • CERNEVIT BIO-SET
  • Pharmaceutical form:
  • Pdr for Soln Inj/Inf
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CERNEVIT BIO-SET
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0167/097/002
  • Authorization date:
  • 22-06-2007
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0167/097/002

CaseNo:2068802

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

BaxterHealthcareLimited

CaxtonWay,Thetford,NorfolkIP243SE,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Cernevit,Bioset,PowderforSolutionforInjectionorInfusion

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom09/04/2010.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 12/04/2010 CRN 2068802 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Cernevit,Bioset,PowderforSolutionforInjectionorInfusion

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachvialofpowdercontains:

RetinolPalmitate(VitA) 3500 IU

Colecalciferol(VitD

tocopherol(VitE) 10.20 mg

-correspondingto-tocopherol 11.200IU

Ascorbicacid(VitC) 125 mg

Cocarboxylasetetrahydrate 5.80 mg

-correspondingtoThiamine(VitB

3.510 mg

Riboflavindihydratedsodiumphosphate(VitB

5.67 mg

-correspondingtoRiboflavin 4.14 mg

Pyridoxinehydrochloride(VitB

5.50 mg

-correspondingtoPyridoxine 4.53 mg

Cyanocobalamin(VitB

micrograms

Folicacid 414 micrograms

Dexpanthenol 16.15mg

-correspondingtopantothenicacid 17.25mg

D-Biotin 69 micrograms

Nicotinamide 46 mg

Excipients:Eachvialcontains24mgsodiumandlessthan112.5mgsoyaoil.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

PowderforSolutionforinjectionorinfusion.

Orange-yellowsterilecakeoflyophilisedpowder.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Supplyofvitaminscorrespondingtothedailyneedsofadultsandchildrenover11yearsrequiringmulti-vitamin

supplementationbytheparenteralroutewhenoralnutritioniscontraindicated,impossibleorinsufficient(e.g.dueto

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4.2Posologyandmethodofadministration

Adultsandchildrenagedover11years:1vial/day.

Methodofreconstitution

See6.6Instructionforuseandhandling

Methodofadministration

Intravenousroute-Byslowintravenousinjection(atleast10minutes)orbyinfusionin,forexample,isotonicsalineor

glucosesolution.

Cernevitmaybeincludedinthecompositionofnutritivemixturescombiningcarbohydrates,lipids,amino,acids

electrolytesprovidedthatcompatibilityandstabilityhavebeenconfirmedforeachnutritivemixture.

4.3Contraindications

Pre-existinghyper-vitaminosisorknownhypersensitivitytoanyoftheingredients,inparticularpatientswith

hypersensitivitytothiamine(VitaminB

),soyaorpeanuts.

4.4Specialwarningsandprecautionsforuse

AnaphylacticreactionsmayoccurinallergicsubjectsbecauseofthepresenceofvitaminB

andsoybeanphosphatides.

Mildallergicreactionssuchassneezingormildasthmaarewarningsignsthatafurtherinjectionmaygiveriseto

anaphylacticshock.

Duetoglycocholicacidcontent,repeatedandprolongedadministrationinpatientswithjaundiceofhepaticoriginor

severebiochemicalevidenceofcholestasisrequirescarefulmonitoringofliverfunction.

CautionshouldbeexercisedwhenadministeringCernevittopatientswhomaybereceivingvitaminAfromother

sources.

FollowingIVbolusinjection,amoderateriseonlyinSGPTtransaminaseshasbeennotedinsomepatientswithactive

inflammatoryenterocolitis.Increasedlevelsarerapidlyreversiblefollowingtheinterruptionofadministration.Itis

advisabletomonitortransaminaselevelsinpatientsofthistype.Alsointhecaseofimpairedkidneyfunction,lipid-

solublevitaminlevelsshouldbecarefullymonitored.

CernevitdoesnotcontainVitaminK.VitaminKmustbeadministeredseparatelyifnecessary.

Thismedicinalproductcontains1.04mmolsodiumperdose.Tobetakenintoconsiderationbypatientsona

controlleddiet.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Thecontentofpyridoxinemayinterferewiththeeffectsofconcurrentlevodopatherapy.

Thedosageofdrugsknowntobeinfluencedbyfolicacid,forexamplephenytoin,mustbecarefullymonitored.

4.6Pregnancyandlactation

Thisproductshouldnotbeusedinpregnancyorinwomenbreastfeedinginfants.

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4.7Effectsonabilitytodriveandusemachines

Notapplicable

4.8Undesirableeffects

BecauseofthepresenceofVitaminB,andsoybeanphosphatides,anaphylacticreactionsmayoccurinsubjectswith

underlyingallergy(seesection4.3).

ElevationofSGPTtransaminasesfollowingIVbolusinjectionsinsomepatients(c.f.specialprecautions).

4.9Overdose

ManifestationsofVitaminAhypervitaminosisandVitaminDhypervitaminosis(symtomatologyrelatedto

hypercalcaemia)arepossibleincaseofprolongedadministrationofsignificantdosesofthesevitamins.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Balancedassociationofallwatersolubleandfatsoluble,vitaminsessentialforthemetabolismoftheadultandthe

childagedover11years,withtheexceptionofVitaminK.

5.2Pharmacokineticproperties

Notapplicable.

5.3Preclinicalsafetydata

Notapplicable

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Glycine

Glycocholicacid

Soybeanphosphatides

Sodiumhydroxide(forpHadjustment)

HydrochloricAcid(forpHadjustment)

6.2Incompatibilities

None.

6.3ShelfLife

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Oncereconstituted:ChemicalandPhysicalin-usestabilityhasbeendemonstratedforCernevitfor24hoursat25°C

whenreconstitutedwith5mlofWaterforInjections.

Fromamicrobiologicalpointofview,theproductshouldbeusedimmediately.Ifnotusedimmediately,inusestorage

timesandconditionspriortousearetheresponsibilityoftheuserandwouldnormallynotbelongerthan24hoursat2

to8°C,unlessreconstitution/dilutionetchastakenplaceincontrolledandvalidatedasepticconditions.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

Keepthevialintheoutercarton.

6.5Natureandcontentsofcontainer

TypeIPh.Eur.brownglassvialwithaBIO-SET,containinganorange-yellowsterilecakeofpowder;

Boxof1,10or20vialsoflyophilisedpowder

Notallpacksizesmaybemarketed

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Donotuseunlesssolutionisclearandthecontainerisundamaged.

Forsingleuseonly.Discardanyunusedcontent.

CernevitBIO-SETallowsadirectreconstitutionincontainers(bothsingleormulti-compartmentplasticbags)

equippedwithaninjectionport.

Mono-bag:

1.Removethecapbytwistingandthenpullingtobreakthesecurityring.

2.ConnectdirectlytheBIO-SETtothebaginjectionport.

3.ActivatetheBIO-SETbyapplyingapressureonthetransparentmobilepartoftheBio-set.Thisactionpuncturesthe

rubberstopperofthevial.

4.Holdverticallytheconnectedsystem(CernevitBIO-SETandinfusionbag),thebagbeingontopofit.Gently

squeezetheinfusionbagseveraltimestotransferthesolutionintothevial(about5ml).Agiattethevilatoreconstitute

Cernevit.

5.Upturntheconnectedsystemandholditveticallyupsidedown.Gentlysqueezetheinfusionbagseveraltimesto

movetheheadspacegasvolumeintothevial,thusallowingreversetransferofthesolutionintotheinfusionbag.

6.Repeatinstructions4and5untilthevialisempty.

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Multi-compartmentbag:

ReconstitutionofCERNEVITBIO-SEThastobemadebeforeactivationofthemulti-chamberbag(beforeopeningthe

non-permanentsealsandbeforemixingthecontentofeachdepartment).

1.Placethemulti-chamberbagonabench

2.RemovethecapofCernevitbytwistingandthenpulingtobreakthesecurityring.

3.ConnectdirectlytheBIO-SETtothemuli-chamberbaginjectionport.

4.ActivatetheBIO-SETbyapplyingpressureonthetransparentmobilepartoftheBIO-SET.Thisactionpuncturesthe

rubberstopperofthevial.

5.Holdthevialvertically.Gentlysqueezethecompartmentseveraltimestotransferthesolutionintothevial(about

5ml).AgitatethevialtoreconstituteCernevit.

6.Upturntheconnectedsystem,holdingthevialverticallyupsidedown.GentlySqueezethecompartmentseveral

timestomovetheheadspacegasvolumeintothevial,thusallowingreversetransferofthesolutionintotheinfusion

bag.

7.Repeatstep5&6untilthevialisempty.

8.RemoveanddiscardtheCernevitBIO-SET

9.Finally,activatethemulti-chamberbag.

Warning:

TakecarethatthereisnodisconnectionoftheBIO-SETfrontheinjectionportduringallthereconstitutionprocess.

7MARKETINGAUTHORISATIONHOLDER

BaxterHealthcareLtd.,

CaxtonWay,

Thetford,

Norfolk,

IP243SE,UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA167/97/2

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

DateofFirstAuthorisation:22ndJune2007

Dateoflastrenewal:4thJanuary2008

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 12/04/2010 CRN 2068802 page number: 6