DECAN

Main information

  • Trade name:
  • DECAN Concentrate for Soln for Inf
  • Pharmaceutical form:
  • Concentrate for Soln for Inf
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DECAN Concentrate for Soln for Inf
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0167/102/001
  • Authorization date:
  • 07-07-2000
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

DECANconcentrateforsolutionforinfusion

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Compositionper1000mlDECAN

Contentperbottleof40ml

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Concentrateforsolutionforinfusion

Ferrousgluconate 199.9mg

Coppergluconate 85mg

Manganesegluconate 40.5mg

Zincgluconate 1742mg

Sodiumfluoride 80mg

CobaltIIgluconate 0.280mg

Sodiumiodide 0.045mg

Sodiumselenite 3.83mg

Ammoniummolybdate 1.08mg

Chromicchloride 1.14mg

Density 1.00

Osmolality 19mOsmol/kgwater

Osmolarity 17.6mOsmol/liter

DECAN DECAN

Molarcomposition/40ml Weightcomposition/40ml

17.9micromol 1.000mg

153.0micromol 10.00mg

7.550micromol 0.480mg

3.640micromol 0.200mg

76.30micromol 1.450mg

0.0250micromol 1.470microg

0.0120micromol 1.520microg

0.8870micromol 0.070mg

0.2610micromol 0.025mg

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 14/07/2011 CRN 2092014 page number: 1

4CLINICALPARTICULARS

4.1TherapeuticIndications

DECANisusedaspartofanintravenousnutritionregimen,tocoverbasalormoderateincreasedneedsoftrace

elementsinparenteralnutrition.

4.2Posologyandmethodofadministration

Foradultsonly.

Therecommendeddailydoseinpatientswithbasaltomoderatelyincreasedrequirementsisonevial(40ml)of

DECAN.

Incasesofsignificantlyincreasedtraceelementrequirements(suchasextensiveburns,severehypercatabolicmajor

traumapatients)2vials(80ml)ofDECANmaybegivenperday,andmonitoringofserumtraceelementsvaluesis

recommended.

DECANisnotintendedtobeadministeredinitscurrentpresentation

DECANcanalsobeincludedassuchinparenteralnutritionadmixtures.Inthiscase,specialattentionmustbepaidto

thecompatibilityofbothproducts.

Forincompatibilitiesandinstructionsforusesee6.2and6.6.

4.3Contraindications

Childrenorpatientslessthan40kgbodyweight

Pronouncedcholestasis(serumbilirubin>140µmol/l)

DECANshouldnotbeadministered:

topatientswithknownhypersensitivitytotheactivesubstancesandtotheexcipient.

incasesofWilson’sdiseaseandhemochromatosis,andifserumconcentrationsofanyofthetraceelements

containedinDECANareelevated

4.4Specialwarningsandprecautionsforuse

Thesolutionshouldbeusedafteranaccuratecontroloftheclinicalandbiologicalparameters.Manganesebloodlevels

shouldberegularlymonitoredincaseofprolongedartificialnutrition:dosereductionmaybenecessaryorDECAN

infusionshouldbestoppedifmanganeselevelsriseintothepotentiallytoxicrange(pleaserefertoappropriate

referenceranges).

Particularattentionshouldbereservedwhentheproductisgiventopatientswithreducedbiliaryexcretion,sinceit

couldinterferewiththebiliaryeliminationofmanganese,copperandzinc,leadingtoaccumulationandoverdose.

DECANshouldbeusedwithcautioninpatientswithimpairedrenalfunctionasexcretionofsometraceelements

(selenium,fluoride,chromium,molybdenumandzinc)maybesignificantlydecreased.

Inpatientswithrenal,hepaticimpairmentsormildcholestasistheposologyshouldbeadapted.

Inpatientsundergoingmediumtolongtermparenteralnutrition,thereisanincreasedfrequencyofiron,zincand

seleniumdeficiency.Duetotheverylowcontentofiodine,iodinedeficiencycanoccurintheabsenceofothersupply

suchasiodinecontainingantibacterialskinsolutions.Insuchcircumstances,whennecessary,thedosageshouldbe

adaptedwiththeuseofanextrasupplyofsolutions,whichcontainonlytheseindividualcomponents.

Forpatientsreceivingrepeatedbloodtransfusions,ariskofironoverloadcanbeobserved.

Thisproductcontains0.078mmolofsodium(1.796mg)perdose,i.eessentially“sodiumfree”.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 14/07/2011 CRN 2092014 page number: 2

4.6Fertility,pregnancyandlactation

NosafetydataforDECANareavailablewhenitisadministeredduringpregnancyandlactation.Therefore,DECAN

shouldnotbeusedduringpregnancyandlactationexceptafterspecialconsiderationandifitisabsolutelynecessary.

4.7Effectsonabilitytodriveandusemachines

Nonestated.

4.8Undesirableeffects

Thefollowingadversereaction(s)havebeenreportedspontaneouslyduringPost-Marketinguseoftheproduct.The

frequencycannotbeestimatedduetothenatureofthedata.

4.9Overdose

OverdosewithDECANisextremelyunlikelysincethequantityoftraceelementspervialiswellbelowknowntoxic

levels.Anaphylacticreactionshavebeenobservedinsomecaseswhenironwasgivenintravenously.Ifoverdoseis

suspected,treatmentwithDECANshouldbewithdrawn.Overdosewouldbeconfirmedbyappropriatelaboratory

tests.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Solutionoftraceelementsforinfusion-B05X

DECANisabalancedsolutioncomposedofthetenessentialtraceelements,whicharenecessarytomaintainthe

metabolicequilibrium.

Traceelementsarenormallyderivedfromabalanceddiet,buttheneedincreasesincaseofhypercatabolism(surgery,

majortrauma,burns),insufficientsupplyorabnormallossandincasesofpoorabsorption(shortboweldiseaseor

Crohn’sdisease).

ThecompositionofDECANisbasedonpresentinternationalrecommendationsconcerningtherequirementsfortrace

elements:

Systemorganclass(SOC) MedDRAPreferredTerm

GENERAL DISORDERS AND

ADMINISTRATIONSITECONDITIONS Applicationsitepain

DECAN Recommended*IntravenousDaily

(1-2vials) Intakes

Fe(mg) 1-2 1.2

Zn(mg) 10-20 2.4-15

Cu(mg) 0.48-0.96 0.3-1.6

Mn(mg) 0.2-0.4 0.15-0.8

(mg) 1.45-2.90 0.95

Co(microg) 1.47-2.94 -

(microg) 1.52-3.04 131

Se(microg) 70-140 30-500

Mo(microg) 25-50 19-200

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 14/07/2011 CRN 2092014 page number: 3

Duringanartificialnutrition,asupplyoftraceelementsisnecessarysinceadeficiencyofoneofthemcangenerate

importantmetabolicandclinicaldisturbances.

5.2Pharmacokineticproperties

Thevariouspathwaysoftraceelementmetabolismcanbesummarisedasfollows:

Bloodtransportbyproteins:albumin(Mn,Cu,Zn,Se),transferrin(Fe,Cr),ceruloplasmin(Cu),cyanocobalamin

(Co),selenomethionine(Se),ornonproteincarriers(F,I,Mo).

Storageinvolvesspecificproteins:ferritin(Fe),thyroidhormones(I),cobalamins(Co),selenoproteins(Se),ornon

specificproteins:metallothioneins(Cu,Zn,Mn,Mo)orfluoroapatite(F).

Elimination:

Thecationictraceelements(Fe,Cu,Mn,Zn)areeliminatedmainlythroughbiliaryexcretion.

Theanionictraceelements(I,F)andsomeoxygenatedformsofminerals(suchasMo,Co,Se,Cr)areprimarily

excretedintheurine.

Eliminationthroughthelungsandtheskinispossible.

5.3Preclinicalsafetydata

Preclinicaldatabasedonconventionalstudiesofsafetypharmacology,repeateddosetoxicity,toxicitytoreproduction,

genotoxicityandcarcinogenicityfortraceelementsinDECANareincomplete.SinceDECANisintendedfor

replacementtherapy,theriskfortoxiceffectsisconsideredtobelowatnormalclinicaluse.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Gluconodelta-lactone

WaterforInjections

6.2Incompatibilities

DECANmustnotbeusedasavehicleforotherdrugs.

DECAN,aswithothertraceelementsolutions,cannotbeaddeddirectlytoinorganicphosphate(additive)

solutions.

Degradationofascorbicacidinparenteralnutritionadmixturesisacceleratedbytraceelements

Thismedicinalproductmustnotbemixedwithothermedicinalproductsexceptthosementionedinsection6.6.

6.3Shelflife

2years.

Afterdilution,chemicalandphysicalin-usestabilityhasbeendemonstratedfor24hat25°C.

Fromamicrobiologicalpointofview,theproductshouldbeusedimmediatelyafterdilutionoraddition.Ifnotused

immediately,in-usestoragetimesandconditionspriortousearetheresponsibilityoftheuserandwouldnormallynot

belongerthan24hat5°Cunlessdilutionoradditionhastakenplaceincontrolledandvalidatedasepticconditions.

6.4Specialprecautionsforstorage

Donotstoreabove25°C,donotfreeze

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 14/07/2011 CRN 2092014 page number: 4

6.5Natureandcontentsofcontainer

Glassbottleof50ml(colourless/transparentglasstypeII)filledwith40ml;

Packagesize:40mlx1unit

40mlx25units

6.6Specialprecautionsfordisposalandotherhandling

Beforeusecheckthatthesolutionishomogeneousandthatthebottleisnotdamagedandisfreeofparticles.

DECANisnotintendedtobeadministeredinitscurrentpresentation.DECANmustbedilutedoradmixedwithgentle

agitationduringpreparationunderstrictasepticconditions,beforeinfusion.

DECANmustbedilutedwithrespecttothefinalappropriateosmolarity.Forexample:

40mlofDECANcanbedilutedinatleast250mlofSodiumChloride0.9%solutionforinfusion,

40mlofDECANcanbedilutedinatleast500mlofGlucose5%to70%solutionsforinfusion.Incaseofdilution

ofDecaninGlucosesolutionsabove20%,thedilutionmustnotbeadministeredalonewithregardtothefinal

osmolarity .

Thereconstitutedsolutionforinfusionhastobevisuallyinspectedpriortouse.Onlyclearsolutionwithoutparticles

shouldbeused.

Donotstorepartlyusedcontainersanddiscardallequipmentafteruse.

Thecompatibilitywithsolutionsadministeredsimultaneouslyviaacommoninletcannulamustbeensured.

7MARKETINGAUTHORISATIONHOLDER

BaxterHealthcareLimited

CaxtonWay

Thetford

Norfolk

IP243SE

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA167/102/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:07July2000

Dateoflastrenewal:26March2009

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 14/07/2011 CRN 2092014 page number: 5