AuSPENGUIDELINES

FORINTRAVENOUSTRACE
ELEMENTSANDVITAMINS
1999

DrDavidRussell
DepartmentofGastroenterology
RoyalMelbourneHospital
GrattanStreet
ParkviIle
Victoria3050

CONTENTS
1. Introduction
2. Backgroundinformationonrequirements
forintravenousTraceElementsand
Vitamins
3. NewguidelinesforIntravenousTrace
Elements&Vitamins
4. CompositionofAdditraceandPeditrace
5. Conclusion

1.INTRODUCTION
Atthe22nd AnnualConferenceofAuSPENin1996therewasa
MicroNutrientWorkshopreviewingthecurrentAuSPEN
recommendationsforIntravenousTraceElementsandVitamins
inTotalParenteralNutrition(TPN).
DrAlanShenkin,fromtheDepartmentofClinicalChemistry
UniversityofLiverpoolUK,andDrMichaelBarnett,TheWelsh
SchoolofPharmacy,UniversityofWales,Cardiffwereactive
advisorstotheWorkshop.TogetherwithapanelofAustralian
membersofAuSPENthefollowingupdatedguidelinesare
presented.
Themajorityoftheworkshopfocusedonrecentresearchinto
changesinTraceElementrequirementsduringacuteillness&
TPN.Preventionoftraceelementdeficienciesisclearlycritical,
andmodificationoftraceelementrequirementsasa
consequenceoftheacutephaseresponseisnowbetter
understood.Nosignificantnewrecommendationsweremade
regardingintravenousvitamindosages.
Akeyreferenceformingthebasisoftheserecommendationsis
foundinasupplementtoNUTRITIONJan/Feb1995VolIINo1:
"TheTraceElements:TheirRoleandFunctioninNutritional
Support".

2.BACKGROUNDINFORMATIONONINTRAVENOUS
TRACEELEMENTANDVITAMINREQUIREMENTS
Note:
1.Thefollowingtablessummarisetherecommendationsfrom
previouspublicationsbywellrespectedauthors.Areviewof
theserecommendationsformedthebasisofthenew
guidelines(seereferences)
2.Intraceelements&vitamintables
AMA=AmericanMedicalAssociation
GRI=GlasgowRoyalInfirmary
AAP=AmericanAcademyofPaediatrics
3. Molecularweightsofsometraceelements
n=m/MW
Chromium52
Copper63.55
lodide(I)126.9
Manganese54.94
Selenium78.96
Zinc65.38
4.Vitamins:ConversionInternationalUnits(IU)toweight
VitaminA1IU=0.344 microgram
VitaminD1IU=25nanogram
VitaminE1IU=1milligram

TRACEELEMENTS:Adultsmicromolperday

Copper
Chromium
Iron
Fluoride
lodide
Molybdenum
Manganese
Selenium
Zinc

AuSPEN

Shenkin Fleming Elia

16
0.4
20

030
0.20.3

5.77.9
0.20.4

5
1.5
>50

0.51
3661

0.4
0.2
8
1.5
30

Leung

AMA

GR
I
824
824
9.127.3 20
0.190.29 0.190.29 0.190.29 0.2
20
50150
50
0.81.6
1
0.150.3
0.2
2.714
2.714.5 5
0.40.8
0.51
0.4
3861
3861
3861
100

TRACEELEMENTS:Children115yearmicromol/kg/day
AuSPEN216yr
Copper
0.4
Chromium
0.002
lodide
0.01
Manganese 0.15
Selenium
0.03
Zinc
0.4

Greene
0.3
0.004
0.007
0.018
0.025
0.77

AMA
0.031
0.0030.004
0.030.18

TRACEELEMENTS:Infants01yearmicromol/kg/day
AuSPEN02yrs Greene CanadianPS
Copper
0.6
0.3
0.3
Chromium
0.005
0.004
0.004
Iron
1.8
Fluoride
0.007
lodide
0.05
0.008
Molybdenum
0.018
0.0026
Manganese 0.04
0.025
0.02
Selenium
0.04
1.53.8 0.020.025
Zinc
1.4
6.5
Cobalt

Ricour
0.3
0.004
50mg
1.7
0.04
0.090.18
0.04
1.5
15 mg

TRACEELEMENTS:Pretermmicromol/kg/day
Shils
Copper
Chromium
Iodine
Molybdenum
Manganese
Selenium
Zinc

Zlotkin Leung

0.3
0.99
0.0020.004

0.040.18
4.5

6.7

Greene Canadian
PS
0.30.55 0.3
1.11.9
0.004
0.0010.002
0.007
0.2
0.0020.004
0.018
0.010.02
0.025
0.040.06
3.86.1 6.15
6.5

VITAMINS:Adultsperday

A(mg)
D(mg)
E(mg)
K(mg)
C(mg)
Thiamine(mg)
Riboflavin(mg)
Pyridoxine(mg)
Niacin(mg)
B12(mg)
Pantothenicacid(mg)
Biotin(mg)
FolicAcid(mg)

AMA
1000
5
10
100
3
3.6
4
40
5
15
60
400

GRI
1000
5
10
150
100
3
3.6
4
40
5
15
60
400

AuSPEN
324
1.4
2.9

MVI12(10ml)
1135
5
10

64
8
3.9
2.9
47
1.4
7.5
17.1
2143

100
3
3.6
4
40
5
15
60
400

VITAMINS:Childrenperday
AAP
400700
A(mg)
10
D(mg)
E(mg)
58
1560
K(mg)
C(mg)
45
Thiamine(mg)
0.71.2
Riboflavin(mg) 0.81.4
Pyridoxine(mg) 0.91.6
Niacin(mg)
916
23
B12(mg)
Pantothenicacid 35
(mg)
65120
Biotin(mg)
100300
FolicAcid(mg)

Greene
700
10
7
200
80
1.2
1.4
1
17
1
5

AuSPEN
1400
20
14
400
160
2.4
2.8
2
34
2
10

MVIPaed(5ml)
700
10
7
200
80
1.2
1.4
1
17
1
5

20
140

40
280

20
140

VITAMINS:Infantsperday
AAP01yrs MVIPaed(5ml)
400420
700
A(mg)
10
10
D(mg)
E(mg)
34
10
1220
200
K(mg)
C(mg)
35
80
Thiamine(mg)
0.30.5
1.2
Riboflavin(mg)
0.40.6
1.4
Pyridoxine(mg)
0.30.6
1
Niacin(mg)
68
17
0.51.5
1
B12(mg)
Pantothenicacid(mg)
23
5
3550
20
Biotin(mg)
3045
140
FolicAcid(mg)

VITAMINS:Preterm

A(mg)
D(mg)
E(mg)
K(mg)
C(mg)
Thiamine(mg)
Riboflavin(mg)
Pyridoxine(mg)
Niacin(mg)
B12(mg)
Pantothenicacid(mg)
Biotin(mg)
FolicAcid(mg)

Greeneper MVIPaed(2ml)
kg
500
316
4
4
2.8
2.8
80
80
25
32
0.35
0.48
0.15
0.56
0.18
0.4
6.8
6.8
0.3
0.4
2
2
6
8
56
56

3.1999GUIDELINESFOR
INTRAVENOUSTRACEELEMENTS&VITAMINS
1.TRACEELEMENTS
PreviousAuSPENguidelinesfortraceelementdosagesin
adultandpaediatricpractice,meantthatpharmacists
compoundedindividualelementsorpurchaseda"trace
elementmixture"composingaselectionofelements.The
newAuSPENguidelinesareinlinewiththeinternationally
publishedliteratureandrecommendedbytheexpertpanel
(AuSPENMicronutrientWorkshop1996).Thenew
guidelinesinadultpracticerecommendroutine
administrationofintravenousiron,whereasitsusein
paediatricpracticeisnotdefined.Thecommerciallyavailable
multielementsolutionsAdditraceandPeditracemeetthe
newAuSPENdosageguidelines.
2.VITAMINS
RecentAustraliawideshortageofintravenousmultivitamins
(MVI12andMVIpaediatric)hasmeantthatother
commerciallyavailableproducts(Cernevit,VitalipidNand
Soluvit)havebeenassessedandtheTGAhasbeen
approachedforlicensing.
Adult&Childrenover11yearsofage
AnalternativetoMVI12isCernevit.Cernevitisamultivitamin
preparationofbothwaterandfatsolublevitamins.The
recommendeddoseis5ml/d.
Children<11yrsofageincludinginfantsandneonates
AnalternativetoMVIPaediatricisacombinationofSoluvitN
(watersolublevitaminpreparation)andVitalipidN(fatsoluble
vitaminpreparation).ThesuggesteddoseofSoluvitNis
1ml/kg/daytoamaximumdoseof10ml/dayandVitalipidNis
4ml/kg/daytoamaximumdoseof10ml/day.

1999AUSPENTRACEELEMENTSGUIDELINES
ADULT
mmols/day
Zinc(Zn)*
Copper(Cu)#
Selenium(Se)
Iron(Fe)
Manganese(Mn)^
Chromium(Cr)
Molybdenum(Mo)
lodide

50100
520
0.41.5
20
5
0.20.4
0.4
1.0

CHILDREN
(115yrs)
mmols/kg/day
0.43.0
0.30.4
0.03
NotDefined
0.018

INFANTS
(01yr)
mmols/kg/day
1.53.8
0.3
0.0250.04
NotDefined
0.018

0.0040.008

0.007

PRETERM
mmols/kg/day
3.06.5
0.3
0.0160.025
NotDefined
0.0140.018
0.001
0.0040.007

*Increasedzincsupplementsmayberequiredwithdiarrhoea,orincreasedlosses
fromanintestinalfistulaorstoma
#Increasedcoppersupplementsmayberequiredwithabnormalgastrointestinalfluid
loss.Reducedcoppersupplementsshouldbegiveninthepresenceofliveror
biliarytractdisease
^Reducedmanganesesupplementsshouldbegiveninthepresenceofcholestasis

1999ADULTVITAMINGUIDELINES
AuSPEN
(Dose/day)
1000
A(mg)
5
D(mg)
E(mg)
10
None
K(mg)
C(mg)
100
Thiamine(mg)
3
Riboflavin(mg)
3.6
Pyridoxine(mg)
4
Niacin(mg)
40
5
B12(mg)
Pantothenicacid(mg) 15
60
Biotin(mg)
400
FolicAcid(mg)

MV112
(10ml)
1135
5
10
None
100
3
3.6
4
40
5
15
60
400

CERNEVIT
(5ml)
1204
5.5
11.2
None
125
3.52
4.14
4.54
46
6
17.25
69
414

INTRAVITE
(2ml)

50
10
5
5
50
5

1999PAEDIATRICVITAMINGUIDELINES

A(mg)
D(mg)
E(mg)
K(mg)
C(mg)
Thiamine
(mg)
Riboflavin
(mg)
Pyridoxine
(mg)
Niacin(mg)
B12(mg)
Pantothenic
acid(mg)
Biotin(mg)
FolicAcid
(mg)

AuSPEN
MVIPAED SOLUVITN VITALIPIDN
(Dose/kg/day) (Dose/ml) (1ml/kg/day) (4ml/kg/day)
500
460
920
4
2
4
2.8
1.4
2.8
80
40
80
25
16
10
0.35
0.24
0.32
0.35

0.28

0.36

0.15

0.2

0.18
0.3
2

0.34
0.2
1

4
1.5
6

6
56

4
28

40
0.5

RecommendeddailydosesofMVIPaed/kg
<0.750kg
0.7501kg
11.5kg
1.52kg
23kg
>3kgto<12yrs

1ml/d
1.5ml/d
2mls/d
3mls/d
4mls/d
5mls/d

4.COMPOSITIONOFADDITRACEANDPEDITRACE
Severalcommercialpreparationsofmultielementsolutionsare
nowavailable.TheformulationsofAdditraceandPeditraceare
verysimilartothenewAuSPENGuidelines.Indeed,Alan
ShenkinandMichaelBarnettwerekeyadviserstoPharmaciain
thisproductformulation.
Consequently10mlofAdditraceperdayinmostadultpatients
onTPNisoptimalreplacement.However,modificationof
dosagemayberequiredinhepaticorrenaldysfunction(see
productcontraindicationsandwarnings).
Peditrace(1ml/kgm)isappropriateinthepaediatricpatientstoa
maximumof15ml/day.

DATASHEET
ADDITRACE

Pharmacia&UpjohnLimited
DavyAvenue
MiltonKeynes
MK58PH
UnitedKingdom
January1997

PRESENTATION:

A clear, almost colourless solution containing trace elements for addition to Vamin
aminoacidsolutionsintheintravenousnutritionofadults.Additracecorrespondsto
thefollowingformula:
Ferricchloride6H2O
Zincchloride
Manganesechloride4H2O
Copperchioride2H2O
Chromicchloride
Sodiumselenite5H2O
Sodiummolybdate2H2O
Sodiumfluoride
Potassiumiodide
Xylitol
Waterforinjectionsto1ml
pH2.2

0.54 mg
1.36 mg
99.0 micrograms
0.34 mg
5.33 micrograms
10.5 micrograms
4.85 micrograms
0.21 mg
16.6 micrograms
300 mg

Oneampoule(10mlAdditrace)containsthefollowingamountsoftraceelements:
Fe3+
Zn2+
Mn2+
Cu2+
Cr3+
Se4+
Mo6+
F
I

20 micromol
100 micromol
5 micromol
20 micromol
0.2 micromol
0.4 micromol
0.2 micromol
50 micromol
1 micromol

OneampouleofAdditracecontainslessthan1mmolofboth,potassiumandsodium.
USES:
Additrace is used as part of a complete intravenous nutrition regimen providing a
sourceoftraceelementsforadultsandchildrenover40kg.
DOSAGEANDADMINISTRATION:
Recommendeddosageforadults:
1 ampoule (10 ml) of Additrace is added to either 500 ml or 1000 ml of a solution
listed in the table below. Where higher amounts of trace elements are considered
necessary, 2 ampoules of Additrace may be added to 1000 ml solution. Additrace
should not be added to Vamin 9 amino acid solution. Where a regimen includes
Vamin9,Additraceshouldbeaddedtotheglucoseinfusion.

Additrace does not contain calcium, magnesium or phosphate. These minerals

should be added to the intravenous nutrition regimen if appropriate. (Vamin 9
Glucose and Vamin 14 contain calcium and magnesium. See appropriate data
sheet/SPC.)SimilarlyAdditracedoesnotcontainsignificantamountsofpotassiumor
sodium(see'Presentation'above)sincetherequirementsfortheseelectrolytesvary
with different clinical conditions. Potassium and sodium salts should therefore be
added as appropriate to the individual patient's regimen. (Vamin 9 Glucose and
Vamin14containpotassiumandsodium.Seeappropriatedatasheet/SPC.)
Infusionsolution

Vamin9Glucose
Vamin14
Vamin14El~ctrolyteFree
Vamin18ElectrolytFree
Glucose550%

Volumetowhich10ml
Additracemaybeadded(ml)
5001000
5001000
5001000
5001000
5001000

Infusionshouldbe
completedwithin
24hoursof
addition.

Additracemustonlybeaddedtosolutionswherecompatibilityisknown.
TheabovemixturescontainingVaminshouldbeinfusedatanappropriaterateforthe
amino acid solution and the infusion completed not more than 24 hours after
preparation. If Additrace is added to a solution other than those listed above, then
ensurethatthesolutionisadministeredoveraperiodofnotlessthan2hours,soas
tominimiserenallosses.
Recommendeddosageforinfantsandchildrenunder40kg:
ThetraceelementsolutionPeditrace shouldbeused.
CONTRAINDICATIONS,WARNINGS,ETC.
Contraindications:Shouldnotbeadministeredundiluted
Useinpregnancyandlactation:Additraceisasolutionoftraceelementsindicatedas
asupplementinTPNregimens.Itcontainsthefollowingelements:Fe3+,Zn2+,Mn2+,
Cu2+, Cr3+, Se4+, Mo6+, F, I in amounts per ampoule not exceeding daily
recommended requirements where these exist. No hazard is expected if used in
pregnancy at the recommended dosage. No animal studies have been performed.
Thereare,however,publishedreportsonsafeandsuccessfuluseoftraceelements
aspartofaTPNregimenduringpregnancyinthehuman.
Otherspecialwarningsandprecautions:Careshouldbetakenintheadministration
of Additrace to patients with impaired liver function (especially cholestasis).
Manganesetoxicityismorelikelytooccurinpatientswithimpairedliverfunctionand
cholestasis as manganese is almost entirely dependent on the biliary route for
excretion. Manganese blood levels and liverfunction should be monitored regularly
(monthly)insuchpatients.Additraceshouldbestoppedifmanganeselevelsriseinto

the potentially toxic range (please refer to appropriate reference ranges for the
testinglaboratory).
Additraceshouldbeusedwithcautioninpatientswithimpairedrenalfunctionwhen
the excretion of some trace elements (zinc, selenium, fluoride, chromium and
molybdenum)maybesignificantlydecreased.
Overdosage:
In general overdosage with Additrace is extremely unlikely as the quantity of trace
elementsperampoulelieswellbelowknowntoxiclevelsofadministration
Chronic overdosage may very rarely occur secondary to an unsuspected idio
syncratic deficiency in metabolism or excretion for a specific trace element. In this
case, signs may be observed such as nail dystrophy with insidious onset of
symptoms secondary to haematological changes or tissue deposition Diagnosis
would be confirmed by biochemical and haematological tests and treatment should
bewithdrawalofAdditrace.

PHARMACEUTICALPRECAUTIONS:
NootheradditionsshouldbemadetosolutionscontainingAdditraceunless
compatibilityisknown.
1. Storeatroomtemperature(25Corbelow).
2. TheadditionofAdditraceshouldbeperformedasepticallyimmediatelybeforethe
startoftheinfusionandthesolutionshouldbeusedwithin24hours.
LEGALCATEGORY:
POM.
PACKAGEQUANTITIES:
Boxesof20x10mlpolypropyleneampoules.
FURTHERINFORMAT1ON:
Themanufacturercanbeconsultedforfullinformationoncompleteand
balancedintravenousnutritionregimens.
PRODUCTLICENCENUMBER:
0022/0064
PRODUCTLICENCEHOLDER:
PharmaciaLaboratoriesLimited.
DATEOFPREPARATION:
January1997

PEDITRACE

Summaryof
ProductCharacteristics

Pharmacia&UpjohnLimited
DavyAvenue
Knowlhill
MiltonKeynes
MK58PH
UnitedKingdom
July1995
1. NAMEOFPROPRIFEARYMEDICINALPRODUCT
Peditrace
2. QUALITATlVEANDQUANTITATIVECOMPOSITION
1mlofPeditracecontains:

Active
Ingredients
Zincchloride
Copperchloride
2H2O
Manganese
chloride4H2O
Sodiumselenite
5H2O
Sodiumfluoride
Potassiumiodide

Quantity
tostandard

Reference

521 mg
53.7 mg

USP

3.60 mg

USP

6.66 mg

87/84

126 mg
1.31 mg

PhEur

BP
PhEur

Theactiveingredientsin1mlcorrespondto:
Zn
250 mg
Cu
20 mg
Mn
1 mg
Se
2 mg
F
57 mg
I
1 mg
Other
ingredients
Hydrochloric
acid
Waterfor
injections

Quantity
topH20
to1ml

3.82 mmol
0.315 mmol
18.2nmol
25.3nmol
3.00 mmol
7.88nmol
Reference
tostandard
PhEur
PhEur

3. PHARMACEUTICALFORM
A10mlpolypropylenevialofasterile,clear,colourlesssolutioncontainingtrace
elementsforadditiontocertaininfusionfluidsintheintravenousnutritionof
paediatricpatients.
4. CLINICALPARTICULARS
4.1 Therapeuticindications
Peditraceisanintegralpartofthecompleteintravenousnutritionofinfants
andchildren.Itisintendedtomeetbasalrequirementsfortraceelements
andshouldbeusedinconjunctionwithVaminolact,Vamin 14
ElectrolyteFree(atphysician'sdiscretion:seedatasheet)oraglucose
solution.
Astherequirementsoftraceelementsmayvaryindifferentclinical
conditions,thesesubstancesmayhavetobeaddedasappropriateinthe
individualpatient.
Peditraceadministrationshouldnotbestarteduntilkidneyfunctionis
establishedusuallyduringtheseconddayoflife.

Itisnottobegivenundiluted.
4.2. Posologyandmethodofadministration
Adultsandelderly:
Peditraceisdesignedforpaediatricuse.
Additraceshouldbeusedinadultsandelderly.
Infantsandchildren(weighing15kgorless):
Basalrequirementsoftheincludedtraceelements are covered by 1 ml
Peditraceperkgbodyweightperdaytoamaximumdoseof15ml.
Children(weighing15kgormore):
A daily dose of 15ml Peditrace should meet basic trace element
requirements. However, for patients weighing more than 40 kg the adult
preparationAdditraceshouldbeused.
Patients who are likely to lose higher than average amounts of trace
elements, or those requiring prolonged intravenous nutrition should be
monitored biochemically to confirm that requirements are being
appropriatelymet.Peditracecanbeaddedtoeitheranaminoacidsolution
orglucosesolutionandinthesecases,upto6mlPeditracecanbeadded
to 100 ml Vaminolact@, Vamin 14~ElectrolyteFree (at physician's
discretion:seedatasheet)orglucosesolution(50500mg/ml).Itmayalso
be administered as a paediatric admixture but only admixtures in which
compatibilityhasbeendocumentedaretobeused.
Theinfusionshouldbegivenataveryslowrate(minimuminfusionperiod8
hours)andisbestdonewithanappropriatepumporanautomaticdroprate
counter.
The requirements of potassium and sodium vary with different patient
conditions.Peditraceisnotintendedtomeettheserequirements.
4.3. Contraindications:
Shouldnotbegivenundiluted.
4.4. Specialwarningsandspecialprecautionsforuse:
Administrationshouldbecarriedoutonlyunderspecialistsurveillance
especiallyinpatientswithpreexistingimbalances,inrenalfailureorin
hepaticdisease.
Peditraceshouldbeusedwithcautioninconditionswhereexcretioninthe
bileisreducedparticularitywhencholestaticliverdiseaseispresentand/or
when urinary excretionis markedly reduced. Patients with such conditions
require careful biochemical monitoring as the excretion of trace elements
may also be significantly decreased. (Copper and manganese being
normallyexcretedinbileseleniumandzincespeciallyinpatientsreceiving
parenteralnutritionbeingexcretedmainlyintheurine).

Patientsrequiringlongtermtotalparenteralnutrition(TPN)(definedas
longerthanonemonth)shouldhaveabaselinewholeblood orserum
manganeselevelwithinorbelowthenormalrangeandnormalliverfunction
beforereceivingPeditrace.
Manganeselevelsandliverfunctionshouldbemonitoredregularly
(monthly)wholethepatientismaintainedonPeditrace.
Peditraceshouldbestoppedifmanganeselevelsriseintothepotentially
toxicrange(pleaserefertoappropriatereferencerangesforthetesting
laboratory)orifcholestasisdevelops.
Additionofotherdrugstobeavoidedduetotheriskofprecipitation.
Acloudysolutionoronecontainingaprecipitatemustnotbeused.
TheadditionofPeditracemustbedoneasepticallywithinonehourbefore
thestartofinfusion.Tominimisetheriskofinfectiontheinfusateshouldbe
usedwithin24hours.
4.5. Interactionwithothermedicamentsandotherformsofinteraction:
Nointeractionswithotherdrugshavebeenobserved
4.6. Pregnancyandlactation:
Notappropriatetotheuseofthisproduct.
4.7. Effectsonabilitytodriveandusemachines:
Notappropriatetotheuseofthisproduct.
4.8. Undesirableeffects
Impairedrenalorhepaticexcretionmayleadtochronicoverdoseofoneor
moretraceelements.
4.9. Overdose:
InrecommendeddosesPeditracesuppliestraceelementsatthelevelof
normaldailyrequirements.
Acute
Acuteoverdoseofthesetraceelementsisunlikelytobehazardous.
Chronic
Chronic overdose of manganese has been recorded as causing
ParkinsonismandPsychosis.
Chronicoverdosagemayveryrarelyoccursecondarytoanunsuspected
idiosyncraticdeficiencyinmetabolismorexcretionforaspecifictrace
element.Inthiscase,signsmaybeobservedsuchasnaildystrophywith
insidiousonsetofsymptomssecondarytohaematologicalchangesor
tissuedeposition.Diagnosiswouldbeconfirmedbybiochemicaland
haematologicaltestsandtreatmentshouldbewithdrawalofPeditrace.

5. PHARMACOLOGICALPROPERTIES
5.1 Pharmacodynamicproperties:
Peditraceisaconcentratedtraceelementsolutionformulatedtocoverthe
requirementsofneonatesandinfantsreceivingtotalparenteralnutrition.
Potassium,magnesiumandcalciumarenotincludedintheformulationas
individualrequirementsvaryfrompatienttopatient.
5.2 Pharmacokineticproperties:
ThetraceelementsinPeditracewheninfusedinphysiologicalamounts
shouldbeutilisedinthesamewayaselementsabsorbedfromanoraldiet.
NopharmacokineticstudieswithPeditracehavebeenperformed.
5.1 Preclinicalsafetydata.
Notoxiceffectswereobservedduringthepreclinicalstudies.
6. PHARMACEUTICALPARTICULARS
6.1 Listofexcipients:
Hydrochloricacid
PhEur
Waterforinjections
PhEur
6.2Incompatibilities:
DonotadddrugswithPeditracetoinfusionsolutionunlessthecompatibility
profileissatisfactory.
DonotaddPeditracetoinfusionsolutionsotherthanthoserecommended
unlessthecompatibilityprofileissatisfactory.
6.3Shelflife:
Theshelflifeis24monthswhenstoredinroomtemperature(below25C).
6.4Specialprecautionsforstorage:
Donotfreeze.Protectvialsfromlight.Storebelow25C.
6.5Natureandcontentsofcontainer:
Peditraceissuppliedin10mlpolypropyleneplasticvialsforinjection,which
fulfilthetestsaccordingtoPhEur.Thevialsaresealedwithachlorobutyl
rubberstoppercoatedwithasteelbluefluoropolymerandflipoffcaps.
6.6Instructionsforuse/handling:
Mustnotbegivenundiluted.Peditracecanbeaddedtoeitheranaminoacid
solutionorglucosesolution(seebelow)andgivenduringaminimuminfusion
periodof8hours.Theinfusionshouldbegivenataveryslowrateandis
bestdonewithanappropriatepumporanautomaticdropratecounter.Only
admixturesinwhichcompatibilityhasbeendocumentedaretobeused.
TheadditionofPeditracemustbedoneasepticallywithinonehourbeforethe
startofinfusion.Tominimisetheriskofinfectiontheinfusateshouldbeused
within24hours.
Compatibility

Upto6mlofPeditracecanbeaddedto100mlVaminolact,Vamin14
ElectrolyteFreeorglucosesolution(5500mg/ml).
7. MARKETINGAUTHORISATIONHOLDER
PharmaciaLimited
DavyAvenue
MiltonKeynes
MK58PH
8. MARKET1NGAUTHORISATTIONNUMBER
0022/0160
9. DATEOFFIRSTAUTHORISATION/RENEWALOFAUTHORISATION
Notapplicable.
10. DATEOF(PARTIAL)REVISIONOFTHETEXT
Notapplicable.
Dateofpreparation:July1995

5.CONCLUSION
DiscussionhasalreadycommencedwiththeTherapeutics
GoodsAssociation(TGA)andBaxterHealthCareAustraliain
associationwithFreseniusKabiaboutlicensingAdditrace,
Peditrace,Cernevit,SoluvitNandVitalipidNinAustralia.

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