clinimix and clinimix e injections for pediatric patients · clinimix and clinimix e injections can...
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CLINIMIX and CLINIMIX E Injections for Pediatric Patients:
Multi-chamber bag (MCB) technology may reduce the risk of medication errors and contamination during preparation.
Appropriate source of amino acids and dextrose for pediatric patients.
Key component of goal-directed nutrition therapy.
IndicationsCLINIMIX sulfite-free (Amino Acid in Dextrose) and CLINIMIX E sulfite-free (Amino Acid with Electrolytes in Dextrose with Calcium) Injections are indicated as a caloric component in a parenteral nutrition regimen and as the protein (nitrogen) source for offsetting nitrogen loss or for the treatment of negative nitrogen balance in patients where:
- The alimentary tract cannot or should not be used,
- Gastrointestinal absorption of protein is impaired, or
- Metabolic requirements for protein are substantially increased, as with extensive burns.
Pediatric Use- Use of CLINIMIX and CLINIMIX E sulfite-free Injections in pediatric patients
is governed by the same considerations that affect the use of any amino acid solution in pediatrics.
- The amount administered is dosed on the basis of grams of amino acids/kg of body weight/day.
- Solution administration by peripheral vein should not exceed twice normal serum osmolarity (718 mOsmol/L).
Pediatric Precautions- Dextrose is safe and effective for the above indications in pediatric patients.
- As reported in the literature, the dosage selection and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low birth weight infants, because of increased risk of hyperglycemia/hypoglycemia.
- Frequent monitoring of serum glucose concentrations is required in these patient populations.
- Safety and effectiveness of CLINIMIX and CLINIMIX E Injections in pediatric patients have not been established by adequate and well-controlled studies.
- However, use of amino acid injections in pediatric patients to help offset nitrogen loss or treat negative nitrogen balance is referenced in the medical literature.
Important Risk Information- CLINIMIX and CLINIMIX E Injections are contraindicated in patients having
intracranial or intraspinal hemorrhage, in patients who are severely dehydrated, in patients hypersensitive to one or more amino acids and in patients with severe liver disease or hepatic coma. Solutions containing corn-derived dextrose may be contraindicated in patients with known allergy to corn or corn products.
- Because of the potential for life-threatening events, caution should be taken to ensure that precipitates have not formed in any parenteral nutrient admixture.
- Use with caution when administering to patients with anuria or renal insufficiency, pulmonary insufficiency, or heart disease. The intravenous administration of these solutions can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states, or pulmonary edema.
- Metabolic complications have been reported, such as acid-base, electrolyte, and blood glucose imbalances, elevated liver enzymes, and osmotic diuresis and dehydration.
- Other adverse reactions that may occur include febrile response, infection at the site of injection, extravasation, and hypervolemia. The infusion of hypertonic nutrient injections into a peripheral vein may result in vein irritation, vein damage, and thrombosis.
- This product contains aluminum that may be toxic with prolonged parenteral administration if kidney function is impaired.
- CLINIMIX and CLINIMIX E Injections must be admixed prior to infusion.
Please see enclosed package inserts for complete prescribing information.
Guidelines – American Academy of Pediatrics (AAP)1
Guidelines – American Society of Parenteral and Enteral Nutrition (A.S.P.E.N.)2
Weight Daily Recommendation Weight / Age Daily Recommendation
Protein10-20 kg 1-2.5 g/kg >10 kg or 1-10 yrs 1-2 g/kg
>20 kg 0.8-2 g/kg 11-17 yrs 0.8-1.5 g/kg
Energy
10-20 kg 60-90 kcal/kg 1-7 yrs 75-90 kcal/kg
>20 kg 30-75 kcal/kg 7-12 yrs 50-75 kcal/kg
>12-18 yrs 30-50 kcal/kg
Fluid10-20 kg 1000 mL for 10 kg + 50 mL/kg for each kg >10 >10-20 kg 1000 mL for 10 kg + 50 mL/kg for each kg >10
>20 kg 1500 mL for 20 kg + 20 mL/kg for each kg >20 >20 kg 1500 mL for 20 kg + 20 mL/kg for each kg >20
Carbohydrates (Dextrose)
10-20 kg 8-28 g/kgCarbohydrates should comprise 40% to 60% of the total caloric intake.
>20 kg 5-20 g/kg
IV Fat Emulsion >10 kg 1-3 g/kg The minimum fat requirement is determined by essential fatty acid need, and the daily maximum is 50% to 60% of energy.
Nonprotein Calorie- to-Nitrogen Ratio 150:1 to 300:1 is most likely to achieve positive nitrogen balance.
1. Kleinman RE. Pediatric Nutrition Handbook 6th Edition. 2009:519-540.
The guidelines listed above are not all inclusive and are provided for reference only. Clinical judgement based on current medical practices must be used in each individual patient when prescribing total parenteral nutrition.
2. Forchielli ML, Miller SJ. The ASPEN Nutrition Support Practice Manual. 2005:38-53.
It is essential that a carefully prepared protocol based on current medical practices be followed, preferably by an experienced team. Frequent clinical evaluation and laboratory determinations are necessary for proper monitoring during administration.
CLINIMIX and CLINIMIX E Injections can align with AAP and ASPEN guidelines to provide pediatric patients with appropriate protein and caloric nutrition therapy.- MCB technology may reduce the risk of medication errors and
contamination during preparation.
- Appropriate source of amino acids and dextrose.
- Protein source for the treatment of negative nitrogen balance.
- CLINIMIX E Injections also provide a source of essential electrolytes.
Adam is a 3 year-old boy with short-term parenteral nutrition needs. (Hypothetical patient)
Rate mL/hr 31.3
CLIN
IMIX
5/2
0 In
ject
ion*
Amino Acid
g/day 37.5
g/kg/day (goal 1-2.5 g/kg) 2.5
protein kcal/day 150
% kcal from protein 13.5%
Dextrose
g/day 150
g/kg/day (goal 8-28 g/kg) 10
dextrose kcal/day 510
% kcal from dextrose 46%
Total CLINIMIX Volume 751
Baseline CLINIMIX Osmolarity mOsmol/L 1505
20% IV Fat Emulsion
g/day 45
g/kg/day (goal 1-3 g/kg) 3
IVFE mL/day 225
IVFE kcal/day 450
% kcal from IVFE 40.5%
TPN
Non-protein calorie-to-nitrogen ratio 154:1
Total Volume/day 976
Total kcal/day 1110
Total kcal/kg/day 74
Total kcal/mL/day 1.13
Variance from kcal goal -15
Variance from fluid goal -274
Adam’s Needs: Weight = 15 kg
Adam’s Daily Goals
Protein 2.5 g/kg
Energy 75 kcal/kg
Fluid 1250 mL/day
20% IV Fat Emulsion 3 g/kg
CLINIMIX 5/20 Injections can be used to help achieve Adam’s nutritional goals.
Conclusion:
* Maintenance vitamins, additional electrolytes, and trace elements are not included and should be administered as required.
Baxter, Clinimix, Clinimix E, Clinimix Logo, Committed to a Safer Healthcare Environment and Nourish the Outcome are trademarks of Baxter International Inc.
All other brand names or trademarks that may appear herein are the property of their respective owners.
Baxter Healthcare Corporation, Route 120 and Wilson Road, Round Lake, IL 60073 www.baxter.com 801142 2,500 10/09
FSC LOGO
Supporting Goal-Directed Therapy
Baxter Healthcare Corporation has 75-plus years in developing Parenteral
Nutrition solutions that work together to improve patient outcomes. Baxter
offers clinicians and patients the broadest portfolio of Parenteral Nutrition
in the industry and includes our innovative commercially manufactured
multi-chamber bag of Parenteral Nutrition formulations. Baxter also offers
Multiple Vitamins for infusion; IV fat emulsion for infusion and automated
compounding equipment and software. Parenteral Nutrition Solutions from
Baxter efficiently help you meet the nutritional goals of your patients.
Learn more about CLINIMIX Injections: Clinimix.com • 888-229-0001 • Contact your Baxter representative
CLIN
IMIX
sulfi
te-f
ree
(Am
ino
Acid
in D
extro
se)I
njec
tions
in C
LARI
TY D
ual C
ham
ber C
onta
iner
07-1
9-47
-385
Desc
riptio
nCL
INIM
IX s
ulfit
e-fre
e (A
min
o Ac
id in
Dex
trose
) Inj
ectio
ns a
re s
teril
e, n
onpy
roge
nic,
hype
rtoni
c so
lutio
ns in
a C
LARI
TY D
ual C
ham
ber C
onta
iner
.Th
e su
lfite
-free
Am
ino
Acid
Inje
ctio
ns in
the
outle
t por
t cha
mbe
r are
sol
utio
ns o
fes
sent
ial a
nd n
ones
sent
ial a
min
o ac
ids.
The
Dext
rose
Inje
ctio
ns, U
SP in
the
inje
ctio
n po
rt ch
ambe
r are
sol
utio
ns fo
r flu
idre
plen
ishm
ent a
nd c
alor
ic s
uppl
y.Af
ter o
peni
ng th
e se
al b
etw
een
the
cham
bers
and
mix
ing
thor
ough
ly, th
e ad
mix
edpr
oduc
t is
inte
nded
for i
ntra
veno
us u
se.
See
Tabl
e 1
for c
ompo
sitio
n, p
H, o
smol
arity
,io
nic
conc
entra
tion
and
calo
ric c
onte
nt o
f the
adm
ixed
pro
duct
.Th
e CL
ARIT
Y Du
al C
ham
ber C
onta
iner
is a
lipi
d-co
mpa
tible
pla
stic
con
tain
er
(PL
2401
Pla
stic
). T
he a
mou
nt o
f wat
er th
at c
an p
erm
eate
from
insi
de th
e co
ntai
ner
into
the
over
wra
p is
insu
ffici
ent t
o af
fect
the
solu
tion
sign
ifica
ntly.
Sol
utio
ns in
con
tact
with
the
plas
tic c
onta
iner
may
leac
h ou
t cer
tain
che
mic
al c
ompo
nent
s fro
m th
e pl
astic
in v
ery
smal
l am
ount
s; h
owev
er, b
iolo
gica
l tes
ting
was
sup
porti
ve o
f the
saf
ety
of th
epl
astic
con
tain
er m
ater
ials
.
Clin
ical
Pha
rmac
olog
yCL
INIM
IX s
ulfit
e-fre
e (A
min
o Ac
id in
Dex
trose
) Inj
ectio
ns a
dmin
iste
red
intra
veno
usly
prov
ide
biol
ogic
ally
util
izabl
e so
urce
mat
eria
l for
pro
tein
syn
thes
is a
nd h
ave
valu
eas
a
sour
ce o
f cal
orie
s an
d w
ater
.
Indi
catio
ns a
nd U
sage
CLIN
IMIX
sul
fite-
free
(Am
ino
Acid
in D
extro
se) I
njec
tions
are
indi
cate
d as
a c
alor
icco
mpo
nent
in a
par
ente
ral n
utrit
ion
regi
men
and
as
the
prot
ein
(nitr
ogen
) sou
rce
for
offs
ettin
g ni
troge
n lo
ss o
r for
trea
tmen
t of n
egat
ive
nitro
gen
bala
nce
in p
atie
nts
whe
re:
(1)t
he a
limen
tary
trac
t can
not o
r sho
uld
not b
e us
ed,
(2)g
astro
inte
stin
al a
bsor
ptio
n of
pro
tein
is im
paire
d, o
r (3
)met
abol
ic re
quire
men
ts fo
r pro
tein
are
sub
stan
tially
incr
ease
d,
as w
ith e
xten
sive
bur
ns.
Cent
ral V
ein
Adm
inis
trat
ion:
Cen
tral v
ein
infu
sion
sho
uld
be u
sed
whe
n am
ino
acid
solu
tions
are
adm
ixed
with
hyp
erto
nic
dext
rose
to p
rom
ote
prot
ein
synt
hesi
s su
ch a
sfo
r hyp
erca
tabo
lic o
r dep
lete
d pa
tient
s or
thos
e re
quiri
ng lo
ng te
rm p
aren
tera
l nut
ritio
n.Pe
riphe
ral V
ein
Adm
inis
trat
ion:
For
pat
ient
s in
who
m th
e ce
ntra
l vei
n ro
ute
is n
otin
dica
ted,
am
ino
acid
sol
utio
ns d
ilute
d w
ith lo
w d
extro
se c
once
ntra
tions
may
be
infu
sed
by p
erip
hera
l vei
n.
Cont
rain
dica
tions
CLIN
IMIX
sul
fite-
free
(Am
ino
Acid
in D
extro
se) I
njec
tions
are
con
train
dica
ted
in p
atie
nts
havi
ng in
tracr
ania
l or i
ntra
spin
al h
emor
rhag
e, in
pat
ient
s w
ho a
re s
ever
ely
dehy
drat
ed,
in p
atie
nts
hype
rsen
sitiv
e to
one
or m
ore
amin
o ac
ids,
and
in p
atie
nts
with
sev
ere
liver
dise
ase
or h
epat
ic c
oma.
Solu
tions
con
tain
ing
corn
-der
ived
dex
trose
may
be
cont
rain
dica
ted
in p
atie
nts
with
know
n al
lerg
y to
cor
n or
cor
n pr
oduc
ts.
War
ning
sAd
ditiv
es m
ay b
e in
com
patib
le.
Cons
ult w
ith p
harm
acis
t, if
avai
labl
e.W
hen
intro
duci
ng a
dditi
ves,
use
ase
ptic
tech
niqu
es.
Mix
thor
ough
ly. D
o no
t sto
re.
Beca
use
of th
e po
tent
ial f
or li
fe-th
reat
enin
g ev
ents
, cau
tion
shou
ld b
e ta
ken
to e
nsur
eth
at p
reci
pita
tes
have
not
form
ed in
any
par
ente
ral n
utrie
nt a
dmix
ture
.Th
ese
CLIN
IMIX
sul
fite-
free
(Am
ino
Acid
in D
extro
se) I
njec
tions
, mus
t be
adm
ixed
prio
rto
infu
sion
. Fo
r adm
ixin
g in
stru
ctio
ns s
ee D
irect
ions
for U
se o
f Pla
stic
Con
tain
er.
The
infu
sion
of h
yper
toni
c nu
trien
t inj
ectio
ns in
to a
per
iphe
ral v
ein
may
resu
lt in
vei
nirr
itatio
n, v
ein
dam
age,
and
thro
mbo
sis.
Afte
r mix
ing,
stro
ngly
hyp
erto
nic
nutri
ent
inje
ctio
ns s
houl
d on
ly b
e ad
min
iste
red
thro
ugh
an in
dwel
ling
intra
veno
us c
athe
ter
with
the
tip lo
cate
d in
a la
rge
cent
ral v
ein,
suc
h as
the
supe
rior v
ena
cava
.Pr
oper
adm
inis
tratio
n of
thes
e ad
mix
ed a
min
o ac
id/d
extro
se in
ject
ions
requ
ires
akn
owle
dge
of fl
uid
and
elec
troly
te b
alan
ce a
nd n
utrit
ion
as w
ell a
s cl
inic
al e
xper
tise
in re
cogn
ition
and
trea
tmen
t of t
he c
ompl
icat
ions
whi
ch m
ay o
ccur
.
Labo
rato
ry T
ests
Freq
uent
clin
ical
eva
luat
ion
and
labo
rato
ry d
eter
min
atio
ns a
re n
eces
sary
for
prop
er m
onito
ring
durin
g ad
min
istr
atio
n.St
udie
s sh
ould
incl
ude
bloo
d su
gar,
seru
m p
rote
ins,
kid
ney
and
liver
func
tion
test
s, e
lect
roly
tes,
com
plet
e bl
ood
coun
t w
ith d
iffer
entia
l, ca
rbon
dio
xide
com
bini
ng p
ower
or c
onte
nt, s
erum
osm
olar
ities
, bl
ood
cultu
res,
and
blo
od a
mm
onia
leve
ls.
Adm
inis
tratio
n of
am
ino
acid
sol
utio
ns to
a p
atie
nt w
ith h
epat
ic in
suffi
cien
cy m
ay re
sult
in s
erum
am
ino
acid
imba
lanc
es, h
yper
amm
onem
ia, s
tupo
r, an
d co
ma.
Hype
ram
mon
emia
is o
f spe
cial
sig
nific
ance
in in
fant
s.Th
is re
actio
n ap
pear
s to
be
rela
ted
to a
def
icie
ncy
of th
e ur
ea c
ycle
am
ino
acid
s of
gen
etic
or p
rodu
ct o
rigin
.It
is e
ssen
tial t
hat b
lood
am
mon
ia b
e m
easu
red
frequ
ently
in in
fant
s.Co
nser
vativ
e do
ses
of th
ese
adm
ixed
am
ino
acid
/dex
trose
inje
ctio
ns s
houl
d be
giv
en
to p
atie
nts
with
kno
wn
or s
uspe
cted
hep
atic
dys
func
tion.
Sho
uld
sym
ptom
s of
hype
ram
mon
emia
dev
elop
, adm
inis
tratio
n sh
ould
be
disc
ontin
ued
and
the
patie
nt’s
clin
ical
sta
tus
be re
eval
uate
d.Ad
min
istra
tion
of a
min
o ac
id s
olut
ions
in th
e pr
esen
ce o
f im
paire
d re
nal f
unct
ion
pres
ents
spe
cial
issu
es a
ssoc
iate
d w
ith re
tent
ion
of e
lect
roly
tes.
Thes
e ad
mix
ed in
ject
ions
sho
uld
not b
e ad
min
iste
red
sim
ulta
neou
sly
with
blo
odth
roug
h th
e sa
me
infu
sion
set
bec
ause
of t
he p
ossi
bilit
y of
pse
udoa
gglu
tinat
ion.
In v
ery
low
birt
h w
eigh
t inf
ants
, exc
essi
ve o
r rap
id a
dmin
istra
tion
of d
extro
se in
ject
ion
may
resu
lt in
incr
ease
d se
rum
osm
olal
ity a
nd p
ossi
ble
intra
cere
bral
hem
orrh
age.
WAR
NING
: Th
is p
rodu
ct c
onta
ins
alum
inum
that
may
be
toxi
c. A
lum
inum
may
re
ach
toxi
c le
vels
with
pro
long
ed p
aren
tera
l adm
inis
tratio
n if
kidn
ey fu
nctio
n is
impa
ired.
Pre
mat
ure
neon
ates
are
par
ticul
arly
at r
isk
beca
use
thei
r kid
neys
are
imm
atur
e, a
nd th
ey re
quire
larg
e am
ount
s of
cal
cium
and
pho
spha
te s
olut
ions
, w
hich
con
tain
alu
min
um.
Rese
arch
indi
cate
s th
at p
atie
nts
with
impa
ired
kidn
ey fu
nctio
n, in
clud
ing
prem
atur
ene
onat
es, w
ho re
ceiv
e pa
rent
eral
leve
ls o
f alu
min
um a
t gre
ater
than
4 to
5 µ
g/kg
/day
accu
mul
ate
alum
inum
at l
evel
s as
soci
ated
with
cen
tral n
ervo
us s
yste
m a
nd b
one
toxi
city
. Ti
ssue
load
ing
may
occ
ur a
t eve
n lo
wer
rate
s of
adm
inis
tratio
n.
Prec
autio
nsW
ith th
e ad
min
istra
tion
of th
ese
CLIN
IMIX
sul
fite-
free
(Am
ino
Acid
in D
extro
se)
Inje
ctio
ns, h
yper
glyc
emia
, gly
cosu
ria, a
nd h
yper
osm
olar
syn
drom
e m
ay re
sult.
Bloo
d an
d ur
ine
gluc
ose
shou
ld b
e m
onito
red
on a
rout
ine
basi
s in
pat
ient
s re
ceiv
ing
this
ther
apy.
Use
with
cau
tion
whe
n ad
min
iste
ring
to p
atie
nts
with
anu
ria o
r ren
al fa
ilure
.El
ectro
lyte
s m
ay b
e ad
ded
to th
e ad
mix
ed a
min
o ac
id/d
extro
se in
ject
ions
as
dict
ated
by
the
patie
nt’s
elec
troly
te p
rofil
e.Th
e m
etab
oliza
ble
acet
ate
anio
n an
d am
ino
acid
pro
files
in th
ese
adm
ixed
inje
ctio
nsw
ere
desi
gned
to m
inim
ize o
r pre
vent
occ
urre
nces
of h
yper
chlo
rem
ic m
etab
olic
acid
osis
and
hyp
eram
mon
emia
. Ho
wev
er, t
he p
hysi
cian
sho
uld
be a
war
e of
app
ropr
iate
coun
term
easu
res
if th
ey b
ecom
e ne
cess
ary.
Clin
ical
eva
luat
ion
and
perio
dic
labo
rato
ry d
eter
min
atio
ns a
re n
eces
sary
to m
onito
rch
ange
s in
flui
d ba
lanc
e, e
lect
roly
te c
once
ntra
tions
, and
aci
d-ba
se b
alan
ce d
urin
gpr
olon
ged
pare
nter
al th
erap
y or
whe
neve
r the
con
ditio
n of
the
patie
nt w
arra
nts
such
eva
luat
ion.
Beca
use
of it
s an
ti-an
abol
ic a
ctiv
ity, c
oncu
rren
t adm
inis
tratio
n of
tetra
cycl
ine
may
redu
ce th
e pr
otei
n-sp
arin
g ef
fect
of i
nfus
ed a
min
o ac
ids.
The
intra
veno
us a
dmin
istra
tion
of th
ese
solu
tions
can
cau
se fl
uid
and/
or s
olut
eov
erlo
adin
g re
sulti
ng in
dilu
tion
of s
erum
ele
ctro
lyte
con
cent
ratio
ns, o
verh
ydra
tion,
cong
este
d st
ates
, or p
ulm
onar
y ed
ema;
par
ticul
arly
in p
atie
nts
with
rena
l dis
ease
,pu
lmon
ary
insu
ffici
ency
, and
hea
rt di
seas
e.Ad
min
istra
tion
of a
dmix
ed a
min
o ac
id/d
extro
se in
ject
ions
and
oth
er n
utrie
nts
via
cent
ral o
r per
iphe
ral v
enou
s ca
thet
er m
ay b
e as
soci
ated
with
com
plic
atio
ns w
hich
ca
n be
pre
vent
ed o
r min
imize
d by
car
eful
atte
ntio
n to
all
aspe
cts
of th
e pr
oced
ure.
This
incl
udes
atte
ntio
n to
sol
utio
n pr
epar
atio
n, a
dmin
istra
tion,
and
pat
ient
mon
itorin
g.It
is e
ssen
tial t
hat a
car
eful
ly p
repa
red
prot
ocol
bas
ed o
ncu
rren
t med
ical
pr
actic
es b
e fo
llow
ed, p
refe
rabl
y by
an
expe
rienc
ed te
am.
Alth
ough
a d
etai
led
disc
ussi
on o
f the
com
plic
atio
ns is
bey
ond
the
scop
e of
this
inse
rt,th
e fo
llow
ing
sum
mar
y lis
ts th
ose
base
d on
cur
rent
lite
ratu
re:
Tech
nica
l: T
he p
lace
men
t of a
cen
tral v
enou
s ca
thet
er s
houl
d be
rega
rded
as
asu
rgic
al p
roce
dure
. Th
e ph
ysic
ian
shou
ld b
e fu
lly a
cqua
inte
d w
ith v
ario
us te
chni
ques
of
cat
hete
r ins
ertio
n as
wel
l as
reco
gniti
on a
nd tr
eatm
ent o
f com
plic
atio
ns.
For d
etai
lsof
tech
niqu
es a
nd p
lace
men
t site
s, c
onsu
lt th
e m
edic
al li
tera
ture
. X-
ray
is th
e be
stm
eans
of v
erify
ing
cath
eter
pla
cem
ent.
Com
plic
atio
ns k
now
n to
occ
ur fr
om th
epl
acem
ent o
f cen
tral v
enou
s ca
thet
ers
are
pneu
mot
hora
x, h
emot
hora
x, h
ydro
thor
ax,
arte
ry p
unct
ure
and
trans
ectio
n, in
jury
to th
e br
achi
al p
lexu
s, m
alpo
sitio
n of
the
cath
eter
, for
mat
ion
of a
rterio
veno
us fi
stul
a, p
hleb
itis,
thro
mbo
sis,
car
diac
arr
hyth
mia
,an
d ca
thet
er e
mbo
lus.
Sept
ic:
The
cons
tant
risk
of s
epsi
s is
pre
sent
dur
ing
tota
l par
ente
ral n
utrit
ion.
Sinc
e co
ntam
inat
ed s
olut
ions
and
infu
sion
cat
hete
rs a
re p
oten
tial s
ourc
es o
f inf
ectio
n,
it is
impe
rativ
e th
at th
e pr
epar
atio
n of
sol
utio
n an
d th
e pl
acem
ent a
nd c
are
of c
athe
ters
be a
ccom
plis
hed
unde
r con
trolle
d as
eptic
con
ditio
ns.
If fe
ver d
evel
ops,
the
solu
tion,
its
del
iver
y sy
stem
, and
the
site
of t
he in
dwel
ling
cath
eter
sho
uld
be c
hang
ed.
0719
4738
5
*BA
R C
OD
E P
OS
ITIO
N O
NLY
Pedi
atric
Use
:Us
e of
CLI
NIM
IX s
ulfit
e-fre
e (A
min
o Ac
id in
Dex
trose
) Inj
ectio
ns in
pedi
atric
pat
ient
s is
gov
erne
d by
the
sam
e co
nsid
erat
ions
that
affe
ct th
e us
e of
any
amin
o ac
id s
olut
ion
in p
edia
trics
. Th
e am
ount
adm
inis
tere
d is
dos
ed o
n th
e ba
sis
ofgr
ams
of a
min
o ac
ids/
kg o
f bod
y w
eigh
t/day
. Tw
o to
3 g
/kg
of b
ody
wei
ght f
or in
fant
sw
ith a
dequ
ate
calo
ries
are
gene
rally
suf
ficie
nt to
sat
isfy
pro
tein
nee
ds a
nd p
rom
ote
posi
tive
nitro
gen
bala
nce.
Sol
utio
n ad
min
istra
tions
by
perip
hera
l vei
n sh
ould
not
exce
ed tw
ice
norm
al s
erum
osm
olar
ity (7
18m
Osm
ol/L
).Ce
ntra
l Vei
n Ad
min
istr
atio
n: H
yper
toni
c m
ixtu
res
of a
min
o ac
id/d
extro
se in
ject
ions
may
be
adm
inis
tere
d sa
fely
by
cont
inuo
us in
fusi
on th
roug
h a
cent
ral v
ein
cath
eter
with
the
tip lo
cate
d in
the
vena
cav
a. I
n ad
ditio
n to
mee
ting
nitro
gen
need
s, th
ead
min
istra
tion
rate
is g
over
ned,
esp
ecia
lly d
urin
g th
e fir
st fe
w d
ays
ofth
erap
y, by
th
e pa
tient
’s to
lera
nce
to d
extro
se, a
s in
dica
ted
by fr
eque
nt d
eter
min
atio
ns o
f urin
e an
d bl
ood
suga
r lev
els.
Dai
ly in
take
of a
min
o ac
ids
in d
extro
se s
houl
d be
incr
ease
dgr
adua
lly to
the
max
imum
requ
ired
dose
.Su
dden
ces
satio
n in
adm
inis
tratio
n of
thes
e ad
mix
ed in
ject
ions
may
resu
lt in
insu
linre
actio
n du
e to
con
tinue
d en
doge
nous
insu
lin p
rodu
ctio
n. P
aren
tera
l nut
ritio
n m
ixtu
res
shou
ld b
e w
ithdr
awn
slow
ly.Pe
riphe
ral V
ein
Adm
inis
trat
ion:
For
pat
ient
s re
quiri
ng p
aren
tera
l nut
ritio
n in
who
m
the
cent
ral v
ein
rout
e is
not
indi
cate
d, lo
w c
once
ntra
tion
amin
o ac
id/d
extro
se in
ject
ions
may
be
adm
inis
tere
d by
per
iphe
ral v
ein.
In
pedi
atric
pat
ient
s, th
e fin
al s
olut
ion
shou
ldno
t exc
eed
twic
e no
rmal
ser
um o
smol
arity
(718
mOs
mol
/L).
Dire
ctio
ns fo
r Use
of P
last
ic C
onta
iner
WAR
NING
: Do
not
use
pla
stic
con
tain
ers
in s
erie
s co
nnec
tions
. Su
ch u
se c
ould
resu
lt in
air
embo
lism
due
to re
sidu
al a
ir be
ing
draw
n fr
om th
e pr
imar
y co
ntai
ner
befo
re a
dmin
istr
atio
n of
the
fluid
from
the
seco
ndar
y co
ntai
ner i
s co
mpl
eted
.BE
SUR
ETH
ECO
NTEN
TSOF
BOT
H CH
AMBE
RS A
REM
IXED
TOG
ETHE
R AF
TER
OPEN
ING
SEAL
BET
WEE
N CH
AMBE
RS.
Afte
r ope
ning
sea
l bet
wee
n ch
ambe
rs, l
ipid
s an
d/or
addi
tives
can
be
intr
oduc
ed to
the
cont
aine
r. Th
orou
gh m
ixin
g en
sure
s co
mpl
ete
deliv
ery
of a
ll in
gred
ient
s.
To O
pen
Tear
ove
rwra
p ac
ross
top
at s
lit a
nd re
mov
e so
lutio
n co
ntai
ner.
Som
e op
acity
of t
hepl
astic
due
to m
oist
ure
abso
rptio
n du
ring
the
ster
iliza
tion
proc
ess
may
be
obse
rved
.Th
is is
nor
mal
and
doe
s no
t affe
ct th
e so
lutio
n qu
ality
or s
afet
y. T
he o
paci
ty w
illdi
min
ish
grad
ually
.Ch
eck
to e
nsur
e se
al b
etw
een
cham
bers
is in
tact
, i.e
., so
lutio
ns a
re c
onta
ined
inse
para
te c
ham
bers
. Ch
eck
for m
inut
e le
aks
by s
epar
atel
y sq
ueez
ing
each
cha
mbe
r.
If ex
tern
al le
aks
or le
akag
e be
twee
n th
e ch
ambe
rs a
re fo
und,
dis
card
sol
utio
n as
st
erili
ty o
r sta
bilit
y m
ay b
e im
paire
d.
To M
ix S
olut
ions
Gras
p th
e co
ntai
ner f
irmly
on
each
sid
e of
the
top
of th
e ba
g an
d ro
ll ba
g to
ope
n se
al b
etw
een
cham
bers
as
show
n in
Fig
ure
1. M
ix s
olut
ions
thor
ough
ly a
s sh
own
in F
igur
e 2.
Che
ck fo
r lea
ks.
Stor
age:
Stor
age
of th
e ad
mix
ture
mus
t be
unde
r ref
riger
atio
n an
d lim
ited
to a
brie
fpe
riod
of ti
me,
no
long
er th
an 2
4 ho
urs.
To a
dd F
at E
mul
sion
for 3
-in-1
adm
ixtu
re:
A.Pr
ior t
o ad
ding
fat e
mul
sion
, mix
am
ino
acid
and
dex
trose
inje
ctio
n as
sho
wn
in F
igur
e 2.
B.Pr
epar
e fa
t em
ulsi
on tr
ansf
er s
et fo
llow
ing
inst
ruct
ions
pro
vide
d.C.
Atta
ch tr
ansf
er s
et to
fat e
mul
sion
bot
tle, u
sing
ase
ptic
tech
niqu
e.D.
Twis
t off
prot
ecto
r on
the
addi
tive
port
of th
e CL
ARIT
Y co
ntai
ner.
E.At
tach
the
trans
fer s
et to
the
expo
sed
addi
tive
port.
F.Op
en c
lam
p on
tran
sfer
set
.G.
Afte
r com
plet
ing
trans
fer,
use
appr
opria
te p
last
ic c
lam
p or
met
al fe
rrul
e to
sea
l off
addi
tive
port
tube
.H.
Rem
ove
trans
fer s
et.
I.M
ix c
onte
nts
of C
LARI
TY c
onta
iner
thor
ough
ly. C
heck
for l
eaks
.St
orag
e:St
orag
e of
the
3-in
-1 a
dmix
ture
mus
t be
unde
r ref
riger
atio
n an
d lim
ited
to a
brie
f per
iod
of ti
me,
no
long
er th
an 2
4 ho
urs.
See
War
ning
sse
ctio
n re
gard
ing
inco
mpa
tible
add
itive
s.
To A
dd M
edic
atio
nW
ARNI
NG:
Addi
tives
may
be
inco
mpa
tible
.Su
pple
men
tal m
edic
atio
n m
ay b
e ad
ded
with
a 1
9 to
22
gaug
e ne
edle
thro
ugh
the
med
icat
ion
port.
A.Pr
epar
e m
edic
atio
n po
rt.B.
Usin
g sy
ringe
with
19
to 2
2 ga
uge
need
le, p
unct
ure
rese
alab
le m
edic
atio
n po
rt an
d in
ject
.C.
Mix
sol
utio
n an
d m
edic
atio
n th
orou
ghly.
For
hig
h de
nsity
med
icat
ion,
suc
h as
pota
ssiu
m c
hlor
ide,
squ
eeze
por
ts w
hile
por
ts a
re u
prig
ht a
nd m
ix th
orou
ghly.
D.Ch
eck
for l
eaks
.
Prep
arat
ion
for A
dmin
istr
atio
nA.
Susp
end
cont
aine
r fro
m e
yele
t sup
port.
B.Tw
ist o
ff pr
otec
tor f
rom
out
let p
ort a
t bot
tom
of c
onta
iner
.C.
Atta
ch a
dmin
istra
tion
set.
Ref
er to
com
plet
e di
rect
ions
acc
ompa
nyin
g se
t.
How
Sup
plie
dSe
e Ta
ble
1.Ex
posu
re o
f pha
rmac
eutic
al p
rodu
cts
to h
eat s
houl
d be
min
imize
d.Av
oid
exce
ssiv
e he
at.
Prot
ect f
rom
free
zing.
It i
s re
com
men
ded
that
the
prod
uct
best
ored
at r
oom
tem
pera
ture
(25°
C/77
°F):
brie
f exp
osur
e up
to 4
0°C/
104°
F do
es n
ot a
dver
sely
affe
ct th
e pr
oduc
t.Do
not
rem
ove
cont
aine
r fro
m o
verp
ouch
unt
il re
ady
to u
se.
Do n
ot u
se if
ove
rpou
ch h
as b
een
prev
ious
ly o
pene
d or
dam
aged
.
Figu
re 1
Figu
re 2
Inje
ctio
n/M
edic
atio
nPo
rtTw
ist-O
ffPr
otec
tor o
nAd
ditiv
e Po
rt
Twis
t-Off
Prot
ecto
r on
Out
let P
ort
Baxt
er H
ealth
care
Cor
pora
tion
Clin
tec
Nutri
tion
Divi
sion
Deer
field
, IL
6001
5 US
APr
inte
d in
USA
BAXT
ER, C
LINI
MIX
, and
CLA
RITY
are
trad
emar
ks o
f Bax
ter I
nter
natio
nal I
nc.
07-1
9-47
-385
Rev.
May
200
5
1.
O
OH •
H 2O
OH
OH
HO
HO
Dext
rose
Hyd
rous
, USP
(D-G
luco
se m
onoh
ydra
te)
2.Ba
lanc
ed b
y io
ns fr
om a
min
o ac
ids.
3.De
rived
from
gla
cial
ace
tic a
cid
(for p
Had
just
men
t).4.
Cont
ribut
ed b
y th
e ly
sine
hyd
roch
lorid
e.5.
pH o
f sul
fite-
free
Amin
o Ac
id In
ject
ion
inth
e ou
tlet p
ort c
ham
ber w
as a
djus
ted
with
glac
ial a
cetic
aci
d.
Dosa
ge a
nd A
dmin
istr
atio
nIf
a pa
tient
is u
nabl
e to
take
ora
l nou
rishm
ent f
or a
pro
long
ed p
erio
d of
tim
e, in
stitu
tion
of to
tal p
aren
tera
l nut
ritio
n sh
ould
be
cons
ider
ed.
The
tota
l dai
ly d
ose
of C
LINI
MIX
sul
fite-
free
(Am
ino
Acid
in D
extro
se) I
njec
tions
depe
nds
onth
e pa
tient
’s m
etab
olic
requ
irem
ent a
nd c
linic
al re
spon
se.
The
dete
rmin
atio
nof
nitr
ogen
bal
ance
and
acc
urat
e da
ily b
ody
wei
ghts
, cor
rect
ed fo
r flu
id b
alan
ce,
are
prob
ably
the
best
mea
ns o
f ass
essi
ng in
divi
dual
nitr
ogen
requ
irem
ents
.Re
com
men
ded
Diet
ary
Allo
wan
ces*
of p
rote
in ra
nge
from
app
roxi
mat
ely
0.75
g/kg
of
bod
y w
eigh
t for
adu
lts to
1.6
8 g/
kg fo
r inf
ants
up
to th
ree
mon
ths
of a
ge.
It m
ust
be re
cogn
ized,
how
ever
, tha
t pro
tein
as
wel
l as
calo
ric re
quire
men
ts in
trau
mat
ized
or m
alno
uris
hed
patie
nts
may
be
incr
ease
d su
bsta
ntia
lly.
Daily
am
ino
acid
dos
es o
fap
prox
imat
ely
1.0
to 1
.5 g
/kg
of b
ody
wei
ght f
or a
dults
with
ade
quat
e ca
lorie
s ar
ege
nera
lly s
uffic
ient
to s
atis
fy p
rote
in n
eeds
and
pro
mot
e po
sitiv
e ni
troge
n ba
lanc
e.Fo
r the
initi
al tr
eatm
ent o
f tra
uma
or p
rote
in c
alor
ie m
alnu
tritio
n, h
ighe
r dos
esof
prot
ein
with
cor
resp
ondi
ng q
uant
ities
of c
arbo
hydr
ate
will
be
nece
ssar
y to
pro
mot
ead
equa
te p
atie
nt re
spon
se to
ther
apy.
The
sev
erity
of t
he il
lnes
s be
ing
treat
ed is
the
prim
ary
cons
ider
atio
n in
det
erm
inin
g pr
oper
dos
e le
vel.
Suc
h hi
gher
dos
es, e
spec
ially
in in
fant
s, m
ust b
e ac
com
pani
ed b
y m
ore
frequ
ent l
abor
ator
y ev
alua
tion.
Care
sho
uld
be e
xerc
ised
to in
sure
the
mai
nten
ance
of p
rope
r lev
els
of s
erum
pota
ssiu
m.
Quan
titie
s of
60
to 1
80 m
Eq o
f pot
assi
um p
er d
ay h
ave
been
use
d w
ith a
dequ
ate
clin
ical
effe
ct.
It m
ay b
e ne
cess
ary
to a
dd q
uant
ities
of t
his
elec
troly
te
to th
ese
adm
ixed
inje
ctio
ns, d
epen
ding
prim
arily
on
the
amou
nt o
f car
bohy
drat
ead
min
iste
red
to a
nd m
etab
olize
d by
the
patie
nt.
Patie
nts
rece
ivin
g CL
INIM
IX s
ulfit
e-fre
e (A
min
o Ac
id in
Dex
trose
) Inj
ectio
ns
with
out e
lect
roly
tes
shou
ld b
e m
onito
red
frequ
ently
and
thei
r ele
ctro
lyte
re
quire
men
ts in
divi
dual
ized.
Tota
l dai
ly fl
uid
requ
irem
ents
can
be
met
bey
ond
the
volu
me
of a
min
o ac
ids
solu
tion
bysu
pple
men
ting
with
non
carb
ohyd
rate
or c
arbo
hydr
ate-
cont
aini
ng e
lect
roly
te s
olut
ions
.M
aint
enan
ce v
itam
ins,
add
ition
al e
lect
roly
tes,
and
trac
e el
emen
ts s
houl
d be
adm
inis
tere
d as
requ
ired.
In m
any
patie
nts,
pro
visi
on o
f ade
quat
e ca
lorie
s in
the
form
of h
yper
toni
c de
xtro
se
may
requ
ire th
e ad
min
istra
tion
of e
xoge
nous
insu
lin to
pre
vent
hyp
ergl
ycem
ia a
ndgl
ycos
uria
.Fa
t em
ulsi
on a
dmin
istra
tion
shou
ld b
e co
nsid
ered
whe
n pr
olon
ged
(mor
e th
an 5
days
)pa
rent
eral
nut
ritio
n is
requ
ired
in o
rder
to p
reve
nt e
ssen
tial f
atty
aci
d de
ficie
ncy
(EFA
D).
Seru
m li
pids
sho
uld
be m
onito
red
for e
vide
nce
of E
FAD
in p
atie
nts
mai
ntai
ned
on
fat-f
ree
TPN.
Intra
veno
us fa
t em
ulsi
ons
prov
ide
appr
oxim
atel
y 1.
1 kc
al p
er m
L (1
0%),
2.0
kcal
per
mL
(20%
), or
3.0
kca
l per
mL
(30%
) and
may
be
adm
ixed
alo
ng w
itham
ino
acid
/dex
trose
inje
ctio
ns in
the
CLAR
ITY
Cont
aine
r to
supp
lem
ent c
alor
ic in
take
.De
pend
ing
upon
the
clin
ical
con
ditio
n of
the
patie
nt, a
ppro
xim
atel
y 3
liter
s of
sol
utio
nm
ay b
e ad
min
iste
red
per 2
4 ho
ur p
erio
d. W
hen
used
pos
tope
rativ
ely,
the
ther
apy
shou
ld b
egin
with
100
0 m
L on
the
first
pos
tope
rativ
e da
y. T
here
afte
r, th
e do
se m
ay
be in
crea
sed
to 3
000
mL
per d
ay.
Do n
ot a
dmin
iste
r unl
ess
seal
bet
wee
n ch
ambe
rs is
ope
ned,
oth
er s
eals
are
inta
ct,
and
solu
tion
is c
lear
and
thor
ough
ly m
ixed
.Pa
rent
eral
dru
g pr
oduc
ts s
houl
d be
insp
ecte
d vi
sual
ly fo
r par
ticul
ate
mat
ter a
nddi
scol
orat
ion
prio
r to
adm
inis
tratio
n w
hene
ver s
olut
ion
and
cont
aine
r per
mit.
Use
of a
fina
l filt
er is
reco
mm
ende
d du
ring
adm
inis
tratio
n of
all
pare
nter
al s
olut
ions
,w
here
pos
sibl
e.A
slig
ht y
ello
w c
olor
doe
s no
t alte
r the
qua
lity
and
effic
acy
of th
is p
rodu
ct.
Addi
tives
may
be
inco
mpa
tible
. Co
mpl
ete
info
rmat
ion
is n
ot a
vaila
ble.
Tho
se a
dditi
ves
know
n to
be
inco
mpa
tible
sho
uld
not b
e us
ed.
Cons
ult w
ith p
harm
acis
t, if
avai
labl
e.If,
in th
e in
form
ed ju
dgem
ent o
f the
phy
sici
an, i
t is
deem
ed a
dvis
able
to in
trodu
cead
ditiv
es, u
se a
sept
ic te
chni
que.
Mix
thor
ough
ly w
hen
addi
tives
hav
e be
en in
trodu
ced.
Do n
ot s
tore
sol
utio
ns c
onta
inin
g ad
ditiv
es.
Thes
e am
ino
acid
/dex
trose
inje
ctio
ns s
houl
d be
use
d pr
ompt
ly a
fter m
ixin
g. A
ny s
tora
gesh
ould
be
unde
r ref
riger
atio
n an
d lim
ited
to a
brie
f per
iod
of ti
me,
less
than
24
hour
s.
Met
abol
ic:
The
follo
win
g m
etab
olic
com
plic
atio
ns h
ave
been
repo
rted:
met
abol
ic a
cido
sis,
hyp
opho
spha
tem
ia, a
lkal
osis
, hyp
ergl
ycem
ia a
nd g
lyco
suria
,os
mot
ic d
iure
sis
and
dehy
drat
ion,
rebo
und
hypo
glyc
emia
, ele
vate
d liv
er e
nzym
es,
hypo
- and
hyp
ervi
tam
inos
is, e
lect
roly
te im
bala
nces
, and
hyp
eram
mon
emia
. Fr
eque
nt c
linic
al e
valu
atio
n an
d la
bora
tory
det
erm
inat
ions
are
nec
essa
ry, e
spec
ially
durin
g th
e fir
st fe
w d
ays
of th
erap
y to
pre
vent
or m
inim
ize th
ese
com
plic
atio
ns.
Caut
ion
mus
t be
exer
cise
d in
the
adm
inis
tratio
n of
thes
e ad
mix
ed a
min
o ac
id/d
extro
sein
ject
ions
to p
atie
nts
rece
ivin
g co
rtico
ster
oids
or c
ortic
otro
pin.
Thes
e ad
mix
ed in
ject
ions
sho
uld
be u
sed
with
cau
tion
in p
atie
nts
with
ove
rt or
kno
wn
subc
linic
al d
iabe
tes
mel
litus
.Dr
ug p
rodu
ct c
onta
ins
no m
ore
than
25
µg/L
of a
lum
inum
.Ca
rcin
ogen
esis
, Mut
agen
esis
, Im
pairm
ent o
f Fer
tility
:St
udie
s w
ith C
LINI
MIX
su
lfite
-free
(Am
ino
Acid
in D
extro
se) I
njec
tions
hav
e no
t bee
n pe
rform
ed to
eva
luat
eca
rcin
ogen
ic p
oten
tial,
mut
agen
ic p
oten
tial,
or e
ffect
s on
ferti
lity.
Preg
nanc
y:Te
rato
geni
c Ef
fect
sPr
egna
ncy
Cate
gory
C.
Anim
al re
prod
uctio
n st
udie
s ha
ve n
ot b
een
cond
ucte
d w
ith C
LINI
MIX
sul
fite-
free
(Am
ino
Acid
in D
extro
se) I
njec
tions
. It
is a
lso
not k
now
nw
heth
er C
LINI
MIX
sul
fite-
free
(Am
ino
Acid
in D
extro
se) I
njec
tions
can
cau
se fe
tal
harm
whe
n ad
min
iste
red
to a
pre
gnan
t wom
an o
rcan
affe
ct re
prod
uctio
n ca
paci
ty.
CLIN
IMIX
sul
fite-
free
(Am
ino
Acid
in D
extro
se) I
njec
tions
sho
uld
be g
iven
toa
preg
nant
wom
an o
nly
if cl
early
nee
ded.
Nurs
ing
Mot
hers
:Ca
utio
n sh
ould
be
exer
cise
d w
hen
CLIN
IMIX
sul
fite-
free
(Am
ino
Acid
in D
extro
se) I
njec
tions
are
adm
inis
tere
d to
a n
ursi
ng w
oman
.Pe
diat
ric U
se:
Dext
rose
is s
afe
and
effe
ctiv
e fo
r the
sta
ted
indi
catio
ns in
ped
iatri
cpa
tient
s (s
ee In
dica
tions
and
Usa
ge).
As
repo
rted
in th
e lit
erat
ure,
the
dosa
gese
lect
ion
and
cons
tant
infu
sion
rate
of i
ntra
veno
us d
extro
se m
ust b
e se
lect
ed w
ithca
utio
n in
ped
iatri
c pa
tient
s, p
artic
ular
ly n
eona
tes
and
low
birt
h w
eigh
t inf
ants
, bec
ause
of th
e in
crea
sed
risk
of h
yper
glyc
emia
/hyp
ogly
cem
ia.
Freq
uent
mon
itorin
g of
ser
umgl
ucos
e co
ncen
tratio
ns is
requ
ired
whe
n de
xtro
se is
pre
scrib
ed to
ped
iatri
c pa
tient
s,pa
rticu
larly
neo
nate
s an
d lo
w b
irth
wei
ght i
nfan
ts.
Safe
ty a
nd e
ffect
iven
ess
of C
LINI
MIX
sul
fite-
free
(Am
ino
Acid
in D
extro
se) I
njec
tions
in
ped
iatri
c pa
tient
s ha
ve n
ot b
een
esta
blis
hed
by a
dequ
ate
and
wel
l-con
trolle
d st
udie
s.Ho
wev
er, t
he u
se o
f am
ino
acid
inje
ctio
ns in
ped
iatri
c pa
tient
s as
an
adju
nct i
n th
eof
fset
ting
of n
itrog
en lo
ss o
r in
the
treat
men
t of n
egat
ive
nitro
gen
bala
nce
is re
fere
nced
in th
e m
edic
al li
tera
ture
. Se
e Do
sage
and
Adm
inis
trat
ion.
Geria
tric
Use
:Cl
inic
al s
tudi
es o
f CLI
NIM
IX s
ulfit
e-fre
e (A
min
o Ac
id in
Dex
trose
)In
ject
ions
did
not
incl
ude
suffi
cien
t num
bers
of s
ubje
cts
aged
65
and
over
to d
eter
min
ew
heth
er th
ey re
spon
d di
ffere
ntly
from
oth
er y
oung
er s
ubje
cts.
Oth
er re
porte
d cl
inic
alex
perie
nce
has
not i
dent
ified
diff
eren
ces
in re
spon
ses
betw
een
the
elde
rly a
nd
youn
ger p
atie
nts.
In g
ener
al, d
ose
sele
ctio
n fo
r an
elde
rly p
atie
nt s
houl
d be
cau
tious
, usu
ally
sta
rting
at
the
low
end
of t
he d
osin
g ra
nge,
refle
ctin
g th
e gr
eate
r fre
quen
cy o
f dec
reas
ed h
epat
ic,
rena
l, or
car
diac
func
tion,
and
of c
onco
mita
nt d
isea
se o
r dru
g th
erap
y.
Adve
rse
Reac
tions
See
War
ning
san
dPr
ecau
tions
Too
rapi
d in
fusi
on o
f the
se C
LINI
MIX
sul
fite-
free
(Am
ino
Acid
in D
extro
se) I
njec
tions
may
resu
lt in
diu
resi
s, h
yper
glyc
emia
, gly
cosu
ria, a
nd h
yper
osm
olar
com
a. C
ontin
ual
clin
ical
mon
itorin
g of
the
patie
nt is
nec
essa
ry in
ord
er to
iden
tify
and
initi
ate
mea
sure
sfo
r the
se c
linic
al c
ondi
tions
.Re
actio
ns th
at m
ay o
ccur
bec
ause
of t
he s
olut
ion
or th
e te
chni
que
of a
dmin
istra
tion
incl
ude
febr
ile re
spon
se, i
nfec
tion
at th
e si
te o
f inj
ectio
n, v
enou
s th
rom
bosi
s or
ph
lebi
tis e
xten
ding
from
the
site
of i
njec
tion,
ext
rava
satio
n, a
nd h
yper
vole
mia
. Po
licie
s an
d pr
oced
ures
sho
uld
be e
stab
lishe
d fo
r the
reco
gniti
on a
nd m
anag
emen
t of
suc
h re
actio
ns.
If an
adv
erse
reac
tion
does
occ
ur, d
isco
ntin
ue th
e in
fusi
on, e
valu
ate
the
patie
nt,
inst
itute
app
ropr
iate
ther
apeu
tic c
ount
erm
easu
res,
and
sav
e th
e re
mai
nder
of t
he
fluid
for e
xam
inat
ion
if de
emed
nec
essa
ry.
*Fo
od a
nd N
utrit
ion
Boar
d Na
tiona
l Aca
dem
y of
Sci
ence
s -
Natio
nalR
esea
rch
Coun
cil (
Revi
sed
1989
).
CLIN
IMIX
2.7
5/5
sulfi
te-fr
ee
(2.7
5% A
min
o Ac
id in
5%
Dex
trose
)In
ject
ion
Code
2B7
725
NDC
0338
-113
2-03
Code
2B7
701
NDC
0338
-108
3-04
CLIN
IMIX
4.2
5/5
sulfi
te-fr
ee
(4.2
5% A
min
o Ac
id in
5%
Dex
trose
)In
ject
ion
CLIN
IMIX
4.2
5/10
sul
fite-
free
(4.2
5% A
min
o Ac
id in
10%
Dex
trose
)In
ject
ion
CLIN
IMIX
4.2
5/20
sul
fite-
free
(4.2
5% A
min
o Ac
id in
20%
Dex
trose
)In
ject
ion
CLIN
IMIX
4.2
5/25
sul
fite-
free
(4.2
5% A
min
o Ac
id in
25%
Dex
trose
)In
ject
ion
CLIN
IMIX
5/1
5 su
lfite
-free
(5
% A
min
o Ac
id in
15%
Dex
trose
)In
ject
ion
CLIN
IMIX
5/2
0 su
lfite
-free
(5
% A
min
o Ac
id in
20%
Dex
trose
)In
ject
ion
CLIN
IMIX
5/2
5 su
lfite
-free
(5
% A
min
o Ac
id in
25%
Dex
trose
)In
ject
ion
Code
2B7
726
NDC
0338
-113
3-03
Code
2B7
704
NDC
0338
-108
9-04
Code
2B7
727
NDC
0338
-113
4-03
Code
2B7
705
NDC
0338
-109
1-04
Code
2B7
728
NDC
0338
-113
5-03
Code
2B7
706
NDC
0338
-109
3-04
Code
2B7
729
NDC
0338
-113
6-03
Code
2B7
707
NDC
0338
-109
5-04
Code
2B7
730
NDC
0338
-113
7-03
Code
2B7
709
NDC
0338
-109
9-04
Code
2B7
731
NDC
0338
-113
8-03
Code
2B7
710
NDC
0338
-110
1-04
Code
2B7
732
NDC
0338
-113
9-03
Code
2B7
711
NDC
0338
-110
3-04
6.0
(4.5
to 7
.0)
6.0
(4.5
to 7
.0)
6.0
(4.5
to 7
.0)
6.0
(4.5
to 7
.0)
6.0
(4.5
to 7
.0)
6.0
(4.5
to 7
.0)
6.0
(4.5
to 7
.0)
6.0
(4.5
to 7
.0)
Cont
ents
of A
dmix
ed P
rodu
ct
52.
7545
420
116
516
015
915
413
211
611
050
570
316
283
187
138
11
54.
2570
231
125
524
724
723
820
417
917
077
880
489
438
289
213
17
104.
2570
231
125
524
724
723
820
417
917
077
880
489
438
289
213
17
204.
2570
231
125
524
724
723
820
417
917
077
880
489
438
289
213
17
254.
2570
231
125
524
724
723
820
417
917
077
880
489
438
289
213
17
155
826
365
300
290
290
280
240
210
200
9010
3557
551
534
025
020
205
826
365
300
290
290
280
240
210
200
9010
3557
551
534
025
020
255
826
365
300
290
290
280
240
210
200
9010
3557
551
534
025
020
170
110
280
170
170
340
340
170
510
680
170
850
850
170
1020
510
200
710
680
200
880
850
200
1050
525
675
930
1435
1685
1255
1505
1760
2411
3717
3717
3717
3717
4220
4220
4220
Esse
ntia
l Am
ino
Acid
s (m
g/10
0 m
L)No
ness
entia
l Am
ino
Acid
s (m
g/10
0 m
L)An
ion
Prof
ile(m
Eq/L
)2
Com
posi
tion
Calo
ric C
onte
nt(k
cal/L
)
How
Sup
plie
d
Tabl
e 1
Afte
r mix
ing,
the
prod
uct r
epre
sent
s10
00 m
L Co
de a
nd N
DC N
umbe
r20
00 m
L Co
de a
nd N
DC N
umbe
r
Dextrose Hydrous, USP1(g/100 mL)
Amino Acids (g/100 mL)
Total Nitrogen (mg/100 mL)
Leucine- (CH3)2CHCH2CH (NH2) COOH
Isoleucine- CH3CH2CH (CH3) CH (NH2) COOH
Valine- (CH3)2CHCH (NH2) COOH
Lysine (added as the hydrochloride salt)- H2N (CH2)4CH (NH2) COOH
Phenylalanine- (C6H5) CH2CH (NH2) COOH
Histidine- (C3H3N2) CH2CH (NH2) COOH
Threonine- CH3CH (OH) CH (NH2) COOH
Methionine- CH3S (CH2)2CH (NH2) COOH
Tryptophan- (C8H6N) CH2CH (NH2) COOH
Alanine- CH3CH (NH2) COOH
Arginine- H2NC (NH) NH (CH2)3CH (NH2) COOH
Glycine- H2NCH2COOH
Proline- [(CH2)3NH CH] COOH
Serine - HOCH2CH (NH2) COOH
Tyrosine- [C6H4(OH)] CH2CH (NH2) COOH
Acetate3
Chloride4
pH5
(range)
Osmolarity(mOsmol/L)(calc)
From Dextrose
From Amino Acids
TOTAL(Dextrose and Amino Acids)
07-19-47-385
CLIN
IMIX
E su
lfite
-fre
e(A
min
o Ac
id w
ith E
lect
roly
tes
in D
extro
se w
ith C
alci
um)I
njec
tions
in C
LARI
TY D
ual C
ham
ber C
onta
iner
07-1
9-47
-386
Desc
riptio
nCL
INIM
IX E
sul
fite-
free
(Am
ino
Acid
with
Ele
ctro
lyte
s in
Dex
trose
with
Cal
cium
) Inj
ectio
nsar
e st
erile
, non
pyro
geni
c, h
yper
toni
c so
lutio
ns in
a C
LARI
TY D
ual C
ham
ber C
onta
iner
.Th
e su
lfite
-free
Am
ino
Acid
Inje
ctio
ns w
ith E
lect
roly
tes
in th
e ou
tlet p
ort c
ham
ber
are
solu
tions
of e
ssen
tiala
nd n
ones
sent
ial a
min
o ac
ids
prov
ided
with
ele
ctro
lyte
s.Th
e De
xtro
se In
ject
ions
with
Cal
cium
in th
e in
ject
ion
port
cham
ber a
re s
olut
ions
for f
luid
repl
enis
hmen
t and
cal
oric
sup
ply.
Afte
r ope
ning
the
seal
bet
wee
n th
e ch
ambe
rs a
nd m
ixin
g th
orou
ghly,
the
adm
ixed
pro
duct
is in
tend
ed fo
r int
rave
nous
use
. Se
e Ta
ble
1 fo
r com
posi
tion,
pH,
osm
olar
ity, i
onic
conc
entra
tion
and
calo
ric c
onte
nt o
f the
adm
ixed
pro
duct
.Th
e CL
ARIT
Y Du
al C
ham
ber C
onta
iner
is a
lipi
d-co
mpa
tible
pla
stic
con
tain
er
(PL
2401
Pla
stic
). T
he a
mou
nt o
f wat
er th
at c
an p
erm
eate
from
insi
de th
e co
ntai
ner
into
the
over
wra
p is
insu
ffici
ent t
o af
fect
the
solu
tion
sign
ifica
ntly.
Sol
utio
ns in
con
tact
with
the
plas
tic c
onta
iner
may
leac
h ou
t cer
tain
che
mic
al c
ompo
nent
s fro
m th
e pl
astic
in
ver
y sm
all a
mou
nts;
how
ever
, bio
logi
cal t
estin
g w
as s
uppo
rtive
of t
he s
afet
y of
the
plas
tic c
onta
iner
mat
eria
ls.
Clin
ical
Pha
rmac
olog
yCL
INIM
IX E
sul
fite-
free
(Am
ino
Acid
with
Ele
ctro
lyte
s in
Dex
trose
with
Cal
cium
) Inj
ectio
nsad
min
iste
red
intra
veno
usly
pro
vide
bio
logi
cally
util
izabl
e so
urce
mat
eria
l for
pro
tein
synt
hesi
s an
d ha
ve v
alue
as
a so
urce
of c
alor
ies,
ele
ctro
lyte
s, a
nd w
ater
.
Indi
catio
ns a
nd U
sage
CLIN
IMIX
E s
ulfit
e-fre
e (A
min
o Ac
id w
ith E
lect
roly
tes
in D
extro
se w
ith C
alci
um) I
njec
tions
are
indi
cate
d as
a c
alor
ic c
ompo
nent
in a
par
ente
ral n
utrit
ion
regi
men
and
as
the
prot
ein
(nitr
ogen
) sou
rce
for o
ffset
ting
nitro
gen
loss
or f
or tr
eatm
ent o
f neg
ativ
e ni
troge
n ba
lanc
ein
pat
ient
s w
here
:(1
) the
alim
enta
ry tr
act c
anno
t or s
houl
d no
t be
used
, (2
) gas
troin
test
inal
abs
orpt
ion
of p
rote
in is
impa
ired,
or
(3) m
etab
olic
requ
irem
ents
for p
rote
in a
re s
ubst
antia
lly in
crea
sed,
as
with
ext
ensi
ve b
urns
.Ce
ntra
l Vei
n Ad
min
istr
atio
n: C
entra
l vei
n in
fusi
on s
houl
d be
use
d w
hen
amin
o ac
idso
lutio
ns a
re a
dmix
ed w
ith h
yper
toni
c de
xtro
se to
pro
mot
e pr
otei
n sy
nthe
sis
such
as
for h
yper
cata
bolic
or d
eple
ted
patie
nts
or th
ose
requ
iring
long
term
par
ente
ral n
utrit
ion.
Perip
hera
l Vei
n Ad
min
istr
atio
n: F
or p
atie
nts
in w
hom
the
cent
ral v
ein
rout
e is
not
indi
cate
d, a
min
o ac
id s
olut
ions
dilu
ted
with
low
dex
trose
con
cent
ratio
ns m
ay b
e in
fuse
d by
per
iphe
ral v
ein.
Cont
rain
dica
tions
CLIN
IMIX
E s
ulfit
e-fre
e (A
min
o Ac
id w
ith E
lect
roly
tes
in D
extro
se w
ith C
alci
um) I
njec
tions
are
cont
rain
dica
ted
in p
atie
nts
havi
ng in
tracr
ania
l or i
ntra
spin
al h
emor
rhag
e, in
pat
ient
sw
ho a
re s
ever
ely
dehy
drat
ed, i
n pa
tient
s hy
pers
ensi
tive
to o
ne o
r mor
e am
ino
acid
s an
d in
pat
ient
s w
ith s
ever
e liv
er d
isea
se o
r hep
atic
com
a.So
lutio
ns c
onta
inin
g co
rn-d
eriv
ed d
extro
se m
ay b
e co
ntra
indi
cate
d in
pat
ient
s w
ith k
now
nal
lerg
y to
cor
n or
cor
n pr
oduc
ts.
War
ning
sAd
ditiv
es m
ay b
e in
com
patib
le.
Cons
ult w
ith p
harm
acis
t, if
avai
labl
e.W
hen
intro
duci
ng a
dditi
ves,
use
ase
ptic
tech
niqu
es.
Mix
thor
ough
ly. D
o no
t sto
re.
Beca
use
of th
e po
tent
ial f
or li
fe-th
reat
enin
g ev
ents
, cau
tion
shou
ld b
e ta
ken
to e
nsur
e th
at p
reci
pita
tes
have
not
form
ed in
any
par
ente
ral n
utrie
nt a
dmix
ture
.Th
ese
CLIN
IMIX
E s
ulfit
e-fre
e (A
min
o Ac
id w
ith E
lect
roly
tes
in D
extro
se w
ith C
alci
um)
Inje
ctio
ns,m
ust b
ead
mix
ed p
rior t
o in
fusi
on.
For a
dmix
ing
inst
ruct
ions
see
Dire
ctio
nsfo
r Use
of P
last
ic C
onta
iner
.Th
e in
fusi
on o
f hyp
erto
nic
nutri
ent i
njec
tions
into
a p
erip
hera
l vei
n m
ay re
sult
in v
ein
irrita
tion,
vei
n da
mag
e, a
nd th
rom
bosi
s. A
fter m
ixin
g, s
trong
ly h
yper
toni
c nu
trien
tin
ject
ions
sho
uld
only
be
adm
inis
tere
d th
roug
h an
indw
ellin
g in
trave
nous
cat
hete
r with
th
e tip
loca
ted
in a
larg
e ce
ntra
l vei
n, s
uch
as th
e su
perio
r ven
a ca
va.
Prop
er a
dmin
istra
tion
of th
ese
adm
ixed
am
ino
acid
with
ele
ctro
lyte
s/de
xtro
se w
ith c
alci
umin
ject
ions
requ
ires
akn
owle
dge
of fl
uid
and
elec
troly
te b
alan
ce a
nd n
utrit
ion
as w
ell a
scl
inic
al e
xper
tise
in re
cogn
ition
and
trea
tmen
t of t
he c
ompl
icat
ions
whi
ch m
ay o
ccur
.
Labo
rato
ry T
ests
Freq
uent
clin
ical
eva
luat
ion
and
labo
rato
ry d
eter
min
atio
ns a
re n
eces
sary
for p
rope
rm
onito
ring
durin
g ad
min
istr
atio
n.St
udie
s sh
ould
incl
ude
bloo
d su
gar,
seru
m p
rote
ins,
kidn
ey a
nd li
ver f
unct
ion
test
s, e
lect
roly
tes,
com
plet
e bl
ood
coun
t with
diff
eren
tial,
carb
on d
ioxi
de c
ombi
ning
pow
er o
r con
tent
, ser
um o
smol
ariti
es, b
lood
cul
ture
s, a
nd
bloo
d am
mon
ia le
vels
.Ad
min
istra
tion
of a
min
o ac
id s
olut
ions
to a
pat
ient
with
hep
atic
insu
ffici
ency
may
resu
lt in
ser
um a
min
o ac
id im
bala
nces
, hyp
eram
mon
emia
, stu
por,
and
com
a.
Hype
ram
mon
emia
is o
f spe
cial
sig
nific
ance
in in
fant
s.Th
is re
actio
n ap
pear
s to
be
rela
ted
to a
def
icie
ncy
of th
e ur
ea c
ycle
am
ino
acid
s of
gen
etic
or p
rodu
ct o
rigin
.It
is e
ssen
tial t
hat b
lood
am
mon
ia b
e m
easu
red
frequ
ently
in in
fant
s.Co
nser
vativ
e do
ses
of th
ese
adm
ixed
am
ino
acid
with
ele
ctro
lyte
s/de
xtro
se w
ith c
alci
umin
ject
ions
sho
uld
be g
iven
to p
atie
nts
with
kno
wn
or s
uspe
cted
hep
atic
dys
func
tion.
Shou
ld s
ympt
oms
of h
yper
amm
onem
ia d
evel
op, a
dmin
istra
tion
shou
ld b
e di
scon
tinue
dan
d th
e pa
tient
’s cl
inic
al s
tatu
s be
reev
alua
ted.
Adm
inis
tratio
n of
am
ino
acid
sol
utio
ns in
the
pres
ence
of i
mpa
ired
rena
l fun
ctio
n pr
esen
tssp
ecia
l iss
ues
asso
ciat
ed w
ith re
tent
ion
of e
lect
roly
tes.
Thes
e ad
mix
ed in
ject
ions
sho
uld
not b
e ad
min
iste
red
sim
ulta
neou
sly
with
blo
od th
roug
hth
e sa
me
infu
sion
set
bec
ause
of t
he p
ossi
bilit
y of
pse
udoa
gglu
tinat
ion.
In v
ery
low
birt
h w
eigh
t inf
ants
, exc
essi
ve o
r rap
id a
dmin
istra
tion
of d
extro
se in
ject
ion
may
resu
lt in
incr
ease
d se
rum
osm
olal
ity a
nd p
ossi
ble
intra
cere
bral
hem
orrh
age.
WAR
NING
: Th
is p
rodu
ct c
onta
ins
alum
inum
that
may
be
toxi
c. A
lum
inum
may
reac
h to
xic
leve
ls w
ith p
rolo
nged
par
ente
ral a
dmin
istra
tion
if ki
dney
func
tion
is im
paire
d.Pr
emat
ure
neon
ates
are
par
ticul
arly
at r
isk
beca
use
thei
r kid
neys
are
imm
atur
e, a
nd
they
requ
ire la
rge
amou
nts
of c
alci
um a
nd p
hosp
hate
sol
utio
ns, w
hich
con
tain
alu
min
um.
Rese
arch
indi
cate
s th
at p
atie
nts
with
impa
ired
kidn
ey fu
nctio
n, in
clud
ing
prem
atur
ene
onat
es, w
ho re
ceiv
e pa
rent
eral
leve
ls o
f alu
min
um a
t gre
ater
than
4 to
5 µ
g/kg
/day
accu
mul
ate
alum
inum
at l
evel
s as
soci
ated
with
cen
tral n
ervo
us s
yste
m a
nd b
one
toxi
city
.Ti
ssue
load
ing
may
occ
ur a
t eve
n lo
wer
rate
s of
adm
inis
tratio
n.
Prec
autio
nsW
ith th
e ad
min
istra
tion
of th
ese
CLIN
IMIX
E s
ulfit
e-fre
e (A
min
o Ac
id w
ith E
lect
roly
tes
inDe
xtro
se w
ith C
alci
um) I
njec
tions
, hyp
ergl
ycem
ia, g
lyco
suria
, and
hyp
eros
mol
ar s
yndr
ome
may
resu
lt. B
lood
and
urin
e gl
ucos
e sh
ould
be
mon
itore
d on
a ro
utin
e ba
sis
in p
atie
nts
rece
ivin
g th
is th
erap
y.Us
e w
ith c
autio
n w
hen
adm
inis
terin
g to
pat
ient
s w
ith a
nuria
or r
enal
failu
re.
Thes
e in
ject
ions
con
tain
suf
ficie
nt e
lect
roly
tes
to p
rovi
de fo
r mos
t par
ente
ral n
utrit
iona
lne
eds
with
the
poss
ible
exc
eptio
n of
pot
assi
um, w
here
sup
plem
enta
tion
may
be
requ
ired.
How
ever
, rep
lace
men
t of e
xcep
tiona
l ele
ctro
lyte
loss
due
to n
asog
astri
c su
ctio
n, fi
stul
adr
aina
ge, o
r unu
sual
tiss
ue e
xuda
tion
may
be
nece
ssar
y. P
artic
ular
atte
ntio
n sh
ould
be
give
n to
mon
itorin
g se
rum
pot
assi
um le
vels
.Th
e m
etab
oliza
ble
acet
ate
anio
n an
d am
ino
acid
pro
files
in th
ese
adm
ixed
inje
ctio
ns
wer
e de
sign
ed to
min
imize
or p
reve
nt o
ccur
renc
es o
f hyp
erch
lore
mic
met
abol
ic a
cido
sis
and
hype
ram
mon
emia
. Ho
wev
er, t
he p
hysi
cian
sho
uld
be a
war
e of
app
ropr
iate
coun
term
easu
res
if th
ey b
ecom
e ne
cess
ary.
Clin
ical
eva
luat
ion
and
perio
dic
labo
rato
ry d
eter
min
atio
ns a
re n
eces
sary
to m
onito
rch
ange
s in
flui
d ba
lanc
e, e
lect
roly
te c
once
ntra
tions
and
aci
d-ba
se b
alan
ce d
urin
gpr
olon
ged
pare
nter
al th
erap
y or
whe
neve
r the
con
ditio
n of
the
patie
nt w
arra
nts
such
eva
luat
ion.
Beca
use
of it
s an
ti-an
abol
ic a
ctiv
ity, c
oncu
rren
t adm
inis
tratio
n of
tetra
cycl
ine
may
redu
ceth
e pr
otei
n-sp
arin
g ef
fect
of i
nfus
ed a
min
o ac
ids.
The
intra
veno
us a
dmin
istra
tion
of th
ese
solu
tions
can
cau
se fl
uid
and/
or s
olut
e ov
erlo
adin
gre
sulti
ng in
dilu
tion
of s
erum
ele
ctro
lyte
con
cent
ratio
ns, o
verh
ydra
tion,
con
gest
ed s
tate
s,or
pul
mon
ary
edem
a; p
artic
ular
ly in
pat
ient
s w
ith re
nal d
isea
se, p
ulm
onar
y in
suffi
cien
cy,
and
hear
t dis
ease
.Ad
min
istra
tion
of a
dmix
ed a
min
o ac
id w
ith e
lect
roly
tes/
dext
rose
with
cal
cium
inje
ctio
nsan
d ot
her n
utrie
nts
via
cent
ral o
r per
iphe
ral v
enou
s ca
thet
er m
ay b
e as
soci
ated
with
com
plic
atio
ns w
hich
can
be
prev
ente
d or
min
imize
d by
car
eful
atte
ntio
n to
all
aspe
cts
ofth
e pr
oced
ure.
Thi
s in
clud
es a
ttent
ion
to s
olut
ion
prep
arat
ion,
adm
inis
tratio
n, a
nd p
atie
ntm
onito
ring.
It is
ess
entia
l tha
t a c
aref
ully
pre
pare
d pr
otoc
ol b
ased
on
curr
ent m
edic
alpr
actic
es b
e fo
llow
ed, p
refe
rabl
y by
an
expe
rienc
ed te
am.
Alth
ough
a d
etai
led
disc
ussi
on o
f the
com
plic
atio
ns is
bey
ond
the
scop
e of
this
inse
rt,
the
follo
win
g su
mm
ary
lists
thos
e ba
sed
on c
urre
nt li
tera
ture
:Te
chni
cal:
The
pla
cem
ent o
f a c
entra
l ven
ous
cath
eter
sho
uld
be re
gard
ed a
s a
surg
ical
proc
edur
e. T
he p
hysi
cian
sho
uld
be fu
lly a
cqua
inte
d w
ith v
ario
us te
chni
ques
of c
athe
ter
inse
rtion
as
wel
l as
reco
gniti
on a
nd tr
eatm
ent o
f com
plic
atio
ns.
For d
etai
ls o
f tec
hniq
ues
and
plac
emen
t site
s, c
onsu
lt th
e m
edic
al li
tera
ture
. X-
ray
is th
e be
st m
eans
of v
erify
ing
cath
eter
pla
cem
ent.
Com
plic
atio
ns k
now
n to
occ
ur fr
om th
e pl
acem
ent o
f cen
tral v
enou
sca
thet
ers
are
pneu
mot
hora
x, h
emot
hora
x, h
ydro
thor
ax, a
rtery
pun
ctur
e an
d tra
nsec
tion,
inju
ry to
the
brac
hial
ple
xus,
mal
posi
tion
of th
e ca
thet
er, f
orm
atio
n of
arte
riove
nous
fist
ula,
phle
bitis
, thr
ombo
sis,
car
diac
arr
hyth
mia
, and
cat
hete
r em
bolu
s.Se
ptic
:Th
e co
nsta
nt ri
sk o
f sep
sis
is p
rese
nt d
urin
g to
tal p
aren
tera
l nut
ritio
n.Si
nce
cont
amin
ated
sol
utio
ns a
nd in
fusi
on c
athe
ters
are
pot
entia
l sou
rces
of i
nfec
tion,
it
is im
pera
tive
that
the
prep
arat
ion
of s
olut
ion
and
the
plac
emen
t and
car
e of
cat
hete
rs
be a
ccom
plis
hed
unde
r con
trolle
d as
eptic
con
ditio
ns.
If fe
ver d
evel
ops,
the
solu
tion,
its
del
iver
y sy
stem
, and
the
site
of t
he in
dwel
ling
cath
eter
sho
uld
be c
hang
ed.
0719
4738
6
*BA
R C
OD
E P
OS
ITIO
N O
NLY
Pedi
atric
Use
:Us
e of
CLI
NIM
IX E
sul
fite-
free
(Am
ino
Acid
with
Ele
ctro
lyte
s in
Dex
trose
w
ith C
alci
um) I
njec
tions
in p
edia
tric
patie
nts
is g
over
ned
by th
e sa
me
cons
ider
atio
ns th
ataf
fect
the
use
of a
ny a
min
o ac
id s
olut
ion
in p
edia
trics
. Th
e am
ount
adm
inis
tere
d is
dos
edon
the
basi
s of
gra
ms
of a
min
o ac
ids/
kg o
f bod
y w
eigh
t/day
. Tw
o to
3 g
/kg
of b
ody
wei
ght
for i
nfan
ts w
ith a
dequ
ate
calo
ries
are
gene
rally
suf
ficie
nt to
sat
isfy
pro
tein
nee
ds a
ndpr
omot
e po
sitiv
e ni
troge
n ba
lanc
e. S
olut
ion
adm
inis
tratio
ns b
y pe
riphe
ral v
ein
shou
ld
not e
xcee
d tw
ice
norm
al s
erum
osm
olar
ity (7
18m
Osm
ol/L
).Ce
ntra
l Vei
n Ad
min
istr
atio
n: H
yper
toni
c m
ixtu
res
of a
min
o ac
id w
ith e
lect
roly
tes/
dext
rose
with
cal
cium
inje
ctio
ns m
ay b
e ad
min
iste
red
safe
ly b
y co
ntin
uous
infu
sion
thro
ugh
ace
ntra
l vei
n ca
thet
erw
ith th
e tip
loca
ted
in th
e ve
na c
ava.
In
addi
tion
to m
eetin
g ni
troge
nne
eds,
the
adm
inis
tratio
n ra
te is
gov
erne
d, e
spec
ially
dur
ing
the
first
few
day
s of
ther
apy,
by th
e pa
tient
’s to
lera
nce
to d
extro
se, a
s in
dica
ted
by fr
eque
nt d
eter
min
atio
ns o
f urin
e an
d bl
ood
suga
r lev
els.
Dai
ly in
take
of a
min
o ac
id w
ith e
lect
roly
tes/
dext
rose
with
cal
cium
inje
ctio
ns s
houl
d be
incr
ease
d gr
adua
lly to
the
max
imum
requ
ired
dose
.Su
dden
ces
satio
n in
adm
inis
tratio
n of
thes
e ad
mix
ed in
ject
ions
may
resu
lt in
insu
linre
actio
n du
e to
con
tinue
d en
doge
nous
insu
lin p
rodu
ctio
n. P
aren
tera
l nut
ritio
n m
ixtu
res
shou
ld b
e w
ithdr
awn
slow
ly.Pe
riphe
ral V
ein
Adm
inis
trat
ion:
For
pat
ient
s re
quiri
ng p
aren
tera
l nut
ritio
n in
who
m th
ece
ntra
l vei
n ro
ute
is n
ot in
dica
ted,
low
con
cent
ratio
n am
ino
acid
with
ele
ctro
lyte
s/de
xtro
sew
ith c
alci
um in
ject
ions
may
be
adm
inis
tere
d by
per
iphe
ral v
ein.
In
pedi
atric
pat
ient
s,
the
final
sol
utio
n sh
ould
not
exc
eed
twic
e no
rmal
ser
um o
smol
arity
(718
mOs
mol
/L).
Dire
ctio
ns fo
r Use
of P
last
ic C
onta
iner
WAR
NING
: Do
not
use
pla
stic
con
tain
ers
in s
erie
s co
nnec
tions
. Su
ch u
se c
ould
re
sult
in a
ir em
bolis
m d
ue to
resi
dual
air
bein
g dr
awn
from
the
prim
ary
cont
aine
rbe
fore
adm
inis
trat
ion
of th
e flu
id fr
om th
e se
cond
ary
cont
aine
r is
com
plet
ed.
BE S
URE
THE
CONT
ENTS
OF B
OTH
CHAM
BERS
ARE
MIX
ED T
OGET
HER
AFTE
R OP
ENIN
GSE
AL B
ETW
EEN
CHAM
BERS
. Af
ter o
peni
ng s
eal b
etw
een
cham
bers
, lip
ids
and/
orad
ditiv
es c
an b
e in
trod
uced
to th
e co
ntai
ner.
Thor
ough
mix
ing
ensu
res
com
plet
ede
liver
y of
all
ingr
edie
nts.
To O
pen
Tear
ove
rwra
p ac
ross
top
at s
lit a
nd re
mov
e so
lutio
n co
ntai
ner.
Som
e op
acity
of t
he
plas
tic d
ue to
moi
stur
e ab
sorp
tion
durin
g th
e st
erili
zatio
n pr
oces
s m
ay b
e ob
serv
ed.
This
is n
orm
al a
nd d
oes
not a
ffect
the
solu
tion
qual
ity o
r saf
ety.
The
opa
city
will
dim
inis
hgr
adua
lly.
Chec
k to
ens
ure
seal
bet
wee
n ch
ambe
rs is
inta
ct, i
.e.,
solu
tions
are
con
tain
ed in
sep
arat
ech
ambe
rs.
Chec
k fo
r min
ute
leak
s by
sep
arat
ely
sque
ezin
g ea
ch c
ham
ber.
If e
xter
nal l
eaks
or le
akag
e be
twee
n th
e ch
ambe
rs a
re fo
und,
dis
card
sol
utio
n as
ste
rility
or s
tabi
lity
may
be
impa
ired.
To M
ix S
olut
ions
Gras
p th
e co
ntai
ner f
irmly
on
each
sid
e of
the
top
of th
e ba
g an
d ro
ll ba
g to
ope
n se
albe
twee
n ch
ambe
rs a
s sh
own
in F
igur
e 1.
Mix
sol
utio
ns th
orou
ghly
as
show
n in
Fig
ure
2.Ch
eck
for l
eaks
.St
orag
e:St
orag
e of
the
adm
ixtu
re m
ust b
e un
der r
efrig
erat
ion
and
limite
d to
a b
rief p
erio
dof
tim
e, n
o lo
nger
than
24
hour
s.
To a
dd F
at E
mul
sion
for 3
-in-1
adm
ixtu
re:
A.Pr
ior t
o ad
ding
fat e
mul
sion
, mix
am
ino
acid
and
dex
trose
inje
ctio
n as
sho
wn
in F
igur
e 2.
B.Pr
epar
e fa
t em
ulsi
on tr
ansf
er s
et fo
llow
ing
inst
ruct
ions
pro
vide
d.C.
Atta
ch tr
ansf
er s
et to
fat e
mul
sion
bot
tle u
sing
ase
ptic
tech
niqu
e.D.
Twis
t off
prot
ecto
r on
the
addi
tive
port
of th
e CL
ARIT
Y co
ntai
ner.
E.At
tach
the
trans
fer s
et to
the
expo
sed
addi
tive
port.
F.Op
en c
lam
p on
tran
sfer
set
.G.
Afte
r com
plet
ing
trans
fer,
use
appr
opria
te p
last
ic c
lam
p or
met
al fe
rrul
e to
sea
l off
addi
tive
port
tube
.H.
Rem
ove
trans
fer s
et.
I.M
ix c
onte
nts
of C
LARI
TY c
onta
iner
thor
ough
ly. C
heck
for l
eaks
.St
orag
e:St
orag
e of
the
3-in
-1 a
dmix
ture
mus
t be
unde
r ref
riger
atio
n an
d lim
ited
to a
brie
f per
iod
of ti
me,
no
long
er th
an 2
4 ho
urs.
See
War
ning
sse
ctio
n re
gard
ing
inco
mpa
tible
add
itive
s.
To A
dd M
edic
atio
nW
ARNI
NG:
Addi
tives
may
be
inco
mpa
tible
.Su
pple
men
tal m
edic
atio
n m
ay b
e ad
ded
with
a 1
9 to
22
gaug
e ne
edle
thro
ugh
the
med
icat
ion
port.
A.Pr
epar
e m
edic
atio
n po
rt.B.
Usin
g sy
ringe
with
19
to 2
2 ga
uge
need
le, p
unct
ure
rese
alab
le m
edic
atio
n po
rt an
d in
ject
.C.
Mix
sol
utio
n an
d m
edic
atio
n th
orou
ghly.
For
hig
h de
nsity
med
icat
ion,
suc
h as
po
tass
ium
chl
orid
e, s
quee
ze p
orts
whi
le p
orts
are
upr
ight
and
mix
thor
ough
ly.D.
Chec
k fo
r lea
ks.
Prep
arat
ion
for A
dmin
istr
atio
nA.
Susp
end
cont
aine
r fro
m e
yele
t sup
port.
B.Tw
ist o
ff pr
otec
tor f
rom
out
let p
ort a
t bot
tom
of c
onta
iner
.C.
Atta
ch a
dmin
istra
tion
set.
Ref
er to
com
plet
e di
rect
ions
acc
ompa
nyin
g se
t.
How
Sup
plie
dSe
e Ta
ble
1.Ex
posu
re o
f pha
rmac
eutic
al p
rodu
cts
to h
eat s
houl
d be
min
imize
d. A
void
exc
essi
ve h
eat.
Prot
ect f
rom
free
zing.
It i
s re
com
men
ded
that
the
prod
uct b
e st
ored
at r
oom
tem
pera
ture
(25°
C/77
°F):
brie
f exp
osur
e up
to 4
0°C/
104°
F do
es n
ot a
dver
sely
affe
ct th
e pr
oduc
t.Do
not
rem
ove
cont
aine
r fro
m o
verp
ouch
unt
il re
ady
to u
se.
Do n
ot u
se if
ove
rpou
ch h
as b
een
prev
ious
ly o
pene
d or
dam
aged
.
Figu
re 1
Figu
re 2
Inje
ctio
n/M
edic
atio
nPo
rtTw
ist-O
ffPr
otec
tor o
nAd
ditiv
e Po
rt
Twis
t-Off
Prot
ecto
r on
Out
let P
ort
Baxt
er H
ealth
care
Cor
pora
tion
Clin
tec
Nutri
tion
Divi
sion
Deer
field
, IL
6001
5 US
APr
inte
d in
USA
BAXT
ER, C
LINI
MIX
E, a
nd C
LARI
TY a
re tr
adem
arks
of B
axte
r Int
erna
tiona
l Inc
.07
-19-
47-3
86Re
v. M
ay 2
005
E
1.
O
OH •
H 2O
OH
OH
HO
HO
Dext
rose
Hyd
rous
, USP
(D-G
luco
se m
onoh
ydra
te)
2.Ba
lanc
ed b
y io
ns fr
om a
min
o ac
ids.
3.De
rived
from
gla
cial
ace
tic a
cid
(for p
H ad
just
men
t) an
d so
dium
ace
tate
.4.
Cont
ribut
ed b
y ca
lciu
m c
hlor
ide,
lysi
nehy
droc
hlor
ide,
mag
nesi
um c
hlor
ide,
an
d so
dium
chl
orid
e.5.
pH o
f sul
fite-
free
Amin
o Ac
id In
ject
ion
with
Ele
ctro
lyte
s in
the
outle
t por
t cha
mbe
rw
as a
djus
ted
with
gla
cial
ace
tic a
cid.
Dosa
ge a
nd A
dmin
istr
atio
nIf
a pa
tient
is u
nabl
e to
take
ora
l nou
rishm
ent f
or a
pro
long
ed p
erio
d of
tim
e, in
stitu
tion
of to
tal p
aren
tera
l nut
ritio
n sh
ould
be
cons
ider
ed.
The
tota
l dai
ly d
ose
of C
LINI
MIX
E s
ulfit
e-fre
e (A
min
o Ac
id w
ith E
lect
roly
tes
in D
extro
sew
ith C
alci
um) I
njec
tions
dep
ends
on
the
patie
nt’s
met
abol
ic re
quire
men
t and
clin
ical
resp
onse
. Th
e de
term
inat
ion
of n
itrog
en b
alan
ce a
nd a
ccur
ate
daily
bod
y w
eigh
ts,
corr
ecte
d fo
r flu
id b
alan
ce, a
re p
roba
bly
the
best
mea
ns o
f ass
essi
ng in
divi
dual
nitr
ogen
requ
irem
ents
.Re
com
men
ded
Diet
ary
Allo
wan
ces*
of p
rote
in ra
nge
from
app
roxi
mat
ely
0.75
g/kg
of
bod
y w
eigh
t for
adu
lts to
1.6
8 g/
kg fo
r inf
ants
up
to th
ree
mon
ths
of a
ge.
It m
ust
be re
cogn
ized,
how
ever
, tha
t pro
tein
as
wel
l as
calo
ric re
quire
men
ts in
trau
mat
ized
or m
alno
uris
hed
patie
nts
may
be
incr
ease
d su
bsta
ntia
lly.
Daily
am
ino
acid
dos
es o
fap
prox
imat
ely
1.0
to 1
.5 g
/kg
of b
ody
wei
ght f
or a
dults
with
ade
quat
e ca
lorie
s ar
e ge
nera
lly s
uffic
ient
to s
atis
fy p
rote
in n
eeds
and
pro
mot
e po
sitiv
e ni
troge
n ba
lanc
e.Fo
r the
initi
al tr
eatm
ent o
f tra
uma
or p
rote
in c
alor
ie m
alnu
tritio
n, h
ighe
r dos
es o
fpro
tein
with
cor
resp
ondi
ng q
uant
ities
of c
arbo
hydr
ates
will
be
nece
ssar
y to
pro
mot
e ad
equa
tepa
tient
resp
onse
to th
erap
y. T
he s
ever
ity o
f the
illn
ess
bein
g tre
ated
is th
e pr
imar
yco
nsid
erat
ion
in d
eter
min
ing
prop
er d
ose
leve
l. S
uch
high
er d
oses
, esp
ecia
lly in
infa
nts,
mus
t be
acco
mpa
nied
by
mor
e fre
quen
t lab
orat
ory
eval
uatio
n.Ca
re s
houl
d be
exe
rcis
ed to
insu
re th
e m
aint
enan
ce o
f pro
per l
evel
s of
ser
um p
otas
sium
.Qu
antit
ies
of 6
0 to
180
mEq
of p
otas
sium
per
day
hav
e be
en u
sed
with
ade
quat
e cl
inic
alef
fect
. It
may
be
nece
ssar
y to
add
qua
ntiti
es o
f thi
s el
ectro
lyte
to th
ese
adm
ixed
inje
ctio
ns,
depe
ndin
g pr
imar
ily o
n th
e am
ount
of c
arbo
hydr
ate
adm
inis
tere
d to
and
met
abol
ized
byth
e pa
tient
.To
tal d
aily
flui
d re
quire
men
ts c
an b
e m
et b
eyon
d th
e vo
lum
e of
am
ino
acid
s so
lutio
n by
sup
plem
entin
g w
ith n
onca
rboh
ydra
te o
r car
bohy
drat
e-co
ntai
ning
ele
ctro
lyte
sol
utio
ns.
Mai
nten
ance
vita
min
s, a
dditi
onal
ele
ctro
lyte
s, a
nd tr
ace
elem
ents
sho
uld
be a
dmin
iste
red
as re
quire
d.In
man
y pa
tient
s, p
rovi
sion
of a
dequ
ate
calo
ries
in th
e fo
rm o
f hyp
erto
nic
dext
rose
may
requ
ire th
e ad
min
istra
tion
of e
xoge
nous
insu
lin to
pre
vent
hyp
ergl
ycem
ia a
nd g
lyco
suria
.
Fat e
mul
sion
adm
inis
tratio
n sh
ould
be
cons
ider
ed w
hen
prol
onge
d (m
ore
than
5da
ys)
pare
nter
al n
utrit
ion
is re
quire
d in
ord
er to
pre
vent
ess
entia
l fat
ty a
cid
defic
ienc
y (E
FAD)
.Se
rum
lipi
ds s
houl
d be
mon
itore
d fo
r evi
denc
e of
EFA
D in
pat
ient
s m
aint
aine
d on
fa
t-fre
e TP
N.In
trave
nous
fat e
mul
sion
s pr
ovid
e ap
prox
imat
ely
1.1
kcal
per
mL
(10%
), 2.
0kc
al p
er m
L(2
0%),
or 3
.0 k
cal p
er m
L (3
0%) a
nd m
ay b
e ad
mix
ed a
long
with
am
ino
acid
with
elec
troly
tes/
dext
rose
with
cal
cium
inje
ctio
ns in
the
CLAR
ITY
Cont
aine
r to
supp
lem
ent
calo
ric in
take
.De
pend
ing
upon
the
clin
ical
con
ditio
n of
the
patie
nt, a
ppro
xim
atel
y 3
liter
s of
sol
utio
n m
ay b
e ad
min
iste
red
per 2
4 ho
ur p
erio
d. W
hen
used
pos
tope
rativ
ely,
the
ther
apy
shou
ldbe
gin
with
100
0 m
L on
the
first
pos
tope
rativ
e da
y. T
here
afte
r, th
e do
se m
ay b
e in
crea
sed
to 3
000
mL
per d
ay.
Do n
ot a
dmin
iste
r unl
ess
seal
bet
wee
n ch
ambe
rs is
ope
ned,
oth
er s
eals
are
inta
ct, a
ndso
lutio
n is
cle
ar a
nd th
orou
ghly
mix
ed.
Pare
nter
al d
rug
prod
ucts
sho
uld
be in
spec
ted
visu
ally
for p
artic
ulat
e m
atte
r and
disc
olor
atio
n pr
ior t
o ad
min
istra
tion
whe
neve
r sol
utio
n an
d co
ntai
ner p
erm
it.Us
e of
a fi
nal f
ilter
is re
com
men
ded
durin
g ad
min
istra
tion
of a
ll pa
rent
eral
sol
utio
ns,
whe
re p
ossi
ble.
A sl
ight
yel
low
col
or d
oes
not a
lter t
he q
ualit
y an
d ef
ficac
y of
this
pro
duct
.Ad
ditiv
es m
ay b
e in
com
patib
le.
Com
plet
e in
form
atio
n is
not
ava
ilabl
e. T
hose
add
itive
skn
own
to b
e in
com
patib
le s
houl
d no
t be
used
. Co
nsul
t with
pha
rmac
ist,
if av
aila
ble.
If, in
the
info
rmed
judg
emen
t of t
he p
hysi
cian
, it i
s de
emed
adv
isab
le to
intro
duce
addi
tives
, use
ase
ptic
tech
niqu
e. M
ix th
orou
ghly
whe
n ad
ditiv
es h
ave
been
intro
duce
d.Do
not
sto
re s
olut
ions
con
tain
ing
addi
tives
.Th
ese
amin
o ac
id w
ith e
lect
roly
tes/
dext
rose
with
cal
cium
inje
ctio
ns s
houl
d be
use
dpr
ompt
ly a
fter m
ixin
g. A
ny s
tora
ge s
houl
d be
und
er re
frige
ratio
n an
d lim
ited
to a
brie
fpe
riod
of ti
me,
less
than
24
hour
s.
Met
abol
ic:
The
follo
win
g m
etab
olic
com
plic
atio
ns h
ave
been
repo
rted:
met
abol
ic a
cido
sis,
hyp
opho
spha
tem
ia, a
lkal
osis
, hyp
ergl
ycem
ia a
nd g
lyco
suria
, os
mot
ic d
iure
sis
and
dehy
drat
ion,
rebo
und
hypo
glyc
emia
, ele
vate
d liv
er e
nzym
es, h
ypo-
and
hype
rvita
min
osis
, ele
ctro
lyte
imba
lanc
es, a
nd h
yper
amm
onem
ia.
Freq
uent
clin
ical
eval
uatio
n an
d la
bora
tory
det
erm
inat
ions
are
nec
essa
ry, e
spec
ially
dur
ing
the
first
few
da
ys o
f the
rapy
to p
reve
nt o
r min
imize
thes
e co
mpl
icat
ions
.Ca
utio
n m
ust b
e ex
erci
sed
in th
e ad
min
istra
tion
of th
ese
adm
ixed
am
ino
acid
with
elec
troly
tes/
dext
rose
with
cal
cium
inje
ctio
ns to
pat
ient
s re
ceiv
ing
corti
cost
eroi
ds
or c
ortic
otro
pin.
Thes
e ad
mix
ed in
ject
ions
sho
uld
be u
sed
with
cau
tion
in p
atie
nts
with
ove
rt or
kno
wn
subc
linic
al d
iabe
tes
mel
litus
.Dr
ug p
rodu
ct c
onta
ins
no m
ore
than
25
µg/L
of a
lum
inum
.Ca
rcin
ogen
esis
, Mut
agen
esis
, Im
pairm
ent o
f Fer
tility
:St
udie
s w
ith C
LINI
MIX
E
sulfi
te-fr
ee (A
min
o Ac
id w
ith E
lect
roly
tes
in D
extro
se w
ith C
alci
um) I
njec
tions
hav
e no
t bee
n pe
rform
ed to
eva
luat
e ca
rcin
ogen
ic p
oten
tial,
mut
agen
ic p
oten
tial,
or e
ffect
s on
ferti
lity.
Preg
nanc
y:Te
rato
geni
c Ef
fect
sPr
egna
ncy
Cate
gory
C.
Anim
al re
prod
uctio
n st
udie
s ha
ve n
ot b
een
cond
ucte
d w
ith
CLIN
IMIX
E s
ulfit
e-fre
e (A
min
o Ac
id w
ith E
lect
roly
tes
in D
extro
se w
ith C
alci
um) I
njec
tions
.It
is a
lso
not k
now
n w
heth
er C
LINI
MIX
E s
ulfit
e-fre
e (A
min
o Ac
id w
ith E
lect
roly
tes
inDe
xtro
se w
ith C
alci
um) I
njec
tions
can
cau
se fe
tal h
arm
whe
n ad
min
iste
red
to a
pre
gnan
tw
oman
or c
an a
ffect
repr
oduc
tion
capa
city
. CL
INIM
IX E
sul
fite-
free
(Am
ino
Acid
with
Elec
troly
tes
in D
extro
se w
ith C
alci
um) I
njec
tions
sho
uld
be g
iven
toa
preg
nant
wom
anon
ly if
cle
arly
nee
ded.
Nurs
ing
Mot
hers
:Ca
utio
n sh
ould
be
exer
cise
d w
hen
CLIN
IMIX
E s
ulfit
e-fre
e (A
min
o Ac
idw
ith E
lect
roly
tes
in D
extro
se w
ith C
alci
um) I
njec
tions
are
adm
inis
tere
d to
a n
ursi
ng w
oman
.Pe
diat
ric U
se:
Dext
rose
is s
afe
and
effe
ctiv
e fo
r the
sta
ted
indi
catio
ns in
ped
iatri
c pa
tient
s(s
eeIn
dica
tions
and
Usa
ge).
As
repo
rted
in th
e lit
erat
ure,
the
dosa
ge s
elec
tion
and
cons
tant
infu
sion
rate
of i
ntra
veno
us d
extro
se m
ust b
e se
lect
ed w
ith c
autio
n in
ped
iatri
cpa
tient
s, p
artic
ular
ly n
eona
tes
and
low
birt
h w
eigh
t inf
ants
, bec
ause
of t
he in
crea
sed
risk
of h
yper
glyc
emia
/hyp
ogly
cem
ia.
Freq
uent
mon
itorin
g of
ser
um g
luco
se c
once
ntra
tions
is
requ
ired
whe
n de
xtro
se is
pre
scrib
ed to
ped
iatri
c pa
tient
s, p
artic
ular
ly n
eona
tes
and
low
birt
h w
eigh
t inf
ants
.
Safe
ty a
nd e
ffect
iven
ess
of C
LINI
MIX
E s
ulfit
e-fre
e (A
min
o Ac
id w
ith E
lect
roly
tes
in D
extro
se w
ith C
alci
um) I
njec
tions
in p
edia
tric
patie
nts
have
not
bee
n es
tabl
ishe
d by
ade
quat
e an
d w
ell-c
ontro
lled
stud
ies.
How
ever
, the
use
of a
min
o ac
id in
ject
ions
in
ped
iatri
c pa
tient
s as
an
adju
nct i
n th
e of
fset
ting
of n
itrog
en lo
ss o
r in
the
treat
men
t of
neg
ativ
e ni
troge
n ba
lanc
e is
refe
renc
ed in
the
med
ical
lite
ratu
re.
See
Dosa
ge a
ndAd
min
istr
atio
n.Ge
riatr
ic U
se:
Clin
ical
stu
dies
of C
LINI
MIX
E s
ulfit
e-fre
e (A
min
o Ac
id w
ith E
lect
roly
tes
in D
extro
se w
ith C
alci
um) I
njec
tions
did
not
incl
ude
suffi
cien
t num
bers
of s
ubje
cts
aged
65
and
ove
r to
dete
rmin
e w
heth
er th
ey re
spon
d di
ffere
ntly
from
oth
er y
oung
er s
ubje
cts.
Othe
r rep
orte
d cl
inic
al e
xper
ienc
e ha
s no
t ide
ntifi
ed d
iffer
ence
s in
resp
onse
s be
twee
n th
e el
derly
and
you
nger
pat
ient
s. I
n ge
nera
l, do
se s
elec
tion
for a
n el
derly
pat
ient
sho
uld
be c
autio
us, u
sual
ly s
tarti
ng a
t the
low
end
of t
he d
osin
g ra
nge,
refle
ctin
g th
e gr
eate
rfre
quen
cy o
f dec
reas
ed h
epat
ic, r
enal
, or c
ardi
ac fu
nctio
n, a
nd o
f con
com
itant
dis
ease
or
dru
g th
erap
y.
Adve
rse
Reac
tions
See
War
ning
san
dPr
ecau
tions
Too
rapi
d in
fusi
on o
f the
se C
LINI
MIX
E s
ulfit
e-fre
e (A
min
o Ac
id w
ith E
lect
roly
tes
inDe
xtro
se w
ith C
alci
um) I
njec
tions
may
resu
lt in
diu
resi
s, h
yper
glyc
emia
, gly
cosu
ria,
and
hype
rosm
olar
com
a. C
ontin
ual c
linic
al m
onito
ring
of th
e pa
tient
is n
eces
sary
in
ord
er to
iden
tify
and
initi
ate
mea
sure
s fo
r the
se c
linic
al c
ondi
tions
.Re
actio
ns th
at m
ay o
ccur
bec
ause
of t
he s
olut
ion
or th
e te
chni
que
of a
dmin
istra
tion
incl
ude
febr
ile re
spon
se, i
nfec
tion
at th
e si
te o
f inj
ectio
n, v
enou
s th
rom
bosi
s or
phl
ebiti
sex
tend
ing
from
the
site
of i
njec
tion,
ext
rava
satio
n, a
nd h
yper
vole
mia
. Po
licie
s an
dpr
oced
ures
sho
uld
be e
stab
lishe
d fo
r the
reco
gniti
on a
nd m
anag
emen
t of s
uch
reac
tions
.If
an a
dver
se re
actio
n do
es o
ccur
, dis
cont
inue
the
infu
sion
, eva
luat
e th
e pa
tient
, in
stitu
te a
ppro
pria
te th
erap
eutic
cou
nter
mea
sure
s, a
nd s
ave
the
rem
aind
er o
f the
flui
d fo
r exa
min
atio
n if
deem
ed n
eces
sary
.
*Fo
od a
nd N
utrit
ion
Boar
d Na
tiona
l Aca
dem
y of
Sci
ence
s -
Natio
nalR
esea
rch
Coun
cil (
Revi
sed
1989
).
CLIN
IMIX
E 2
.75/
5 su
lfite
-free
(2
.75%
Am
ino
Acid
with
Ele
ctro
lyte
s in
5% D
extro
se w
ith C
alci
um) I
njec
tion
Code
2B7
735
NDC
0338
-114
2-03
Code
2B7
713
NDC
0338
-110
7-04
CLIN
IMIX
E 2
.75/
10 s
ulfit
e-fre
e (2
.75%
Am
ino
Acid
with
Ele
ctro
lyte
s in
10%
Dex
trose
with
Cal
cium
) Inj
ectio
n
CLIN
IMIX
E 4
.25/
5 su
lfite
-free
(4
.25%
Am
ino
Acid
with
Ele
ctro
lyte
s in
5% D
extro
se w
ith C
alci
um) I
njec
tion
CLIN
IMIX
E 4
.25/
10 s
ulfit
e-fre
e (4
.25%
Am
ino
Acid
with
Ele
ctro
lyte
s in
10%
Dex
trose
with
Cal
cium
) Inj
ectio
n
CLIN
IMIX
E 4
.25/
25 s
ulfit
e-fre
e (4
.25%
Am
ino
Acid
with
Ele
ctro
lyte
s in
25%
Dex
trose
with
Cal
cium
) Inj
ectio
n
CLIN
IMIX
E 5
/15
sulfi
te-fr
ee
(5%
Am
ino
Acid
with
Ele
ctro
lyte
s in
15%
Dex
trose
with
Cal
cium
) Inj
ectio
n
CLIN
IMIX
E 5
/20
sulfi
te-fr
ee
(5%
Am
ino
Acid
with
Ele
ctro
lyte
s in
20%
Dex
trose
with
Cal
cium
) Inj
ectio
n
CLIN
IMIX
E 5
/25
sulfi
te-fr
ee
(5%
Am
ino
Acid
with
Ele
ctro
lyte
s in
25%
Dex
trose
with
Cal
cium
) Inj
ectio
n
CLIN
IMIX
E 5
/35
sulfi
te-fr
ee
(5%
Am
ino
Acid
with
Ele
ctro
lyte
s in
35%
Dex
trose
with
Cal
cium
) Inj
ectio
n
Code
2B7
736
NDC
0338
-114
3-03
Code
2B7
714
NDC
0338
-110
9-04
Code
2B7
737
NDC
0338
-114
4-03
Code
2B7
716
NDC
0338
-111
3-04
Code
2B7
738
NDC
0338
-114
5-03
Code
2B7
717
NDC
0338
-111
5-04
Code
2B7
739
NDC
0338
-114
6-03
Code
2B7
719
NDC
0338
-111
9-04
Code
2B7
740
NDC
0338
-114
7-03
Code
2B7
721
NDC
0338
-112
3-04
Code
2B7
741
NDC
0338
-114
8-03
Code
2B7
722
NDC
0338
-112
5-04
Code
2B7
742
NDC
0338
-114
9-03
Code
2B7
723
NDC
0338
-112
7-04
Code
2B7
744
NDC
0338
-115
1-03
N/A
6.0
(4.5
to 7
.0)
6.0
(4.5
to 7
.0)
6.0
(4.5
to 7
.0)
6.0
(4.5
to 7
.0)
6.0
(4.5
to 7
.0)
6.0
(4.5
to 7
.0)
6.0
(4.5
to 7
.0)
6.0
(4.5
to 7
.0)
6.0
(4.5
to 7
.0)
4.5
(2.2
mm
ol/L
)
4.5
(2.2
mm
ol/L
)
4.5
(2.2
mm
ol/L
)
4.5
(2.2
mm
ol/L
)
4.5
(2.2
mm
ol/L
)
4.5
(2.2
mm
ol/L
)
4.5
(2.2
mm
ol/L
)
4.5
(2.2
mm
ol/L
)
4.5
(2.2
mm
ol/L
)
30(1
5 m
mol
/L)
30(1
5 m
mol
/L)
30(1
5 m
mol
/L)
30(1
5 m
mol
/L)
30(1
5 m
mol
/L)
30(1
5 m
mol
/L)
30(1
5 m
mol
/L)
30(1
5 m
mol
/L)
30(1
5 m
mol
/L)
Cont
ents
of A
dmix
ed P
rodu
ct
52.
7545
420
116
516
015
915
413
211
611
050
570
316
283
187
138
1121
726
111
251
3335
305
102.
7545
420
116
516
015
915
413
211
611
050
570
316
283
187
138
1121
726
111
251
3335
305
54.
2570
231
125
524
724
723
820
417
917
077
880
489
438
289
213
1729
726
177
5133
3530
5
104.
2570
231
125
524
724
723
820
417
917
077
880
489
438
289
213
1729
726
177
5133
3530
5
254.
2570
231
125
524
724
723
820
417
917
077
880
489
438
289
213
1729
726
177
5133
3530
5
155
826
365
300
290
290
280
240
210
200
9010
3557
551
534
025
020
340
261
5951
3335
305
205
826
365
300
290
290
280
240
210
200
9010
3557
551
534
025
020
340
261
5951
3335
305
255
826
365
300
290
290
280
240
210
200
9010
3557
551
534
025
020
340
261
5951
3335
305
355
826
365
300
290
290
280
240
210
200
9010
3557
551
534
025
020
340
261
5951
3335
305
170
110
280
340
110
450
170
170
340
340
170
510
850
170
1020
510
200
710
680
200
880
850
200
1050
1190
200
1390
665
920
815
1070
1825
1395
1650
1900
2405
5139
5139
7039
7039
7039
8039
8039
8039
8039
Elec
trol
yte
Prof
ile
(mEq
/L)2
Esse
ntia
l Am
ino
Acid
s (m
g/10
0 m
L)No
ness
entia
l Am
ino
Acid
s (m
g/10
0 m
L)El
ectr
olyt
es(m
g/10
0 m
L)
Com
posi
tion
Calo
ric C
onte
nt(k
cal/L
)
How
Sup
plie
d
Tabl
e 1
Afte
r mix
ing,
the
prod
uct r
epre
sent
s10
00 m
L Co
de a
nd N
DC N
umbe
r20
00 m
L Co
de a
nd N
DC N
umbe
r
Dextrose Hydrous, USP1(g/100 mL)
Amino Acids (g/100 mL)
Total Nitrogen (mg/100 mL)
Leucine- (CH3)2CHCH2CH (NH2) COOH
Isoleucine- CH3CH2CH (CH3) CH (NH2) COOH
Valine- (CH3)2CHCH (NH2) COOH
Lysine (added as the hydrochloride salt)- H2N (CH2)4CH (NH2) COOH
Phenylalanine- (C6H5) CH2CH (NH2) COOH
Histidine- (C3H3N2) CH2CH (NH2) COOH
Threonine- CH3CH (OH) CH (NH2) COOH
Methionine- CH3S (CH2)2CH (NH2) COOH
Tryptophan- (C8H6N) CH2CH (NH2) COOH
Alanine- CH3CH (NH2) COOH
Arginine- H2NC (NH) NH (CH2)3CH (NH2) COOH
Glycine- H2NCH2COOH
Proline- [(CH2)3NH CH] COOH
Serine - HOCH2CH (NH2) COOH
Tyrosine- [C6H4(OH)] CH2CH (NH2) COOH
Sodium Acetate Trihydrate, USP - C2H3NaO2•3H2O
Dibasic Potassium Phosphate, USP - K2HPO4
Sodium Chloride, USP - NaCl
Magnesium Chloride, USP - MgCl2•6H2O
Calcium Chloride Dihydrate, USP - CaCl2•2H2O
Sodium
Potassium
Magnesium
Calcium
Acetate3
Chloride4
Phosphate (as HPO4=)
pH5
(range)
Osmolarity(mOsmol/L)(calc)
From Dextrose
From Amino Acids
TOTAL(Dextrose and Amino Acids)
07-19-47-386