CLINIMIX and CLINIMIX E Injections

Macronutrient & Micronutrient

Infusion Rate Chart

INDICATIONS

CLINIMIX (amino acids in dextrose) Injections

and CLINIMIX E (amino acids with electrolytes in
dextrose with calcium) Injections are indicated as
a source of calories and protein (and electrolytes
for CLINIMIX E) for patients requiring parenteral nutrition when oral or enteral
nutrition is not possible, insufficient, or contraindicated. CLINIMIX and CLINIMIX E
may be used to treat negative nitrogen balance in patients.

Please see Indications and Important Risk Information on the inside front cover.
Please see accompanying full Prescribing Information.
CLINIMIX and CLINIMIX E Injections
Macronutrient & Micronutrient
Infusion Rate Chart

1
IMPORTANT RISK INFORMATION
• CLINIMIX and CLINIMIX E Injections are contraindicated in patients with
known hypersensitivity to one or more amino acids or dextrose; in patients
with inborn errors of amino acid metabolism due to risk of severe metabolic
and neurologic complications; and in patients with pulmonary edema or
acidosis due to low cardiac output. In addition, CLINIMIX E is contraindicated
in neonates (less than 28 days of age) receiving concomitant treatment with
ceftriaxone, even if separate infusion lines are used, due to the risk of fatal
ceftriaxone calcium salt precipitation in the neonate’s bloodstream.
• Pulmonary vascular precipitates causing pulmonary vascular emboli and
pulmonary distress have been reported in patients receiving parenteral
nutrition. Excessive addition of calcium and phosphate increases the risk
of the formation of calcium phosphate precipitates. The solution should be
inspected for precipitates before admixing, after admixing, and again before
administration. If signs of pulmonary distress occur, stop the infusion and
initiate a medical evaluation.
• Precipitation of ceftriaxone-calcium can occur when ceftriaxone is mixed with
CLINIMIX E, in the same intravenous administration line. Do not administer
ceftriaxone simultaneously with CLINIMIX E via a Y-site.
• Stop infusion immediately and treat patient accordingly if signs or symptoms
of a hypersensitivity reaction develop.
• Monitor for signs and symptoms of early infections.
• Refeeding severely undernourished patients may result in refeeding
syndrome. Thiamine deficiency and fluid retention may also develop. Monitor
severely undernourished patients and slowly increase nutrient intakes.
• CLINIMIX and CLINIMIX E solutions containing more than 5% dextrose have
an osmolarity of ≥ 900 mOsm/L and must be infused through a central
catheter.
• CLINIMIX and CLINIMIX E contain no more than 25 mcg/L of aluminum
which may reach toxic levels with prolonged administration in patients with
renal impairment. Preterm infants are at greater risk because their kidneys
are immature, and they require large amounts of calcium and phosphate
solutions which contain aluminum. Patients with renal impairment, including
preterm infants, who receive parenteral levels of aluminum at greater than
4 to 5 mcg/kg/day, accumulate aluminum at levels associated with central
nervous system and bone toxicity. Tissue loading may occur at even lower
rates of administration.
• Parenteral Nutrition Associated Liver Disease (PNALD) has been reported
in patients who receive parenteral nutrition for extended periods of time,
especially preterm infants. If CLINIMIX and CLINIMIX E treated patients
develop liver test abnormalities consider discontinuation or dosage
reduction.
• Use CLINIMIX and CLINIMIX E with caution in patients with cardiac
insufficiency or renal impairment due to increased risk of electrolyte and
fluid volume imbalance.
• Monitor renal and liver function parameters, ammonia levels, fluid and
electrolyte status, serum osmolarity, blood glucose, blood count and
coagulation parameters throughout treatment. In situations of severely
elevated electrolyte levels, stop CLINIMIX and CLINIMIX E until levels have
been corrected.
• Adverse reactions include diuresis, extravasation, glycosuria, hyperglycemia,
and hyperosmolar coma.
Please see accompanying Package Inserts for full Prescribing Information
4.25/5

Grams kcal
Rate 24 hour volume Grams of Amino kcal from Amino Total mEq/d Acetate mEq/d Chloride
of from
mL/hr (mL) Acids Acids kcal provided provided
Dextrose Dextrose

CLINIMIX Injections
30 720 31 122 36 122 245 27 12
35 840 36 143 42 143 286 31 14
40 960 41 163 48 163 326 36 16
41.7 1000 42.5 170 50 170 340 37 17
45 1080 46 184 54 184 367 40 18
50 1200 51 204 60 204 408 44 20
55 1320 56 224 66 224 449 49 22
60 1440 61 245 72 245 490 53 24
62.5 1500 64 255 75 255 510 56 26
65 1560 66 265 78 265 530 58 27
70 1680 71 286 84 286 571 62 29
75 1800 77 306 90 306 612 67 31
80 1920 82 326 96 326 653 71 33
83.3 2000 85 340 100 340 680 74 34
85 2040 87 347 102 347 694 75 35
90 2160 92 367 108 367 734 80 37
95 2280 97 388 114 388 775 84 39
100 2400 102 408 120 408 816 89 41
105 2520 107 428 126 428 857 93 43
110 2640 112 449 132 449 898 98 45
115 2760 117 469 138 469 938 102 47
120 2880 122 490 144 490 979 107 49
125 3000 128 510 150 510 1020 111 51

4 Please see Indications and Important Risk Information on the inside front cover. 5
Please see accompanying full Prescribing Information.
 4.25/10

Grams kcal
Rate 24 hour volume Grams of Amino kcal from Amino Total mEq/d Acetate mEq/d Chloride
of from
mL/hr (mL) Acids Acids kcal provided provided
Dextrose Dextrose
CLINIMIX Injections

30 720 31 122 72 245 367 27 12

35 840 36 143 84 286 428 31 14
40 960 41 163 96 326 490 36 16
41.7 1000 42.5 170 100 340 510 37 17
45 1080 46 184 108 367 551 40 18
50 1200 51 204 120 408 612 44 20

CLINIMIX Injections
55 1320 56 224 132 449 673 49 22
60 1440 61 245 144 490 734 53 24
62.5 1500 64 255 150 510 765 56 26
65 1560 66 265 156 530 796 58 27
70 1680 71 286 168 571 857 62 29
75 1800 77 306 180 612 918 67 31
80 1920 82 326 192 653 979 71 33
83.3 2000 85 340 200 680 1020 74 34
85 2040 87 347 204 694 1040 75 35
90 2160 92 367 216 734 1102 80 37
95 2280 97 388 228 775 1163 84 39
100 2400 102 408 240 816 1224 89 41
105 2520 107 428 252 857 1285 93 43
110 2640 112 449 264 898 1346 98 45
115 2760 117 469 276 938 1408 102 47
120 2880 122 490 288 979 1469 107 49
125 3000 128 510 300 1020 1530 111 51

6 7
5/15

Grams kcal
Rate 24 hour volume Grams of Amino kcal from Amino Total mEq/d Acetate mEq/d Chloride
of from
mL/hr (mL) Acids Acids kcal provided provided
Dextrose Dextrose

30 720 36 144 108 367 511 30 14

35 840 42 168 126 428 596 35 17
40 960 48 192 144 490 682 40 19
41.7 1000 50 200 150 510 710 42 20
45 1080 54 216 162 551 767 45 22
50 1200 60 240 180 612 852 50 24

CLINIMIX Injections
55 1320 66 264 198 673 937 55 26
60 1440 72 288 216 734 1022 60 29
62.5 1500 75 300 225 765 1065 63 30
65 1560 78 312 234 796 1108 66 31
70 1680 84 336 252 857 1193 71 34
75 1800 90 360 270 918 1278 76 36
80 1920 96 384 288 979 1363 81 38
83.3 2000 100 400 300 1020 1420 84 40
85 2040 102 408 306 1040 1448 86 41
90 2160 108 432 324 1102 1534 91 43
95 2280 114 456 342 1163 1619 96 46
100 2400 120 480 360 1224 1704 101 48
105 2520 126 504 378 1285 1789 106 50
110 2640 132 528 396 1346 1874 111 53
115 2760 138 552 414 1408 1960 116 55
120 2880 144 576 432 1469 2045 121 58
125 3000 150 600 450 1530 2130 126 60

9
5/20

Grams kcal
Rate 24 hour volume Grams of Amino kcal from Amino Total mEq/d Acetate mEq/d Chloride
of from
mL/hr (mL) Acids Acids kcal provided provided
Dextrose Dextrose

30 720 36 144 144 490 634 30 14

35 840 42 168 168 571 739 35 17
40 960 48 192 192 653 845 40 19
41.7 1000 50 200 200 680 880 42 20
45 1080 54 216 216 734 950 45 22
50 1200 60 240 240 816 1056 50 24

CLINIMIX Injections
55 1320 66 264 264 898 1162 55 26
60 1440 72 288 288 979 1267 60 29
62.5 1500 75 300 300 1020 1320 63 30
65 1560 78 312 312 1061 1373 66 31
70 1680 84 336 336 1142 1478 71 34
75 1800 90 360 360 1224 1584 76 36
80 1920 96 384 384 1306 1690 81 38
83.3 2000 100 400 400 1360 1760 84 40
85 2040 102 408 408 1387 1795 86 41
90 2160 108 432 432 1469 1901 91 43
95 2280 114 456 456 1550 2006 96 46
100 2400 120 480 480 1632 2112 101 48
105 2520 126 504 504 1714 2218 106 50
110 2640 132 528 528 1795 2323 111 53
115 2760 138 552 552 1877 2429 116 55
120 2880 144 576 576 1958 2534 121 58
125 3000 150 600 600 2040 2640 126 60

11
2.75/5

24 hour Grams kcal from Grams kcal mEq/d mEq/d mEq/d mEq/d mMol/d mEq/d mEq/d
Rate Total
volume of Amino Amino of from Na+ K+ Mg++ Ca++ PO4- Acetate Chloride
mL/hr kcal
(mL) Acids Acids Dextrose Dextrose provided provided provided provided provided provided provided

30 720 20 79 36 122 202 25 22 4 3 11 37 28

35 840 23 92 42 143 235 29 25 4 4 13 43 33
40 960 26 106 48 163 269 34 29 5 4 14 49 37
41.7 1000 27.5 110 50 170 280 35 30 5 4.5 15 51 39
45 1080 30 119 54 184 302 38 32 5 5 16 55 42
50 1200 33 132 60 204 336 42 36 6 5 18 61 47
55 1320 36 145 66 224 370 46 40 7 6 20 67 51
60 1440 40 158 72 245 403 50 43 7 6 22 73 56
62.5 1500 41 165 75 255 420 53 45 8 7 23 77 59
65 1560 43 172 78 265 437 55 47 8 7 23 80 61
70 1680 46 185 84 286 470 59 50 8 8 25 86 66
75 1800 50 198 90 306 504 63 54 9 8 27 92 70

CLINIMIX E Injections
80 1920 53 211 96 326 538 67 58 10 9 29 98 75
83.3 2000 55 220 100 340 560 70 60 10 9 30 102 78
85 2040 56 224 102 347 571 71 61 10 9 31 104 80
90 2160 59 238 108 367 605 76 65 11 10 32 110 84
95 2280 63 251 114 388 638 80 68 11 10 34 116 89
100 2400 66 264 120 408 672 84 72 12 11 36 122 94
105 2520 69 277 126 428 706 88 76 13 11 38 129 98
110 2640 73 290 132 449 739 92 79 13 12 40 135 103
115 2760 76 304 138 469 773 97 83 14 12 41 141 108
120 2880 79 317 144 490 806 101 86 14 13 43 147 112
125 3000 83 330 150 510 840 105 90 15 14 45 153 117

12 Please see Indications and Important Risk Information on the inside front cover. 13
Please see accompanying full Prescribing Information.
 4.25/5

24 hour Grams kcal from Grams kcal mEq/d mEq/d mEq/d mEq/d mMol/d mEq/d mEq/d
Rate Total
volume of Amino Amino of from Na+ K+ Mg++ Ca++ PO4- Acetate Chloride
mL/hr kcal
(mL) Acids Acids Dextrose Dextrose provided provided provided provided provided provided provided
CLINIMIX E Injections

30 720 31 122 36 122 245 25 22 4 3 11 50 28

35 840 36 143 42 143 286 29 25 4 4 13 59 33
40 960 41 163 48 163 326 34 29 5 4 14 67 37
41.7 1000 42.5 170 50 170 340 35 30 5 4.5 15 70 39
45 1080 46 184 54 184 367 38 32 5 5 16 76 42
50 1200 51 204 60 204 408 42 36 6 5 18 84 47

CLINIMIX E Injections
55 1320 56 224 66 224 449 46 40 7 6 20 92 51
60 1440 61 245 72 245 490 50 43 7 6 22 101 56
62.5 1500 64 255 75 255 510 53 45 8 7 23 105 59
65 1560 66 265 78 265 530 55 47 8 7 23 109 61
70 1680 71 286 84 286 571 59 50 8 8 25 118 66
75 1800 77 306 90 306 612 63 54 9 8 27 126 70
80 1920 82 326 96 326 653 67 58 10 9 29 134 75
83.3 2000 85 340 100 340 680 70 60 10 9 30 140 78
85 2040 87 347 102 347 694 71 61 10 9 31 143 80
90 2160 92 367 108 367 734 76 65 11 10 32 151 84
95 2280 97 388 114 388 775 80 68 11 10 34 160 89
100 2400 102 408 120 408 816 84 72 12 11 36 168 94
105 2520 107 428 126 428 857 88 76 13 11 38 176 98
110 2640 112 449 132 449 898 92 79 13 12 40 185 103
115 2760 117 469 138 469 938 97 83 14 12 41 193 108
120 2880 122 490 144 490 979 101 86 14 13 43 202 112
125 3000 128 510 150 510 1020 105 90 15 14 45 210 117

14 Please see Indications and Important Risk Information on the inside front cover.
15 15
Please see accompanying full Prescribing Information.
4.25/10

24 hour Grams kcal from Grams kcal mEq/d mEq/d mEq/d mEq/d mMol/d mEq/d mEq/d
Rate Total
volume of Amino Amino of from Na+ K+ Mg++ Ca++ PO4- Acetate Chloride
mL/hr kcal
(mL) Acids Acids Dextrose Dextrose provided provided provided provided provided provided provided

30 720 31 122 72 245 367 25 22 4 3 11 50 28

35 840 36 143 84 286 428 29 25 4 4 13 59 33
40 960 41 163 96 326 490 34 29 5 4 14 67 37
41.7 1000 42.5 170 100 340 510 35 30 5 4.5 15 70 39
45 1080 46 184 108 367 551 38 32 5 5 16 76 42
50 1200 51 204 120 408 612 42 36 6 5 18 84 47

CLINIMIX E Injections
55 1320 56 224 132 449 673 46 40 7 6 20 92 51
60 1440 61 245 144 490 734 50 43 7 6 22 101 56
62.5 1500 64 255 150 510 765 53 45 8 7 23 105 59
65 1560 66 265 156 530 796 55 47 8 7 23 109 61
70 1680 71 286 168 571 857 59 50 8 8 25 118 66
75 1800 77 306 180 612 918 63 54 9 8 27 126 70
80 1920 82 326 192 653 979 67 58 10 9 29 134 75
83.33 2000 85 340 200 680 1020 70 60 10 9 30 140 78
85 2040 87 347 204 694 1040 71 61 10 9 31 143 80
90 2160 92 367 216 734 1102 76 65 11 10 32 151 84
95 2280 97 388 228 775 1163 80 68 11 10 34 160 89
100 2400 102 408 240 816 1224 84 72 12 11 36 168 94
105 2520 107 428 252 857 1285 88 76 13 11 38 176 98
110 2640 112 449 264 898 1346 92 79 13 12 40 185 103
115 2760 117 469 276 938 1408 97 83 14 12 41 193 108
120 2880 122 490 288 979 1469 101 86 14 13 43 202 112
125 3000 128 510 300 1020 1530 105 90 15 14 45 210 117

16 Please see Indications and Important Risk Information on the inside front cover. 17
Please see accompanying full Prescribing Information.
5/15

24 hour Grams kcal from Grams kcal mEq/d mEq/d mEq/d mEq/d mMol/d mEq/d mEq/d
Rate Total
volume of Amino Amino of from Na+ K+ Mg++ Ca++ PO4- Acetate Chloride
mL/hr kcal
(mL) Acids Acids Dextrose Dextrose provided provided provided provided provided provided provided

30 720 36 144 108 367 511 25 22 4 3 11 58 28

35 840 42 168 126 428 596 29 25 4 4 13 67 33
40 960 48 192 144 490 682 34 29 5 4 14 77 37
41.7 1000 50 200 150 510 710 35 30 5 4.5 15 80 39
45 1080 54 216 162 551 767 38 32 5 5 16 86 42
50 1200 60 240 180 612 852 42 36 6 5 18 96 47

CLINIMIX E Injections
55 1320 66 264 198 673 937 46 40 7 6 20 106 51
60 1440 72 288 216 734 1022 50 43 7 6 22 115 56
62.5 1500 75 300 225 765 1065 53 45 8 7 23 120 59
65 1560 78 312 234 796 1108 55 47 8 7 23 125 61
70 1680 84 336 252 857 1193 59 50 8 8 25 134 66
75 1800 90 360 270 918 1278 63 54 9 8 27 144 70
80 1920 96 384 288 979 1363 67 58 10 9 29 154 75
83.3 2000 100 400 300 1020 1420 70 60 10 9 30 160 78
85 2040 102 408 306 1040 1448 71 61 10 9 31 163 80
90 2160 108 432 324 1102 1534 76 65 11 10 32 173 84
95 2280 114 456 342 1163 1619 80 68 11 10 34 182 89
100 2400 120 480 360 1224 1704 84 72 12 11 36 192 94
105 2520 126 504 378 1285 1789 88 76 13 11 38 202 98
110 2640 132 528 396 1346 1874 92 79 13 12 40 211 103
115 2760 138 552 414 1408 1960 97 83 14 12 41 221 108
120 2880 144 576 432 1469 2045 101 86 14 13 43 230 112
125 3000 150 600 450 1530 2130 105 90 15 14 45 240 117

18 Please see Indications and Important Risk Information on the inside front cover. 19
Please see accompanying full Prescribing Information.
5/20

24 hour Grams kcal from Grams kcal mEq/d mEq/d mEq/d mEq/d mMol/d mEq/d mEq/d
Rate Total
volume of Amino Amino of from Na+ K+ Mg++ Ca++ PO4- Acetate Chloride
mL/hr kcal
(mL) Acids Acids Dextrose Dextrose provided provided provided provided provided provided provided

30 720 36 144 144 490 634 25 22 4 3 11 58 28

35 840 42 168 168 571 739 29 25 4 4 13 67 33
40 960 48 192 192 653 845 34 29 5 4 14 77 37
41.66 1000 50 200 200 680 880 35 30 5 4.5 15 80 39
45 1080 54 216 216 734 950 38 32 5 5 16 86 42
50 1200 60 240 240 816 1056 42 36 6 5 18 96 47

CLINIMIX E Injections
55 1320 66 264 264 898 1162 46 40 7 6 20 106 51
60 1440 72 288 288 979 1267 50 43 7 6 22 115 56
62.5 1500 75 300 300 1020 1320 53 45 8 7 23 120 59
65 1560 78 312 312 1061 1373 55 47 8 7 23 125 61
70 1680 84 336 336 1142 1478 59 50 8 8 25 134 66
75 1800 90 360 360 1224 1584 63 54 9 8 27 144 70
80 1920 96 384 384 1306 1690 67 58 10 9 29 154 75
83.33 2000 100 400 400 1360 1760 70 60 10 9 30 160 78
85 2040 102 408 408 1387 1795 71 61 10 9 31 163 80
90 2160 108 432 432 1469 1901 76 65 11 10 32 173 84
95 2280 114 456 456 1550 2006 80 68 11 10 34 182 89
100 2400 120 480 480 1632 2112 84 72 12 11 36 192 94
105 2520 126 504 504 1714 2218 88 76 13 11 38 202 98
110 2640 132 528 528 1795 2323 92 79 13 12 40 211 103
115 2760 138 552 552 1877 2429 97 83 14 12 41 221 108
120 2880 144 576 576 1958 2534 101 86 14 13 43 230 112
125 3000 150 600 600 2040 2640 105 90 15 14 45 240 117

20 Please see Indications and Important Risk Information on the inside front cover. 21
Please see accompanying full Prescribing Information.
 For more information,
contact Medical Information at
1-800-422-2751 or visit
www.baxtermedicationdeliveryproducts.com

Please see Indications and Important Risk Information on inside page

Please see accompanying Package Inserts for full Prescribing Information

Helping Optimize Your Performance

www.baxter.com

Baxter Healthcare Corporation

One Baxter Parkway
Deerfield, IL 60015

Baxter, Clinimix, Clinimix E, and the Clinimix logo are trademarks of Baxter International Inc.

USMP/78/14-0014(3) 6/18
Confidential Property of Baxter Healthcare Corporation and its Affiliates
Document No.: 07-19-57-385
Change No.: CP0329253
PROOFREADING INSPECTION / RELEASED ARTWORK
Page 1 of 2 Proofreading Approval ________________________ ________________________ ________
Print Name Signature Date
P1 16 Sep 2010 sbh Proofreading Approval ________________________ ________________________ ________
Print Name Signature Date
Pediatric Use: Use of CLINIMIX E sulfite-free (Amino Acid with Electrolytes in Dextrose
with Calcium) 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. Two to 3 g/kg of body weight
for infants with adequate calories are generally sufficient to satisfy protein needs and
promote positive nitrogen balance. Solution administrations by peripheral vein should
not exceed twice normal serum osmolarity (718 mOsmol/L).
Central Vein Administration: Hypertonic mixtures of amino acid with electrolytes/dextrose
with calcium injections may be administered safely by continuous infusion through a
central vein catheter with the tip located in the vena cava. In addition to meeting nitrogen
needs, the administration rate is governed, especially during the first few days of therapy,
by the patient’s tolerance to dextrose, as indicated by frequent determinations of urine
and blood sugar levels. Daily intake of amino acid with electrolytes/dextrose with calcium
injections should be increased gradually to the maximum required dose.
Sudden cessation in administration of these admixed injections may result in insulin
reaction due to continued endogenous insulin production. Parenteral nutrition mixtures
should be withdrawn slowly.
Peripheral Vein Administration: For patients requiring parenteral nutrition in whom the
central vein route is not indicated, low concentration amino acid with electrolytes/dextrose
with calcium injections may be administered by peripheral vein. In pediatric patients,
the final solution should not exceed twice normal serum osmolarity (718 mOsmol/L).
Directions for Use of Plastic Container
WARNING: Do not use plastic containers in series connections. Such use could
result in air embolism due to residual air being drawn from the primary container
before administration of the fluid from the secondary container is completed.
BE SURE THE CONTENTS OF BOTH CHAMBERS ARE MIXED TOGETHER AFTER OPENING
SEAL BETWEEN CHAMBERS. After opening seal between chambers, lipids and/or
additives can be introduced to the container. Thorough mixing ensures complete
delivery of all ingredients.
To Open
Tear overwrap across top at slit and remove solution container. Some opacity of the
plastic due to moisture absorption during the sterilization process may be observed.
This is normal and does not affect the solution quality or safety. The opacity will diminish
gradually.
Check to ensure seal between chambers is intact, i.e., solutions are contained in separate
chambers. Check for minute leaks by separately squeezing each chamber. If external leaks
or leakage between the chambers are found, discard solution as sterility or stability may
be impaired.
To Mix Solutions
Grasp the container firmly on each side of the top of the bag and roll bag to open seal
between chambers as shown in Figure 1. Mix solutions thoroughly as shown in Figure 2.
Check for leaks.
Storage: If removed from the overwrap and the contents are not mixed, CLINIMIX E
Injection solutions may be stored under refrigeration for up to 9 days.
Upon mixing of bag contents, CLINIMIX E Injection solutions remain stable when stored
under refrigeration, not to exceed 9 days from when the product was originally removed
from the overwrap.
Twist-Off Protector
Injection/ on Outlet Port
Medication Twist-Off
Port Protector
on Additive
Port
Figure 1
*BAR CODE POSITION ONLY
071957385
* This artwork requires that the supplier insert a code 39 bar code master in the position indicated. Bar code must
match human readable on art and on spec. Bar code must conform to all applicable Baxter specifications.
CLINIMIX E Injection solutions containing additives should be used promptly after
admixture. Any storage should be under refrigeration and limited to a brief period
of time, less than 24 hours.
To add Fat Emulsion for 3-in-1 admixture:
See Warnings section regarding incompatible additives including fat emulsions.
1. Prior to adding fat emulsion, mix amino acid and dextrose injection
as shown in Figure 2.
2. Prepare fat emulsion transfer set following instructions provided.
CLINIMIX E sulfite-free
3. Attach transfer set to fat emulsion bottle using aseptic technique.
4. Twist off protector on the additive port of the CLARITY container. (Amino Acid with Electrolytes in Dextrose with Calcium) Injections
5. Attach the transfer set to the exposed additive port.
6. Open clamp on transfer set. in CLARITY Dual Chamber Container
7. After completing transfer, use appropriate plastic clamp or metal ferrule
to seal off additive port tube.
8. Remove transfer set. Description
9. Mix contents of CLARITY container thoroughly. Check for leaks. CLINIMIX E sulfite-free (Amino Acid with Electrolytes in Dextrose with Calcium) Injections
Storage: Storage of the 3-in-1 admixture must be under refrigeration and limited are sterile, nonpyrogenic, hypertonic solutions in a CLARITY Dual Chamber Container.
to a brief period of time, no longer than 24 hours. See Warnings section regarding The sulfite-free Amino Acid Injections with Electrolytes in the outlet port chamber
incompatible additives. are solutions of essential and nonessential amino acids provided with electrolytes.
To Add Medication The Dextrose Injections with Calcium in the injection port chamber are solutions for fluid
replenishment and caloric supply.
WARNING: Additives may be incompatible.
After opening the seal between the chambers and mixing thoroughly, the admixed product
Supplemental medication may be added with a 19 to 22 gauge needle through the
is intended for intravenous use. See Table 1 for composition, pH, osmolarity, ionic
medication port.
concentration and caloric content of the admixed product.
1. Prepare medication port.
The CLARITY Dual Chamber Container is a lipid-compatible plastic container
2. Using syringe with 19 to 22 gauge needle, puncture resealable medication port (PL 2401 Plastic). The amount of water that can permeate from inside the container
and inject. into the overwrap is insufficient to affect the solution significantly. Solutions in contact
3. Mix solution and medication thoroughly. For high density medication, such as with the plastic container may leach out certain chemical components from the plastic
potassium chloride, squeeze ports while ports are upright and mix thoroughly. in very small amounts; however, biological testing was supportive of the safety of the
4. Check for leaks. plastic container materials.
Preparation for Administration Clinical Pharmacology
1. Suspend container from eyelet support. CLINIMIX E sulfite-free (Amino Acid with Electrolytes in Dextrose with Calcium) Injections
2. Twist off protector from outlet port at bottom of container. administered intravenously provide biologically utilizable source material for protein
3. Attach administration set. Refer to complete directions accompanying set. synthesis and have value as a source of calories, electrolytes, and water.
Indications and Usage
How Supplied
CLINIMIX E sulfite-free (Amino Acid with Electrolytes in Dextrose with Calcium) Injections
See Table 1.
are indicated as a caloric component in a parenteral nutrition regimen and as the protein
Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat.
(nitrogen) source for offsetting nitrogen loss or for treatment of negative nitrogen balance
Protect from freezing. It is recommended that the product be stored at room temperature in patients where:
(25°C/77°F): brief exposure up to 40°C/104°F does not adversely affect the product. (1) the alimentary tract cannot or should not be used,
(2) gastrointestinal absorption of protein is impaired, or
Refrigerated storage is limited to 9 days once overwrap has been opened.
(3) metabolic requirements for protein are substantially increased, as with extensive burns.
Do not use if overwrap has been previously opened or damaged.
Central Vein Administration: Central vein infusion should be used when amino acid
solutions are admixed with hypertonic dextrose to promote protein synthesis such as
for hypercatabolic or depleted patients or those requiring long term parenteral nutrition.
Peripheral Vein Administration: For patients in whom the central vein route is not
indicated, amino acid solutions diluted with low dextrose concentrations may be infused
by peripheral vein.
Contraindications
CLINIMIX E sulfite-free (Amino Acid with Electrolytes in Dextrose with Calcium) 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.
Warnings
Additives may be incompatible including fat emulsions. Consult with pharmacist, if
available.
When introducing additives, use aseptic techniques. Mix thoroughly.
Because of the potential for life-threatening events, caution should be taken to ensure
that precipitates have not formed in any parenteral nutrient admixture.
These CLINIMIX E sulfite-free (Amino Acid with Electrolytes in Dextrose with Calcium)
Injections, must be admixed prior to infusion. For admixing instructions see Directions
for Use of Plastic Container.
Figure 2
The infusion of hypertonic nutrient injections into a peripheral vein may result in vein
irritation, vein damage, and thrombosis. After mixing, strongly hypertonic nutrient
injections should only be administered through an indwelling intravenous catheter with
the tip located in a large central vein, such as the superior vena cava.
Proper administration of these admixed amino acid with electrolytes/dextrose with calcium
injections requires a knowledge of fluid and electrolyte balance and nutrition as well as
clinical expertise in recognition and treatment of the complications which may occur.
Laboratory Tests
Baxter Healthcare Corporation Frequent clinical evaluation and laboratory determinations are necessary for proper
Deerfield, IL 60015 USA monitoring during administration. Studies should include blood sugar, serum proteins,
Printed in USA kidney and liver function tests, electrolytes, complete blood count with differential,
carbon dioxide combining power or content, serum osmolarities, blood cultures, and
Baxter, Clinimix E, and Clarity are trademarks of Baxter International Inc. blood ammonia levels.
07-19-57-385 Administration of amino acid solutions to a patient with hepatic insufficiency may result
Rev. July 2010
07-19-57-385
E
in serum amino acid imbalances, hyperammonemia, stupor, and coma.
Hyperammonemia is of special significance in infants. This reaction appears to
be related to a deficiency of the urea cycle amino acids of genetic or product origin.
It is essential that blood ammonia be measured frequently in infants.
Conservative doses of these admixed amino acid with electrolytes/dextrose with calcium
injections should be given to patients with known or suspected hepatic dysfunction.
Should symptoms of hyperammonemia develop, administration should be discontinued
and the patient’s clinical status be reevaluated.
Administration of amino acid solutions in the presence of impaired renal function presents
special issues associated with retention of electrolytes.
These admixed injections should not be administered simultaneously with blood through
the same infusion set because of the possibility of pseudoagglutination.
In very low birth weight infants, excessive or rapid administration of dextrose injection
may result in increased serum osmolality and possible intracerebral hemorrhage.
WARNING: This product contains aluminum that may be toxic. Aluminum may reach
toxic levels with prolonged parenteral administration if kidney function is impaired.
Premature neonates are particularly at risk because their kidneys are immature, and
they require large amounts of calcium and phosphate solutions, which contain aluminum.
Research indicates that patients with impaired kidney function, including premature
neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day
accumulate aluminum at levels associated with central nervous system and bone toxicity.
Tissue loading may occur at even lower rates of administration.
Precautions
With the administration of these CLINIMIX E sulfite-free (Amino Acid with Electrolytes in
Dextrose with Calcium) Injections, hyperglycemia, glycosuria, and hyperosmolar syndrome
may result. Blood and urine glucose should be monitored on a routine basis in patients
receiving this therapy.
Use with caution when administering to patients with anuria or renal failure.
These injections contain sufficient electrolytes to provide for most parenteral nutritional
needs with the possible exception of potassium, where supplementation may be required.
However, replacement of exceptional electrolyte loss due to nasogastric suction, fistula
drainage, or unusual tissue exudation may be necessary. Particular attention should be
given to monitoring serum potassium levels.
The metabolizable acetate anion and amino acid profiles in these admixed injections
were designed to minimize or prevent occurrences of hyperchloremic metabolic
acidosis and hyperammonemia. However, the physician should be aware of appropriate
countermeasures if they become necessary.
Clinical evaluation and periodic laboratory determinations are necessary to monitor
changes in fluid balance, electrolyte concentrations and acid-base balance during
prolonged parenteral therapy or whenever the condition of the patient warrants
such evaluation.
Because of its anti-anabolic activity, concurrent administration of tetracycline may reduce
the protein-sparing effect of infused amino acids.
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; particularly in patients with renal disease, pulmonary insufficiency,
and heart disease.
Administration of admixed amino acid with electrolytes/dextrose with calcium injections
and other nutrients via central or peripheral venous catheter may be associated with
complications which can be prevented or minimized by careful attention to all aspects of
the procedure. This includes attention to solution preparation, administration, and patient
monitoring. It is essential that a carefully prepared protocol based on current medical
practices be followed, preferably by an experienced team.
Although a detailed discussion of the complications is beyond the scope of this insert,
the following summary lists those based on current literature:
Technical: The placement of a central venous catheter should be regarded as a surgical
procedure. The physician should be fully acquainted with various techniques of catheter
insertion as well as recognition and treatment of complications. For details of techniques
and placement sites, consult the medical literature. X-ray is the best means of verifying
catheter placement. Complications known to occur from the placement of central venous
catheters are pneumothorax, hemothorax, hydrothorax, artery puncture and transection,
injury to the brachial plexus, malposition of the catheter, formation of arteriovenous fistula,
phlebitis, thrombosis, cardiac arrhythmia, and catheter embolus.
Septic: The constant risk of sepsis is present during total parenteral nutrition.
Since contaminated solutions and infusion catheters are potential sources of infection,
it is imperative that the preparation of solution and the placement and care of catheters
be accomplished under controlled aseptic conditions. If fever develops, the solution,
its delivery system, and the site of the indwelling catheter should be changed.
Confidential Property of Baxter Healthcare Corporation and its Affiliates

Document No.: 07-19-57-385

Change No.: CP0329253
PROOFREADING INSPECTION / RELEASED ARTWORK
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P1 27 Aug 2010 sbh Proofreading Approval ________________________ ________________________ ________
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Metabolic: The following metabolic complications have been reported:
metabolic acidosis, hypophosphatemia, alkalosis, hyperglycemia and glycosuria,
osmotic diuresis and dehydration, rebound hypoglycemia, elevated liver enzymes, hypo-
and hypervitaminosis, electrolyte imbalances, and hyperammonemia. Frequent clinical
evaluation and laboratory determinations are necessary, especially during the first few
days of therapy to prevent or minimize these complications.
Caution must be exercised in the administration of these admixed amino acid with
electrolytes/dextrose with calcium injections to patients receiving corticosteroids
or corticotropin.
These admixed injections should be used with caution in patients with overt or known
subclinical diabetes mellitus.
Drug product contains no more than 25 mcg/L of aluminum.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies with CLINIMIX E
sulfite-free (Amino Acid with Electrolytes in Dextrose with Calcium) Injections have
not been performed to evaluate carcinogenic potential, mutagenic potential, or effects
on fertility.
Pregnancy: Teratogenic Effects
Pregnancy Category C. Animal reproduction studies have not been conducted with
CLINIMIX E sulfite-free (Amino Acid with Electrolytes in Dextrose with Calcium) Injections.
It is also not known whether CLINIMIX E sulfite-free (Amino Acid with Electrolytes in
Dextrose with Calcium) Injections can cause fetal harm when administered to a pregnant
woman or can affect reproduction capacity. CLINIMIX E sulfite-free (Amino Acid with
Electrolytes in Dextrose with Calcium) Injections should be given to a pregnant woman
only if clearly needed.
Nursing Mothers: Caution should be exercised when CLINIMIX E sulfite-free (Amino Acid
with Electrolytes in Dextrose with Calcium) Injections are administered to a nursing woman.
Pediatric Use: Dextrose is safe and effective for the stated indications in pediatric patients
(see Indications and Usage). 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 the increased risk
of hyperglycemia/hypoglycemia. Frequent monitoring of serum glucose concentrations
is required when dextrose is prescribed to pediatric patients, particularly neonates and
low birth weight infants.
Safety and effectiveness of CLINIMIX E sulfite-free (Amino Acid with Electrolytes Dosage and Administration Fat emulsion administration should be considered when prolonged (more than 5 days)
in Dextrose with Calcium) Injections in pediatric patients have not been established parenteral nutrition is required in order to prevent essential fatty acid deficiency (EFAD).
by adequate and well-controlled studies. However, the use of amino acid injections If a patient is unable to take oral nourishment for a prolonged period of time, institution Serum lipids should be monitored for evidence of EFAD in patients maintained on
in pediatric patients as an adjunct in the offsetting of nitrogen loss or in the treatment of total parenteral nutrition should be considered. fat-free TPN.
of negative nitrogen balance is referenced in the medical literature. See Dosage and The total daily dose of CLINIMIX E sulfite-free (Amino Acid with Electrolytes in Dextrose Intravenous fat emulsions provide approximately 1.1 kcal per mL (10%), 2.0 kcal per
Administration. with Calcium) Injections depends on the patient’s metabolic requirement and clinical mL (20%), or 3.0 kcal per mL (30%) and may be admixed along with amino acid with
Geriatric Use: Clinical studies of CLINIMIX E sulfite-free (Amino Acid with Electrolytes response. The determination of nitrogen balance and accurate daily body weights, electrolytes/dextrose with calcium injections in the CLARITY Container to supplement
in Dextrose with Calcium) Injections did not include sufficient numbers of subjects aged corrected for fluid balance, are probably the best means of assessing individual nitrogen caloric intake.
65 and over to determine whether they respond differently from other younger subjects. requirements.
Depending upon the clinical condition of the patient, approximately 3 liters of solution
Other reported clinical experience has not identified differences in responses between Recommended Dietary Allowances* of protein range from approximately 0.75 g/kg may be administered per 24 hour period. When used postoperatively, the therapy should
the elderly and younger patients. In general, dose selection for an elderly patient should of body weight for adults to 1.68 g/kg for infants up to three months of age. It must begin with 1000 mL on the first postoperative day. Thereafter, the dose may be increased
be cautious, usually starting at the low end of the dosing range, reflecting the greater be recognized, however, that protein as well as caloric requirements in traumatized to 3000 mL per day.
frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or malnourished patients may be increased substantially. Daily amino acid doses of
or drug therapy. approximately 1.0 to 1.5 g/kg of body weight for adults with adequate calories are Do not administer unless seal between chambers is opened, other seals are intact, and
generally sufficient to satisfy protein needs and promote positive nitrogen balance. solution is clear and thoroughly mixed.
Adverse Reactions For the initial treatment of trauma or protein calorie malnutrition, higher doses of protein Parenteral drug products should be inspected visually for particulate matter and
See Warnings and Precautions with corresponding quantities of carbohydrates will be necessary to promote adequate discoloration prior to administration whenever solution and container permit.
patient response to therapy. The severity of the illness being treated is the primary Use of a final filter is recommended during administration of all parenteral solutions,
Too rapid infusion of these CLINIMIX E sulfite-free (Amino Acid with Electrolytes in consideration in determining proper dose level. Such higher doses, especially in infants, where possible.
Dextrose with Calcium) Injections may result in diuresis, hyperglycemia, glycosuria,
must be accompanied by more frequent laboratory evaluation. A slight yellow color does not alter the quality and efficacy of this product.
and hyperosmolar coma. Continual clinical monitoring of the patient is necessary
in order to identify and initiate measures for these clinical conditions. Care should be exercised to insure the maintenance of proper levels of serum potassium. Additives may be incompatible. Complete information is not available. Those additives
Quantities of 60 to 180 mEq of potassium per day have been used with adequate clinical known to be incompatible should not be used. Consult with pharmacist, if available.
Reactions that may occur because of the solution or the technique of administration effect. It may be necessary to add quantities of this electrolyte to these admixed injections,
include febrile response, infection at the site of injection, venous thrombosis or phlebitis If, in the informed judgment of the physician, it is deemed advisable to introduce additives,
depending primarily on the amount of carbohydrate administered to and metabolized by use aseptic technique. Mix thoroughly when additives have been introduced.
extending from the site of injection, extravasation, and hypervolemia. Policies and the patient.
procedures should be established for the recognition and management of such reactions. Do not store solutions containing additives. These amino acid with electrolytes/dextrose
Total daily fluid requirements can be met beyond the volume of amino acids solution with calcium injections should be used promptly after mixing. Any storage with additives
If an adverse reaction does occur, discontinue the infusion, evaluate the patient, by supplementing with noncarbohydrate or carbohydrate-containing electrolyte solutions.
institute appropriate therapeutic countermeasures, and save the remainder of the fluid should be under refrigeration and limited to a brief period of time, less than 24 hours.
for examination if deemed necessary. Maintenance vitamins, additional electrolytes, and trace elements should be administered
as required.
In many patients, provision of adequate calories in the form of hypertonic dextrose may
require the administration of exogenous insulin to prevent hyperglycemia and glycosuria.
* Food and Nutrition Board National Academy of Sciences -
National Research Council (Revised 1989).

Table 1 Contents of Admixed Product

Composition
Caloric Content
Essential Amino Acids Nonessential Amino Acids Electrolytes Electrolyte Profile (kcal/L)
(mg/100 mL) (mg/100 mL) (mg/100 mL) (mEq/L) 2
H2NC (NH) NH (CH2)3 CH (NH2) COOH

Dibasic Potassium Phosphate, USP -

Dextrose Hydrous, USP 1 (g/100 mL)

TOTAL (Dextrose and Amino Acids)

salt) - H2N (CH2)4 CH (NH2) COOH
Lysine (added as the hydrochloride

Calcium Chloride Dihydrate, USP -

CH3CH2CH (CH3) CH (NH2) COOH

Sodium Acetate Trihydrate, USP -

[C6H4 (OH)] CH2CH (NH2) COOH
Proline - [(CH2)3 NH CH] COOH

Serine - HOCH2CH (NH2) COOH

(CH3)2 CHCH2CH (NH2) COOH

(C3H3N2) CH2CH (NH2) COOH

(C8H6N) CH2 CH (NH2) COOH

Alanine - CH3CH (NH2) COOH

CH3S (CH2)2 CH (NH2) COOH
CH3CH (OH) CH (NH2) COOH

Sodium Chloride, USP - NaCl

(C6H5) CH2 CH (NH2) COOH
Total Nitrogen (mg/100 mL)

Magnesium Chloride, USP -

(CH3)2 CHCH (NH2) COOH
Amino Acids (g/100 mL)

Glycine - H2NCH2COOH

Osmolarity (mOsmol/L)
Phosphate (as HPO4=)

From Amino Acids

C2H3NaO2•3H2O
Phenylalanine -

From Dextrose
Tryptophan -
Methionine -

MgCl2•6H2O
How Supplied

CaCl2•2H2O
Isoleucine -

Magnesium
Threonine -

Potassium
Histidine -

Tyrosine -
Arginine -

Chloride 4
Leucine -

Acetate 3
K2HPO4

Calcium
Sodium
Valine -

(range)
1000 mL 2000 mL

(calc)
pH 5
After mixing, the product represents Code and NDC Number Code and NDC Number
CLINIMIX E 2.75/5 sulfite-free
Code 2B7735 Code 2B7713 4.5 30 6.0
(2.75% Amino Acid with Electrolytes in 5 2.75 454 201 165 160 159 154 132 116 110 50 570 316 283 187 138 11 217 261 112 51 33 35 30 5 51 39 665 170 110 280
NDC 0338-1142-03 NDC 0338-1107-04 (2.2 mmol/L) (15 mmol/L) (4.5 to 7.0)
5% Dextrose with Calcium) Injection

CLINIMIX E 2.75/10 sulfite-free 1. HO

(2.75% Amino Acid with Electrolytes in Code 2B7736 Code 2B7714 4.5 30 6.0
10 2.75 454 201 165 160 159 154 132 116 110 50 570 316 283 187 138 11 217 261 112 51 33 35 30 5 51 39 920 340 110 450
10% Dextrose with Calcium) Injection NDC 0338-1143-03 NDC 0338-1109-04 (2.2 mmol/L) (15 mmol/L) (4.5 to 7.0)
O
CLINIMIX E 4.25/5 sulfite-free
(4.25% Amino Acid with Electrolytes in Code 2B7737 Code 2B7716 4.5 30 6.0 OH • H2O
5 4.25 702 311 255 247 247 238 204 179 170 77 880 489 438 289 213 17 297 261 77 51 33 35 30 5 70 39 815 170 170 340 OH
5% Dextrose with Calcium) Injection NDC 0338-1144-03 NDC 0338-1113-04 (2.2 mmol/L) (15 mmol/L) (4.5 to 7.0)
HO
CLINIMIX E 4.25/10 sulfite-free
(4.25% Amino Acid with Electrolytes in Code 2B7738 Code 2B7717 4.5 30 6.0
10 4.25 702 311 255 247 247 238 204 179 170 77 880 489 438 289 213 17 297 261 77 51 33 35 30 5 70 39 1070 340 170 510 OH
10% Dextrose with Calcium) Injection NDC 0338-1145-03 NDC 0338-1115-04 (2.2 mmol/L) (15 mmol/L) (4.5 to 7.0)
Dextrose Hydrous, USP
(D-Glucose monohydrate)
CLINIMIX E 4.25/25 sulfite-free
(4.25% Amino Acid with Electrolytes in Code 2B7739 Code 2B7719 4.5 30 6.0
25 4.25 702 311 255 247 247 238 204 179 170 77 880 489 438 289 213 17 297 261 77 51 33 35 30 5 70 39 1825 850 170 1020
25% Dextrose with Calcium) Injection NDC 0338-1146-03 NDC 0338-1119-04 (2.2 mmol/L) (15 mmol/L) (4.5 to 7.0)
2. Balanced by ions from amino acids.
CLINIMIX E 5/15 sulfite-free
(5% Amino Acid with Electrolytes in Code 2B7740 Code 2B7721 4.5 30 6.0 3. Derived from glacial acetic acid
15 5 826 365 300 290 290 280 240 210 200 90 1035 575 515 340 250 20 340 261 59 51 33 35 30 5 80 39 1395 510 200 710
NDC 0338-1147-03 NDC 0338-1123-04 (2.2 mmol/L) (15 mmol/L) (4.5 to 7.0)
15% Dextrose with Calcium) Injection (for pH adjustment) and sodium acetate.
CLINIMIX E 5/20 sulfite-free 4. Contributed by calcium chloride, lysine
(5% Amino Acid with Electrolytes in Code 2B7741 Code 2B7722 4.5 30 6.0 hydrochloride, magnesium chloride,
20 5 826 365 300 290 290 280 240 210 200 90 1035 575 515 340 250 20 340 261 59 51 33 35 30 5 80 39 1650 680 200 880
NDC 0338-1148-03 NDC 0338-1125-04 (2.2 mmol/L) (15 mmol/L) (4.5 to 7.0)
07-19-57-385

20% Dextrose with Calcium) Injection and sodium chloride.

CLINIMIX E 5/25 sulfite-free 5. pH of sulfite-free Amino Acid Injection
(5% Amino Acid with Electrolytes in Code 2B7742 Code 2B7723 4.5 30 6.0 with Electrolytes in the outlet port chamber
25 5 826 365 300 290 290 280 240 210 200 90 1035 575 515 340 250 20 340 261 59 51 33 35 30 5 80 39 1900 850 200 1050
NDC 0338-1149-03 NDC 0338-1127-04 (2.2 mmol/L) (15 mmol/L) (4.5 to 7.0)
25% Dextrose with Calcium) Injection was adjusted with glacial acetic acid.
Confidential Property of Baxter Healthcare Corporation and its Affiliates
Document No.: 07-19-57-358
Change No.: CP0329253
PROOFREADING INSPECTION / RELEASED ARTWORK
Page 1 of 2 Proofreading Approval ________________________ ________________________ ________
Print Name Signature Date
P1 16 Sep 2010 sbh Proofreading Approval ________________________ ________________________ ________
Print Name Signature Date
Pediatric Use: Use of CLINIMIX sulfite-free (Amino Acid in Dextrose) 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. Two to 3 g/kg of body weight for infants
with adequate calories are generally sufficient to satisfy protein needs and promote
positive nitrogen balance. Solution administrations by peripheral vein should not
exceed twice normal serum osmolarity (718 mOsmol/L).
Central Vein Administration: Hypertonic mixtures of amino acid/dextrose injections
may be administered safely by continuous infusion through a central vein catheter  2. Prepare fat emulsion transfer set following instructions provided.
with the tip located in the vena cava. In addition to meeting nitrogen needs, the
administration rate is governed, especially during the first few days of therapy, by
the patient’s tolerance to dextrose, as indicated by frequent determinations of urine
and blood sugar levels. Daily intake of amino acids in dextrose should be increased
gradually to the maximum required dose.
Sudden cessation in administration of these admixed injections may result in insulin
reaction due to continued endogenous insulin production. Parenteral nutrition mixtures
should be withdrawn slowly.
Peripheral Vein Administration: For patients requiring parenteral nutrition in whom
the central vein route is not indicated, low concentration amino acid/dextrose injections
may be administered by peripheral vein. In pediatric patients, the final solution should
not exceed twice normal serum osmolarity (718 mOsmol/L).
Directions for Use of Plastic Container
WARNING: Do not use plastic containers in series connections. Such use could
result in air embolism due to residual air being drawn from the primary container
before administration of the fluid from the secondary container is completed.
BE SURE THE CONTENTS OF BOTH CHAMBERS ARE MIXED TOGETHER AFTER OPENING
SEAL BETWEEN CHAMBERS. After opening seal between chambers, lipids and/or
additives can be introduced to the container. Thorough mixing ensures complete
delivery of all ingredients.
To Open
Tear overwrap across top at slit and remove solution container. Some opacity of the
plastic due to moisture absorption during the sterilization process may be observed.
This is normal and does not affect the solution quality or safety. The opacity will
diminish gradually.
Check to ensure seal between chambers is intact, i.e., solutions are contained in
separate chambers. Check for minute leaks by separately squeezing each chamber.
If external leaks or leakage between the chambers are found, discard solution as
sterility or stability may be impaired.
To Mix Solutions
Grasp the container firmly on each side of the top of the bag and roll bag to open
seal between chambers as shown in Figure 1. Mix solutions thoroughly as shown
in Figure 2. Check for leaks.
Storage: If removed from the overwrap and the contents are not mixed, CLINIMIX
Injection solutions may be stored under refrigeration for up to 9 days.
Upon mixing of bag contents, CLINIMIX Injection solutions remain stable when stored
under refrigeration, not to exceed 9 days from when the product was originally removed
from the overwrap.
Twist-Off Protector
on Outlet Port
Injection/
Medication
Port
Figure 1
*BAR CODE POSITION ONLY
071957358
* This artwork requires that the supplier insert a code 39 bar code master in the position indicated. Bar code must
match human readable on art and on spec. Bar code must conform to all applicable Baxter specifications.
CLINIMIX Injection solutions containing additives should be used promptly after
admixture. Any storage should be under refrigeration and limited to a brief
period of time, less than 24 hours.
To add Fat Emulsion for 3-in-1 admixture:
See Warnings section regarding incompatible additives including fat emulsions.
1. Prior to adding fat emulsion, mix amino acid and dextrose injection CLINIMIX sulfite-free (Amino Acid in Dextrose) Injections
as shown in Figure 2.
3. Attach transfer set to fat emulsion bottle, using aseptic technique. in CLARITY Dual Chamber Container
4. Twist off protector on the additive port of the CLARITY container.
5. Attach the transfer set to the exposed additive port.
6. Open clamp on transfer set. Description
7. After completing transfer, use appropriate plastic clamp or metal ferrule
CLINIMIX sulfite-free (Amino Acid in Dextrose) Injections are sterile, nonpyrogenic,
to seal off additive port tube.
hypertonic solutions in a CLARITY Dual Chamber Container.
8. Remove transfer set.
The sulfite-free Amino Acid Injections in the outlet port chamber are solutions of
9. Mix contents of CLARITY container thoroughly. Check for leaks.
essential and nonessential amino acids.
Storage: Storage of the 3-in-1 admixture must be under refrigeration and limited
The Dextrose Injections, USP in the injection port chamber are solutions for fluid
to a brief period of time, no longer than 24 hours. See Warnings section regarding
replenishment and caloric supply.
incompatible additives.
After opening the seal between the chambers and mixing thoroughly, the admixed
To Add Medication product is intended for intravenous use. See Table 1 for composition, pH, osmolarity,
WARNING: Additives may be incompatible. ionic concentration and caloric content of the admixed product.
Supplemental medication may be added with a 19 to 22 gauge needle through the The CLARITY Dual Chamber Container is a lipid-compatible plastic container
medication port. (PL 2401 Plastic). The amount of water that can permeate from inside the container
1. Prepare medication port. into the overwrap is insufficient to affect the solution significantly. Solutions in contact
with the plastic container may leach out certain chemical components from the plastic
2. Using syringe with 19 to 22 gauge needle, puncture resealable medication port in very small amounts; however, biological testing was supportive of the safety of the
and inject. plastic container materials.
3. Mix solution and medication thoroughly. For high density medication, such as
potassium chloride, squeeze ports while ports are upright and mix thoroughly. Clinical Pharmacology
4. Check for leaks.
CLINIMIX sulfite-free (Amino Acid in Dextrose) Injections administered intravenously
provide biologically utilizable source material for protein synthesis and have value as
Preparation for Administration
a source of calories and water.
1. Suspend container from eyelet support.
2. Twist off protector from outlet port at bottom of container.
Indications and Usage
3. Attach administration set. Refer to complete directions accompanying set.
CLINIMIX sulfite-free (Amino Acid in Dextrose) Injections are indicated as a caloric
component in a parenteral nutrition regimen and as the protein (nitrogen) source for
How Supplied
offsetting nitrogen loss or for treatment of negative nitrogen balance in patients where:
See Table 1. (1) the alimentary tract cannot or should not be used,
(2) gastrointestinal absorption of protein is impaired, or
Exposure of pharmaceutical products to heat should be minimized.
Avoid excessive heat. Protect from freezing. It is recommended that the product (3) metabolic requirements for protein are substantially increased,
be stored at room temperature (25°C/77°F): brief exposure up to 40°C/104°F as with extensive burns.
does not adversely affect the product. Central Vein Administration: Central vein infusion should be used when amino acid
Refrigerated storage is limited to 9 days once overwrap has been opened. solutions are admixed with hypertonic dextrose to promote protein synthesis such as
for hypercatabolic or depleted patients or those requiring long term parenteral nutrition.
Do not use if overwrap has been previously opened or damaged.
Peripheral Vein Administration: For patients in whom the central vein route is not
indicated, amino acid solutions diluted with low dextrose concentrations may be infused
by peripheral vein.
Contraindications
CLINIMIX sulfite-free (Amino Acid in Dextrose) 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
Twist-Off
Protector disease or hepatic coma.
on Additive
Solutions containing corn-derived dextrose may be contraindicated in patients with
Port
known allergy to corn or corn products.
Warnings
Additives may be incompatible including fat emulsions. Consult with pharmacist,
if available. When introducing additives, use aseptic techniques. Mix thoroughly.
Because of the potential for life-threatening events, caution should be taken to ensure
that precipitates have not formed in any parenteral nutrient admixture.
These CLINIMIX sulfite-free (Amino Acid in Dextrose) Injections, must be admixed prior
to infusion. For admixing instructions see Directions for Use of Plastic Container.
The infusion of hypertonic nutrient injections into a peripheral vein may result in vein
Figure 2
irritation, vein damage, and thrombosis. After mixing, strongly hypertonic nutrient
injections should only be administered through an indwelling intravenous catheter
with the tip located in a large central vein, such as the superior vena cava.
Proper administration of these admixed amino acid/dextrose injections requires
a knowledge of fluid and electrolyte balance and nutrition as well as clinical expertise
in recognition and treatment of the complications which may occur.
Laboratory Tests
Frequent clinical evaluation and laboratory determinations are necessary for
Baxter Healthcare Corporation proper monitoring during administration. Studies should include blood sugar,
Deerfield, IL 60015 USA serum proteins, kidney and liver function tests, electrolytes, complete blood count
Printed in USA with differential, carbon dioxide combining power or content, serum osmolarities,
blood cultures, and blood ammonia levels.
Baxter, Clinimix, and Clarity are trademarks of Baxter International Inc.
Administration of amino acid solutions to a patient with hepatic insufficiency may result
07-19-57-358 in serum amino acid imbalances, hyperammonemia, stupor, and coma.
Rev. July 2010
07-19-57-358
Hyperammonemia is of special significance in infants. This reaction appears to
be related to a deficiency of the urea cycle amino acids of genetic or product origin.
It is essential that blood ammonia be measured frequently in infants.
Conservative doses of these admixed amino acid/dextrose injections should be given
to patients with known or suspected hepatic dysfunction. Should symptoms of
hyperammonemia develop, administration should be discontinued and the patient’s
clinical status be reevaluated.
Administration of amino acid solutions in the presence of impaired renal function
presents special issues associated with retention of electrolytes.
These admixed injections should not be administered simultaneously with blood
through the same infusion set because of the possibility of pseudoagglutination.
In very low birth weight infants, excessive or rapid administration of dextrose injection
may result in increased serum osmolality and possible intracerebral hemorrhage.
WARNING: This product contains aluminum that may be toxic. Aluminum may
reach toxic levels with prolonged parenteral administration if kidney function is
impaired. Premature neonates are particularly at risk because their kidneys are
immature, and they require large amounts of calcium and phosphate solutions,
which contain aluminum.
Research indicates that patients with impaired kidney function, including premature
neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/
day accumulate aluminum at levels associated with central nervous system and bone
toxicity. Tissue loading may occur at even lower rates of administration.
Precautions
With the administration of these CLINIMIX sulfite-free (Amino Acid in Dextrose)
Injections, hyperglycemia, glycosuria, and hyperosmolar syndrome may result.
Blood and urine glucose should be monitored on a routine basis in patients receiving
this therapy.
Use with caution when administering to patients with anuria or renal failure.
Electrolytes may be added to the admixed amino acid/dextrose injections as dictated
by the patient’s electrolyte profile.
The metabolizable acetate anion and amino acid profiles in these admixed injections
were designed to minimize or prevent occurrences of hyperchloremic metabolic
acidosis and hyperammonemia. However, the physician should be aware of appropriate
countermeasures if they become necessary.
Clinical evaluation and periodic laboratory determinations are necessary to monitor
changes in fluid balance, electrolyte concentrations, and acid-base balance during
prolonged parenteral therapy or whenever the condition of the patient warrants
such evaluation.
Because of its anti-anabolic activity, concurrent administration of tetracycline
may reduce the protein-sparing effect of infused amino acids.
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; particularly in patients with renal disease,
pulmonary insufficiency, and heart disease.
Administration of admixed amino acid/dextrose injections and other nutrients via 
central or peripheral venous catheter may be associated with complications which
can be prevented or minimized by careful attention to all aspects of the procedure.
This includes attention to solution preparation, administration, and patient monitoring.
It is essential that a carefully prepared protocol based on current medical
practices be followed, preferably by an experienced team.
Although a detailed discussion of the complications is beyond the scope of this insert,
the following summary lists those based on current literature:
Technical: The placement of a central venous catheter should be regarded as a 
surgical procedure. The physician should be fully acquainted with various techniques
of catheter insertion as well as recognition and treatment of complications. For
details of techniques and placement sites, consult the medical literature. X-ray is the
best means of verifying catheter placement. Complications known to occur from the
placement of central venous catheters are pneumothorax, hemothorax, hydrothorax,
artery puncture and transection, injury to the brachial plexus, malposition of the
catheter, formation of arteriovenous fistula, phlebitis, thrombosis, cardiac arrhythmia,
and catheter embolus.
Septic: The constant risk of sepsis is present during total parenteral nutrition.
Since contaminated solutions and infusion catheters are potential sources of infection,
it is imperative that the preparation of solution and the placement and care of catheters
be accomplished under controlled aseptic conditions. If fever develops, the solution,
its delivery system, and the site of the indwelling catheter should be changed.
Confidential Property of Baxter Healthcare Corporation and its Affiliates

Document No.: 07-19-57-358

Change No.: CP0329253
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Metabolic: The following metabolic complications have been reported:
metabolic acidosis, hypophosphatemia, alkalosis, hyperglycemia and glycosuria,
osmotic diuresis and dehydration, rebound hypoglycemia, elevated liver enzymes,
hypo- and hypervitaminosis, electrolyte imbalances, and hyperammonemia.
Frequent clinical evaluation and laboratory determinations are necessary, especially
during the first few days of therapy to prevent or minimize these complications.
Caution must be exercised in the administration of these admixed amino acid/dextrose
injections to patients receiving corticosteroids or corticotropin.
These admixed injections should be used with caution in patients with overt or known
subclinical diabetes mellitus.
Drug product contains no more than 25 mcg/L of aluminum.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies with CLINIMIX
sulfite-free (Amino Acid in Dextrose) Injections have not been performed to evaluate
carcinogenic potential, mutagenic potential, or effects on fertility.
Pregnancy: Teratogenic Effects
Pregnancy Category C. Animal reproduction studies have not been conducted
with CLINIMIX sulfite-free (Amino Acid in Dextrose) Injections. It is also not known
whether CLINIMIX sulfite-free (Amino Acid in Dextrose) Injections can cause fetal
harm when administered to a pregnant woman or can affect reproduction capacity.
CLINIMIX sulfite-free (Amino Acid in Dextrose) Injections should be given to a pregnant
woman only if clearly needed.
Nursing Mothers: Caution should be exercised when CLINIMIX sulfite-free
(Amino Acid in Dextrose) Injections are administered to a nursing woman.
Pediatric Use: Dextrose is safe and effective for the stated indications in pediatric
patients (see Indications and Usage). 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 the
increased risk of hyperglycemia/hypoglycemia. Frequent monitoring of serum glucose
concentrations is required when dextrose is prescribed to pediatric patients, particularly
neonates and low birth weight infants.
Safety and effectiveness of CLINIMIX sulfite-free (Amino Acid in Dextrose) Injections Dosage and Administration In many patients, provision of adequate calories in the form of hypertonic dextrose
in pediatric patients have not been established by adequate and well-controlled studies. may require the administration of exogenous insulin to prevent hyperglycemia and
If a patient is unable to take oral nourishment for a prolonged period of time, institution
However, the use of amino acid injections in pediatric patients as an adjunct in the glycosuria.
of total parenteral nutrition should be considered.
offsetting of nitrogen loss or in the treatment of negative nitrogen balance is referenced Fat emulsion administration should be considered when prolonged (more than 5 days)
in the medical literature. See Dosage and Administration. The total daily dose of CLINIMIX sulfite-free (Amino Acid in Dextrose) Injections parenteral nutrition is required in order to prevent essential fatty acid deficiency (EFAD).
depends on the patient’s metabolic requirement and clinical response. The determination Serum lipids should be monitored for evidence of EFAD in patients maintained on
Geriatric Use: Clinical studies of CLINIMIX sulfite-free (Amino Acid in Dextrose)
of nitrogen balance and accurate daily body weights, corrected for fluid balance, fat-free TPN.
Injections did not include sufficient numbers of subjects aged 65 and over to determine
are probably the best means of assessing individual nitrogen requirements.
whether they respond differently from other younger subjects. Other reported clinical Intravenous fat emulsions provide approximately 1.1 kcal per mL (10%), 2.0 kcal per mL
experience has not identified differences in responses between the elderly and Recommended Dietary Allowances* of protein range from approximately 0.75 g/kg (20%), or 3.0 kcal per mL (30%) and may be admixed along with amino acid/dextrose
younger patients. of body weight for adults to 1.68 g/kg for infants up to three months of age. It must injections in the CLARITY Container to supplement caloric intake.
be recognized, however, that protein as well as caloric requirements in traumatized
In general, dose selection for an elderly patient should be cautious, usually starting at Depending upon the clinical condition of the patient, approximately 3 liters of solution
or malnourished patients may be increased substantially. Daily amino acid doses of
the low end of the dosing range, reflecting the greater frequency of decreased hepatic, may be administered per 24 hour period. When used postoperatively, the therapy
approximately 1.0 to 1.5 g/kg of body weight for adults with adequate calories are
renal, or cardiac function, and of concomitant disease or drug therapy. should begin with 1000 mL on the first postoperative day. Thereafter, the dose may
generally sufficient to satisfy protein needs and promote positive nitrogen balance.
be increased to 3000 mL per day.
Adverse Reactions For the initial treatment of trauma or protein calorie malnutrition, higher doses of protein Do not administer unless seal between chambers is opened, other seals are intact,
with corresponding quantities of carbohydrate will be necessary to promote adequate and solution is clear and thoroughly mixed.
See Warnings and Precautions patient response to therapy. The severity of the illness being treated is the primary
Parenteral drug products should be inspected visually for particulate matter and
Too rapid infusion of these CLINIMIX sulfite-free (Amino Acid in Dextrose) Injections consideration in determining proper dose level. Such higher doses, especially in
may result in diuresis, hyperglycemia, glycosuria, and hyperosmolar coma. Continual infants, must be accompanied by more frequent laboratory evaluation. discoloration prior to administration whenever solution and container permit.
Use of a final filter is recommended during administration of all parenteral solutions,
clinical monitoring of the patient is necessary in order to identify and initiate measures Care should be exercised to insure the maintenance of proper levels of serum
for these clinical conditions. where possible.
potassium. Quantities of 60 to 180 mEq of potassium per day have been used
Reactions that may occur because of the solution or the technique of administration A slight yellow color does not alter the quality and efficacy of this product.
with adequate clinical effect. It may be necessary to add quantities of this electrolyte
include febrile response, infection at the site of injection, venous thrombosis or to these admixed injections, depending primarily on the amount of carbohydrate Additives may be incompatible. Complete information is not available. Those additives
phlebitis extending from the site of injection, extravasation, and hypervolemia. administered to and metabolized by the patient. known to be incompatible should not be used. Consult with pharmacist, if available.
Policies and procedures should be established for the recognition and management If, in the informed judgment of the physician, it is deemed advisable to introduce
Patients receiving CLINIMIX sulfite-free (Amino Acid in Dextrose) Injections additives, use aseptic technique. Mix thoroughly when additives have been introduced.
of such reactions. without electrolytes should be monitored frequently and their electrolyte
Do not store solutions containing additives. These amino acid with electrolytes/
If an adverse reaction does occur, discontinue the infusion, evaluate the patient, requirements individualized.
institute appropriate therapeutic countermeasures, and save the remainder of the dextrose with calcium injections should be used promptly after mixing. Any storage
Total daily fluid requirements can be met beyond the volume of amino acids solution by with additives should be under refrigeration and limited to a brief period of time, less
fluid for examination if deemed necessary. supplementing with noncarbohydrate or carbohydrate-containing electrolyte solutions. than 24 hours.
Maintenance vitamins, additional electrolytes, and trace elements should be
administered as required. * Food and Nutrition Board National Academy of Sciences -
National Research Council (Revised 1989).

Table 1 Contents of Admixed Product

Composition
Caloric Content
Essential Amino Acids Nonessential Amino Acids Anion Profile (kcal/L)
(mg/100 mL) (mg/100 mL) (mEq/L) 2

H2NC (NH) NH (CH2)3 CH (NH2) COOH

Dextrose Hydrous, USP 1 (g/100 mL)

TOTAL (Dextrose and Amino Acids)

salt) - H2N (CH2)4 CH (NH2) COOH
Lysine (added as the hydrochloride
CH3CH2CH (CH3) CH (NH2) COOH

[C6H4 (OH)] CH2CH (NH2) COOH

Proline - [(CH2)3 NH CH] COOH

Serine - HOCH2CH (NH2) COOH

(CH3)2 CHCH2CH (NH2) COOH

(C3H3N2) CH2CH (NH2) COOH

(C8H6N) CH2 CH (NH2) COOH

Alanine - CH3CH (NH2) COOH

CH3S (CH2)2 CH (NH2) COOH
CH3CH (OH) CH (NH2) COOH
(C6H5) CH2 CH (NH2) COOH
Total Nitrogen (mg/100 mL)

(CH3)2 CHCH (NH2) COOH

Amino Acids (g/100 mL)

Glycine - H2NCH2COOH

Osmolarity (mOsmol/L)

From Amino Acids

Phenylalanine -

From Dextrose
Tryptophan -
Methionine -

How Supplied
Isoleucine -

Threonine -
Histidine -

Tyrosine -
Arginine -

Chloride 4
Leucine -

Acetate 3
Valine -

(range)
1000 mL 2000 mL

(calc)
pH 5
After mixing, the product represents Code and NDC Number Code and NDC Number

CLINIMIX 2.75/5 sulfite-free

Code 2B7725 Code 2B7701 6.0
(2.75% Amino Acid in 5% Dextrose) 5 2.75 454 201 165 160 159 154 132 116 110 50 570 316 283 187 138 11 24 11 525 170 110 280
NDC 0338-1132-03 NDC 0338-1083-04 (4.5 to 7.0)
Injection

CLINIMIX 4.25/5 sulfite-free

Code 2B7726 Code 2B7704 6.0
(4.25% Amino Acid in 5% Dextrose) 5 4.25 702 311 255 247 247 238 204 179 170 77 880 489 438 289 213 17 37 17 675 170 170 340
NDC 0338-1133-03 NDC 0338-1089-04 (4.5 to 7.0)
Injection 1. HO
CLINIMIX 4.25/10 sulfite-free
Code 2B7727 Code 2B7705 6.0
(4.25% Amino Acid in 10% Dextrose) 10 4.25 702 311 255 247 247 238 204 179 170 77 880 489 438 289 213 17 37 17 930 340 170 510 O
NDC 0338-1134-03 NDC 0338-1091-04 (4.5 to 7.0)
Injection
OH OH • H2O
CLINIMIX 4.25/20 sulfite-free
Code 2B7728 Code 2B7706 6.0
(4.25% Amino Acid in 20% Dextrose) 20 4.25 702 311 255 247 247 238 204 179 170 77 880 489 438 289 213 17 37 17 1435 680 170 850
NDC 0338-1135-03 NDC 0338-1093-04 (4.5 to 7.0) HO
Injection

CLINIMIX 4.25/25 sulfite-free OH

Code 2B7729 Code 2B7707 6.0
(4.25% Amino Acid in 25% Dextrose) 25 4.25 702 311 255 247 247 238 204 179 170 77 880 489 438 289 213 17 37 17 1685 850 170 1020 Dextrose Hydrous, USP
NDC 0338-1136-03 NDC 0338-1095-04 (4.5 to 7.0) (D-Glucose monohydrate)
Injection

CLINIMIX 5/15 sulfite-free

Code 2B7730 Code 2B7709 6.0
(5% Amino Acid in 15% Dextrose) 15 5 826 365 300 290 290 280 240 210 200 90 1035 575 515 340 250 20 42 20 1255 510 200 710
NDC 0338-1137-03 NDC 0338-1099-04 (4.5 to 7.0) 2. Balanced by ions from amino acids.
Injection

CLINIMIX 5/20 sulfite-free

3. Derived from glacial acetic acid (for pH
(5% Amino Acid in 20% Dextrose)
Code 2B7731 Code 2B7710
20 5 826 365 300 290 290 280 240 210 200 90 1035 575 515 340 250 20 42 20
6.0
1505 680 200 880 adjustment).
07-19-57-358

NDC 0338-1138-03 NDC 0338-1101-04 (4.5 to 7.0)

Injection 4. Contributed by the lysine hydrochloride.
CLINIMIX 5/25 sulfite-free
Code 2B7732 Code 2B7711 6.0
5. pH of sulfite-free Amino Acid Injection in
(5% Amino Acid in 25% Dextrose) 25 5 826 365 300 290 290 280 240 210 200 90 1035 575 515 340 250 20 42 20 1760 850 200 1050 the outlet port chamber was adjusted with
NDC 0338-1139-03 NDC 0338-1103-04 (4.5 to 7.0)
Injection glacial acetic acid.