CLINIMIX and CLINIMIX E Injections · CLINIMIX and CLINIMIX E Injections Macronutrient & Micronutrient Infusion Rate Chart INDICATIONS CLINIMIX sulfite-free (Amino Acid in Dextrose)

CLINIMIX and CLINIMIX E InjectionsMacronutrient & Micronutrient Infusion Rate Chart

INDICATIONS

CLINIMIX sulfite-free (Amino Acid in Dextrose) Injections 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

(1) the alimentary tract cannot or should not be used, (2) gastrointestinal absorption of protein is impaired, or (3) metabolic requirements for protein are substantially increased, as with extensive burns.

Please see accompany Full Prescribing Information.Please see Indications and Important Risk Information on page 1.

INDICATIONS

CLINIMIX sulfite-free (Amino Acid in Dextrose) Injections 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 (1) the alimentary tract cannot or should not be used, (2) gastrointestinal absorption of protein is impaired, or

(3) metabolic requirements for protein are substantially increased, as with extensive burns.

IMPORTANT RISK INFORMATION

n 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.

n 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.

n Because of the potential for life-threatening events, caution should be taken to ensure that precipitates have not formed in any parenteral nutrient admixture.

n 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.

n Metabolic complications have been reported, such as acid-base, electrolyte, and blood glucose imbalances, elevated liver enzymes, and osmotic diuresis and dehydration.

n 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.

n This product contains aluminum that may be toxic with prolonged parenteral administration if kidney function is impaired.

n CLINIMIX and CLINIMIX E Injections must be admixed prior to infusion.

Please see accompany Full Prescribing Information.1

CLIN

IMIX

E In

ject

ions

CLIN

IMIX

Inje

ctio

ns

Rate mL/hr

24 hour volume

(mL)

Grams of Amino

Acids

Kcal from Amino Acids

Grams of

Dextrose

Kcal from

Dextrose

Total Kcal

mEq/d Acetateprovided

mEq/d Chlorideprovided

30 720 20 79 36 122 202 17 835 840 23 92 42 143 235 20 940 960 26 106 48 163 269 23 11

41.7 1000 27.5 110 50 170 280 24 1145 1080 30 119 54 184 302 26 1250 1200 33 132 60 204 336 29 1355 1320 36 145 66 224 370 32 1560 1440 40 158 72 245 403 35 16

62.5 1500 41 165 75 255 420 36 1765 1560 43 172 78 265 437 37 1770 1680 46 185 84 286 470 40 1875 1800 50 198 90 306 504 43 2080 1920 53 211 96 326 538 46 21

83.3 2000 55 220 100 340 560 48 2285 2040 56 224 102 347 571 49 2290 2160 59 238 108 367 605 52 2495 2280 63 251 114 388 638 55 25

100 2400 66 264 120 408 672 58 26105 2520 69 277 126 428 706 60 28110 2640 73 290 132 449 739 63 29115 2760 76 304 138 469 773 66 30120 2880 79 317 144 490 806 69 32125 3000 83 330 150 510 840 72 33

Rate mL/hr

24 hour volume

(mL)

Grams of Amino

Acids


Grams of

Dextrose

Kcal from

Dextrose

Total Kcal

mEq/d Na+

provided

mEq/d K+

provided

mEq/d Mg++

provided

mEq/d Ca++

provided

mMol/d PO4-

provided



30 720 20 79 36 122 202 25 22 4 3 11 37 2835 840 23 92 42 143 235 29 25 4 4 13 43 3340 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 3945 1080 30 119 54 184 302 38 32 5 5 16 55 4250 1200 33 132 60 204 336 42 36 6 5 18 61 4755 1320 36 145 66 224 370 46 40 7 6 20 67 5160 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 5965 1560 43 172 78 265 437 55 47 8 7 23 80 6170 1680 46 185 84 286 470 59 50 8 8 25 86 6675 1800 50 198 90 306 504 63 54 9 8 27 92 7080 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 7885 2040 56 224 102 347 571 71 61 10 9 31 104 8090 2160 59 238 108 367 605 76 65 11 10 32 110 8495 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 94105 2520 69 277 126 428 706 88 76 13 11 38 129 98110 2640 73 290 132 449 739 92 79 13 12 40 135 103115 2760 76 304 138 469 773 97 83 14 12 41 141 108120 2880 79 317 144 490 806 101 86 14 13 43 147 112125 3000 83 330 150 510 840 105 90 15 14 45 153 117

2.75/5


2

3 Please see accompany Full Prescribing Information.Please see Indications and Important Risk Information on page 1.

CLIN

IMIX

E In

ject

ions

CLIN

IMIX

Inje

ctio

ns

Rate mL/hr

24 hour volume

(mL)

Grams of Amino

Acids


Grams of

Dextrose

Kcal from

Dextrose

Total Kcal

mEq/d Na+

provided

mEq/d K+

provided

mEq/d Mg++

provided

mEq/d Ca++

provided

mMol/d PO4-

provided



30 720 20 79 36 122 202 17 835 840 23 92 42 143 235 20 940 960 26 106 48 163 269 23 11

41.7 1000 27.5 110 50 170 280 24 1145 1080 30 119 54 184 302 26 1250 1200 33 132 60 204 336 29 1355 1320 36 145 66 224 370 32 1560 1440 40 158 72 245 403 35 16

62.5 1500 41 165 75 255 420 36 1765 1560 43 172 78 265 437 37 1770 1680 46 185 84 286 470 40 1875 1800 50 198 90 306 504 43 2080 1920 53 211 96 326 538 46 21

83.3 2000 55 220 100 340 560 48 2285 2040 56 224 102 347 571 49 2290 2160 59 238 108 367 605 52 2495 2280 63 251 114 388 638 55 25

100 2400 66 264 120 408 672 58 26105 2520 69 277 126 428 706 60 28110 2640 73 290 132 449 739 63 29115 2760 76 304 138 469 773 66 30120 2880 79 317 144 490 806 69 32125 3000 83 330 150 510 840 72 33

Rate mL/hr

24 hour volume

(mL)

Grams of Amino

Acids


Grams of

Dextrose

Kcal from

Dextrose

Total Kcal

mEq/d Na+

provided

mEq/d K+

provided

mEq/d Mg++

provided

mEq/d Ca++

provided

mMol/d PO4-

provided



30 720 20 79 72 245 324 25 22 4 3 11 37 2835 840 23 92 84 286 378 29 25 4 4 13 43 3340 960 26 106 96 326 432 34 29 5 4 14 49 37

41.7 1000 27.5 110 100 340 450 35 30 5 4.5 15 51 3945 1080 30 119 108 367 486 38 32 5 5 16 55 4250 1200 33 132 120 408 540 42 36 6 5 18 61 4755 1320 36 145 132 449 594 46 40 7 6 20 67 5160 1440 40 158 144 490 648 50 43 7 6 22 73 56

62.5 1500 41 165 150 510 675 53 45 8 7 23 77 5965 1560 43 172 156 530 702 55 47 8 7 23 80 6170 1680 46 185 168 571 756 59 50 8 8 25 86 6675 1800 50 198 180 612 810 63 54 9 8 27 92 7080 1920 53 211 192 653 864 67 58 10 9 29 98 75

83.3 2000 55 220 200 680 900 70 60 10 9 30 102 7885 2040 56 224 204 694 918 71 61 10 9 31 104 8090 2160 59 238 216 734 972 76 65 11 10 32 110 8495 2280 63 251 228 775 1026 80 68 11 10 34 116 89

100 2400 66 264 240 816 1080 84 72 12 11 36 122 94105 2520 69 277 252 857 1134 88 76 13 11 38 129 98110 2640 73 290 264 898 1188 92 79 13 12 40 135 103115 2760 76 304 276 938 1242 97 83 14 12 41 141 108120 2880 79 317 288 979 1296 101 86 14 13 43 147 112125 3000 83 330 300 1020 1350 105 90 15 14 45 153 117

2.75/10


4

CLIN

IMIX

E In

ject

ions

CLIN

IMIX

Inje

ctio

ns

Rate mL/hr

24 hour volume

(mL)

Grams of Amino

Acids


Grams of

Dextrose

Kcal from

Dextrose

Total Kcal



30 720 31 122 36 122 245 27 1235 840 36 143 42 143 286 31 1440 960 41 163 48 163 326 36 16

41.7 1000 42.5 170 50 170 340 37 1745 1080 46 184 54 184 367 40 1850 1200 51 204 60 204 408 44 2055 1320 56 224 66 224 449 49 2260 1440 61 245 72 245 490 53 24

62.5 1500 64 255 75 255 510 56 2665 1560 66 265 78 265 530 58 2770 1680 71 286 84 286 571 62 2975 1800 77 306 90 306 612 67 3180 1920 82 326 96 326 653 71 33

83.3 2000 85 340 100 340 680 74 3485 2040 87 347 102 347 694 75 3590 2160 92 367 108 367 734 80 3795 2280 97 388 114 388 775 84 39

100 2400 102 408 120 408 816 89 41105 2520 107 428 126 428 857 93 43110 2640 112 449 132 449 898 98 45115 2760 117 469 138 469 938 102 47120 2880 122 490 144 490 979 107 49125 3000 128 510 150 510 1020 111 51

Rate mL/hr

24 hour volume

(mL)

Grams of Amino

Acids


Grams of

Dextrose

Kcal from

Dextrose

Total Kcal

mEq/d Na+

provided

mEq/d K+

provided

mEq/d Mg++

provided

mEq/d Ca++

provided

mMol/d PO4-

provided



30 720 31 122 36 122 245 25 22 4 3 11 50 2835 840 36 143 42 143 286 29 25 4 4 13 59 3340 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 3945 1080 46 184 54 184 367 38 32 5 5 16 76 4250 1200 51 204 60 204 408 42 36 6 5 18 84 4755 1320 56 224 66 224 449 46 40 7 6 20 92 5160 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 5965 1560 66 265 78 265 530 55 47 8 7 23 109 6170 1680 71 286 84 286 571 59 50 8 8 25 118 6675 1800 77 306 90 306 612 63 54 9 8 27 126 7080 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 7885 2040 87 347 102 347 694 71 61 10 9 31 143 8090 2160 92 367 108 367 734 76 65 11 10 32 151 8495 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 94105 2520 107 428 126 428 857 88 76 13 11 38 176 98110 2640 112 449 132 449 898 92 79 13 12 40 185 103115 2760 117 469 138 469 938 97 83 14 12 41 193 108120 2880 122 490 144 490 979 101 86 14 13 43 202 112125 3000 128 510 150 510 1020 105 90 15 14 45 210 117

4.25/5


CLIN

IMIX

E In

ject

ions

CLIN

IMIX

Inje

ctio

ns

Rate mL/hr

24 hour volume

(mL)

Grams of Amino

Acids


Grams of

Dextrose

Kcal from

Dextrose

Total Kcal



30 720 31 122 72 245 367 27 1235 840 36 143 84 286 428 31 1440 960 41 163 96 326 490 36 16

41.7 1000 42.5 170 100 340 510 37 1745 1080 46 184 108 367 551 40 1850 1200 51 204 120 408 612 44 2055 1320 56 224 132 449 673 49 2260 1440 61 245 144 490 734 53 24

62.5 1500 64 255 150 510 765 56 2665 1560 66 265 156 530 796 58 2770 1680 71 286 168 571 857 62 2975 1800 77 306 180 612 918 67 3180 1920 82 326 192 653 979 71 33

83.3 2000 85 340 200 680 1020 74 3485 2040 87 347 204 694 1040 75 3590 2160 92 367 216 734 1102 80 3795 2280 97 388 228 775 1163 84 39

100 2400 102 408 240 816 1224 89 41105 2520 107 428 252 857 1285 93 43110 2640 112 449 264 898 1346 98 45115 2760 117 469 276 938 1408 102 47120 2880 122 490 288 979 1469 107 49125 3000 128 510 300 1020 1530 111 51

Rate mL/hr

24 hour volume

(mL)

Grams of Amino

Acids


Grams of

Dextrose

Kcal from

Dextrose

Total Kcal

mEq/d Na+

provided

mEq/d K+

provided

mEq/d Mg++

provided

mEq/d Ca++

provided

mMol/d PO4-

provided



30 720 31 122 72 245 367 25 22 4 3 11 50 2835 840 36 143 84 286 428 29 25 4 4 13 59 3340 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 3945 1080 46 184 108 367 551 38 32 5 5 16 76 4250 1200 51 204 120 408 612 42 36 6 5 18 84 4755 1320 56 224 132 449 673 46 40 7 6 20 92 5160 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 5965 1560 66 265 156 530 796 55 47 8 7 23 109 6170 1680 71 286 168 571 857 59 50 8 8 25 118 6675 1800 77 306 180 612 918 63 54 9 8 27 126 7080 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 7885 2040 87 347 204 694 1040 71 61 10 9 31 143 8090 2160 92 367 216 734 1102 76 65 11 10 32 151 8495 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 94105 2520 107 428 252 857 1285 88 76 13 11 38 176 98110 2640 112 449 264 898 1346 92 79 13 12 40 185 103115 2760 117 469 276 938 1408 97 83 14 12 41 193 108120 2880 122 490 288 979 1469 101 86 14 13 43 202 112125 3000 128 510 300 1020 1530 105 90 15 14 45 210 117

4.25/10


6

CLIN

IMIX

E In

ject

ions

CLIN

IMIX

Inje

ctio

ns

Rate mL/hr

24 hour volume

(mL)

Grams of Amino

Acids


Grams of

Dextrose

Kcal from

Dextrose

Total Kcal



30 720 31 122 144 490 612 27 1235 840 36 143 168 571 714 31 1440 960 41 163 192 653 816 36 16

41.7 1000 42.5 170 200 680 850 37 1745 1080 46 184 216 734 918 40 1850 1200 51 204 240 816 1020 44 2055 1320 56 224 264 898 1122 49 2260 1440 61 245 288 979 1224 53 24

62.5 1500 64 255 300 1020 1275 56 2665 1560 66 265 312 1061 1326 58 2770 1680 71 286 336 1142 1428 62 2975 1800 77 306 360 1224 1530 67 3180 1920 82 326 384 1306 1632 71 33

83.3 2000 85 340 400 1360 1700 74 3485 2040 87 347 408 1387 1734 75 3590 2160 92 367 432 1469 1836 80 3795 2280 97 388 456 1550 1938 84 39

100 2400 102 408 480 1632 2040 89 41105 2520 107 428 504 1714 2142 93 43110 2640 112 449 528 1795 2244 98 45115 2760 117 469 552 1877 2346 102 47120 2880 122 490 576 1958 2448 107 49125 3000 128 510 600 2040 2550 111 51

Rate mL/hr

24 hour volume

(mL)

Grams of Amino

Acids


Grams of

Dextrose

Kcal from

Dextrose

Total Kcal

mEq/d Na+

provided

mEq/d K+

provided

mEq/d Mg++

provided

mEq/d Ca++

provided

mMol/d PO4-

provided



326 720 31 122 36 122 245 25 22 4 3 11 50 2836 840 36 143 42 143 286 29 25 4 4 13 59 3316 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 391000 1080 46 184 54 184 367 38 32 5 5 16 76 4242.5 1200 51 204 60 204 408 42 36 6 5 18 84 47170 1320 56 224 66 224 449 46 40 7 6 20 92 5150 1440 61 245 72 245 490 50 43 7 6 22 101 56

170 1500 64 255 75 255 510 53 45 8 7 23 105 59340 1560 66 265 78 265 530 55 47 8 7 23 109 6137 1680 71 286 84 286 571 59 50 8 8 25 118 6617 1800 77 306 90 306 612 63 54 9 8 27 126 7045 1920 82 326 96 326 653 67 58 10 9 29 134 75

1080 2000 85 340 100 340 680 70 60 10 9 30 140 7846 2040 87 347 102 347 694 71 61 10 9 31 143 80

184 2160 92 367 108 367 734 76 65 11 10 32 151 8454 2280 97 388 114 388 775 80 68 11 10 34 160 89

184 2400 102 408 120 408 816 84 72 12 11 36 168 94367 2520 107 428 126 428 857 88 76 13 11 38 176 9840 2640 112 449 132 449 898 92 79 13 12 40 185 10318 2760 117 469 138 469 938 97 83 14 12 41 193 10850 2880 122 490 144 490 979 101 86 14 13 43 202 112

1200 3000 128 510 150 510 1020 105 90 15 14 45 210 117

4.25/20


CLIN

IMIX

E In

ject

ions

CLIN

IMIX

Inje

ctio

ns

Rate mL/hr

24 hour volume

(mL)

Grams of Amino

Acids


Grams of

Dextrose

Kcal from

Dextrose

Total Kcal



30 720 31 122 180 612 734 27 1235 840 36 143 210 714 857 31 1440 960 41 163 240 816 979 36 16

41.7 1000 42.5 170 250 850 1020 37 1745 1080 46 184 270 918 1102 40 1850 1200 51 204 300 1020 1224 44 2055 1320 56 224 330 1122 1346 49 2260 1440 61 245 360 1224 1469 53 24

62.5 1500 64 255 375 1275 1530 56 2665 1560 66 265 390 1326 1591 58 2770 1680 71 286 420 1428 1714 62 2975 1800 77 306 450 1530 1836 67 3180 1920 82 326 480 1632 1958 71 33

83.3 2000 85 340 500 1700 2040 74 3485 2040 87 347 510 1734 2081 75 3590 2160 92 367 540 1836 2203 80 3795 2280 97 388 570 1938 2326 84 39

100 2400 102 408 600 2040 2448 89 41105 2520 107 428 630 2142 2570 93 43110 2640 112 449 660 2244 2693 98 45115 2760 117 469 690 2346 2815 102 47120 2880 122 490 720 2448 2938 107 49125 3000 128 510 750 2550 3060 111 51

Rate mL/hr

24 hour volume

(mL)

Grams of Amino

Acids


Grams of

Dextrose

Kcal from

Dextrose

Total Kcal

mEq/d Na+

provided

mEq/d K+

provided

mEq/d Mg++

provided

mEq/d Ca++

provided

mMol/d PO4-

provided



30 720 31 122 180 612 734 25 22 4 3 11 50 2835 840 36 143 210 714 857 29 25 4 4 13 59 3340 960 41 163 240 816 979 34 29 5 4 14 67 37

41.7 1000 42.5 170 250 850 1020 35 30 5 4.5 15 70 3945 1080 46 184 270 918 1102 38 32 5 5 16 76 4250 1200 51 204 300 1020 1224 42 36 6 5 18 84 4755 1320 56 224 330 1122 1346 46 40 7 6 20 92 5160 1440 61 245 360 1224 1469 50 43 7 6 22 101 56

62.5 1500 64 255 375 1275 1530 53 45 8 7 23 105 5965 1560 66 265 390 1326 1591 55 47 8 7 23 109 6170 1680 71 286 420 1428 1714 59 50 8 8 25 118 6675 1800 77 306 450 1530 1836 63 54 9 8 27 126 7080 1920 82 326 480 1632 1958 67 58 10 9 29 134 75

83.3 2000 85 340 500 1700 2040 70 60 10 9 30 140 7885 2040 87 347 510 1734 2081 71 61 10 9 31 143 8090 2160 92 367 540 1836 2203 76 65 11 10 32 151 8495 2280 97 388 570 1938 2326 80 68 11 10 34 160 89

100 2400 102 408 600 2040 2448 84 72 12 11 36 168 94105 2520 107 428 630 2142 2570 88 76 13 11 38 176 98110 2640 112 449 660 2244 2693 92 79 13 12 40 185 103115 2760 117 469 690 2346 2815 97 83 14 12 41 193 108120 2880 122 490 720 2448 2938 101 86 14 13 43 202 112125 3000 128 510 750 2550 3060 105 90 15 14 45 210 117

4.25/25


8

CLIN

IMIX

E In

ject

ions

CLIN

IMIX

Inje

ctio

ns

Rate mL/hr

24 hour volume

(mL)

Grams of Amino

Acids


Grams of

Dextrose

Kcal from

Dextrose

Total Kcal



30 720 36 144 108 367 511 30 1435 840 42 168 126 428 596 35 1740 960 48 192 144 490 682 40 19

41.7 1000 50 200 150 510 710 42 2045 1080 54 216 162 551 767 45 2250 1200 60 240 180 612 852 50 2455 1320 66 264 198 673 937 55 2660 1440 72 288 216 734 1022 60 29

62.5 1500 75 300 225 765 1065 63 3065 1560 78 312 234 796 1108 66 3170 1680 84 336 252 857 1193 71 3475 1800 90 360 270 918 1278 76 3680 1920 96 384 288 979 1363 81 38

83.3 2000 100 400 300 1020 1420 84 4085 2040 102 408 306 1040 1448 86 4190 2160 108 432 324 1102 1534 91 4395 2280 114 456 342 1163 1619 96 46

100 2400 120 480 360 1224 1704 101 48105 2520 126 504 378 1285 1789 106 50110 2640 132 528 396 1346 1874 111 53115 2760 138 552 414 1408 1960 116 55120 2880 144 576 432 1469 2045 121 58125 3000 150 600 450 1530 2130 126 60

Rate mL/hr

24 hour volume

(mL)

Grams of Amino

Acids


Grams of

Dextrose

Kcal from

Dextrose

Total Kcal

mEq/d Na+

provided

mEq/d K+

provided

mEq/d Mg++

provided

mEq/d Ca++

provided

mMol/d PO4-

provided



30 720 36 144 108 367 511 25 22 4 3 11 58 2835 840 42 168 126 428 596 29 25 4 4 13 67 3340 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 3945 1080 54 216 162 551 767 38 32 5 5 16 86 4250 1200 60 240 180 612 852 42 36 6 5 18 96 4755 1320 66 264 198 673 937 46 40 7 6 20 106 5160 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 5965 1560 78 312 234 796 1108 55 47 8 7 23 125 6170 1680 84 336 252 857 1193 59 50 8 8 25 134 6675 1800 90 360 270 918 1278 63 54 9 8 27 144 7080 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 7885 2040 102 408 306 1040 1448 71 61 10 9 31 163 8090 2160 108 432 324 1102 1534 76 65 11 10 32 173 8495 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 94105 2520 126 504 378 1285 1789 88 76 13 11 38 202 98110 2640 132 528 396 1346 1874 92 79 13 12 40 211 103115 2760 138 552 414 1408 1960 97 83 14 12 41 221 108120 2880 144 576 432 1469 2045 101 86 14 13 43 230 112125 3000 150 600 450 1530 2130 105 90 15 14 45 240 117

5/15


CLIN

IMIX

E In

ject

ions

CLIN

IMIX

Inje

ctio

ns

Rate mL/hr

24 hour volume

(mL)

Grams of Amino

Acids


Grams of

Dextrose

Kcal from

Dextrose

Total Kcal



30 720 36 144 144 490 634 30 1435 840 42 168 168 571 739 35 1740 960 48 192 192 653 845 40 19

41.7 1000 50 200 200 680 880 42 2045 1080 54 216 216 734 950 45 2250 1200 60 240 240 816 1056 50 2455 1320 66 264 264 898 1162 55 2660 1440 72 288 288 979 1267 60 29

62.5 1500 75 300 300 1020 1320 63 3065 1560 78 312 312 1061 1373 66 3170 1680 84 336 336 1142 1478 71 3475 1800 90 360 360 1224 1584 76 3680 1920 96 384 384 1306 1690 81 38

83.3 2000 100 400 400 1360 1760 84 4085 2040 102 408 408 1387 1795 86 4190 2160 108 432 432 1469 1901 91 4395 2280 114 456 456 1550 2006 96 46

100 2400 120 480 480 1632 2112 101 48105 2520 126 504 504 1714 2218 106 50110 2640 132 528 528 1795 2323 111 53115 2760 138 552 552 1877 2429 116 55120 2880 144 576 576 1958 2534 121 58125 3000 150 600 600 2040 2640 126 60

Rate mL/hr

24 hour volume

(mL)

Grams of Amino

Acids


Grams of

Dextrose

Kcal from

Dextrose

Total Kcal

mEq/d Na+

provided

mEq/d K+

provided

mEq/d Mg++

provided

mEq/d Ca++

provided

mMol/d PO4-

provided



30 720 36 144 144 490 634 25 22 4 3 11 58 2835 840 42 168 168 571 739 29 25 4 4 13 67 3340 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 3945 1080 54 216 216 734 950 38 32 5 5 16 86 4250 1200 60 240 240 816 1056 42 36 6 5 18 96 4755 1320 66 264 264 898 1162 46 40 7 6 20 106 5160 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 5965 1560 78 312 312 1061 1373 55 47 8 7 23 125 6170 1680 84 336 336 1142 1478 59 50 8 8 25 134 6675 1800 90 360 360 1224 1584 63 54 9 8 27 144 7080 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 7885 2040 102 408 408 1387 1795 71 61 10 9 31 163 8090 2160 108 432 432 1469 1901 76 65 11 10 32 173 8495 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 94105 2520 126 504 504 1714 2218 88 76 13 11 38 202 98110 2640 132 528 528 1795 2323 92 79 13 12 40 211 103115 2760 138 552 552 1877 2429 97 83 14 12 41 221 108120 2880 144 576 576 1958 2534 101 86 14 13 43 230 112125 3000 150 600 600 2040 2640 105 90 15 14 45 240 117

5/20


10

CLIN

IMIX

E In

ject

ions

CLIN

IMIX

Inje

ctio

ns

Rate mL/hr

24 hour volume

(mL)

Grams of Amino

Acids


Grams of

Dextrose

Kcal from

Dextrose

Total Kcal



30 720 36 144 180 612 756 30 1435 840 42 168 210 714 882 35 1740 960 48 192 240 816 1008 40 19

41.7 1000 50 200 250 850 1050 42 2045 1080 54 216 270 918 1134 45 2250 1200 60 240 300 1020 1260 50 2455 1320 66 264 330 1122 1386 55 2660 1440 72 288 360 1224 1512 60 29

62.5 1500 75 300 375 1275 1575 63 3065 1560 78 312 390 1326 1638 66 3170 1680 84 336 420 1428 1764 71 3475 1800 90 360 450 1530 1890 76 3680 1920 96 384 480 1632 2016 81 38

83.3 2000 100 400 500 1700 2100 84 4085 2040 102 408 510 1734 2142 86 4190 2160 108 432 540 1836 2268 91 4395 2280 114 456 570 1938 2394 96 46

100 2400 120 480 600 2040 2520 101 48105 2520 126 504 630 2142 2646 106 50110 2640 132 528 660 2244 2772 111 53115 2760 138 552 690 2346 2898 116 55120 2880 144 576 720 2448 3024 121 58125 3000 150 600 750 2550 3150 126 60

Rate mL/hr

24 hour volume

(mL)

Grams of Amino

Acids


Grams of

Dextrose

Kcal from

Dextrose

Total Kcal

mEq/d Na+

provided

mEq/d K+

provided

mEq/d Mg++

provided

mEq/d Ca++

provided

mMol/d PO4-

provided



30 720 36 144 180 612 756 25 22 4 3 11 58 2835 840 42 168 210 714 882 29 25 4 4 13 67 3340 960 48 192 240 816 1008 34 29 5 4 14 77 37

41.7 1000 50 200 250 850 1050 35 30 5 4.5 15 80 3945 1080 54 216 270 918 1134 38 32 5 5 16 86 4250 1200 60 240 300 1020 1260 42 36 6 5 18 96 4755 1320 66 264 330 1122 1386 46 40 7 6 20 106 5160 1440 72 288 360 1224 1512 50 43 7 6 22 115 56

62.5 1500 75 300 375 1275 1575 53 45 8 7 23 120 5965 1560 78 312 390 1326 1638 55 47 8 7 23 125 6170 1680 84 336 420 1428 1764 59 50 8 8 25 134 6675 1800 90 360 450 1530 1890 63 54 9 8 27 144 7080 1920 96 384 480 1632 2016 67 58 10 9 29 154 75

83.3 2000 100 400 500 1700 2100 70 60 10 9 30 160 7885 2040 102 408 510 1734 2142 71 61 10 9 31 163 8090 2160 108 432 540 1836 2268 76 65 11 10 32 173 8495 2280 114 456 570 1938 2394 80 68 11 10 34 182 89

100 2400 120 480 600 2040 2520 84 72 12 11 36 192 94105 2520 126 504 630 2142 2646 88 76 13 11 38 202 98110 2640 132 528 660 2244 2772 92 79 13 12 40 211 103115 2760 138 552 690 2346 2898 97 83 14 12 41 221 108120 2880 144 576 720 2448 3024 101 86 14 13 43 230 112125 3000 150 600 750 2550 3150 105 90 15 14 45 240 117

5/25

Place your order now. Call you Baxter representative at 1-888-229-0001Visit www.baxtermedicationdeliveryproducts.com

USMP/78/14-0014 8/14

www.baxter.com

Baxter Healthcare CorporationRoute 120 and Wilson RoadRound Lake, IL 60073

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

Nutrition. Customize. Standardize. Or both.

Different patient populations require parenteral nutrition formulation options. Different physicians have different prescribing practices. Different pharmacies have varying levels of nutrition compounding capability and

expertise. The only constant is your need for diverse and flexible nutrition solutions.

CLINIMIX E sulfite-free (Amino Acid with Electrolytes in Dextrose with Calcium) Injectionsin CLARITY Dual Chamber Container

07-19-57-385

DescriptionCLINIMIX E sulfite-free (Amino Acid with Electrolytes in Dextrose with Calcium) Injections are sterile, nonpyrogenic, hypertonic solutions in a CLARITY Dual Chamber Container.The sulfite-free Amino Acid Injections with Electrolytes in the outlet port chamber are solutions of essential and nonessential amino acids provided with electrolytes.The Dextrose Injections with Calcium in the injection port chamber are solutions for fluid replenishment and caloric supply.After opening the seal between the chambers and mixing thoroughly, the admixed product is intended for intravenous use. See Table 1 for composition, pH, osmolarity, ionic concentration and caloric content of the admixed product.The CLARITY Dual Chamber Container is a lipid-compatible plastic container (PL 2401 Plastic). The amount of water that can permeate from inside the container 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 in very small amounts; however, biological testing was supportive of the safety of the plastic container materials.

Clinical PharmacologyCLINIMIX E sulfite-free (Amino Acid with Electrolytes in Dextrose with Calcium) Injections administered intravenously provide biologically utilizable source material for protein synthesis and have value as a source of calories, electrolytes, and water.

Indications and UsageCLINIMIX 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 treatment of negative nitrogen balance in patients where: (1) the alimentary tract cannot or should not be used, (2) gastrointestinal absorption of protein is impaired, or (3) metabolic requirements for protein are substantially increased, as with extensive burns.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.

ContraindicationsCLINIMIX 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.

WarningsAdditives 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.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 TestsFrequent clinical evaluation and laboratory determinations are necessary for proper monitoring during administration. Studies should include blood sugar, serum proteins, kidney and liver function tests, electrolytes, complete blood count with differential, carbon dioxide combining power or content, serum osmolarities, blood cultures, and blood ammonia levels.Administration of amino acid solutions to a patient with hepatic insufficiency may result

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.

PrecautionsWith 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.071957385

*BAR CODE POSITION ONLY

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 ContainerWARNING: 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 OpenTear 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 SolutionsGrasp 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.

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.3. Attach transfer set to fat emulsion bottle using aseptic technique.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.7. After completing transfer, use appropriate plastic clamp or metal ferrule

to seal off additive port tube.8. Remove transfer set.9. Mix contents of CLARITY container thoroughly. Check for leaks.Storage: Storage of the 3-in-1 admixture must be under refrigeration and limited to a brief period of time, no longer than 24 hours. See Warnings section regarding incompatible additives.

To Add MedicationWARNING: Additives may be incompatible.Supplemental medication may be added with a 19 to 22 gauge needle through the medication port.1. Prepare medication port.2. Using syringe with 19 to 22 gauge needle, puncture resealable medication port

and inject.3. Mix solution and medication thoroughly. For high density medication, such as

potassium chloride, squeeze ports while ports are upright and mix thoroughly.4. Check for leaks.

Preparation for Administration1. Suspend container from eyelet support.2. Twist off protector from outlet port at bottom of container.3. Attach administration set. Refer to complete directions accompanying set.

How SuppliedSee Table 1.Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C/77°F): brief exposure up to 40°C/104°F does not adversely affect the product.Refrigerated storage is limited to 9 days once overwrap has been opened.Do not use if overwrap has been previously opened or damaged.

Baxter Healthcare Corporation Deerfield, IL 60015 USAPrinted in USABaxter, Clinimix E, and Clarity are trademarks of Baxter International Inc.07-19-57-385 Rev. July 2010

E

PROOFREADING INSPECTION / RELEASED ARTWORKProofreading Approval ________________________ ________________________ ________ Print Name Signature Date

Proofreading Approval ________________________ ________________________ ________ Print Name Signature Date

Confidential Property of Baxter Healthcare Corporation and its Affiliates

Document No.: 07-19-57-385Change No.: CP0329253Page 1 of 2

P1 16 Sep 2010 sbh

Figure 1 Figure 2

Injection/ Medication Port

Twist-Off Protector on Additive Port

Twist-Off Protector on Outlet Port

* 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.

Dosage and AdministrationIf a patient is unable to take oral nourishment for a prolonged period of time, institution of total parenteral nutrition should be considered.The total daily dose of CLINIMIX E sulfite-free (Amino Acid with Electrolytes in Dextrose with Calcium) Injections depends on the patient’s metabolic requirement and clinical response. The determination of nitrogen balance and accurate daily body weights, corrected for fluid balance, are probably the best means of assessing individual nitrogen requirements.Recommended Dietary Allowances* of protein range from approximately 0.75 g/kg of body weight for adults to 1.68 g/kg for infants up to three months of age. It must be recognized, however, that protein as well as caloric requirements in traumatized or malnourished patients may be increased substantially. Daily amino acid doses of approximately 1.0 to 1.5 g/kg of body weight for adults with adequate calories are generally sufficient to satisfy protein needs and promote positive nitrogen balance.For the initial treatment of trauma or protein calorie malnutrition, higher doses of protein with corresponding quantities of carbohydrates will be necessary to promote adequate patient response to therapy. The severity of the illness being treated is the primary consideration in determining proper dose level. Such higher doses, especially in infants, must be accompanied by more frequent laboratory evaluation.Care should be exercised to insure the maintenance of proper levels of serum potassium. Quantities of 60 to 180 mEq of potassium per day have been used with adequate clinical effect. It may be necessary to add quantities of this electrolyte to these admixed injections, depending primarily on the amount of carbohydrate administered to and metabolized by the patient.Total daily fluid requirements can be met beyond the volume of amino acids solution by supplementing with noncarbohydrate or carbohydrate-containing electrolyte solutions.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.

Fat emulsion administration should be considered when prolonged (more than 5 days) parenteral nutrition is required in order to prevent essential fatty acid deficiency (EFAD). Serum lipids should be monitored for evidence of EFAD in patients maintained on fat-free TPN.Intravenous fat emulsions provide approximately 1.1 kcal per mL (10%), 2.0 kcal per mL (20%), or 3.0 kcal per mL (30%) and may be admixed along with amino acid with electrolytes/dextrose with calcium injections in the CLARITY Container to supplement caloric intake.Depending upon the clinical condition of the patient, approximately 3 liters of solution may be administered per 24 hour period. When used postoperatively, the therapy should begin with 1000 mL on the first postoperative day. Thereafter, the dose may be increased to 3000 mL per day.Do not administer unless seal between chambers is opened, other seals are intact, and solution is clear and thoroughly mixed.Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Use of a final filter is recommended during administration of all parenteral solutions, where possible.A slight yellow color does not alter the quality and efficacy of this product.Additives may be incompatible. Complete information is not available. Those additives known to be incompatible should not be used. Consult with pharmacist, if available. If, in the informed judgment of the physician, it is deemed advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced. Do not store solutions containing additives. These amino acid with electrolytes/dextrose with calcium injections should be used promptly after mixing. Any storage with additives should be under refrigeration and limited to a brief period of time, less than 24 hours.

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 in Dextrose with Calcium) Injections in pediatric patients have not been established by adequate and well-controlled studies. However, the use of amino acid injections in pediatric patients as an adjunct in the offsetting of nitrogen loss or in the treatment of negative nitrogen balance is referenced in the medical literature. See Dosage and Administration.Geriatric Use: Clinical studies of CLINIMIX E sulfite-free (Amino Acid with Electrolytes in Dextrose with Calcium) Injections did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from other younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or drug therapy.

Adverse ReactionsSee Warnings and PrecautionsToo rapid infusion of these CLINIMIX E sulfite-free (Amino Acid with Electrolytes in Dextrose with Calcium) Injections may result in diuresis, hyperglycemia, glycosuria, and hyperosmolar coma. Continual clinical monitoring of the patient is necessary in order to identify and initiate measures for these clinical conditions.Reactions that may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation, and hypervolemia. Policies and procedures should be established for the recognition and management of such reactions.If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary.

* Food and Nutrition Board National Academy of Sciences - National Research Council (Revised 1989).

07-1

9-57

-385

1.

O

OH • H2O

OH

OH

HO

HO

Dextrose Hydrous, USP (D-Glucose monohydrate)

2. Balanced by ions from amino acids.3. Derived from glacial acetic acid

(for pH adjustment) and sodium acetate.4. Contributed by calcium chloride, lysine

hydrochloride, magnesium chloride, and sodium chloride.

5. pH of sulfite-free Amino Acid Injection with Electrolytes in the outlet port chamber was adjusted with glacial acetic acid.





P1 27 Aug 2010 sbh

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 mmol/L)

4.5 (2.2 mmol/L)

4.5 (2.2 mmol/L)

4.5 (2.2 mmol/L)

4.5 (2.2 mmol/L)

4.5 (2.2 mmol/L)

4.5 (2.2 mmol/L)

4.5 (2.2 mmol/L)

30 (15 mmol/L)

30 (15 mmol/L)

30 (15 mmol/L)

30 (15 mmol/L)

30 (15 mmol/L)

30 (15 mmol/L)

30 (15 mmol/L)

30 (15 mmol/L)

Contents of Admixed Product

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

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

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

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

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

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

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

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

170 110 280

340 110 450

170 170 340

340 170 510

850 170 1020

510 200 710

680 200 880

850 200 1050

665

920

815

1070

1825

1395

1650

1900

51 39

51 39

70 39

70 39

70 39

80 39

80 39

80 39

Electrolyte Profile (mEq/L)2

Essential Amino Acids (mg/100 mL)

Nonessential Amino Acids (mg/100 mL)

Electrolytes (mg/100 mL)

CompositionCaloric Content

(kcal/L)

How Supplied

Table 1

After mixing, the product represents

1000 mL Code and NDC Number

2000 mL Code and NDC Number Dext

rose

Hyd

rous

, USP

1 (g

/100

mL)

Amin

o Ac

ids

(g/1

00 m

L)

Tota

l Nitr

ogen

(mg/

100

mL)

Leuc

ine

- (C

H 3) 2

CHC

H 2CH

(NH 2

) COO

H

Isol

euci

ne -

CH

3CH 2

CH (C

H 3) C

H (N

H 2) C

OOH

Valin

e -

(CH 3

) 2 C

HCH

(NH 2

) COO

H

Lysi

ne (a

dded

as

the

hydr

ochl

orid

e

salt)

- H 2

N (C

H 2) 4

CH

(NH 2

) COO

H

Phen

ylal

anin

e -

(C6H

5) C

H 2 C

H (N

H 2) C

OOH

Hist

idin

e -

(C3H

3N2)

CH 2

CH (N

H 2) C

OOH

Thre

onin

e -

CH3C

H (O

H) C

H (N

H 2) C

OOH

Met

hion

ine

- CH

3S (C

H 2) 2

CH

(NH 2

) COO

H

Tryp

toph

an -

(C

8H6N

) CH 2

CH

(NH 2

) COO

H

Alan

ine

- CH 3

CH (N

H 2) C

OOH

Argi

nine

-

H 2NC

(NH)

NH

(CH 2

) 3 C

H (N

H 2) C

OOH

Glyc

ine

- H2N

CH2C

OOH

Prol

ine

- [(C

H 2) 3

NH

CH] C

OOH

Serin

e - H

OCH 2

CH (N

H 2) C

OOH

Tyro

sine

-

[C6H

4 (O

H)] C

H 2CH

(NH 2

) COO

H

Sodi

um A

ceta

te T

rihyd

rate

, USP

-

C 2H 3

NaO 2

•3H 2

O

Diba

sic

Pota

ssiu

m P

hosp

hate

, USP

-

K 2HP

O 4

Sodi

um C

hlor

ide,

USP

- Na

Cl

Mag

nesi

um C

hlor

ide,

USP

-

MgC

l 2•6

H 2O

Calc

ium

Chl

orid

e Di

hydr

ate,

USP

-

CaCl

2•2H

2O

Sodi

um

Pota

ssiu

m

Mag

nesi

um

Calc

ium

Acet

ate3

Chlo

ride4

Phos

phat

e (a

s HP

O 4= )

pH5

(ran

ge)

Osm

olar

ity (m

Osm

ol/L

) (c

alc)

From

Dex

trose

From

Am

ino

Acid

s

TOTA

L (D

extro

se a

nd A

min

o Ac

ids)

CLINIMIX E 2.75/5 sulfite-free (2.75% Amino Acid with Electrolytes in 5% Dextrose with Calcium) Injection

Code 2B7736 NDC 0338-1143-03

Code 2B7737 NDC 0338-1144-03

Code 2B7738 NDC 0338-1145-03

Code 2B7739 NDC 0338-1146-03

Code 2B7740 NDC 0338-1147-03

Code 2B7741 NDC 0338-1148-03

Code 2B7742 NDC 0338-1149-03

Code 2B7735 NDC 0338-1142-03

Code 2B7714 NDC 0338-1109-04

Code 2B7716 NDC 0338-1113-04

Code 2B7717 NDC 0338-1115-04

Code 2B7719 NDC 0338-1119-04

Code 2B7721 NDC 0338-1123-04

Code 2B7722 NDC 0338-1125-04

Code 2B7723 NDC 0338-1127-04

Code 2B7713 NDC 0338-1107-04





CLINIMIX E 5/15 sulfite-free (5% Amino Acid with Electrolytes in 15% Dextrose with Calcium) Injection







P1 16 Sep 2010 sbh

CLINIMIX sulfite-free (Amino Acid in Dextrose) Injectionsin CLARITY Dual Chamber Container

07-19-57-358

DescriptionCLINIMIX sulfite-free (Amino Acid in Dextrose) Injections are sterile, nonpyrogenic, hypertonic solutions in a CLARITY Dual Chamber Container.The sulfite-free Amino Acid Injections in the outlet port chamber are solutions of essential and nonessential amino acids.The Dextrose Injections, USP in the injection port chamber are solutions for fluid replenishment and caloric supply.After opening the seal between the chambers and mixing thoroughly, the admixed product is intended for intravenous use. See Table 1 for composition, pH, osmolarity, ionic concentration and caloric content of the admixed product.The CLARITY Dual Chamber Container is a lipid-compatible plastic container (PL 2401 Plastic). The amount of water that can permeate from inside the container 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 in very small amounts; however, biological testing was supportive of the safety of the plastic container materials.

Clinical PharmacologyCLINIMIX sulfite-free (Amino Acid in Dextrose) Injections administered intravenously provide biologically utilizable source material for protein synthesis and have value as a source of calories and water.

Indications and UsageCLINIMIX 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 offsetting nitrogen loss or for treatment of negative nitrogen balance in patients where: (1) the alimentary tract cannot or should not be used, (2) gastrointestinal absorption of protein is impaired, or (3) metabolic requirements for protein are substantially increased, as with extensive burns.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.

ContraindicationsCLINIMIX 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 disease or hepatic coma.Solutions containing corn-derived dextrose may be contraindicated in patients with known allergy to corn or corn products.

WarningsAdditives 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 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 TestsFrequent clinical evaluation and laboratory determinations are necessary for proper monitoring during administration. Studies should include blood sugar, serum proteins, kidney and liver function tests, electrolytes, complete blood count with differential, carbon dioxide combining power or content, serum osmolarities, blood cultures, and blood ammonia levels.Administration of amino acid solutions to a patient with hepatic insufficiency may result 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/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.

PrecautionsWith 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.

071957358

*BAR CODE POSITION ONLY

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 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 ContainerWARNING: 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 OpenTear 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 SolutionsGrasp 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.

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

as shown in Figure 2.2. Prepare fat emulsion transfer set following instructions provided.3. Attach transfer set to fat emulsion bottle, using aseptic technique.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.7. After completing transfer, use appropriate plastic clamp or metal ferrule

to seal off additive port tube.8. Remove transfer set.9. Mix contents of CLARITY container thoroughly. Check for leaks.Storage: Storage of the 3-in-1 admixture must be under refrigeration and limited to a brief period of time, no longer than 24 hours. See Warnings section regarding incompatible additives.

To Add MedicationWARNING: Additives may be incompatible.Supplemental medication may be added with a 19 to 22 gauge needle through the medication port.1. Prepare medication port.2. Using syringe with 19 to 22 gauge needle, puncture resealable medication port

and inject.3. Mix solution and medication thoroughly. For high density medication, such as

potassium chloride, squeeze ports while ports are upright and mix thoroughly.4. Check for leaks.

Preparation for Administration1. Suspend container from eyelet support.2. Twist off protector from outlet port at bottom of container.3. Attach administration set. Refer to complete directions accompanying set.

How SuppliedSee Table 1.Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C/77°F): brief exposure up to 40°C/104°F does not adversely affect the product.Refrigerated storage is limited to 9 days once overwrap has been opened.Do not use if overwrap has been previously opened or damaged.

Figure 1 Figure 2

Injection/ Medication Port

Twist-Off Protector on Additive Port

Twist-Off Protector on Outlet Port

Baxter Healthcare Corporation Deerfield, IL 60015 USAPrinted in USABaxter, Clinimix, and Clarity are trademarks of Baxter International Inc.07-19-57-358 Rev. July 2010

* 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.

1.

O

OH • H2O

OH

OH

HO

HO

Dextrose Hydrous, USP (D-Glucose monohydrate)

2. Balanced by ions from amino acids.3. Derived from glacial acetic acid (for pH

adjustment).4. Contributed by the lysine hydrochloride.5. pH of sulfite-free Amino Acid Injection in

the outlet port chamber was adjusted with glacial acetic acid.

Dosage and AdministrationIf a patient is unable to take oral nourishment for a prolonged period of time, institution of total parenteral nutrition should be considered.The total daily dose of CLINIMIX sulfite-free (Amino Acid in Dextrose) Injections depends on the patient’s metabolic requirement and clinical response. The determination of nitrogen balance and accurate daily body weights, corrected for fluid balance, are probably the best means of assessing individual nitrogen requirements.Recommended Dietary Allowances* of protein range from approximately 0.75 g/kg of body weight for adults to 1.68 g/kg for infants up to three months of age. It must be recognized, however, that protein as well as caloric requirements in traumatized or malnourished patients may be increased substantially. Daily amino acid doses of approximately 1.0 to 1.5 g/kg of body weight for adults with adequate calories are generally sufficient to satisfy protein needs and promote positive nitrogen balance.For the initial treatment of trauma or protein calorie malnutrition, higher doses of protein with corresponding quantities of carbohydrate will be necessary to promote adequate patient response to therapy. The severity of the illness being treated is the primary consideration in determining proper dose level. Such higher doses, especially in infants, must be accompanied by more frequent laboratory evaluation.Care should be exercised to insure the maintenance of proper levels of serum potassium. Quantities of 60 to 180 mEq of potassium per day have been used with adequate clinical effect. It may be necessary to add quantities of this electrolyte to these admixed injections, depending primarily on the amount of carbohydrate administered to and metabolized by the patient.Patients receiving CLINIMIX sulfite-free (Amino Acid in Dextrose) Injections without electrolytes should be monitored frequently and their electrolyte requirements individualized.Total daily fluid requirements can be met beyond the volume of amino acids solution by supplementing with noncarbohydrate or carbohydrate-containing electrolyte solutions.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.Fat emulsion administration should be considered when prolonged (more than 5 days) parenteral nutrition is required in order to prevent essential fatty acid deficiency (EFAD). Serum lipids should be monitored for evidence of EFAD in patients maintained on fat-free TPN.Intravenous fat emulsions provide approximately 1.1 kcal per mL (10%), 2.0 kcal per mL (20%), or 3.0 kcal per mL (30%) and may be admixed along with amino acid/dextrose injections in the CLARITY Container to supplement caloric intake.Depending upon the clinical condition of the patient, approximately 3 liters of solution may be administered per 24 hour period. When used postoperatively, the therapy should begin with 1000 mL on the first postoperative day. Thereafter, the dose may be increased to 3000 mL per day.Do not administer unless seal between chambers is opened, other seals are intact, and solution is clear and thoroughly mixed.Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Use of a final filter is recommended during administration of all parenteral solutions, where possible.A slight yellow color does not alter the quality and efficacy of this product.Additives may be incompatible. Complete information is not available. Those additives known to be incompatible should not be used. Consult with pharmacist, if available. If, in the informed judgment of the physician, it is deemed advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced. Do not store solutions containing additives. These amino acid with electrolytes/dextrose with calcium injections should be used promptly after mixing. Any storage with additives should be under refrigeration and limited to a brief period of time, less than 24 hours.

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 in pediatric patients have not been established by adequate and well-controlled studies. However, the use of amino acid injections in pediatric patients as an adjunct in the offsetting of nitrogen loss or in the treatment of negative nitrogen balance is referenced in the medical literature. See Dosage and Administration.Geriatric Use: Clinical studies of CLINIMIX sulfite-free (Amino Acid in Dextrose) Injections did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from other younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or drug therapy.

Adverse ReactionsSee Warnings and PrecautionsToo rapid infusion of these CLINIMIX sulfite-free (Amino Acid in Dextrose) Injections may result in diuresis, hyperglycemia, glycosuria, and hyperosmolar coma. Continual clinical monitoring of the patient is necessary in order to identify and initiate measures for these clinical conditions.Reactions that may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation, and hypervolemia. Policies and procedures should be established for the recognition and management of such reactions.If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary.

* Food and Nutrition Board National Academy of Sciences - National Research Council (Revised 1989).

CLINIMIX 2.75/5 sulfite-free (2.75% Amino Acid in 5% Dextrose) Injection

Code 2B7725 NDC 0338-1132-03

Code 2B7701 NDC 0338-1083-04





CLINIMIX 5/15 sulfite-free (5% Amino Acid in 15% Dextrose) Injection



Code 2B7726 NDC 0338-1133-03

Code 2B7704 NDC 0338-1089-04

Code 2B7727 NDC 0338-1134-03

Code 2B7705 NDC 0338-1091-04

Code 2B7728 NDC 0338-1135-03

Code 2B7706 NDC 0338-1093-04

Code 2B7729 NDC 0338-1136-03

Code 2B7707 NDC 0338-1095-04

Code 2B7730 NDC 0338-1137-03

Code 2B7709 NDC 0338-1099-04

Code 2B7731 NDC 0338-1138-03

Code 2B7710 NDC 0338-1101-04

Code 2B7732 NDC 0338-1139-03

Code 2B7711 NDC 0338-1103-04

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)

Contents of Admixed Product

5 2.75 454 201 165 160 159 154 132 116 110 50 570 316 283 187 138 11

5 4.25 702 311 255 247 247 238 204 179 170 77 880 489 438 289 213 17

10 4.25 702 311 255 247 247 238 204 179 170 77 880 489 438 289 213 17

20 4.25 702 311 255 247 247 238 204 179 170 77 880 489 438 289 213 17

25 4.25 702 311 255 247 247 238 204 179 170 77 880 489 438 289 213 17

15 5 826 365 300 290 290 280 240 210 200 90 1035 575 515 340 250 20

20 5 826 365 300 290 290 280 240 210 200 90 1035 575 515 340 250 20

25 5 826 365 300 290 290 280 240 210 200 90 1035 575 515 340 250 20

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

24 11

37 17

37 17

37 17

37 17

42 20

42 20

42 20

Essential Amino Acids (mg/100 mL)

Nonessential Amino Acids (mg/100 mL)

Anion Profile (mEq/L)2

CompositionCaloric Content

(kcal/L)

How Supplied

Table 1

After mixing, the product represents

1000 mL Code and NDC Number

2000 mL Code and NDC Number De

xtro

se H

ydro

us, U

SP1

(g/1

00 m

L)

Amin

o Ac

ids

(g/1

00 m

L)

Tota

l Nitr

ogen

(mg/

100

mL)

Leuc

ine

- (C

H 3) 2

CHC

H 2CH

(NH 2

) COO

H

Isol

euci

ne -

CH

3CH 2

CH (C

H 3) C

H (N

H 2) C

OOH

Valin

e -

(CH 3

) 2 C

HCH

(NH 2

) COO

H

Lysi

ne (a

dded

as

the

hydr

ochl

orid

e

salt)

- H 2

N (C

H 2) 4

CH

(NH 2

) COO

H

Phen

ylal

anin

e -

(C6H

5) C

H 2 C

H (N

H 2) C

OOH

Hist

idin

e -

(C3H

3N2)

CH 2

CH (N

H 2) C

OOH

Thre

onin

e -

CH3C

H (O

H) C

H (N

H 2) C

OOH

Met

hion

ine

- CH

3S (C

H 2) 2

CH

(NH 2

) COO

H

Tryp

toph

an -

(C

8H6N

) CH 2

CH

(NH 2

) COO

H

Alan

ine

- CH 3

CH (N

H 2) C

OOH

Argi

nine

-

H 2NC

(NH)

NH

(CH 2

) 3 C

H (N

H 2) C

OOH

Glyc

ine

- H2N

CH2C

OOH

Prol

ine

- [(C

H 2) 3

NH

CH] C

OOH

Serin

e - H

OCH 2

CH (N

H 2) C

OOH

Tyro

sine

-

[C6H

4 (O

H)] C

H 2CH

(NH 2

) COO

H

Acet

ate3

Chlo

ride4

pH5

(ran

ge)

Osm

olar

ity (m

Osm

ol/L

) (c

alc)

From

Dex

trose

From

Am

ino

Acid

s

TOTA

L (D

extro

se a

nd A

min

o Ac

ids)

07-1

9-57

-358




Document No.: 07-19-57-358Change No.: CP0329253Page 2 of 2P1 27 Aug 2010

Documents

CLINIMIX and CLINIMIX E Injections · CLINIMIX and CLINIMIX E Injections Macronutrient & Micronutrient Infusion Rate Chart INDICATIONS CLINIMIX sulfite-free (Amino Acid in Dextrose)