clinimix and clinimix e injections · please see accompanying package insert for full prescribing...
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CLINIMIX And CLINIMIX E InjectionsNutrient Profile
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 Important Risk Information on inside page Please see accompanying Package Inserts for Full Prescribing Information
To Mix Solutions1 Grasp the container firmly on
each side of the top of the bag (hanger end).
2 Roll the bag to open seal between chambers as shown.
3 Mix solutions thoroughly.4 Check for leaks.
SELECTED IMPORTANT RISK INFORMATIONBecause of the potential for life-threatening events, caution should be taken to ensure that precipitates have not formed in any parenteral nutrient admixture.
With Vertical Peel Seal CLARITY Dual Chamber Container in 1 L and 2 L sizes
* without additives
Please see accompanying Package Insert for full Prescribing Information
Clinimix sulfite-free (Amino Acid in Dextrose) and Clinimix E sulfite-free (Amino Acid with Electrolytes in Dextrose with Calcium) Injections Nutritional Profile: Nutrients per 1-Liter Container
1 ProductCLINIMIX Inj. CLINIMIX Inj. CLINIMIX Inj. CLINIMIX Inj. CLINIMIX Inj. CLINIMIX Inj. CLINIMIX Inj. CLINIMIX Inj. CLINIMIX E Inj. CLINIMIX E Inj. CLINIMIX E Inj. CLINIMIX E Inj. CLINIMIX E Inj. CLINIMIX E Inj. CLINIMIX E Inj. CLINIMIX E Inj.
2B7725 2B7726 2B7727 2B7728 2B7729 2B7730 2B7731 2B7732 2B7735 2B7736 2B7737 2B7738 2B7739 2B7740 2B7741 2B7742liter 2.75/5 4.25/5 4.25/10 4.25/20 4.25/25 5/15 5/20 5/25 2.75/5 2.75/10 4.25/5 4.25/10 4.25/25 5/15 5/20 5/25
Total Volume (without lipids) 1-Liter 1-Liter 1-Liter 1-Liter 1-Liter 1-Liter 1-Liter 1-Liter 1-Liter 1-Liter 1-Liter 1-Liter 1-Liter 1-Liter 1-Liter 1-LiterAmino Acid Concentration 2.75% 4.25% 4.25% 4.25% 4.25% 5% 5% 5% 2.75% 2.75% 4.25% 4.25% 4.25% 5% 5% 5%Dextrose Concentration 5% 5% 10% 20% 25% 15% 20% 25% 5% 10% 5% 10% 25% 15% 20% 25%gm Dextrose/L 50 50 100 200 250 150 200 250 50 100 50 100 250 150 200 250gm Amino Acids/L 27.5 42.5 42.5 42.5 42.5 50 50 50 27.5 27.5 42.5 42.5 42.5 50 50 50gm Nitrogen/L 4.54 7.02 7.02 7.02 7.02 8.26 8.26 8.26 4.54 4.54 7.02 7.02 7.02 8.26 8.26 8.26Sodium (mEq/L) -- -- -- -- -- -- -- -- 35 35 35 35 35 35 35 35Potassium (mEq/L) -- -- -- -- -- -- -- -- 30 30 30 30 30 30 30 30Magnesium (mEq/L) -- -- -- -- -- -- -- -- 5 5 5 5 5 5 5 5Calcium (mEq/L) -- -- -- -- -- -- -- -- 4.5 4.5 4.5 4.5 4.5 4.5 4.5 4.5Acetate (mEq/L) 24 37 37 37 37 42 42 42 51 51 70 70 70 80 80 80Chloride (mEq/L) 11 17 17 17 17 20 20 20 39 39 39 39 39 39 39 39Phosphate (as HPO4
=) (mmol/L) -- -- -- -- -- -- -- -- 15 15 15 15 15 15 15 15pH* 6.0 6.0 6.0 6.0 6.0 6.0 6.0 6.0 6.0 6.0 6.0 6.0 6.0 6.0 6.0 6.0Osmolarity (mOsmol/L) 525 675 930 1435 1685 1255 1505 1760 665 920 815 1070 1825 1395 1650 1900Kcal from Amino Acids/L 110 170 170 170 170 200 200 200 110 110 170 170 170 200 200 200Kcal from Dextrose/L 170 170 340 680 850 510 680 850 170 340 170 340 850 510 680 850Total Kcal/L 280 340 510 850 1020 710 880 1050 280 450 340 510 1020 710 880 1050Total Kcal with IV Fat Emulsion added**
+ 20% 500 mL (1000 Kcal) 1280 1340 1510 1850 2020 1710 1880 2050 1280 1450 1340 1510 2020 1710 1880 2050+ 20% 250 mL (500 Kcal) 780 840 1010 1350 1520 1210 1380 1550 780 950 840 1010 1520 1210 1380 1550+ 10% 500 mL (550 Kcal) 830 890 1060 1400 1570 1260 1430 1600 830 1000 890 1060 1570 1260 1430 1600+ 10% 250 mL (275 Kcal) 555 615 785 1125 1295 985 1155 1325 555 725 615 785 1295 985 1155 1325
Fina
l con
cent
ratio
ns
AFTE
R m
ixin
g.
* pH Range = 4.5-7.0 ** Data on file, Baxter Healthcare Corporation.
Please see accompanying Package Insert for full Prescribing Information
Clinimix sulfite-free (Amino Acid in Dextrose) and Clinimix E sulfite-free (Amino Acid with Electrolytes in Dextrose with Calcium) Injections Nutritional Profile: Nutrients per 1-Liter Container
1 ProductCLINIMIX Inj. CLINIMIX Inj. CLINIMIX Inj. CLINIMIX Inj. CLINIMIX Inj. CLINIMIX Inj. CLINIMIX Inj. CLINIMIX Inj. CLINIMIX E Inj. CLINIMIX E Inj. CLINIMIX E Inj. CLINIMIX E Inj. CLINIMIX E Inj. CLINIMIX E Inj. CLINIMIX E Inj. CLINIMIX E Inj.
2B7725 2B7726 2B7727 2B7728 2B7729 2B7730 2B7731 2B7732 2B7735 2B7736 2B7737 2B7738 2B7739 2B7740 2B7741 2B7742liter 2.75/5 4.25/5 4.25/10 4.25/20 4.25/25 5/15 5/20 5/25 2.75/5 2.75/10 4.25/5 4.25/10 4.25/25 5/15 5/20 5/25
Total Volume (without lipids) 1-Liter 1-Liter 1-Liter 1-Liter 1-Liter 1-Liter 1-Liter 1-Liter 1-Liter 1-Liter 1-Liter 1-Liter 1-Liter 1-Liter 1-Liter 1-LiterAmino Acid Concentration 2.75% 4.25% 4.25% 4.25% 4.25% 5% 5% 5% 2.75% 2.75% 4.25% 4.25% 4.25% 5% 5% 5%Dextrose Concentration 5% 5% 10% 20% 25% 15% 20% 25% 5% 10% 5% 10% 25% 15% 20% 25%gm Dextrose/L 50 50 100 200 250 150 200 250 50 100 50 100 250 150 200 250gm Amino Acids/L 27.5 42.5 42.5 42.5 42.5 50 50 50 27.5 27.5 42.5 42.5 42.5 50 50 50gm Nitrogen/L 4.54 7.02 7.02 7.02 7.02 8.26 8.26 8.26 4.54 4.54 7.02 7.02 7.02 8.26 8.26 8.26Sodium (mEq/L) -- -- -- -- -- -- -- -- 35 35 35 35 35 35 35 35Potassium (mEq/L) -- -- -- -- -- -- -- -- 30 30 30 30 30 30 30 30Magnesium (mEq/L) -- -- -- -- -- -- -- -- 5 5 5 5 5 5 5 5Calcium (mEq/L) -- -- -- -- -- -- -- -- 4.5 4.5 4.5 4.5 4.5 4.5 4.5 4.5Acetate (mEq/L) 24 37 37 37 37 42 42 42 51 51 70 70 70 80 80 80Chloride (mEq/L) 11 17 17 17 17 20 20 20 39 39 39 39 39 39 39 39Phosphate (as HPO4
=) (mmol/L) -- -- -- -- -- -- -- -- 15 15 15 15 15 15 15 15pH* 6.0 6.0 6.0 6.0 6.0 6.0 6.0 6.0 6.0 6.0 6.0 6.0 6.0 6.0 6.0 6.0Osmolarity (mOsmol/L) 525 675 930 1435 1685 1255 1505 1760 665 920 815 1070 1825 1395 1650 1900Kcal from Amino Acids/L 110 170 170 170 170 200 200 200 110 110 170 170 170 200 200 200Kcal from Dextrose/L 170 170 340 680 850 510 680 850 170 340 170 340 850 510 680 850Total Kcal/L 280 340 510 850 1020 710 880 1050 280 450 340 510 1020 710 880 1050Total Kcal with IV Fat Emulsion added**
+ 20% 500 mL (1000 Kcal) 1280 1340 1510 1850 2020 1710 1880 2050 1280 1450 1340 1510 2020 1710 1880 2050+ 20% 250 mL (500 Kcal) 780 840 1010 1350 1520 1210 1380 1550 780 950 840 1010 1520 1210 1380 1550+ 10% 500 mL (550 Kcal) 830 890 1060 1400 1570 1260 1430 1600 830 1000 890 1060 1570 1260 1430 1600+ 10% 250 mL (275 Kcal) 555 615 785 1125 1295 985 1155 1325 555 725 615 785 1295 985 1155 1325
CLINIMIX SULFITE-FREE (AMINO ACID IN DEXTROSE) AND CLINIMIX E SULFITE-FREE (AMINO ACID WITH ELECTROLYTES IN DEXTROSE WITH CALCIUM) INJECTIONSIMPORTANT RISK INFORMATION
• It is essential that a carefully prepared protocol based on current medical practices be followed, preferably by an experienced team. Frequent clinical evaluation and laboratory determinations are necessary for proper monitoring during administration.
• CLINIMIX and CLINIMIX E Injections are contraindicated in patients having intracranial or intraspinal hemorrhage, in patients who are severely dehydrated, in patients hypersensitive to one or more amino acids and in patients with severe liver disease or hepatic coma. Solutions containing corn-derived dextrose may be contraindicated in patients with known allergy to corn or corn products.
• Because of the potential for life-threatening events, caution should be taken to ensure that precipitates have not formed in any parenteral nutrient admixture.
• Use with caution when administering to patients with anuria or renal insufficiency, pulmonary insufficiency, or heart disease. The intravenous administration of these solutions can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states, or pulmonary edema.
• Metabolic complications have been reported, such as acid-base, electrolyte, and blood glucose imbalances, elevated liver enzymes, and osmotic diuresis and dehydration.
• Other adverse reactions that may occur include febrile response, infection at the site of injection, extravasation, and hypervolemia. The infusion of hypertonic nutrient injections into a peripheral vein may result in vein irritation, vein damage, and thrombosis.
• This product contains aluminum that may be toxic with prolonged parenteral administration if kidney function is impaired.
• CLINIMIX and CLINIMIX E Injections must be admixed prior to infusion.
Please see accompanying Package Insert for full Prescribing Information
Total Volume (without lipids) 2-Liter 2-Liter 2-Liter 2-Liter 2-Liter 2-Liter 2-Liter 2-Liter 2-Liter 2-Liter 2-Liter 2-Liter 2-Liter 2-Liter 2-Liter
Amino Acid Concentration 4.25% 4.25% 4.25% 4.25% 5% 5% 5% 2.75% 2.75% 4.25% 4.25% 4.25% 5% 5% 5%
Dextrose Concentration 5% 10% 20% 25% 15% 20% 25% 5% 10% 5% 10% 25% 15% 20% 25%
gm Dextrose/2 L 100 200 400 500 300 400 500 100 200 100 200 500 300 400 500
gm Amino Acids/2 L 85 85 85 85 100 100 100 55 55 85 85 85 100 100 100
gm Nitrogen/2 L 14.04 14.04 14.04 14.04 16.52 16.52 16.52 9.08 9.08 14.04 14.04 14.04 16.52 16.52 16.52
Sodium (mEq/2 L) -- -- -- -- -- -- -- 70 70 70 70 70 70 70 70
Potassium (mEq/2 L) -- -- -- -- -- -- -- 60 60 60 60 60 60 60 60
Magnesium (mEq/2 L) -- -- -- -- -- -- -- 10 10 10 10 10 10 10 10
Calcium (mEq/2 L) -- -- -- -- -- -- -- 9 9 9 9 9 9 9 9
Acetate (mEq/2 L) 74 74 74 74 84 84 84 102 102 140 140 140 160 160 160
Chloride (mEq/2 L) 34 34 34 34 40 40 40 78 78 78 78 78 78 78 78
Phosphate (as HPO4=) (mmol/2 L) -- -- -- -- -- -- -- 30 30 30 30 30 30 30 30
pH* 6.0 6.0 6.0 6.0 6.0 6.0 6.0 6.0 6.0 6.0 6.0 6.0 6.0 6.0 6.0
Osmolarity (mOsmol/L) 675 930 1435 1685 1255 1505 1760 665 920 815 1070 1825 1395 1650 1900
Kcal from Amino Acids/2 L 340 340 340 340 400 400 400 220 220 340 340 340 400 400 400
Kcal from Dextrose/2 L 340 680 1360 1700 1020 1360 1700 340 680 340 680 1700 1020 1360 1700
Total Kcal/2 L 680 1020 1700 2040 1420 1760 2100 560 900 680 1020 2040 1420 1760 2100
Total Kcal with IV Fat Emulsion added**+ 20% 500 mL (1000 Kcal) 1680 2020 2700 3040 2420 2760 3100 1560 1900 1680 2020 3040 2420 2760 3100+ 20% 250 mL (500 Kcal) 1180 1520 2200 2540 1920 2260 2600 1060 1400 1180 1520 2540 1920 2260 2600+ 10% 500 mL (550 Kcal) 1230 1570 2250 2590 1970 2310 2650 1110 1450 1230 1570 2590 1970 2310 2650+ 10% 250 mL (275 Kcal) 955 1295 1975 2315 1695 2035 2375 835 1175 955 1295 2315 1695 2035 2375
* pH Range = 4.5-7.0 ** Data on file, Baxter Healthcare Corporation. Please see accompanying Package Insert for full Prescribing Information
2 ProductCLINIMIX Inj. CLINIMIX Inj. CLINIMIX Inj. CLINIMIX Inj. CLINIMIX Inj. CLINIMIX Inj. CLINIMIX Inj. CLINIMIX E Inj. CLINIMIX E Inj. CLINIMIX E Inj. CLINIMIX E Inj. CLINIMIX E Inj. CLINIMIX E Inj. CLINIMIX E Inj. CLINIMIX E Inj.
2B7704 2B7705 2B7706 2B7707 2B7709 2B7710 2B7711 2B7713 2B7714 2B7716 2B7717 2B7719 2B7721 2B7722 2B7723liter 4.25/5 4.25/10 4.25/20 4.25/25 5/15 5/20 5/25 2.75/5 2.75/10 4.25/5 4.25/10 4.25/25 5/15 5/20 5/25
Clinimix sulfite-free (Amino Acid in Dextrose) and Clinimix E sulfite-free (Amino Acid with Electrolytes in Dextrose with Calcium) Injections Nutritional Profile: Nutrients per 2-Liter Container
Fina
l con
cent
ratio
ns
AFTE
R m
ixin
g.
Total Volume (without lipids) 2-Liter 2-Liter 2-Liter 2-Liter 2-Liter 2-Liter 2-Liter 2-Liter 2-Liter 2-Liter 2-Liter 2-Liter 2-Liter 2-Liter 2-Liter
Amino Acid Concentration 4.25% 4.25% 4.25% 4.25% 5% 5% 5% 2.75% 2.75% 4.25% 4.25% 4.25% 5% 5% 5%
Dextrose Concentration 5% 10% 20% 25% 15% 20% 25% 5% 10% 5% 10% 25% 15% 20% 25%
gm Dextrose/2 L 100 200 400 500 300 400 500 100 200 100 200 500 300 400 500
gm Amino Acids/2 L 85 85 85 85 100 100 100 55 55 85 85 85 100 100 100
gm Nitrogen/2 L 14.04 14.04 14.04 14.04 16.52 16.52 16.52 9.08 9.08 14.04 14.04 14.04 16.52 16.52 16.52
Sodium (mEq/2 L) -- -- -- -- -- -- -- 70 70 70 70 70 70 70 70
Potassium (mEq/2 L) -- -- -- -- -- -- -- 60 60 60 60 60 60 60 60
Magnesium (mEq/2 L) -- -- -- -- -- -- -- 10 10 10 10 10 10 10 10
Calcium (mEq/2 L) -- -- -- -- -- -- -- 9 9 9 9 9 9 9 9
Acetate (mEq/2 L) 74 74 74 74 84 84 84 102 102 140 140 140 160 160 160
Chloride (mEq/2 L) 34 34 34 34 40 40 40 78 78 78 78 78 78 78 78
Phosphate (as HPO4=) (mmol/2 L) -- -- -- -- -- -- -- 30 30 30 30 30 30 30 30
pH* 6.0 6.0 6.0 6.0 6.0 6.0 6.0 6.0 6.0 6.0 6.0 6.0 6.0 6.0 6.0
Osmolarity (mOsmol/L) 675 930 1435 1685 1255 1505 1760 665 920 815 1070 1825 1395 1650 1900
Kcal from Amino Acids/2 L 340 340 340 340 400 400 400 220 220 340 340 340 400 400 400
Kcal from Dextrose/2 L 340 680 1360 1700 1020 1360 1700 340 680 340 680 1700 1020 1360 1700
Total Kcal/2 L 680 1020 1700 2040 1420 1760 2100 560 900 680 1020 2040 1420 1760 2100
Total Kcal with IV Fat Emulsion added**+ 20% 500 mL (1000 Kcal) 1680 2020 2700 3040 2420 2760 3100 1560 1900 1680 2020 3040 2420 2760 3100+ 20% 250 mL (500 Kcal) 1180 1520 2200 2540 1920 2260 2600 1060 1400 1180 1520 2540 1920 2260 2600+ 10% 500 mL (550 Kcal) 1230 1570 2250 2590 1970 2310 2650 1110 1450 1230 1570 2590 1970 2310 2650+ 10% 250 mL (275 Kcal) 955 1295 1975 2315 1695 2035 2375 835 1175 955 1295 2315 1695 2035 2375
Please see accompanying Package Insert for full Prescribing Information
2 ProductCLINIMIX Inj. CLINIMIX Inj. CLINIMIX Inj. CLINIMIX Inj. CLINIMIX Inj. CLINIMIX Inj. CLINIMIX Inj. CLINIMIX E Inj. CLINIMIX E Inj. CLINIMIX E Inj. CLINIMIX E Inj. CLINIMIX E Inj. CLINIMIX E Inj. CLINIMIX E Inj. CLINIMIX E Inj.
2B7704 2B7705 2B7706 2B7707 2B7709 2B7710 2B7711 2B7713 2B7714 2B7716 2B7717 2B7719 2B7721 2B7722 2B7723liter 4.25/5 4.25/10 4.25/20 4.25/25 5/15 5/20 5/25 2.75/5 2.75/10 4.25/5 4.25/10 4.25/25 5/15 5/20 5/25
Clinimix sulfite-free (Amino Acid in Dextrose) and Clinimix E sulfite-free (Amino Acid with Electrolytes in Dextrose with Calcium) Injections Nutritional Profile: Nutrients per 2-Liter Container
For more information, contact Medical Informationat 1-800-422-2751 or visit
www.baxtermedicationdeliveryproducts.com
www.baxter.comBaxter Healthcare Corporation Route 120 and Wilson Road Round Lake, IL 60073
Baxter, Clarity, Clinimix, Clinimix E, the Clinimix logo are trademarks of Baxter International Inc.
USMP/78/14-0004 3/14
Please see Important Risk Information on inside page Please see accompanying Package Inserts for Full Prescribing Information