CLINIMIX And CLINIMIX E Injections
Transcription
CLINIMIX And CLINIMIX E Injections
CLINIMIX And CLINIMIX E Injections Nutrient 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 Solutions 1G rasp the container firmly on each side of the top of the bag (hanger end). 2R oll the bag to open seal between chambers as shown. 3 Mix solutions thoroughly. 4 Check for leaks. SELECTED IMPORTANT RISK INFORMATION Because 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 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 Product Final concentrations AFTER mixing. liter + + + + Total Volume (without lipids) Amino Acid Concentration Dextrose Concentration gm Dextrose/L gm Amino Acids/L gm Nitrogen/L Sodium (mEq/L) Potassium (mEq/L) Magnesium (mEq/L) Calcium (mEq/L) Acetate (mEq/L) Chloride (mEq/L) Phosphate (as HPO4 = ) (mmol/L) pH* Osmolarity (mOsmol/L) Kcal from Amino Acids/L Kcal from Dextrose/L Total Kcal/L Total Kcal with IV Fat Emulsion added** 20% 500 mL (1000 Kcal) 20% 250 mL (500 Kcal) 10% 500 mL (550 Kcal) 10% 250 mL (275 Kcal) * pH Range = 4.5-7.0 ** Data on file, Baxter Healthcare Corporation. CLINIMIX Inj. 2B7725 2.75/5 CLINIMIX Inj. 2B7726 4.25/5 CLINIMIX Inj. 2B7727 4.25/10 CLINIMIX Inj. 2B7728 4.25/20 CLINIMIX Inj. 2B7729 4.25/25 CLINIMIX Inj. 2B7730 5/15 1-Liter 2.75% 5% 50 27.5 4.54 ----24 11 -6.0 525 110 170 280 1-Liter 4.25% 5% 50 42.5 7.02 ----37 17 -6.0 675 170 170 340 1-Liter 4.25% 10% 100 42.5 7.02 ----37 17 -6.0 930 170 340 510 1-Liter 4.25% 20% 200 42.5 7.02 ----37 17 -6.0 1435 170 680 850 1-Liter 4.25% 25% 250 42.5 7.02 ----37 17 -6.0 1685 170 850 1020 1-Liter 5% 15% 150 50 8.26 ----42 20 -6.0 1255 200 510 710 1280 780 830 555 1340 840 890 615 1510 1010 1060 785 1850 1350 1400 1125 2020 1520 1570 1295 1710 1210 1260 985 Please see accompanying Package Insert for full Prescribing Information CLINIMIX Inj. 2B7731 5/20 CLINIMIX Inj. 2B7732 5/25 CLINIMIX E Inj. 2B7735 2.75/5 CLINIMIX E Inj. 2B7736 2.75/10 CLINIMIX E Inj. 2B7737 4.25/5 CLINIMIX E Inj. 2B7738 4.25/10 CLINIMIX E Inj. CLINIMIX E Inj. 2B7739 2B7740 4.25/25 5/15 1-Liter 5% 20% 200 50 8.26 ----42 20 -6.0 1505 200 680 880 1-Liter 5% 25% 250 50 8.26 ----42 20 -6.0 1760 200 850 1050 1-Liter 2.75% 5% 50 27.5 4.54 35 30 5 4.5 51 39 15 6.0 665 110 170 280 1-Liter 2.75% 10% 100 27.5 4.54 35 30 5 4.5 51 39 15 6.0 920 110 340 450 1-Liter 4.25% 5% 50 42.5 7.02 35 30 5 4.5 70 39 15 6.0 815 170 170 340 1-Liter 4.25% 10% 100 42.5 7.02 35 30 5 4.5 70 39 15 6.0 1070 170 340 510 1-Liter 4.25% 25% 250 42.5 7.02 35 30 5 4.5 70 39 15 6.0 1825 170 850 1020 1880 1380 1430 1155 2050 1550 1600 1325 1280 780 830 555 1450 950 1000 725 1340 840 890 615 1510 1010 1060 785 2020 1520 1570 1295 CLINIMIX E Inj. 2B7741 5/20 CLINIMIX E Inj. 2B7742 5/25 1-Liter 5% 15% 150 50 8.26 35 30 5 4.5 80 39 15 6.0 1395 200 510 710 1-Liter 5% 20% 200 50 8.26 35 30 5 4.5 80 39 15 6.0 1650 200 680 880 1-Liter 5% 25% 250 50 8.26 35 30 5 4.5 80 39 15 6.0 1900 200 850 1050 1710 1210 1260 985 1880 1380 1430 1155 2050 1550 1600 1325 CLINIMIX SULFITE-FREE (AMINO ACID IN DEXTROSE) AND CLINIMIX E SULFITE-FREE (AMINO ACID WITH ELECTROLYTES IN DEXTROSE WITH CALCIUM) INJECTIONS IMPORTANT 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 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 2 Product Final concentrations AFTER mixing. liter + + + + Total Volume (without lipids) Amino Acid Concentration Dextrose Concentration gm Dextrose/2 L gm Amino Acids/2 L gm Nitrogen/2 L Sodium (mEq/2 L) Potassium (mEq/2 L) Magnesium (mEq/2 L) Calcium (mEq/2 L) Acetate (mEq/2 L) Chloride (mEq/2 L) Phosphate (as HPO4 = ) (mmol/2 L) pH* Osmolarity (mOsmol/L) Kcal from Amino Acids/2 L Kcal from Dextrose/2 L Total Kcal/2 L Total Kcal with IV Fat Emulsion added** 20% 500 mL (1000 Kcal) 20% 250 mL (500 Kcal) 10% 500 mL (550 Kcal) 10% 250 mL (275 Kcal) * pH Range = 4.5-7.0 ** Data on file, Baxter Healthcare Corporation. CLINIMIX Inj. 2B7704 4.25/5 CLINIMIX Inj. 2B7705 4.25/10 CLINIMIX Inj. 2B7706 4.25/20 CLINIMIX Inj. 2B7707 4.25/25 CLINIMIX Inj. 2B7709 5/15 CLINIMIX Inj. 2B7710 5/20 2-Liter 4.25% 5% 100 85 14.04 ----74 34 -6.0 675 340 340 680 2-Liter 4.25% 10% 200 85 14.04 ----74 34 -6.0 930 340 680 1020 2-Liter 4.25% 20% 400 85 14.04 ----74 34 -6.0 1435 340 1360 1700 2-Liter 4.25% 25% 500 85 14.04 ----74 34 -6.0 1685 340 1700 2040 2-Liter 5% 15% 300 100 16.52 ----84 40 -6.0 1255 400 1020 1420 2-Liter 5% 20% 400 100 16.52 ----84 40 -6.0 1505 400 1360 1760 1680 1180 1230 955 2020 1520 1570 1295 2700 2200 2250 1975 3040 2540 2590 2315 2420 1920 1970 1695 2760 2260 2310 2035 Please see accompanying Package Insert for full Prescribing Information C CLINIMIX Inj. 2B7711 5/25 CLINIMIX E Inj. 2B7713 2.75/5 CLINIMIX E Inj. 2B7714 2.75/10 CLINIMIX E Inj. 2B7716 4.25/5 CLINIMIX E Inj. 2B7717 4.25/10 CLINIMIX E Inj. 2B7719 4.25/25 CLINIMIX E Inj. 2B7721 5/15 CLINIMIX E Inj. 2B7722 5/20 CLINIMIX E Inj. 2B7723 5/25 2-Liter 5% 25% 500 100 16.52 ----84 40 -6.0 1760 400 1700 2100 2-Liter 2.75% 5% 100 55 9.08 70 60 10 9 102 78 30 6.0 665 220 340 560 2-Liter 2.75% 10% 200 55 9.08 70 60 10 9 102 78 30 6.0 920 220 680 900 2-Liter 4.25% 5% 100 85 14.04 70 60 10 9 140 78 30 6.0 815 340 340 680 2-Liter 4.25% 10% 200 85 14.04 70 60 10 9 140 78 30 6.0 1070 340 680 1020 2-Liter 4.25% 25% 500 85 14.04 70 60 10 9 140 78 30 6.0 1825 340 1700 2040 2-Liter 5% 15% 300 100 16.52 70 60 10 9 160 78 30 6.0 1395 400 1020 1420 2-Liter 5% 20% 400 100 16.52 70 60 10 9 160 78 30 6.0 1650 400 1360 1760 2-Liter 5% 25% 500 100 16.52 70 60 10 9 160 78 30 6.0 1900 400 1700 2100 3100 2600 2650 2375 1560 1060 1110 835 1900 1400 1450 1175 1680 1180 1230 955 2020 1520 1570 1295 3040 2540 2590 2315 2420 1920 1970 1695 2760 2260 2310 2035 3100 2600 2650 2375 For more information, contact Medical Information at 1-800-422-2751 or visit www.baxtermedicationdeliveryproducts.com Please see Important Risk Information on inside page Please see accompanying Package Inserts for Full Prescribing Information www.baxter.com Baxter 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