CLINIMIX E

6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the prescribing information. • Pulmonary embolism due to pulmonary vascular precipitates [see Warnings and Precautions (5.1) ] • Death in neonates due to calcium-ceftriaxone precipitates [see Warnings and Precautions (5.2) ] • Hypersensitivity reactions [see Warnings and Precautions (5.3) ] • Risk of Infections [see Warnings and Precautions (5.4) ] • Refeeding syndrome [see Warnings and Precautions (5.5) ] • Hyperglycemia or hyperosmolar hyperglycemic state [see Warnings and Precautions (5.6) ] • Vein damage and thrombosis [see Warnings and Precautions (5.7) ] • Hepatobiliary disorders [see Warnings and Precautions (5.8) ] • Parenteral Nutrition Associated Liver Disease (PNALD) [see Warnings and Precautions (5.10) ] • Electrolyte imbalance and fluid overload [see Warnings and Precautions (5.11) ] The following adverse reactions from voluntary reports or clinical studies have been reported with CLINIMIX E. Because many of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. • Diuresis • Extravasation • Glycosuria • Hyperglycemia • Hyperosmolar coma Adverse reactions include diuresis, extravasation, glycosuria, hyperglycemia, and hyperosmolar coma. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare Corporation at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

4 CONTRAINDICATIONS The use of CLINIMIX E is contraindicated in: 1. Neonates (28 days of age or younger) receiving concomitant treatment with ceftriaxone, even if separate infusion lines are used, due to the risk of fatal ceftriaxone calcium salt precipitation in the neonate’s bloodstream [see Warnings and Precautions (5.2) , Use in Specific Populations (8.4) ] . 2. Patients with known hypersensitivity to one or more amino acids or dextrose [see Warnings and Precautions (5.3) ] . 3. Patients with inborn errors of amino acid metabolism due to risk of severe metabolic and neurologic complications. 4. Patients with pulmonary edema or acidosis due to low cardiac output. • Concomitant treatment with ceftriaxone in neonates (28 days of age or younger). ( 4 ) • Known hypersensitivity to one or more amino acids or dextrose. ( 4 ) • Inborn errors of amino acid metabolism. ( 4 ) • Patients with pulmonary edema or acidosis due to low cardiac output. ( 4 )

11 DESCRIPTION CLINIMIX E sulfite-free (amino acids with electrolytes in dextrose with calcium) injection for intravenous use consists of sterile, nonpyrogenic, hypertonic solutions in a dual chamber container. The outlet port chamber contains essential and nonessential amino acids with electrolytes. The formulas for the individual electrolytes and amino acids are provided in Table 8. Table 8: Formulas for Electrolytes and Amino Acids Electrolytes Sodium Acetate C 2 H 3 NaO 2 •3H 2 O Potassium Phosphate, dibasic K 2 HPO 4 Magnesium Chloride MgCl 2 •6H 2 O Sodium Chloride NaCl Essential Amino Acids Leucine (CH 3 ) 2 CHCH 2 CH (NH 2 ) COOH Isoleucine CH 3 CH 2 CH (CH 3 ) CH (NH 2 ) COOH Valine (CH 3 ) 2 CHCH (NH 2 ) COOH Lysine (added as the hydrochloride salt) H 2 N (CH 2 ) 4 CH (NH 2 ) COOH Phenylalanine (C 6 H 5 ) CH 2 CH (NH 2 ) COOH Histidine (C 3 H 3 N 2 ) CH 2 CH (NH 2 ) COOH Threonine CH 3 CH (OH) CH (NH 2 ) COO Methionine CH 3 S (CH 2 )2 CH (NH 2 ) COOH Tryptophan (C 8 H 6 N) CH 2 CH (NH 2 ) COOH Nonessential Amino Acids Alanine CH 3 CH (NH 2 ) COOH Arginine H 2 NC (NH) NH (CH 2 )3 CH (NH 2 ) COOH Glycine H 2 NCH 2 COOH Proline [(CH 2 ) 3 NH CH] COOH Serine HOCH 2 CH (NH 2 ) COOH Tyrosine [C 6 H 4 (OH)] CH 2 CH (NH 2 ) COOH The injection port chamber contains dextrose with calcium. The formula for Calcium Chloride is: CaCl 2 •2H 2 O. Dextrose, USP, is chemically designated D-glucose, monohydrate (C 6 H 12 O 6 • H 2 O) and has the following structure: Dextrose is derived from corn. See Table 7 for composition, pH, osmolarity, ionic concentration and caloric content of the admixed product [see Dosage Forms and Strengths (3) ]. The dual chamber container is a lipid-compatible plastic container (PL 2401 Plastic). CLINIMIX E contains no more than 25 mcg/L of aluminum. Dextrose Hydrous Structural Formula

2 DOSAGE AND ADMINISTRATION See full prescribing information for information on preparation, administration, instructions for use, dosing considerations, including the recommended dosage in adults and pediatrics, and dosage modifications in patients with kidney disease. ( 2.1 , 2.2 , 2.3 , 2.4 , 2.5 , 2.6 , 2.7 , 2.8 ) 2.1 Preparation Prior to Administration • CLINIMIX E is available in a three port container configuration and a two port container configuration. • Three Port Container: the ports consist of one medication port, one additive port and one outlet port. Additives can be introduced to the container through the medication port and lipids through the additive port on the three port container. • Two Port Container: the ports consist of one medication port and one outlet port. Additives, including lipids, can be introduced to the container through the medication port on the two port container. • Tear protective overwrap at slit and remove solution container. Small amounts of moisture may be found on the solution container from water permeating from inside the container. The amount of permeated water is insufficient to affect the solution significantly. If larger amounts of water are found, the container should be checked for tears or leaks. • Inspect the container prior to activation. 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. Evaluate the following: • If the outlet or additive port protectors are damaged, detached, or not present, discard container as solution path sterility may be impaired. • Check to ensure seal between chambers is intact, solutions are contained in separate chambers, and the content of the individual chambers is clear, colorless or slightly yellow. Discard if the seal is broken or if the solution is bright yellow or yellowish brown. • 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. • Lipids and/or additives can be introduced to the container after opening seal between chambers. Because additives may be incompatible, evaluate all additions to the plastic container for compatibility. Activate chambers of container prior to introduction of additives. Mix thoroughly when additives have been introduced. Supplemental medication may be added with a 19 to 22 gauge needle through the medication port. • Calcium and phosphate ratios must be considered. Excess addition of calcium and phosphate, especially in the form of mineral salts, may result in the formation of calcium phosphate precipitates [see Warnings and Precautions (5.1) ]. • Inspect the container to ensure precipitates have not formed during the mixing or addition of additives. A slight yellow color does not alter the quality and efficacy of this product. If lipid has been added, ensure the emulsion has not separated. Separation of the emulsion can be visibly identified by a yellowish streaking or the accumulation of yellowish droplets in the mixed emulsion. Discard the admixture if any of the above are observed. 2.2 Important Administration Instructions • Set the vent to the closed position on a vented intravenous administration set to prevent air embolism. • Use a dedicated line without any connections to avoid air embolism. • CLINIMIX E is for intravenous infusion only into a central or peripheral vein. The choice of a central or peripheral venous route should depend on the osmolarity of the final infusate. Solutions with osmolarity of 900 mOsm/L or greater must be infused through a central catheter [see Warnings and Precautions (5.7) ]. • For central vein infusion only: CLINIMIX E 4.25/10, 5/15, 5/20, 8/10, 8/14 • For central or peripheral vein infusion: CLINIMIX E 2.75/5 and 4.25/5 • The solution should be inspected for precipitates before admixing, after admixing, and again before administration. • Use a 0.22 micron filter for administration of CLINIMIX E. If a lipid is also administered, use a 1.2 micron filter. • If lipid emulsion is added, do not use administration sets and lines that contain di-2-ethylhexyl phthalate (DEHP). Administration sets that contain polyvinyl chloride (PVC) components have DEHP as a plasticizer. • Ceftriaxone must not be administered simultaneously with calcium-containing intravenous solutions such as CLINIMIX E via a Y-site. However, in patients other than neonates, ceftriaxone and CLINIMIX E may be administered sequentially if the infusion lines are thoroughly flushed between infusions with a compatible fluid [see Contraindications (4) , Warnings and Precautions (5.2) ] . 2.3 Instructions for Use 1. Open by tearing protective overwrap at slit and remove solution container. The two port container includes an oxygen-absorbing sachet. Discard the oxygen-absorbing sachet after removal from the overwrap. 2. To proceed with activation, the container should be at room temperature. Lay the room temperature container onto a flat surface. Grasp the container firmly on each side of the top of the container ( Figure 1 ). 3. Starting from the top, using some pressure, slowly roll the container to open seal between chambers as shown in Figure 2 . Do not pull or rip the seal apart. The seal must be completely opened towards the port side of the container. The upper section of the seal towards the hanger side can remain unbroken. 4. Mix the contents thoroughly by inverting the container upside down to ensure a homogenous admixture ( Figure 3 ). 5. Once the container is mixed, check for leaks. 6. Make additions (if prescribed). Because additives may be incompatible, evaluate all additions to the container for compatibility and stability of the resulting preparation. Consult with pharmacist, if available. Questions about compatibility may be directed to Baxter. If it is deemed advisable to introduce additives, use aseptic technique. For information on adding lipid emulsions see Dosage and Administration (2.4) . 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 ( Figure 3 ). For high density medication (high specific gravity), such as potassium chloride, squeeze ports while ports are upright and mix thoroughly. 7. Inspect final solution for discoloration and particulate matter. Check for leaks. 8. Spike and hang container. 4. Suspend container from eyelet support. 5. Twist off protector from outlet port at bottom of container ( Figure 4 ). 6. Attach administration set. Refer to complete directions accompanying set. For single dose only. Discard unused portion. Figures 1 – 4 (Three Port Container): Figures 1 – 4 (Two Port Container): Instructions on Storage Storage After Removal of Overwrap: Once removed from the protective overwrap, mixed (peel seal activated) or unmixed (peel seal intact), CLINIMIX E solutions may be stored under refrigeration for up to 9 days. Storage Once any Additive is Added: Use promptly after mixing. Any storage with additives should be under refrigeration and limited to a brief period of time, less than 24 hours. After removal from refrigeration, use promptly and complete the infusion within 24 hours. Any remaining mixture must be discarded. Protect the activated parenteral nutrition solution from light. Figure 1-4 Clinimix E Figures 1-4 - (Two Port Container) 2.4 Preparation and Addition of Lipid Emulsion Three Port Container 1. Prior to adding lipid emulsion, mix amino acid and dextrose injection as shown in Figures 1-3 . 2. Prepare lipid emulsion transfer set following instructions provided. 3. Attach transfer set to lipid emulsion container using aseptic technique. 4. Twist off protector on the additive port of the 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 container thoroughly. Inspect final solution for discoloration and particulate matter. Check for leaks. Two Port Container 1. Prior to adding lipid emulsion, mix amino acid and dextrose injection as shown in Figures 1-3. 2. Prepare lipid emulsion transfer set following instructions provided. 3. Attach transfer set to lipid emulsion container using aseptic technique. 4. Prepare medication port. 5. Using a 19 to 22 gauge needle, puncture resealable medication port. 6. Open clamp on transfer set and transfer lipid emulsion. 7. Remove needle. 8. Mix contents of container thoroughly. Inspect final solution for discoloration and particulate matter. Check for leaks. Storage Once Lipids are Added: Use promptly after mixing. Any storage with additives should be under refrigeration and limited to a brief period of time, no longer than 24 hours. After removal from refrigeration, use promptly and complete the infusion within 24 hours. Any mixture remaining must be discarded. 2.5 Dosing Considerations • The dosage of CLINIMIX E should be individualized based on the patient’s clinical condition (ability to adequately metabolize amino acids and dextrose), body weight and nutritional/fluid requirements, as well as additional energy given orally/enterally to the patient. Prior to initiating CLINIMIX E the following patient information should be reviewed: all concomitant medications, gastrointestinal function and laboratory data such as electrolytes (including magnesium, calcium, and phosphorus), glucose, urea/creatinine, liver panel, complete blood count and triglyceride level (if adding lipid emulsion). Refer to the complete prescribing information of lipid emulsion for dosing information. • CLINIMIX E formulations have varying concentrations of protein, carbohydrate and a standard concentration of electrolytes; thus infusion rates to achieve requirements will vary. Protein, caloric, fluid and electrolyte requirements all need to be taken into consideration when determining individual patient dosage needs. • The dosage selection is based only on the recommended protein requirements. The maximum dextrose infusion rates and calorie and fluid requirements must also be considered when determining the clinically appropriate infusion rate for patients. • CLINIMIX E meets the total nutritional requirements for protein and dextrose in stable patients, and can be individualized to meet specific needs with the addition of nutrients. • Total daily fluid requirements can be met beyond the volume of amino acids solution by supplementing with non-carbohydrate or carbohydrate-containing electrolyte solutions. 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. • Prior to administration of CLINIMIX E correct severe fluid, electrolyte and acid-base disorders. • Monitor levels of serum potassium during therapy. It may be necessary to add additional potassium to the CLINIMIX E admixture. • Lipid emulsion administration should be considered with prolonged use (more than 5 days) of CLINIMIX E in order to prevent essential fatty acid deficiency (EFAD). Serum lipids should be monitored for evidence of EFAD in patients maintained on fat-free parenteral nutrition. See prescribing information of lipid emulsion. • The flow rate should be increased gradually. The flow rate must be adjusted taking into account the dose being administered, the daily volume intake, and the duration of the infusion. 2.6 Recommended Dosage in Adults The recommended daily nutritional requirements for protein and dextrose compared to the amount of nutrition provided by CLINIMIX E are shown in Table 1 . As indicated on an individual basis, maintenance vitamins, additional electrolytes, trace elements and other components (including lipids) should be administered as required to prevent deficiencies and complications from developing. The maximum infusion rates in adult patients are show in Table 2 . In addition to meeting protein needs, the administration rate should be governed, especially during the first few day of therapy, by the patient’s tolerance to dextrose. Daily intake of amino acids and dextrose should be increased gradually to the maximum required dose as indicated by frequent determinations of blood glucose levels. Table 1: Nutritional Comparison – Adult Patients Recommended CLINIMIX E Adult Dosage CLINIMIX E 2.75/5 CLINIMIX E 4.25/5 CLINIMIX E 4.25/10 CLINIMIX E 5/15 CLINIMIX E 5/20 CLINIMIX E 8/10 CLINIMIX E 8/14 Fluid (mL/kg/day) 29 to 40 19 to 40 19 to 40 16 to 40 16 to 40 10 to 25 10 to 25 Protein Protein is provided as amino acids. When infused intravenously amino acids are metabolized and utilized as the building blocks of protein. (g/kg/day) (Nitrogen g/kg/day) 0.8 to 1.1 (0.13 to 0.18) 0.8 to 1.7 (0.13 to 0.27) 0.8 to 1.7 (0.13 to 0.27) 0.8 to 2 (0.13 to 0.32) 0.8 to 2 (0.13 to 0.32) 0.8 to 2 (0.13 to 0.32) 0.8 to 2 (0.13 to 0.32) Dextrose (g/kg/day) 1.45 to 2 0.95 to 2 1.9 to 4 2.4 to 6 3.2 to 8 1 to 2.5 1.4 to 3.5 Table 2: Maximum Infusion Rate in Adult Patients Maximum Infusion Rates in Adults Patients CLINIMIX E 2.75/5 CLINIMIX E 4.25/5 CLINIMIX E 4.25/10 CLINIMIX E 5/15 CLINIMIX E 5/20 CLINIMIX E 8/10 CLINIMIX E 8/14 Maximum Infusion Rate (mL/kg/hour) 3.6 2.4 2.4 1.67 1.25 1.3 1.3 Corresponding infusion rate Amino Acid (g/kg/hour) 0.1 Rate limiting factor 0.1 0.1 0.08 0.06 0.1 0.1 Dextrose (g/kg/hour) 0.18 0.12 0.24 0.25 0.25 0.13 0.18 2.7 Dosage Modifications in Patients with Kidney Disease Prior to administration, correct severe fluid or electrolyte imbalances. Closely monitor serum electrolyte levels and adjust the volume of CLINIMIX E administered as required [see Warnings and Precautions (5.11) ] . Chronic kidney disease patients with less than nephrotic range proteinuria require 0.8 g of protein/kg/day. Chronic kidney disease patients with nephrotic range proteinuria require 0.8 g of protein/kg/day plus 1 g of protein for each gram of proteinuria. Patients needing dialysis should receive from 1.2 g of protein/kg/day up to a maximum of 2.5 g of protein/kg/day depending on the nutritional status and the dialysis modality. Serum electrolyte levels should be closely monitored. The CLINIMIX E dosage can be adjusted based on the severity of kidney disease, supplementing protein as indicated. If required, additional amino acids may be added to the CLINIMIX E container or infused separately. Compatibility of additions should be evaluated by a pharmacist and questions may be directed to Baxter. 2.8 Recommended Dosage in Pediatric Patients The dosage and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low weight infants, because of the increased risk of hyperglycemia/hypoglycemia [see Use in Specific Populations (8.4) ] . Frequent monitoring of serum glucose concentrations is required when dextrose is prescribed to pediatric patients, particularly neonates and low birth weight infants. The infusion rate and volume should be determined by the consulting physician experienced in pediatric intravenous fluid therapy. In pediatric patients, CLINIMIX E is dosed on the basis of protein provided as amino acids. The recommended dosage, by age group is provided in Tables 3 - 6 . Infusion rates are based on protein and do not take carbohydrates, fluid or electrolytes into consideration. This product does not contain the amino acids cysteine and taurine, considered conditionally essential for neonates and infants. If possible, these amino acids should be added to this product if used in this pediatric population. Table 3: Preterm and Term Infants Less than 1 Month of Age Recommended CLINIMIX E Dosage in Preterm and Term Infants Less than 1 Month of Age CLINIMIX E 2.75/5 CLINIMIX E 4.25/5 CLINIMIX E 4.25/10 CLINIMIX E 5/15 CLINIMIX E 5/20 CLINIMIX E 8/10 CLINIMIX E 8/14 Infusion Rate Range (mL/kg/hr) 4.5 to 6 2.9 to 3.9 2.9 to 3.9 2.5 to 3.3 2.5 to 3.3 1.6 to 2.1 1.6 to 2.1 Fluid (mL/kg/day) 108 to 144 70 to 94 70 to 94 60 to 79 60 to 79 38.4 to 50 38.4 to 50 Protein Protein is provided as amino acids. When infused intravenously amino acids are metabolized and utilized as the building blocks of protein. (g/kg/day) (Nitrogen g/kg/day) 3 to 4 (0.48 to 0.64) 3 to 4 (0.48 to 0.64) 3 to 4 (0.48 to 0.64) 3 to 4 (0.48 to 0.64) 3 to 4 (0.48 to 0.64) 3 to 4 (0.48 to 0.64) 3 to 4 (0.48 to 0.64) Dextrose (g/kg/day) 5.4 to 7.2 3.5 to 4.7 7 to 9.4 9 to 11.9 12 to 15.8 3.8 to 5 5.4 to 7 Table 4: Pediatric Patients 1 Month to Less than 1 Year of Age Recommended CLINIMIX E Dosage in Pediatric Patients 1 Month to Less than 1 Year of Age CLINIMIX E 2.75/5 CLINIMIX E 4.25/5 CLINIMIX E 4.25/10 CLINIMIX E 5/15 CLINIMIX E 5/20 CLINIMIX E 8/10 CLINIMIX E 8/14 Infusion Rate Range (mL/kg/hr) 3 to 4.5 2 to 2.9 2 to 2.9 1.7 to 2.5 1.7 to 2.5 1 to 1.6 1 to 1.6 Fluid (mL/kg/day) 72 to 108 48 to 70 48 to 70 41 to 60 41 to 60 24 to 38.4 24 to 38.4 Protein Protein is provided as amino acids. When infused intravenously amino acids are metabolized and utilized as the building blocks of protein. (g/kg/day) (Nitrogen g/kg/day) 2 to 3 (0.32 to 0.48) 2 to 3 (0.32 to 0.48) 2 to 3 (0.32 to 0.48) 2 to 3 (0.32 to 0.48) 2 to 3 (0.32 to 0.48) 2 to 3 (0.32 to 0.48) 2 to 3 (0.32 to 0.48) Dextrose (g/kg/day) 3.6 to 5.4 2.4 to 3.5 4.8 to 7 6.1 to 9 8.2 to 12 2.4 to 3.8 3.4 to 5.4 Table 5: Pediatric Patients 1 Year to Less than 11 Years of Age Recommended CLINIMIX E Dosage in Pediatric Patients 1 Year to Less than 11 Years of Age CLINIMIX E 2.75/5 CLINIMIX E 4.25/5 CLINIMIX E 4.25/10 CLINIMIX E 5/15 CLINIMIX E 5/20 CLINIMIX E 8/10 CLINIMIX E 8/14 Infusion Rate Range (mL/kg/hr) 1.5 to 3 1 to 2 1 to 2 0.8 to 1.7 0.8 to 1.7 0.5 to 1 0.5 to 1 Fluid (mL/kg/day) 36 to 72 24 to 48 24 to 48 19 to 41 19 to 41 12 to 24 12 to 24 Protein Protein is provided as amino acids. When infused intravenously amino acids are metabolized and utilized as the building blocks of protein. (g/kg/day) (Nitrogen g/kg/day) 1 to 2 (0.16 to 0.32) 1 to 2 (0.16 to 0.32) 1 to 2 (0.16 to 0.32) 1 to 2 (0.16 to 0.32) 1 to 2 (0.16 to 0.32) 1 to 2 (0.16 to 0.32) 1 to 2 (0.16 to 0.32) Dextrose (g/kg/day) 1.8 to 3.6 1.2 to 2.4 2.4 to 4.8 2.9 to 6.1 3.8 to 8.2 1.2 to 2.4 1.7 to 3.4 Table 6: Pediatric Patients 11 Years to 17 Years of Age Recommended CLINIMIX E Dosage in Pediatric Patients 11 Years to 17 Years of Age CLINIMIX E 2.75/5 CLINIMIX E 4.25/5 CLINIMIX E 4.25/10 CLINIMIX E 5/15 CLINIMIX E 5/20 CLINIMIX E 8/10 CLINIMIX E 8/14 Infusion Rate Range (mL/kg/hr) 1.2 to 2.3 0.8 to 1.5 0.8 to 1.5 0.7 to 1.3 0.7 to 1.3 0.4 to 0.8 0.4 to 0.8 Fluid (mL/kg/day) 29 to 55 19 to 36 19 to 36 17 to 31 17 to 31 9.6 to 19.2 9.6 to 19.2 Protein Protein is provided as amino acids. When infused intravenously amino acids are metabolized and utilized as the building blocks of protein. (g/kg/day) (Nitrogen g/kg/day) 0.8 to 1.5 (0.13 to 0.24) 0.8 to 1.5 (0.13 to 0.24) 0.8 to 1.5 (0.13 to 0.24) 0.8 to 1.5 (0.13 to 0.24) 0.8 to 1.5 (0.13 to 0.24) 0.8 to 1.5 (0.13 to 0.24) 0.8 to 1.5 (0.13 to 0.24) Dextrose (g/kg/day) 1.4 to 2.8 1 to 1.8 1.9 to 3.6 2.5 to 4.7 3.4 to 6.2 1 to 1.9 1.4 to 2.7 2.9 Discontinuation of CLINIMIX E injection To reduce the risk of hypoglycemia after discontinuation, a gradual decrease in flow rate in the last hour of infusion should be considered.

1 INDICATIONS AND USAGE CLINIMIX E is indicated as a source of calories, protein, and electrolytes for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX E may be used to treat negative nitrogen balance in patients. CLINIMIX E is indicated as a source of calories, protein, and electrolytes for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX E may be used to treat negative nitrogen balance in patients. ( 1 )

10 OVERDOSAGE An increased infusion rate of CLINIMIX E can cause hyperglycemia, hyperosmolality, and adverse effects on water and electrolyte balance [see Warnings and Precautions (5.6 , 5.11 )]. Severe hyperglycemia and severe dilutional hyponatremia, and their complications, can be fatal. Discontinue infusion and institute appropriate corrective measures in the event of overhydration or solute overload during therapy, with particular attention to respiratory and cardiovascular systems . For current information on the management of poisoning or overdosage, contact the National Poison Control Center at 1-800-222-1222 or www.poison.org .

7 DRUG INTERACTIONS 7.1 Drugs that Can Cause Hyperkalemia Because of its potassium content, CLINIMIX E should be administered with caution in patients treated with agents or products that can cause hyperkalemia or increase the risk of hyperkalemia, such as potassium sparing diuretics (amiloride, spironolactone, triamterene), with ACE inhibitors, angiotensin II receptor antagonists, or the immunosuppressants tacrolimus and cyclosporine.

12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action CLINIMIX E is used as a supplement of nutrition in patients, providing macronutrients (amino acids and dextrose) and micronutrients (electrolytes) parenterally. The amino acids provide the structural units that make up proteins and are used to synthesize proteins and other biomolecules or are oxidized to urea and carbon dioxide as a source of energy. The administered dextrose is oxidized to carbon dioxide and water, yielding energy. 12.3 Pharmacokinetics The disposition of infused amino acids, dextrose, and electrolytes are essentially the same as those absorbed from ordinary food.

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3 DOSAGE FORMS AND STRENGTHS CLINIMIX E injection is available in 1000 mL and 2000 mL dual chamber containers. The individual chambers contain essential and nonessential amino acids with electrolytes and dextrose with calcium. Table 7 describes the individual components of CLINIMIX E. TABLE 7 INGREDIENTS PER 100mL OF CLINIMIX E Strength of CLINIMIX E CLINIMIX E 2.75/5 sulfite‑free (2.75% Amino Acid in 5% Dextrose) Injection CLINIMIX E 4.25/5 sulfite‑free (4.25% Amino Acid in 5% Dextrose) Injection CLINIMIX E 4.25/10 sulfite‑free (4.25% Amino Acid in 10% Dextrose) Injection CLINIMIX E 5/15 sulfite‑free (5% Amino Acid in 15% Dextrose) Injection CLINIMIX E 5/20 sulfite‑free (5% Amino Acid in 20% Dextrose) Injection CLINIMIX E 8/10 sulfite‑free (8% Amino Acid in 10% Dextrose) Injection CLINIMIX E 8/14 sulfite‑free (8% Amino Acid in 14% Dextrose) Injection Dextrose Hydrous, USP (g/100 mL) 5 5 10 15 20 10 14 Amino Acids (g/100 mL) 2.75 4.25 4.25 5 5 8 8 Total Nitrogen (mg/100 mL) 454 702 702 826 826 1320 1320 Essential Amino Acids (mg/100 mL) Leucine 201 311 311 365 365 584 584 Isoleucine 165 255 255 300 300 480 480 Valine 160 247 247 290 290 464 464 Lysine (added as the hydrochloride salt) 159 247 247 290 290 464 464 Phenylalanine 154 238 238 280 280 448 448 Histidine 132 204 204 240 240 384 384 Threonine 116 179 179 210 210 336 336 Methionine 110 170 170 200 200 320 320 Tryptophan 50 77 77 90 90 144 144 Nonessential Amino Acids (mg/100 mL) Alanine 570 880 880 1035 1035 1656 1656 Arginine 316 489 489 575 575 920 920 Glycine 283 438 438 515 515 824 824 Proline 187 289 289 340 340 544 544 Serine 138 213 213 250 250 400 400 Tyrosine 11 17 17 20 20 32 32 Electrolytes (mg/100 mL) Sodium Acetate Trihydrate, USP 217 297 297 340 340 0 0 Dibasic Potassium Phosphate, USP 261 261 261 261 261 261 261 Sodium Chloride, USP 112 77 77 59 59 205 205 Magnesium Chloride, USP 51 51 51 51 51 51 51 Calcium Chloride Dihydrate, USP 33 33 33 33 33 33 33 Electrolyte Profile (mEq/L) Balanced by ions from amino acids. Sodium 35 35 35 35 35 35 35 Potassium 30 30 30 30 30 30 30 Magnesium 5 5 5 5 5 5 5 Calcium 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) Acetate Derived from glacial acetic acid (for pH adjustment) and sodium acetate. 51 70 70 80 80 83 83 Chloride Contributed by calcium chloride, lysine hydrochloride, magnesium chloride, sodium chloride, and hydrochloric acid. 39 39 39 39 39 76 76 Phosphate (as HPO 4 = ) 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) pH pH of sulfite-free amino acid injection with electrolytes in the outlet port chamber was adjusted with glacial acetic acid and pH of dextrose injection port chamber was adjusted with hydrochloric acid. (Range) 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) Osmolarity (mOsmol/L) (calc) 665 815 1070 1395 1650 1450 1650 Caloric Content (kcal/L) From Dextrose 170 170 340 510 680 343 477 From Amino Acids 110 170 170 200 200 320 320 TOTAL (Dextrose and Amino Acids) 280 340 510 710 880 663 797 CLINIMIX E injection is available in multiple strengths. See full prescribing information for detailed description of each formulation. ( 3 , 11 )

CLINIMIX E Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose LEUCINE LEUCINE PHENYLALANINE PHENYLALANINE LYSINE LYSINE METHIONINE METHIONINE ISOLEUCINE ISOLEUCINE VALINE VALINE HISTIDINE HISTIDINE THREONINE THREONINE TRYPTOPHAN TRYPTOPHAN ALANINE ALANINE GLYCINE GLYCINE ARGININE ARGININE PROLINE PROLINE SERINE SERINE TYROSINE TYROSINE SODIUM ACETATE ACETATE ION SODIUM CATION POTASSIUM PHOSPHATE, DIBASIC PHOSPHATE ION POTASSIUM CATION MAGNESIUM CHLORIDE MAGNESIUM CATION CHLORIDE ION SODIUM CHLORIDE SODIUM CATION CHLORIDE ION CALCIUM CHLORIDE CALCIUM CATION CHLORIDE ION DEXTROSE DEXTROSE ACETIC ACID WATER NITROGEN CLINIMIX E Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose LEUCINE LEUCINE PHENYLALANINE PHENYLALANINE LYSINE LYSINE METHIONINE METHIONINE ISOLEUCINE ISOLEUCINE VALINE VALINE HISTIDINE HISTIDINE THREONINE THREONINE TRYPTOPHAN TRYPTOPHAN ALANINE ALANINE GLYCINE GLYCINE ARGININE ARGININE PROLINE PROLINE SERINE SERINE TYROSINE TYROSINE SODIUM ACETATE ACETATE ION SODIUM CATION POTASSIUM PHOSPHATE, DIBASIC PHOSPHATE ION POTASSIUM CATION MAGNESIUM CHLORIDE MAGNESIUM CATION CHLORIDE ION SODIUM CHLORIDE SODIUM CATION CHLORIDE ION CALCIUM CHLORIDE CALCIUM CATION CHLORIDE ION DEXTROSE DEXTROSE ACETIC ACID WATER NITROGEN CLINIMIX E Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose LEUCINE LEUCINE PHENYLALANINE PHENYLALANINE LYSINE LYSINE METHIONINE METHIONINE ISOLEUCINE ISOLEUCINE VALINE VALINE HISTIDINE HISTIDINE THREONINE THREONINE TRYPTOPHAN TRYPTOPHAN ALANINE ALANINE GLYCINE GLYCINE ARGININE ARGININE PROLINE PROLINE SERINE SERINE TYROSINE TYROSINE SODIUM ACETATE ACETATE ION SODIUM CATION POTASSIUM PHOSPHATE, DIBASIC PHOSPHATE ION POTASSIUM CATION MAGNESIUM CHLORIDE MAGNESIUM CATION CHLORIDE ION SODIUM CHLORIDE SODIUM CATION CHLORIDE ION CALCIUM CHLORIDE CALCIUM CATION CHLORIDE ION DEXTROSE DEXTROSE ACETIC ACID WATER NITROGEN CLINIMIX E Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose LEUCINE LEUCINE PHENYLALANINE PHENYLALANINE LYSINE LYSINE METHIONINE METHIONINE ISOLEUCINE ISOLEUCINE VALINE VALINE HISTIDINE HISTIDINE THREONINE THREONINE TRYPTOPHAN TRYPTOPHAN ALANINE ALANINE GLYCINE GLYCINE ARGININE ARGININE PROLINE PROLINE SERINE SERINE TYROSINE TYROSINE SODIUM ACETATE ACETATE ION SODIUM CATION POTASSIUM PHOSPHATE, DIBASIC PHOSPHATE ION POTASSIUM CATION MAGNESIUM CHLORIDE MAGNESIUM CATION CHLORIDE ION SODIUM CHLORIDE SODIUM CATION CHLORIDE ION CALCIUM CHLORIDE CALCIUM CATION CHLORIDE ION DEXTROSE DEXTROSE ACETIC ACID WATER NITROGEN CLINIMIX E Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose LEUCINE LEUCINE PHENYLALANINE PHENYLALANINE LYSINE LYSINE METHIONINE METHIONINE ISOLEUCINE ISOLEUCINE VALINE VALINE HISTIDINE HISTIDINE THREONINE THREONINE TRYPTOPHAN TRYPTOPHAN ALANINE ALANINE GLYCINE GLYCINE ARGININE ARGININE PROLINE PROLINE SERINE SERINE TYROSINE TYROSINE SODIUM ACETATE ACETATE ION SODIUM CATION POTASSIUM PHOSPHATE, DIBASIC PHOSPHATE ION POTASSIUM CATION MAGNESIUM CHLORIDE MAGNESIUM CATION CHLORIDE ION SODIUM CHLORIDE SODIUM CATION CHLORIDE ION CALCIUM CHLORIDE CALCIUM CATION CHLORIDE ION DEXTROSE DEXTROSE ACETIC ACID WATER NITROGEN CLINIMIX E Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose LEUCINE LEUCINE PHENYLALANINE PHENYLALANINE LYSINE LYSINE METHIONINE METHIONINE ISOLEUCINE ISOLEUCINE VALINE VALINE HISTIDINE HISTIDINE THREONINE THREONINE TRYPTOPHAN TRYPTOPHAN ALANINE ALANINE GLYCINE GLYCINE ARGININE ARGININE PROLINE PROLINE SERINE SERINE TYROSINE TYROSINE SODIUM ACETATE ACETATE ION SODIUM CATION POTASSIUM PHOSPHATE, DIBASIC PHOSPHATE ION POTASSIUM CATION MAGNESIUM CHLORIDE MAGNESIUM CATION CHLORIDE ION SODIUM CHLORIDE SODIUM CATION CHLORIDE ION CALCIUM CHLORIDE CALCIUM CATION CHLORIDE ION DEXTROSE DEXTROSE ACETIC ACID WATER NITROGEN CLINIMIX E Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose LEUCINE LEUCINE PHENYLALANINE PHENYLALANINE LYSINE LYSINE METHIONINE METHIONINE ISOLEUCINE ISOLEUCINE VALINE VALINE HISTIDINE HISTIDINE THREONINE THREONINE TRYPTOPHAN TRYPTOPHAN ALANINE ALANINE GLYCINE GLYCINE ARGININE ARGININE PROLINE PROLINE SERINE SERINE TYROSINE TYROSINE SODIUM ACETATE ACETATE ION SODIUM CATION POTASSIUM PHOSPHATE, DIBASIC PHOSPHATE ION POTASSIUM CATION MAGNESIUM CHLORIDE MAGNESIUM CATION CHLORIDE ION SODIUM CHLORIDE SODIUM CATION CHLORIDE ION CALCIUM CHLORIDE CALCIUM CATION CHLORIDE ION DEXTROSE DEXTROSE ACETIC ACID WATER NITROGEN CLINIMIX E Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose LEUCINE LEUCINE PHENYLALANINE PHENYLALANINE LYSINE LYSINE METHIONINE METHIONINE ISOLEUCINE ISOLEUCINE VALINE VALINE HISTIDINE HISTIDINE THREONINE THREONINE TRYPTOPHAN TRYPTOPHAN ALANINE ALANINE GLYCINE GLYCINE ARGININE ARGININE PROLINE PROLINE SERINE SERINE TYROSINE TYROSINE SODIUM ACETATE ACETATE ION SODIUM CATION POTASSIUM PHOSPHATE, DIBASIC PHOSPHATE ION POTASSIUM CATION MAGNESIUM CHLORIDE MAGNESIUM CATION CHLORIDE ION SODIUM CHLORIDE SODIUM CATION CHLORIDE ION CALCIUM CHLORIDE CALCIUM CATION CHLORIDE ION DEXTROSE DEXTROSE ACETIC ACID WATER NITROGEN CLINIMIX E Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose LEUCINE LEUCINE PHENYLALANINE PHENYLALANINE LYSINE LYSINE METHIONINE METHIONINE ISOLEUCINE ISOLEUCINE VALINE VALINE HISTIDINE HISTIDINE THREONINE THREONINE TRYPTOPHAN TRYPTOPHAN Alanine ALANINE Glycine GLYCINE ARGININE ARGININE PROLINE PROLINE SERINE SERINE TYROSINE TYROSINE SODIUM ACETATE ACETATE ION SODIUM CATION POTASSIUM PHOSPHATE, DIBASIC PHOSPHATE ION POTASSIUM CATION MAGNESIUM CHLORIDE MAGNESIUM CATION CHLORIDE ION SODIUM CHLORIDE SODIUM CATION CHLORIDE ION CALCIUM CHLORIDE CALCIUM CATION CHLORIDE ION DEXTROSE DEXTROSE ACETIC ACID WATER NITROGEN CLINIMIX E Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose LEUCINE LEUCINE PHENYLALANINE PHENYLALANINE LYSINE LYSINE METHIONINE METHIONINE ISOLEUCINE ISOLEUCINE VALINE VALINE HISTIDINE HISTIDINE THREONINE THREONINE TRYPTOPHAN TRYPTOPHAN Alanine ALANINE Glycine GLYCINE ARGININE ARGININE PROLINE PROLINE SERINE SERINE TYROSINE TYROSINE SODIUM ACETATE ACETATE ION SODIUM CATION POTASSIUM PHOSPHATE, DIBASIC PHOSPHATE ION POTASSIUM CATION MAGNESIUM CHLORIDE MAGNESIUM CATION CHLORIDE ION SODIUM CHLORIDE SODIUM CATION CHLORIDE ION CALCIUM CHLORIDE CALCIUM CATION CHLORIDE ION DEXTROSE DEXTROSE ACETIC ACID WATER NITROGEN CLINIMIX E Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose LEUCINE LEUCINE PHENYLALANINE PHENYLALANINE LYSINE LYSINE METHIONINE METHIONINE ISOLEUCINE ISOLEUCINE VALINE VALINE HISTIDINE HISTIDINE THREONINE THREONINE TRYPTOPHAN TRYPTOPHAN Alanine ALANINE Glycine GLYCINE ARGININE ARGININE PROLINE PROLINE SERINE SERINE TYROSINE TYROSINE SODIUM ACETATE ACETATE ION SODIUM CATION POTASSIUM PHOSPHATE, DIBASIC PHOSPHATE ION POTASSIUM CATION MAGNESIUM CHLORIDE MAGNESIUM CATION CHLORIDE ION SODIUM CHLORIDE SODIUM CATION CHLORIDE ION CALCIUM CHLORIDE CALCIUM CATION CHLORIDE ION DEXTROSE DEXTROSE ACETIC ACID WATER NITROGEN CLINIMIX E Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose LEUCINE LEUCINE PHENYLALANINE PHENYLALANINE LYSINE LYSINE METHIONINE METHIONINE ISOLEUCINE ISOLEUCINE VALINE VALINE HISTIDINE HISTIDINE THREONINE THREONINE TRYPTOPHAN TRYPTOPHAN Alanine ALANINE Glycine GLYCINE ARGININE ARGININE PROLINE PROLINE SERINE SERINE TYROSINE TYROSINE SODIUM ACETATE ACETATE ION SODIUM CATION POTASSIUM PHOSPHATE, DIBASIC PHOSPHATE ION POTASSIUM CATION MAGNESIUM CHLORIDE MAGNESIUM CATION CHLORIDE ION SODIUM CHLORIDE SODIUM CATION CHLORIDE ION CALCIUM CHLORIDE CALCIUM CATION CHLORIDE ION DEXTROSE DEXTROSE ACETIC ACID WATER NITROGEN CLINIMIX E Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose LEUCINE LEUCINE PHENYLALANINE PHENYLALANINE LYSINE LYSINE METHIONINE METHIONINE ISOLEUCINE ISOLEUCINE VALINE VALINE HISTIDINE HISTIDINE THREONINE THREONINE TRYPTOPHAN TRYPTOPHAN Alanine ALANINE Glycine GLYCINE ARGININE ARGININE PROLINE PROLINE SERINE SERINE TYROSINE TYROSINE SODIUM ACETATE ACETATE ION SODIUM CATION POTASSIUM PHOSPHATE, DIBASIC PHOSPHATE ION POTASSIUM CATION MAGNESIUM CHLORIDE MAGNESIUM CATION CHLORIDE ION SODIUM CHLORIDE SODIUM CATION CHLORIDE ION CALCIUM CHLORIDE CALCIUM CATION CHLORIDE ION DEXTROSE DEXTROSE ACETIC ACID WATER NITROGEN

NDA020678

CLINIMIX E

Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose

0338-0206

HUMAN PRESCRIPTION DRUG

INTRAVENOUS

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL Container Label LOT EXP 2B7735 NDC 0338-1142-03 CLINIMIX E WITH ELECTROLYTES 2.75/5 SULFITE-FREE (2.75% Amino Acid with Electrolytes in 5% Dextrose with Calcium) Injection 500 mL INJECTION PORT CHAMBER 10% Dextrose Injection with Calcium 500 mL OUTLET PORT CHAMBER 5.5% Amino Acid Injection Rx Only ACTIVATE SEAL AND MIX THOROUGHLY BEFORE USE SEE PRESRCIBING INFORMATION FOR INSTRUCTIONS ON ACTIVATION AFTER MIXING THE PRODUCT REPRESENTS 1000 mL REFRIGERATED STORAGE IS LIMITED TO 9 DAYS A SLIGHT YELLOW COLOR DOES NOT ALTER THE QUALITY AND EFFICACY OF THIS PRODUCT ASK PHARMACIST ABOUT ADDITIVE COMPATIBILITY CONTENTS OF EACH 100 mL OF THE ADMIXED INJECTION DEXTROSE HYDROUS USP 5 g ESSENTIAL AMINO ACIDS LEUCINE 201 mg ISOLEUCINE 165 mg VALINE 160 mg LYSINE (ADDED AS THE HYDROCHLORIDE SALT) 159 mg PHENYLALANINE 154 mg HISTIDINE 132 mg THREONINE 116 mg METHIONINE 110 mg TRYPTOPHAN 50 mg NONESSENTIAL AMINO ACIDS ALANINE 570 mg ARGININE 316 mg GLYCINE 283 mg PROLINE 187 mg SERINE 138 mg TYROSINE 11 mg ELECTROLYTES SODIUM ACETATE TRIHYDRATE USP 217 mg DIBASIC POTASSIUM PHOSPHATE USP 261 mg SODIUM CHLORIDE USP 112 mg MAGNESIUM CHLORIDE USP 51 mg CALCIUM CHLORIDE DIHYDRATE USP 33 mg mEq/L SODIUM 35 POTASSIUM 30 MAGNESIUM 5 CALCIUM 4.5 (2.2 mmol/L) ACETATE 51 CHLORIDE 39 PHOSPHATE 30 (15 mmol/L) BALANCED BY IONS FROM AMINO ACIDS pH ADJUSTED WITH GLACIAL ACETIC ACID STERILE SINGLE DOSE CONTAINER ROOM TEMPERATURE (25°C/77°F) AVOID EXCESSIVE HEAT PROTECT FROM FREEZING SEE PRESCRIBING INFORMATION BAXTER BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 US MADE IN USA Container Label LOT EXP 2B7737 NDC 0338-1144-03 CLINIMIX E WITH ELECTROLYTES 4.25/5 SULFITE-FREE (4.25% Amino Acid with Electrolytes in 5% Dextrose with Calcium) Injection 500 mL INJECTION PORT CHAMBER 10% Dextrose Injection with Calcium 500 mL OUTLET PORT CHAMBER 8.5% Amino Acid Injection Rx Only ACTIVATE SEAL AND MIX THOROUGHLY BEFORE USE SEE PRESRCIBING INFORMATION FOR INSTRUCTIONS ON ACTIVATION AFTER MIXING THE PRODUCT REPRESENTS 1000 mL REFRIGERATED STORAGE IS LIMITED TO 9 DAYS A SLIGHT YELLOW COLOR DOES NOT ALTER THE QUALITY AND EFFICACY OF THIS PRODUCT ASK PHARMACIST ABOUT ADDITIVE COMPATIBILITY CONTENTS OF EACH 100 mL OF THE ADMIXED INJECTION DEXTROSE HYDROUS USP 5 g ESSENTIAL AMINO ACIDS LEUCINE 311 mg ISOLEUCINE 255 mg VALINE 247 mg LYSINE (ADDED AS THE HYDROCHLORIDE SALT) 247 mg PHENYLALANINE 238 mg HISTIDINE 204 mg THREONINE 179 mg METHIONINE 170 mg TRYPTOPHAN 77 mg NONESSENTIAL AMINO ACIDS ALANINE 880 mg ARGININE 489 mg GLYCINE 438 mg PROLINE 289 mg SERINE 213 mg TYROSINE 17 mg ELECTROLYTES SODIUM ACETATE TRIHYDRATE USP 297 mg DIBASIC POTASSIUM PHOSPHATE USP 261 mg SODIUM CHLORIDE USP 77 mg MAGNESIUM CHLORIDE USP 51 mg CALCIUM CHLORIDE DIHYDRATE USP 33 mg mEq/L SODIUM 35 POTASSIUM 30 MAGNESIUM 5 CALCIUM 4.5 (2.2 mmol/L) ACETATE 70 CHLORIDE 39 PHOSPHATE 30 (15 mmol/L) BALANCED BY IONS FROM AMINO ACIDS pH ADJUSTED WITH GLACIAL ACETIC ACID STERILE SINGLE DOSE CONTAINER ROOM TEMPERATURE (25°C/77°F) AVOID EXCESSIVE HEAT PROTECT FROM FREEZING SEE PRESCRIBING INFORMATION BAXTER BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 US MADE IN USA Container Label LOT EXP 2B77`6 NDC 0338-1113-04 CLINIMIX E WITH ELECTROLYTES 4.25/5 SULFITE-FREE (4.25% Amino Acid with Electrolytes in 5% Dextrose with Calcium) Injection 1000 mL INJECTION PORT CHAMBER 10% Dextrose Injection with Calcium 1000 mL OUTLET PORT CHAMBER 8.5% Amino Acid Injection Rx Only ACTIVATE SEAL AND MIX THOROUGHLY BEFORE USE SEE PRESRCIBING INFORMATION FOR INSTRUCTIONS ON ACTIVATION AFTER MIXING THE PRODUCT REPRESENTS 2000 mL REFRIGERATED STORAGE IS LIMITED TO 9 DAYS A SLIGHT YELLOW COLOR DOES NOT ALTER THE QUALITY AND EFFICACY OF THIS PRODUCT ASK PHARMACIST ABOUT ADDITIVE COMPATIBILITY CONTENTS OF EACH 100 mL OF THE ADMIXED INJECTION DEXTROSE HYDROUS USP 5 g ESSENTIAL AMINO ACIDS LEUCINE 311 mg ISOLEUCINE 255 mg VALINE 247 mg LYSINE (ADDED AS THE HYDROCHLORIDE SALT) 247 mg PHENYLALANINE 238 mg HISTIDINE 204 mg THREONINE 179 mg METHIONINE 170 mg TRYPTOPHAN 77 mg NONESSENTIAL AMINO ACIDS ALANINE 880 mg ARGININE 489 mg GLYCINE 438 mg PROLINE 289 mg SERINE 213 mg TYROSINE 17 mg ELECTROLYTES SODIUM ACETATE TRIHYDRATE USP 297 mg DIBASIC POTASSIUM PHOSPHATE USP 261 mg SODIUM CHLORIDE USP 77 mg MAGNESIUM CHLORIDE USP 51 mg CALCIUM CHLORIDE DIHYDRATE USP 33 mg mEq/L SODIUM 35 POTASSIUM 30 MAGNESIUM 5 CALCIUM 4.5 (2.2 mmol/L) ACETATE 70 CHLORIDE 39 PHOSPHATE 30 (15 mmol/L) BALANCED BY IONS FROM AMINO ACIDS pH ADJUSTED WITH GLACIAL ACETIC ACID STERILE SINGLE DOSE CONTAINER ROOM TEMPERATURE (25°C/77°F) AVOID EXCESSIVE HEAT PROTECT FROM FREEZING SEE PRESCRIBING INFORMATION BAXTER BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 US Container Label LOT EXP 2B7738 NDC 0338-1145-03 CLINIMIX E WITH ELECTROLYTES 4.25/10 SULFITE-FREE (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injection 500 mL INJECTION PORT CHAMBER 20% Dextrose Injection with Calcium 500 mL OUTLET PORT CHAMBER 8.5% Amino Acid Injection Rx Only ACTIVATE SEAL AND MIX THOROUGHLY BEFORE USE SEE PRESRCIBING INFORMATION FOR INSTRUCTIONS ON ACTIVATION AFTER MIXING THE PRODUCT REPRESENTS 1000 mL REFRIGERATED STORAGE IS LIMITED TO 9 DAYS A SLIGHT YELLOW COLOR DOES NOT ALTER THE QUALITY AND EFFICACY OF THIS PRODUCT ASK PHARMACIST ABOUT ADDITIVE COMPATIBILITY CONTENTS OF EACH 100 mL OF THE ADMIXED INJECTION DEXTROSE HYDROUS USP 10 g ESSENTIAL AMINO ACIDS LEUCINE 311 mg ISOLEUCINE 255 mg VALINE 247 mg LYSINE (ADDED AS THE HYDROCHLORIDE SALT) 247 mg PHENYLALANINE 238 mg HISTIDINE 204 mg THREONINE 179 mg METHIONINE 170 mg TRYPTOPHAN 77 mg NONESSENTIAL AMINO ACIDS ALANINE 880 mg ARGININE 489 mg GLYCINE 438 mg PROLINE 289 mg SERINE 213 mg TYROSINE 17 mg ELECTROLYTES SODIUM ACETATE TRIHYDRATE USP 297 mg DIBASIC POTASSIUM PHOSPHATE USP 261 mg SODIUM CHLORIDE USP 77 mg MAGNESIUM CHLORIDE USP 51 mg CALCIUM CHLORIDE DIHYDRATE USP 33 mg mEq/L SODIUM 35 POTASSIUM 30 MAGNESIUM 5 CALCIUM 4.5 (2.2 mmol/L) ACETATE 70 CHLORIDE 39 PHOSPHATE 30 (15 mmol/L) BALANCED BY IONS FROM AMINO ACIDS pH ADJUSTED WITH GLACIAL ACETIC ACID STERILE SINGLE DOSE CONTAINER ROOM TEMPERATURE (25°C/77°F) AVOID EXCESSIVE HEAT PROTECT FROM FREEZING SEE PRESCRIBING INFORMATION BAXTER BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 US Container Label LOT EXP 2B7717 NDC 0338-1115-04 CLINIMIX E WITH ELECTROLYTES 4.25/10 SULFITE-FREE (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injection CENTRAL LINE INFUSION ONLY 1000 mL INJECTION PORT CHAMBER 20% Dextrose Injection with Calcium 1000 mL OUTLET PORT CHAMBER 8.5% Amino Acid Injection Rx Only ACTIVATE SEAL AND MIX THOROUGHLY BEFORE USE SEE PRESRCIBING INFORMATION FOR INSTRUCTIONS ON ACTIVATION AFTER MIXING THE PRODUCT REPRESENTS 2000 mL REFRIGERATED STORAGE IS LIMITED TO 9 DAYS A SLIGHT YELLOW COLOR DOES NOT ALTER THE QUALITY AND EFFICACY OF THIS PRODUCT ASK PHARMACIST ABOUT ADDITIVE COMPATIBILITY CONTENTS OF EACH 100 mL OF THE ADMIXED INJECTION DEXTROSE HYDROUS USP 10 g ESSENTIAL AMINO ACIDS LEUCINE 311 mg ISOLEUCINE 255 mg VALINE 247 mg LYSINE (ADDED AS THE HYDROCHLORIDE SALT) 247 mg PHENYLALANINE 238 mg HISTIDINE 204 mg THREONINE 179 mg METHIONINE 170 mg TRYPTOPHAN 77 mg NONESSENTIAL AMINO ACIDS ALANINE 880 mg ARGININE 489 mg GLYCINE 438 mg PROLINE 289 mg SERINE 213 mg TYROSINE 17 mg ELECTROLYTES SODIUM ACETATE TRIHYDRATE USP 297 mg DIBASIC POTASSIUM PHOSPHATE USP 261 mg SODIUM CHLORIDE USP 77 mg MAGNESIUM CHLORIDE USP 51 mg CALCIUM CHLORIDE DIHYDRATE USP 33 mg mEq/L SODIUM 35 POTASSIUM 30 MAGNESIUM 5 CALCIUM 4.5 (2.2 mmol/L) ACETATE 70 CHLORIDE 39 PHOSPHATE 30 (15 mmol/L) BALANCED BY IONS FROM AMINO ACIDS pH ADJUSTED WITH GLACIAL ACETIC ACID STERILE SINGLE DOSE CONTAINER ROOM TEMPERATURE (25°C/77°F) AVOID EXCESSIVE HEAT PROTECT FROM FREEZING SEE PRESCRIBING INFORMATION BAXTER BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 US Container Label LOT EXP 2B7740 NDC 0338-1147-03 CLINIMIX E WITH ELECTROLYTES 5/15 SULFITE-FREE (5% Amino Acid with Electrolytes in 15% Dextrose with Calcium) Injection CENTRAL LINE INFUSION ONLY 500 mL INJECTION PORT CHAMBER 30% Dextrose Injection with Calcium 500 mL OUTLET PORT CHAMBER 10% Amino Acid Injection Rx Only ACTIVATE SEAL AND MIX THOROUGHLY BEFORE USE SEE PRESRCIBING INFORMATION FOR INSTRUCTIONS ON ACTIVATION AFTER MIXING THE PRODUCT REPRESENTS 1000 mL REFRIGERATED STORAGE IS LIMITED TO 9 DAYS A SLIGHT YELLOW COLOR DOES NOT ALTER THE QUALITY AND EFFICACY OF THIS PRODUCT ASK PHARMACIST ABOUT ADDITIVE COMPATIBILITY CONTENTS OF EACH 100 mL OF THE ADMIXED INJECTION DEXTROSE HYDROUS USP 15 g ESSENTIAL AMINO ACIDS LEUCINE 365 mg ISOLEUCINE 300 mg VALINE 290 mg LYSINE (ADDED AS THE HYDROCHLORIDE SALT) 290 mg PHENYLALANINE 280 mg HISTIDINE 240 mg THREONINE 210 mg METHIONINE 200 mg TRYPTOPHAN 90 mg NONESSENTIAL AMINO ACIDS ALANINE 1035 mg ARGININE 575 mg GLYCINE 515 mg PROLINE 340 mg SERINE 250 mg TYROSINE 20 mg ELECTROLYTES SODIUM ACETATE TRIHYDRATE USP 340 mg DIBASIC POTASSIUM PHOSPHATE USP 261 mg SODIUM CHLORIDE USP 59 mg MAGNESIUM CHLORIDE USP 51 mg CALCIUM CHLORIDE DIHYDRATE USP 33 mg mEq/L SODIUM 35 POTASSIUM 30 MAGNESIUM 5 CALCIUM 4.5 (2.2 mmol/L) ACETATE 80 CHLORIDE 39 PHOSPHATE 30 (15 mmol/L) BALANCED BY IONS FROM AMINO ACIDS pH ADJUSTED WITH GLACIAL ACETIC ACID STERILE SINGLE DOSE CONTAINER ROOM TEMPERATURE (25°C/77°F) AVOID EXCESSIVE HEAT PROTECT FROM FREEZING SEE PRESCRIBING INFORMATION BAXTER BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 US Container Label Container Label LOT EXP 2B7721 NDC 0338-1123-04 CLINIMIX E WITH ELECTROLYTES 5/15 SULFITE-FREE (5% Amino Acid with Electrolytes in 15% Dextrose with Calcium) Injection 1000 mL INJECTION PORT CHAMBER 30% Dextrose Injection with Calcium 1000 mL OUTLET PORT CHAMBER 10% Amino Acid Injection Rx Only ACTIVATE SEAL AND MIX THOROUGHLY BEFORE USE SEE PRESRCIBING INFORMATION FOR INSTRUCTIONS ON ACTIVATION AFTER MIXING THE PRODUCT REPRESENTS 2000 mL REFRIGERATED STORAGE IS LIMITED TO 9 DAYS A SLIGHT YELLOW COLOR DOES NOT ALTER THE QUALITY AND EFFICACY OF THIS PRODUCT ASK PHARMACIST ABOUT ADDITIVE COMPATIBILITY CONTENTS OF EACH 100 mL OF THE ADMIXED INJECTION DEXTROSE HYDROUS USP 15 g ESSENTIAL AMINO ACIDS LEUCINE 365 mg ISOLEUCINE 300 mg VALINE 290 mg LYSINE (ADDED AS THE HYDROCHLORIDE SALT) 290 mg PHENYLALANINE 280 mg HISTIDINE 240 mg THREONINE 210 mg METHIONINE 200 mg TRYPTOPHAN 90 mg NONESSENTIAL AMINO ACIDS ALANINE 1035 mg ARGININE 575 mg GLYCINE 515 mg PROLINE 340 mg SERINE 250 mg TYROSINE 20 mg ELECTROLYTES SODIUM ACETATE TRIHYDRATE USP 340 mg DIBASIC POTASSIUM PHOSPHATE USP 261 mg SODIUM CHLORIDE USP 59 mg MAGNESIUM CHLORIDE USP 51 mg CALCIUM CHLORIDE DIHYDRATE USP 33 mg mEq/L SODIUM 35 POTASSIUM 30 MAGNESIUM 5 CALCIUM 4.5 (2.2 mmol/L) ACETATE 80 CHLORIDE 39 PHOSPHATE 30 (15 mmol/L) BALANCED BY IONS FROM AMINO ACIDS pH ADJUSTED WITH GLACIAL ACETIC ACID STERILE SINGLE DOSE CONTAINER ROOM TEMPERATURE (25°C/77°F) AVOID EXCESSIVE HEAT PROTECT FROM FREEZING SEE PRESCRIBING INFORMATION BAXTER BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 US Container Label LOT EXP 2B7741 NDC 0338-1148-03 CLINIMIX E WITH ELECTROLYTES 5/20 SULFITE-FREE (5% Amino Acid with Electrolytes in 20% Dextrose with Calcium) Injection 500 mL INJECTION PORT CHAMBER 40% Dextrose Injection with Calcium 500 mL OUTLET PORT CHAMBER 10% Amino Acid Injection Rx Only ACTIVATE SEAL AND MIX THOROUGHLY BEFORE USE SEE PRESRCIBING INFORMATION FOR INSTRUCTIONS ON ACTIVATION AFTER MIXING THE PRODUCT REPRESENTS 1000 mL REFRIGERATED STORAGE IS LIMITED TO 9 DAYS A SLIGHT YELLOW COLOR DOES NOT ALTER THE QUALITY AND EFFICACY OF THIS PRODUCT ASK PHARMACIST ABOUT ADDITIVE COMPATIBILITY CONTENTS OF EACH 100 mL OF THE ADMIXED INJECTION DEXTROSE HYDROUS USP 20 g ESSENTIAL AMINO ACIDS LEUCINE 365 mg ISOLEUCINE 300 mg VALINE 290 mg LYSINE (ADDED AS THE HYDROCHLORIDE SALT) 290 mg PHENYLALANINE 280 mg HISTIDINE 240 mg THREONINE 210 mg METHIONINE 200 mg TRYPTOPHAN 90 mg NONESSENTIAL AMINO ACIDS ALANINE 1035 mg ARGININE 575 mg GLYCINE 515 mg PROLINE 340 mg SERINE 250 mg TYROSINE 20 mg ELECTROLYTES SODIUM ACETATE TRIHYDRATE USP 340 mg DIBASIC POTASSIUM PHOSPHATE USP 261 mg SODIUM CHLORIDE USP 59 mg MAGNESIUM CHLORIDE USP 51 mg CALCIUM CHLORIDE DIHYDRATE USP 33 mg mEq/L SODIUM 35 POTASSIUM 30 MAGNESIUM 5 CALCIUM 4.5 (2.2 mmol/L) ACETATE 80 CHLORIDE 39 PHOSPHATE 30 (15 mmol/L) BALANCED BY IONS FROM AMINO ACIDS pH ADJUSTED WITH GLACIAL ACETIC ACID STERILE SINGLE DOSE CONTAINER ROOM TEMPERATURE (25°C/77°F) AVOID EXCESSIVE HEAT PROTECT FROM FREEZING SEE PRESCRIBING INFORMATION BAXTER BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 US Container Label LOT EXP 2B7722 NDC 0338-1125-04 CLINIMIX E WITH ELECTROLYTES 5/20 SULFITE-FREE (5% Amino Acid with Electrolytes in 20% Dextrose with Calcium) Injection 1000 mL INJECTION PORT CHAMBER 40% Dextrose Injection with Calcium 1000 mL OUTLET PORT CHAMBER 10% Amino Acid Injection Rx Only ACTIVATE SEAL AND MIX THOROUGHLY BEFORE USE SEE PRESRCIBING INFORMATION FOR INSTRUCTIONS ON ACTIVATION AFTER MIXING THE PRODUCT REPRESENTS 2000 mL REFRIGERATED STORAGE IS LIMITED TO 9 DAYS A SLIGHT YELLOW COLOR DOES NOT ALTER THE QUALITY AND EFFICACY OF THIS PRODUCT ASK PHARMACIST ABOUT ADDITIVE COMPATIBILITY CONTENTS OF EACH 100 mL OF THE ADMIXED INJECTION DEXTROSE HYDROUS USP 20 g ESSENTIAL AMINO ACIDS LEUCINE 365 mg ISOLEUCINE 300 mg VALINE 290 mg LYSINE (ADDED AS THE HYDROCHLORIDE SALT) 290 mg PHENYLALANINE 280 mg HISTIDINE 240 mg THREONINE 210 mg METHIONINE 200 mg TRYPTOPHAN 90 mg NONESSENTIAL AMINO ACIDS ALANINE 1035 mg ARGININE 575 mg GLYCINE 515 mg PROLINE 340 mg SERINE 250 mg TYROSINE 20 mg ELECTROLYTES SODIUM ACETATE TRIHYDRATE USP 340 mg DIBASIC POTASSIUM PHOSPHATE USP 261 mg SODIUM CHLORIDE USP 59 mg MAGNESIUM CHLORIDE USP 51 mg CALCIUM CHLORIDE DIHYDRATE USP 33 mg mEq/L SODIUM 35 POTASSIUM 30 MAGNESIUM 5 CALCIUM 4.5 (2.2 mmol/L) ACETATE 80 CHLORIDE 39 PHOSPHATE 30 (15 mmol/L) BALANCED BY IONS FROM AMINO ACIDS pH ADJUSTED WITH GLACIAL ACETIC ACID STERILE SINGLE DOSE CONTAINER ROOM TEMPERATURE (25°C/77°F) AVOID EXCESSIVE HEAT PROTECT FROM FREEZING SEE PRESCRIBING INFORMATION BAXTER BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 US Container Label EADB9963 1000 mL NDC 0338-0202-01 CLINIMIX E WITH ELECTROLYTES 8/14 SULFITE-FREE (8% Amino Acids with Electrolytes in 14% Dextrose with Calcium) Injection CENTRAL LINE INFUSION ONLY 360 mL INJECTION PORT CHAMBER 39% Dextrose Injection with Calcium 640 mL OUTLET PORT CHAMBER 12.5% Amino Acid Injection with Electrolytes Rx Only ACTIVATE SEAL AND MIX THOROUGHLY BEFORE USE 2000 mL SEE PRESCRIBING INFORMATION FOR INSTRUCTIONS ON ACTIVATION AFTER MIXING THE PRODUCT REPRESENTS 1000 mL REFRIGERATED STORAGE IS LIMITED TO 9 DAYS ONCE OVERWRAP IS OPENED A SLIGHT YELLOW COLOR DOES NOT ALTER THE QUALITY AND EFFICACY OF THIS PRODUCT ASK PHARMACIST ABOUT ADDITIVE COMPATIBILITY EXP CONTENTS OF EACH 100 mL OF THE ADMIXED INJECTION DEXTROSE HYDROUS USP 14 g ESSENTIAL AMINO ACIDS LEUCINE 584 mg ISOLEUCINE 480 mg VALINE 464 mg LYSINE ( ADDED AS THE HYDROCHLORIDE SALT ) 464 mg PHENYLALANINE 448 mg HISTIDINE 384 mg THREONINE 336 mg METHIONINE 320 mg TRYPTOPHAN 144 mg NONESSENTIAL AMINO ACIDS ALANINE 1656 mg ARGININE 920 mg GLYCINE 824 mg PROLINE 544 mg SERINE 400 mg TYROSINE 32 mg ELECTROLYTES DIBASIC POTASSIUM PHOSPHATE USP 261 mg SODIUM CHLORIDE USP 205 mg MAGNESIUM CHLORIDE USP 51 mg CALCIUM CHLORIDE DIHYDRATE USP 33 mg mEq/L SODIUM 35 POTASSIUM 30 MAGNESIUM 5 CALCIUM 4 . 5 ( 2 . 2 mmol / L ) ACETATE 83 CHLORIDE 76 PHOSPHATE 30 ( 15 mmol / L ) BALANCED BY IONS FROM AMINO ACIDS pH ADJUSTED WITH GLACIAL ACETIC ACID AND HYDROCHLORIC ACID STERILE SINGLE DOSE CONTAINER STORE AT ROOM TEMPERATURE ( 25ºC / 77ºF ) IN UNOPENED OVERWRAP AVOID EXCESSIVE HEAT PROTECT FROM FREEZING SEE PRESCRIBING INFORMATION Baxter logo BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 USA MADE IN BELGIUM LOT BE-35-04-044 Container Label EADB9965 2000 mL NDC 0338-0206-01 CLINIMIX E WITH ELECTROLYTES 8/14 SULFITE-FREE (8% Amino Acids with Electrolytes in 14% Dextrose with Calcium) Injection CENTRAL LINE INFUSION ONLY 720 mL INJECTION PORT CHAMBER 39% Dextrose Injection with Calcium 1280 mL OUTLET PORT CHAMBER 12.5% Amino Acid Injection with Electrolytes Rx Only ACTIVATE SEAL AND MIX THOROUGHLY BEFORE USE SEE PRESCRIBING INFORMATION FOR INSTRUCTIONS ON ACTIVATION AFTER MIXING THE PRODUCT REPRESENTS 2000 mL REFRIGERATED STORAGE IS LIMITED TO 9 DAYS ONCE OVERWRAP IS OPENED A SLIGHT YELLOW COLOR DOES NOT ALTER THE QUALITY AND EFFICACY OF THIS PRODUCT ASK PHARMACIST ABOUT ADDITIVE COMPATIBILITY EADB9965 Exp CONTENTS OF EACH 100 mL OF THE ADMIXED INJECTION DEXTROSE HYDROUS USP 14 g ESSENTIAL AMINO ACIDS LEUCINE 584 mg ISOLEUCINE 480 mg VALINE 464 mg LYSINE ( ADDED AS THE HYDROCHLORIDE SALT ) 464 mg PHENYLALANINE 448 mg HISTIDINE 384 mg THREONINE 336 mg METHIONINE 320 mg TRYPTOPHAN 144 mg NONESSENTIAL AMINO ACIDS ALANINE 1656 mg ARGININE 920 mg GLYCINE 824 mg PROLINE 544 mg SERINE 400 mg TYROSINE 32 mg ELECTROLYTES DIBASIC POTASSIUM PHOSPHATE USP 261 mg SODIUM CHLORIDE USP 205 mg MAGNESIUM CHLORIDE USP 51 mg CALCIUM CHLORIDE DIHYDRATE USP 33 mg mEq/L SODIUM 35 POTASSIUM 30 MAGNESIUM 5 CALCIUM 4 . 5 ( 2 . 2 mmol / L ) ACETATE 83 CHLORIDE 76 PHOSPHATE 30 ( 15 mmol / L ) BALANCED BY IONS FROM AMINO ACIDS pH ADJUSTED WITH GLACIAL ACETIC ACID AND HYDROCHLORIC ACID STERILE SINGLE DOSE CONTAINER STORE AT ROOM TEMPERATURE ( 25ºC / 77ºF ) IN UNOPENED OVERWRAP AVOID EXCESSIVE HEAT PROTECT FROM FREEZING SEE PRESCRIBING INFORMATION Baxter Logo BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 USA MADE IN BELGIUM Lot BE-35-04-048 Container Label EADB9943 1000 mL NDC 0338-0210-01 CLINIMIX E WITH ELECTROLYTES 8/10 SULFITE-FREE (8% Amino Acids with Electrolytes in 10% Dextrose with Calcium) Injection CENTRAL LINE INFUSION ONLY 360 mL INJECTION PORT CHAMBER 28% Dextrose Injection with Calcium 640 mL OUTLET PORT CHAMBER 12.5% Amino Acid Injection with Electrolytes Rx Only ACTIVATE SEAL AND MIX THOROUGHLY BEFORE USE SEE PRESCRIBING INFORMATION FOR INSTRUCTIONS ON ACTIVATION AFTER MIXING THE PRODUCT REPRESENTS 1000 mL REFRIGERATED STORAGE IS LIMITED TO 9 DAYS ONCE OVERWRAP IS OPENED A SLIGHT YELLOW COLOR DOES NOT ALTER THE QUALITY AND EFFICACY OF THIS PRODUCT ASK PHARMACIST ABOUT ADDITIVE COMPATIBILITY EXP CONTENTS OF EACH 100 mL OF THE ADMIXED INJECTION DEXTROSE HYDROUS USP 10 g ESSENTIAL AMINO ACIDS LEUCINE 584 mg ISOLEUCINE 480 mg VALINE 464 mg LYSINE ( ADDED AS THE HYDROCHLORIDE SALT ) 464 mg PHENYLALANINE 448 mg HISTIDINE 384 mg THREONINE 336 mg METHIONINE 320 mg TRYPTOPHAN 144 mg NONESSENTIAL AMINO ACIDS ALANINE 1656 mg ARGININE 920 mg GLYCINE 824 mg PROLINE 544 mg SERINE 400 mg TYROSINE 32 mg ELECTROLYTES DIBASIC POTASSIUM PHOSPHATE USP 261 mg SODIUM CHLORIDE USP 205 mg MAGNESIUM CHLORIDE USP 51 mg CALCIUM CHLORIDE DIHYDRATE USP 33 mg mEq/L SODIUM 35 POTASSIUM 30 MAGNESIUM 5 CALCIUM 4 . 5 ( 2 . 2 mmol / L ) ACETATE 83 CHLORIDE 76 PHOSPHATE 30 ( 15 mmol / L ) BALANCED BY IONS FROM AMINO ACIDS pH ADJUSTED WITH GLACIAL ACETIC ACID AND HYDROCHLORIC ACID STERILE SINGLE DOSE CONTAINER STORE AT ROOM TEMPERATURE ( 25ºC / 77ºF ) IN UNOPENED OVERWRAP AVOID EXCESSIVE HEAT PROTECT FROM FREEZING SEE PRESCRIBING INFORMATION Baxter Logo BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 USA MADE IN BELGIUM LOT BE-35-04-042 Container Label EADB9945 2000 mL NDC 0338-0214-01 CLINIMIX E WITH ELECTROLYTES 8/10 SULFITE-FREE (8% Amino Acids with Electrolytes in 10% Dextrose with Calcium) Injection CENTRAL LINE INFUSION ONLY 720 mL INJECTION PORT CHAMBER 28% Dextrose Injection with Calcium 1280 mL OUTLET PORT CHAMBER 12.5% Amino Acid Injection with Electrolytes Rx Only ACTIVATE SEAL AND MIX THOROUGHLY BEFORE USE SEE PRESCRIBING INFORMATION FOR INSTRUCTIONS ON ACTIVATION AFTER MIXING THE PRODUCT REPRESENTS 2000 mL REFRIGERATED STORAGE IS LIMITED TO 9 DAYS ONCE OVERWRAP IS OPENED A SLIGHT YELLOW COLOR DOES NOT ALTER THE QUALITY AND EFFICACY OF THIS PRODUCT ASK PHARMACIST ABOUT ADDITIVE COMPATIBILITY Exp CONTENTS OF EACH 100 mL OF THE ADMIXED INJECTION DEXTROSE HYDROUS USP 10 g ESSENTIAL AMINO ACIDS LEUCINE 584 mg ISOLEUCINE 480 mg VALINE 464 mg LYSINE ( ADDED AS THE HYDROCHLORIDE SALT ) 464 mg PHENYLALANINE 448 mg HISTIDINE 384 mg THREONINE 336 mg METHIONINE 320 mg TRYPTOPHAN 144 mg NONESSENTIAL AMINO ACIDS ALANINE 1656 mg ARGININE 920 mg GLYCINE 824 mg PROLINE 544 mg SERINE 400 mg TYROSINE 32 mg ELECTROLYTES DIBASIC POTASSIUM PHOSPHATE USP 261 mg SODIUM CHLORIDE USP 205 mg MAGNESIUM CHLORIDE USP 51 mg CALCIUM CHLORIDE DIHYDRATE USP 33 mg mEq/L SODIUM35 POTASSIUM30 MAGNESIUM 5 CALCIUM 4 . 5 ( 2 . 2 mmol / L ) ACETATE 83 CHLORIDE 76 PHOSPHATE 30 ( 15 mmol / L ) BALANCED BY IONS FROM AMINO ACIDS pH ADJUSTED WITH GLACIAL ACETIC ACID AND HYDROCHLORIC ACID STERILE SINGLE DOSE CONTAINER STORE AT ROOM TEMPERATURE ( 25ºC / 77ºF ) IN UNOPENED OVERWRAP AVOID EXCESSIVE HEAT PROTECT FROM FREEZING SEE PRESCRIBING INFORMATION BAXTER LOGO BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 USA MADE IN BELGIUM Lot BE35-04-046 Representative Container Label 0338-1142-03 Clinimix E Representative Container Label 0338-1144 Clinimix E Representative Container Label 0338-1113 Clinimix E Representative Container Label 0338-1145 Clinimix E Representative Container Label 0338-1115 Clinimix E Representative Container Label 0338-1147 Clinimix E Representative Container Label 0338-1123 Clinimix E Representative Container Label 0338-1148 Clinimix E Representative Container Label 0338-1125 Clinimix E Representative Container Label 0338-0202-01 Clinimix E Representative Container Label 0338-0206-01 Clinimix E Representative Container Label 0338-0210-01 Clinimix E Representative Container Label 0338-0214-01

Dosage and Administration, Instructions for Use ( 2.3 , 2.7 ) 04/2021 Warnings and Precautions (5.6) 04/2021 Dosage and Administration (2.1 , 2.3 , 2.4 , 2.6 , 2.8) 09/2020

Baxter Healthcare Corporation Deerfield, IL 60015 USA Baxter and Clinimix E are registered trademarks of Baxter International Inc. BE-30-03-649

17 PATIENT COUNSELING INFORMATION Inform patients, caregivers, or home healthcare providers of the following risks of CLINIMIX E: • Pulmonary embolism due to pulmonary vascular precipitates [see Warnings and Precautions (5.1) ] • Death in neonates due to calcium-ceftriaxone precipitates [see Warnings and Precautions (5.2) ] • Hypersensitivity reactions [see Warnings and Precautions (5.3) ] • Risk of Infections [see Warnings and Precautions (5.4) ] • Refeeding syndrome [see Warnings and Precautions (5.5) ] • Hyperglycemia or hyperosmolar hyperglycemic state [see Warnings and Precautions (5.6) ] • Vein damage and thrombosis [see Warnings and Precautions (5.7) ] • Hepatobiliary disorders [see Warnings and Precautions (5.8) ] • Aluminum toxicity [see Warnings and Precautions (5.9) ] • Parenteral Nutrition Associated Liver Disease (PNALD) [see Warnings and Precautions (5.10) ] • Electrolyte imbalance and fluid overload [see Warnings and Precautions (5.11) ]

8.5 Geriatric Use Clinical studies of CLINIMIX E 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.

8.4 Pediatric Use Safety and effectiveness of CLINIMIX E in pediatric patients have not been established by adequate and well-controlled studies. Use of dextrose, amino acid infusions and electrolytes in pediatric patients is based on clinical practice [see Dosage and Administration (2.8) ] . Deaths have occurred in neonates (28 days of age or younger) who received concomitant intravenous calcium-containing solutions with ceftriaxone resulting from calcium-ceftriaxone precipitates in the lungs and kidneys, even when separate infusion lines were used. CLINIMIX E is contraindicated in neonates receiving ceftriaxone [see Contraindications (4) , Warnings and Precautions (5.2) ]. Newborns, especially those born premature and with low birth weight, are at increased risk of developing hypo – or hyperglycemia and therefore need close monitoring during treatment with intravenous glucose solutions to ensure adequate glycemic control in order to avoid potential long term adverse effects. Hypoglycemia in the newborn can cause prolonged seizures, coma and brain damage. Hyperglycemia has been associated with intraventricular hemorrhage, late onset bacterial and fungal infection, retinopathy of prematurity, necrotizing enterocolitis, bronchopulmonary dysplasia, prolonged length of hospital stay, and death. Plasma electrolyte concentrations should be closely monitored in the pediatric population as this population may have impaired ability to regulate fluids and electrolytes. Because of immature renal function, preterm infants receiving prolonged treatment with CLINIMIX E, may be at risk of aluminum toxicity [see Warnings and Precautions (5.9) ] . Patients, including pediatric patients, may be at risk for Parenteral Nutrition Associated Liver Disease (PNALD) [see Warnings and Precautions (5.10) ] . Hyperammonemia is of special significance in infants (birth to two years). 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 [see Warnings and Precautions (5.8) ] .

8.1 Pregnancy Risk Summary There are no adequate or well-controlled studies in pregnant women with CLINIMIX E. Additionally, animal reproduction studies have not been conducted with amino acids and electrolytes and dextrose. It is not known whether CLINIMIX E can cause fetal harm when administered to a pregnant woman. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. However, the estimated background risk in the U.S. general population of major birth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies. Clinical Considerations Disease-Associated Maternal and/or Embryo-Fetal Risk Based on clinical practice guidelines, parenteral nutrition should be considered in cases of severe maternal malnutrition where nutritional requirements cannot be fulfilled by the enteral route because of the risks to the fetus associated with severe malnutrition, such as preterm delivery, low birth weight, intrauterine growth restriction, congenital malformations and perinatal mortality.

8 USE IN SPECIFIC POPULATIONS Pediatric Use: increased risk of hypoglycemia/hyperglycemia: monitor serum glucose concentrations. ( 8.4 ) 8.1 Pregnancy Risk Summary There are no adequate or well-controlled studies in pregnant women with CLINIMIX E. Additionally, animal reproduction studies have not been conducted with amino acids and electrolytes and dextrose. It is not known whether CLINIMIX E can cause fetal harm when administered to a pregnant woman. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. However, the estimated background risk in the U.S. general population of major birth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies. Clinical Considerations Disease-Associated Maternal and/or Embryo-Fetal Risk Based on clinical practice guidelines, parenteral nutrition should be considered in cases of severe maternal malnutrition where nutritional requirements cannot be fulfilled by the enteral route because of the risks to the fetus associated with severe malnutrition, such as preterm delivery, low birth weight, intrauterine growth restriction, congenital malformations and perinatal mortality. 8.2 Lactation Risk Summary It is not known whether CLINIMIX E is present in human milk. There are no data on the effects of CLINIMIX E on the breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for CLINIMIX E and any potential adverse effects on the breastfed child from CLINIMIX E or from the underlying maternal condition. 8.4 Pediatric Use Safety and effectiveness of CLINIMIX E in pediatric patients have not been established by adequate and well-controlled studies. Use of dextrose, amino acid infusions and electrolytes in pediatric patients is based on clinical practice [see Dosage and Administration (2.8) ] . Deaths have occurred in neonates (28 days of age or younger) who received concomitant intravenous calcium-containing solutions with ceftriaxone resulting from calcium-ceftriaxone precipitates in the lungs and kidneys, even when separate infusion lines were used. CLINIMIX E is contraindicated in neonates receiving ceftriaxone [see Contraindications (4) , Warnings and Precautions (5.2) ]. Newborns, especially those born premature and with low birth weight, are at increased risk of developing hypo – or hyperglycemia and therefore need close monitoring during treatment with intravenous glucose solutions to ensure adequate glycemic control in order to avoid potential long term adverse effects. Hypoglycemia in the newborn can cause prolonged seizures, coma and brain damage. Hyperglycemia has been associated with intraventricular hemorrhage, late onset bacterial and fungal infection, retinopathy of prematurity, necrotizing enterocolitis, bronchopulmonary dysplasia, prolonged length of hospital stay, and death. Plasma electrolyte concentrations should be closely monitored in the pediatric population as this population may have impaired ability to regulate fluids and electrolytes. Because of immature renal function, preterm infants receiving prolonged treatment with CLINIMIX E, may be at risk of aluminum toxicity [see Warnings and Precautions (5.9) ] . Patients, including pediatric patients, may be at risk for Parenteral Nutrition Associated Liver Disease (PNALD) [see Warnings and Precautions (5.10) ] . Hyperammonemia is of special significance in infants (birth to two years). 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 [see Warnings and Precautions (5.8) ] . 8.5 Geriatric Use Clinical studies of CLINIMIX E 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.

16 HOW SUPPLIED/STORAGE AND HANDLING CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection (sulfite-free) is available in 1000 mL and 2000 mL volumes (See Table 9 ). Table 9: CLINIMIX E Formulations After mixing, the product represents 1000 mL Code and NDC Number 2000 mL Code and NDC Number CLINIMIX E 2.75/5 sulfite-free (2.75% Amino Acid with Electrolytes in 5% Dextrose with Calcium) Injection Code 2B7735 NDC 0338-1142-03 CLINIMIX E 4.25/5 sulfite-free (4.25% Amino Acid with Electrolytes in 5% Dextrose with Calcium) Injection Code 2B7737 NDC 0338-1144-03 Code 2B7716 NDC 0338-1113-04 CLINIMIX E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injection Code 2B7738 NDC 0338-1145-03 Code 2B7717 NDC 0338-1115-04 CLINIMIX E 5/15 sulfite-free (5% Amino Acid with Electrolytes in 15% Dextrose with Calcium) Injection Code 2B7740 NDC 0338-1147-03 Code 2B7721 NDC 0338-1123-04 CLINIMIX E 5/20 sulfite-free (5% Amino Acid with Electrolytes in 20% Dextrose with Calcium) Injection Code 2B7741 NDC 0338-1148-03 Code 2B7722 NDC 0338-1125-04 CLINIMIX E 8/10 sulfite-free (8% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injection Code EADB9943 NDC 0338-210-06 Code EADB9945 NDC 0338-0214-04 CLINIMIX E 8/14 sulfite-free (8% Amino Acid with Electrolytes in 14% Dextrose with Calcium) Injection Code EADB9963 NDC 0338-0202-06 Code EADB9965 NDC 0338-0206-04 Minimize exposure of CLINIMIX E to heat and avoid excessive heat. Protect from freezing. Store CLINIMIX E at room temperature (25°C/77°F) (may briefly store at up to 40°C/104°F). Refrigerated storage is limited to 9 days once the protective overwrap has been opened. Do not use if the protective overwrap has been previously opened or damaged. For storage of admixed solutions see Dosage and Administration (2.3 , 2.4 ) .