NDC 0338-1148 Clinimix E
Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonin...

Product Information

What is NDC 0338-1148?

The NDC code 0338-1148 is assigned by the FDA to the product Clinimix E which is a human prescription drug product labeled by Baxter Healthcare Corporation. The generic name of Clinimix E is 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. The product's dosage form is injection and is administered via intravenous form. The product is distributed in a single package with assigned NDC code 0338-1148-03 1000 ml in 1 bag . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code0338-1148
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Clinimix E
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
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
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Human Prescription Drug
Dosage FormInjection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Intravenous - Administration within or into a vein or veins.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Baxter Healthcare Corporation
Labeler Code0338
FDA Application Number What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
NDA020678
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
03-26-1997
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
12-31-2023
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

What are the uses for Clinimix E?


Product Packages

NDC Code 0338-1148-03

Package Description: 1000 mL in 1 BAG

Product Details

What are Clinimix E Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • ALANINE 1035 mg/100mL - A non-essential amino acid that occurs in high levels in its free state in plasma. It is produced from pyruvate by transamination. It is involved in sugar and acid metabolism, increases IMMUNITY, and provides energy for muscle tissue, BRAIN, and the CENTRAL NERVOUS SYSTEM.
  • ARGININE 575 mg/100mL - An essential amino acid that is physiologically active in the L-form.
  • CALCIUM CHLORIDE 33 mg/100mL - A salt used to replenish calcium levels, as an acid-producing diuretic, and as an antidote for magnesium poisoning.
  • DEXTROSE 20 g/100mL
  • GLYCINE 515 mg/100mL - A non-essential amino acid. It is found primarily in gelatin and silk fibroin and used therapeutically as a nutrient. It is also a fast inhibitory neurotransmitter.
  • HISTIDINE 240 mg/100mL - An essential amino acid that is required for the production of HISTAMINE.
  • ISOLEUCINE 300 mg/100mL - An essential branched-chain aliphatic amino acid found in many proteins. It is an isomer of LEUCINE. It is important in hemoglobin synthesis and regulation of blood sugar and energy levels.
  • LEUCINE 365 mg/100mL - An essential branched-chain amino acid important for hemoglobin formation.
  • LYSINE 290 mg/100mL - An essential amino acid. It is often added to animal feed.
  • MAGNESIUM CHLORIDE 51 mg/100mL - Magnesium chloride. An inorganic compound consisting of one magnesium and two chloride ions. The compound is used in medicine as a source of magnesium ions, which are essential for many cellular activities. It has also been used as a cathartic and in alloys.
  • METHIONINE 200 mg/100mL - A sulfur-containing essential L-amino acid that is important in many body functions.
  • PHENYLALANINE 280 mg/100mL - An essential aromatic amino acid that is a precursor of MELANIN; DOPAMINE; noradrenalin (NOREPINEPHRINE), and THYROXINE.
  • POTASSIUM PHOSPHATE, DIBASIC 261 mg/100mL
  • PROLINE 340 mg/100mL - A non-essential amino acid that is synthesized from GLUTAMIC ACID. It is an essential component of COLLAGEN and is important for proper functioning of joints and tendons.
  • SERINE 250 mg/100mL - A non-essential amino acid occurring in natural form as the L-isomer. It is synthesized from GLYCINE or THREONINE. It is involved in the biosynthesis of PURINES; PYRIMIDINES; and other amino acids.
  • SODIUM ACETATE 340 mg/100mL - The trihydrate sodium salt of acetic acid, which is used as a source of sodium ions in solutions for dialysis and as a systemic and urinary alkalizer, diuretic, and expectorant.
  • SODIUM CHLORIDE 59 mg/100mL - A ubiquitous sodium salt that is commonly used to season food.
  • THREONINE 210 mg/100mL - An essential amino acid occurring naturally in the L-form, which is the active form. It is found in eggs, milk, gelatin, and other proteins.
  • TRYPTOPHAN 90 mg/100mL - An essential amino acid that is necessary for normal growth in infants and for NITROGEN balance in adults. It is a precursor of INDOLE ALKALOIDS in plants. It is a precursor of SEROTONIN (hence its use as an antidepressant and sleep aid). It can be a precursor to NIACIN, albeit inefficiently, in mammals.
  • TYROSINE 20 mg/100mL - A non-essential amino acid. In animals it is synthesized from PHENYLALANINE. It is also the precursor of EPINEPHRINE; THYROID HORMONES; and melanin.
  • VALINE 290 mg/100mL - A branched-chain essential amino acid that has stimulant activity. It promotes muscle growth and tissue repair. It is a precursor in the penicillin biosynthetic pathway.

Clinimix E Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 1090635 - alanine 8.8 MG/ML / arginine 4.89 MG/ML / calcium chloride 0.004 MEQ/ML / dibasic potassium phosphate 2.61 MG/ML / glucose 100 MG/ML / glycine 4.38 MG/ML / histidine 2.04 MG/ML / isoleucine 2.55 MG/ML / leucine 3.11 MG/ML / lysine 2.47 MG/ML / magnesium chloride 0.01 MEQ/ML / methionine 1.7 MG/ML / phenylalanine 2.38 MG/ML / proline 2.89 MG/ML / serine 2.13 MG/ML / sodium acetate trihydrate 2.97 MG/ML / sodium chloride 0.013 MEQ/ML / threonine 1.79 MG/ML / tryptophan 0.77 MG/ML / tyrosine 0.17 MG/ML / valine 2.47 MG/ML Injectable Solution
  • RxCUI: 1090635 - Alanine 8.8 MG/ML / Arginine 4.89 MG/ML / Calcium Chloride 0.004 MEQ/ML / Dibasic K+ phosphate 2.61 MG/ML / Glucose 100 MG/ML / Glycine 4.38 MG/ML / Histidine 2.04 MG/ML / Isoleucine 2.55 MG/ML / Leucine 3.11 MG/ML / Lysine 2.47 MG/ML / Magnesium Chloride 0.01 MEQ/ML / Methionine 1.7 MG/ML / Phenylalanine 2.38 MG/ML / Proline 2.89 MG/ML / Serine 2.13 MG/ML / Sodium Acetate Trihydrate 2.97 MG/ML / NaCl 0.013 MEQ/ML / Threonine 1.79 MG/ML / Tryptophan 0.77 MG/ML / Tyrosine 0.17 MG/ML / Valine 2.47 MG/ML Injectable Solution
  • RxCUI: 1090635 - Alanine 8.8 MG/ML / Arginine 4.89 MG/ML / Calcium Chloride 0.004 MEQ/ML / Dibasic Pot phosphate 2.61 MG/ML / Glucose 100 MG/ML / Glycine 4.38 MG/ML / Histidine 2.04 MG/ML / Isoleucine 2.55 MG/ML / Leucine 3.11 MG/ML / Lysine 2.47 MG/ML / Magnesium Chloride 0.01 MEQ/ML / Methionine 1.7 MG/ML / Phenylalanine 2.38 MG/ML / Proline 2.89 MG/ML / Serine 2.13 MG/ML / Sodium Acetate Trihydrate 2.97 MG/ML / NaCl 0.013 MEQ/ML / Threonine 1.79 MG/ML / Tryptophan 0.77 MG/ML / Tyrosine 0.17 MG/ML / Valine 2.47 MG/ML Injectable Solution
  • RxCUI: 1090639 - Clinimix E 4.25/10 Injectable Solution
  • RxCUI: 1090639 - alanine 8.8 MG/ML / arginine 4.89 MG/ML / calcium chloride 0.004 MEQ/ML / dibasic potassium phosphate 2.61 MG/ML / glucose 100 MG/ML / glycine 4.38 MG/ML / histidine 2.04 MG/ML / isoleucine 2.55 MG/ML / leucine 3.11 MG/ML / lysine 2.47 MG/ML / magnesium chloride 0.01 MEQ/ML / methionine 1.7 MG/ML / phenylalanine 2.38 MG/ML / proline 2.89 MG/ML / serine 2.13 MG/ML / sodium acetate trihydrate 2.97 MG/ML / sodium chloride 0.013 MEQ/ML / threonine 1.79 MG/ML / tryptophan 0.77 MG/ML / tyrosine 0.17 MG/ML / valine 2.47 MG/ML Injectable Solution [Clinimix E 4.25/10]

Clinimix E Inactive Ingredients UNII Codes

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

Pharmacologic Class(es)

* Please review the disclaimer below.

Clinimix E Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



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.


2.1 Preparation Prior To Administration



  • •Tear protective foil overwrap across top 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 bag 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:
    • oIf the outlet or additive port protectors are damaged, detached, or not present, discard container as solution path sterility may be impaired.
    • oCheck 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.
    • oCheck 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 bag 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 bag 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)].
    • oFor central vein infusion only: CLINIMIX E 2.75/10, 4.25/10, 4.25/25, 5/15, 5/20, 5/25
    • oFor 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 foil overwrap across top at slit and remove solution container.
  • 2.Lay the bag onto a flat surface. Grasp the container firmly on each side of the top of the bag (Figure 1).
  • 3.Starting from the top squeeze and roll bag to open seal between chambers until the peel-seal is completely broken as shown in Figure 2.
  • 4.If the seal has not been separated completely flip the bag over and repeat process.
  • 5.Mix the contents thoroughly by inverting the bag upside down to ensure a homogenous admixture (Figure 3).
  • 6.Once the bag is mixed, check for leaks.
  • 7.Make additions (if prescribed).
  •  Because additives may be incompatible, evaluate all additions to the bag 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).
    • a.Prepare medication port.
    • b.Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.
    • c. 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.
    • 8.Inspect final solution for discoloration and particulate matter. Check for leaks.
    • 9.Spike and hang bag.
      • a.Suspend container from eyelet support.
      • b.Twist off protector from outlet port at bottom of container (Figure 4).
      • c.Attach administration set. Refer to complete directions accompanying set.
      • For single dose only. Discard unused portion.

        Figures 1 – 4:

        Instructions on Storage

        Storage After Removal of Overwrap:

        Once removed from the protective foil overwrap, mixed (peel seal activated) or unmixed (peel seal intact), CLINIMIX E Injection 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.


2.4 Preparation And Addition Of Lipid Emulsion



  •  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.
  • 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: review of all 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.



  •  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 Nutritional Requirements1

    Recommended Clinimix E Adult Dosage

    Stable Patients

    Critically Ill Patients

    Do not use in patients with conditions that are contraindicated [see Contraindications (4)].

    Clinimix E 2.75/5

    Clinimix E 2.75/10

    Clinimix E 4.25/5

    Clinimix E 4.25/10

    Clinimix E 4.25/25

    Clinimix E 5/15

    Clinimix E 5/20

    Clinimix E 5/25

    Fluid (mL/kg/day)

    30 to 40

    Minimum needed to deliver adequate nutrition

    29 to 40

    29 to 40

    19 to 40

    19 to 40

    19 to 40

    16 to 40

    16 to 40

    16 to 40

    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

    (0.13 to 0.16)

    1.5 to 2

    (0.24 to 0.32)

    0.8 to 1.1

    (0.13 to 0.18)

    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 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)

    Dextrose (g/kg/day)

    ≤10

    ≤5.8

    1.45 to 2

    2.9 to 4

    0.95 to 2

    1.9 to 4

    4.75 to 10

    2.4 to 6

    3.2 to 8

    4 to 10

    Table 2: Maximum Infusion Rate in Adult Patients

    Maximum Infusion Rates in Adults Patients

    Clinimix E 2.75/5

    Clinimix E 2.75/10

    Clinimix E 4.25/5

    Clinimix E 4.25/10

    Clinimix E 4.25/25

    Clinimix E 5/15

    Clinimix E 5/20

    Clinimix E 5/25

    Maximum Infusion Rate (mL/kg/hour)

    3.6

    2.5

    2.4

    2.4

    1

    1.67

    1.25

    1

    Corresponding infusion rate

    Amino Acid (g/kg/hour)

    0.1

    Rate limiting factor

    0.07

    0.1

    0.1

    0.04

    0.08

    0.06

    0.05

    Dextrose (g/kg/hour)

    0.18

    0.25

    0.12

    0.24

    0.25

    0.25

    0.25

    0.25


2.7 Dosage Modifications In Patients With Renal Impairment



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)].

Patients with renal impairment not needing dialysis require 0.6 to 0.8 g of protein/kg/day. Serum electrolyte levels should be closely monitored. Patients on hemodialysis or continuous renal replacement therapy should receive 1.2 to 1.8 g of protein/kg/day up to a maximum of 2.5 g of protein/kg/day based on nutritional status and estimated protein losses.2 The CLINIMIX E dosage can be adjusted based on the severity of renal impairment, supplementing protein as indicated. If required, additional amino acids may be added to the CLINIMIX E bag or infused separately. Compatibility of additions should be evaluated by a pharmacist and questions may be directed to Baxter.




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 Nutritional Requirements1

Recommended Clinimix E Dosage in Preterm and Term Infants Less than 1 Month of Age

Clinimix E 2.75/5

Clinimix E 2.75/10

Clinimix E 4.25/5

Clinimix E 4.25/10

Clinimix E 4.25/25

Clinimix E 5/15

Clinimix E 5/20

Clinimix E 5/25

Infusion Rate Range (mL/kg/hr)

4.5 to 6

4.5 to 6

2.9 to 3.9

2.9 to 3.9

2.9 to 3.3

2.5 to 3.3

2.5 to 3.3

2.5 to 3.3

Fluid (mL/kg/day)

100 to 150

108 to 144

108 to 144

70 to 94

70 to 94

70 to 79

60 to 79

60 to 79

60 to 79

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 3.4

(0.48 to 0.54)

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)

7 to 20

5.4 to 7.2

10.8 to 14.4

3.5 to 4.7

7 to 9.4

17.5 to 19.8

9 to 11.9

12 to 15.8

15 to 19.8

  • 1.Protein is provided as amino acids. When infused intravenously amino acids are metabolized and utilized as the building blocks of protein.
  • Table 4: Pediatric Patients 1 Month to Less than 1 Year of Age

    Recommended Nutritional Requirements1

    Recommended Clinimix E Dosage in Pediatric Patients 1 Month to Less than 1 Year of Age

    Clinimix E 2.75/5

    Clinimix E 2.75/10

    Clinimix E 4.25/5

    Clinimix E 4.25/10

    Clinimix E 4.25/25

    Clinimix E 5/15

    Clinimix E 5/20

    Clinimix E 5/25

    Infusion Rate Range (mL/kg/hr)

    3 to 4.5

    3 to 4.5

    2 to 2.9

    2 to 2.9

    2 to 2.9

    1.7 to 2.5

    1.7 to 2.5

    1.7 to 2.5

    Fluid (mL/kg/day)

    100 mL/kg for the first 10 kg + 50 mL/kg for the second 10 kg.

    72 to 108

    72 to 108

    48 to 70

    48 to 70

    48 to 70

    41 to 60

    41 to 60

    41 to 60

    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)

    2 to 3

    (0.32 to 0.48)

    2 to 3

    (0.32 to 0.48)

    Dextrose (g/kg/day)

    7 to 20

    3.6 to 5.4

    7.2 to 10.8

    2.4 to 3.5

    4.8 to 7

    12 to 17.5

    6.1 to 9

    8.2 to 12

    10.2 to 15

    Table 5: Pediatric Patients 1 Year to Less than 11 Years of Age

    Recommended Nutritional Requirements1

    Recommended Clinimix E Dosage in Pediatric Patients 1 Year to Less than 11 Years of Age

    Clinimix E 2.75/5

    Clinimix E 2.75/10

    Clinimix E 4.25/5

    Clinimix E 4.25/10

    Clinimix E 4.25/25

    Clinimix E 5/15

    Clinimix E 5/20

    Clinimix E 5/25

    Infusion Rate Range (mL/kg/hr)

    1.5 to 3

    1.5 to 3

    1 to 2

    1 to 2

    1 to 2

    0.8 to 1.7

    0.8 to 1.7

    0.8 to 1.7

    Fluid (mL/kg/day)

    100 mL/kg for the first 10 kg + 50 mL/kg for the second 10 kg + 20 mL/kg for weight > 20 kg

    36 to 72

    36 to 72

    24 to 48

    24 to 48

    24 to 48

    19 to 41

    19 to 41

    19 to 41

    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)

    1 to 2

    (0.16 to 0.32)

    1 to 2

    (0.16 to 0.32)

    Dextrose (g/kg/day)

    7 to 14

    1.8 to 3.6

    3.6 to 7.2

    1.2 to 2.4

    2.4 to 4.8

    6 to 12

    2.9 to 6.1

    3.8 to 8.2

    4.8 to 10.2

    Table 6: Pediatric Patients 11 Years to 17 Years of Age

    Recommended Nutritional Requirements1

    Recommended Clinimix E Dosage in Pediatric Patients 11 Years to 17 Years of Age

    Clinimix E 2.75/5

    Clinimix E 2.75/10

    Clinimix E 4.25/5

    Clinimix E 4.25/10

    Clinimix E 4.25/25

    Clinimix E 5/15

    Clinimix E 5/20

    Clinimix E 5/25

    Infusion Rate Range (mL/kg/hr)

    1.2 to 2.3

    1.2 to 2.3

    0.8 to 1.5

    0.8 to 1.5

    0.8 to 1.5

    0.7 to 1.3

    0.7 to 1.3

    0.7 to 1.3

    Fluid (mL/kg/day)

    100 mL/kg for the first 10 kg + 50 mL/kg for the second 10 kg + 20 mL/kg for weight > 20 kg

    29 to 55

    29 to 55

    19 to 36

    19 to 36

    19 to 36

    17 to 31

    17 to 31

    17 to 31

    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)

    0.8 to 1.5

    (0.13 to 0.24)

    0.8 to 1.5

    (0.13 to 0.24)

    Dextrose (g/kg/day)

    5 to 9

    1.4 to 2.8

    2.9 to 5.5

    1 to 1.8

    1.9 to 3.6

    4.8 to 9

    2.5 to 4.7

    3.4 to 6.2

    4.2 to 7.8


2.9 Discontinuation Of Clinimix E



To reduce the risk of hypoglycemia after discontinuation, a gradual decrease in flow rate in the last hour of infusion should be considered.


3 Dosage Forms And Strengths



CLINIMIX E injection is available in 1000 mL and 2000 mL dual chamber bags. The individual chambers contain essential and nonessential amino acids with electrolytes and dextrose with calcium. Table 7 describes the individual components of CLINIMIX E.

Essential Amino Acids (mg/100 mL)Nonessential Amino Acids
(mg/100 mL)
Electrolytes
(mg/100 mL)
(mEq/L)

Balanced by ions from amino acids.

(kcal/L)
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 
2.75/10 sulfite‑free
(2.75% Amino Acid in 10% 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 4.25/25 sulfite‑free
(4.25% Amino Acid in 25% 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 
5/25 sulfite‑free
(5% Amino Acid in 25% Dextrose) Injection

Dextrose Hydrous, USP (g/100 mL)

5

10

5

10

25

15

20

25

Amino Acids (g/100 mL)

2.75

2.75

4.25

4.25

4.25

5

5

5

Total Nitrogen (mg/100 mL)

454

454

702

702

702

826

826

826

 

Leucine

201

201

311

311

311

365

365

365

Isoleucine

165

165

255

255

255

300

300

300

Valine

160

160

247

247

247

290

290

290

Lysine (added as the hydrochloride salt)

159

159

247

247

247

290

290

290

Phenylalanine

154

154

238

238

238

280

280

280

Histidine

132

132

204

204

204

240

240

240

Threonine

116

116

179

179

179

210

210

210

Methionine

110

110

170

170

170

200

200

200

Tryptophan

50

50

77

77

77

90

90

90

 

Alanine

570

570

880

880

880

1035

1035

1035

Arginine

316

316

489

489

489

575

575

575

Glycine

283

283

438

438

438

515

515

515

Proline

187

187

289

289

289

340

340

340

Serine

138

138

213

213

213

250

250

250

Tyrosine

11

11

17

17

17

20

20

20

 

Sodium Acetate Trihydrate, USP

217

217

297

297

297

340

340

340

Dibasic Potassium Phosphate, USP

261

261

261

261

261

261

261

261

Sodium Chloride, USP

112

112

77

77

77

59

59

59

Magnesium Chloride, USP

51

51

51

51

51

51

51

51

Calcium Chloride Dihydrate, USP

33

33

33

33

33

33

33

33

Electrolyte Profile

 

Sodium

35

35

35

35

35

35

35

35

Potassium

30

30

30

30

30

30

30

30

Magnesium

5

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)

4.5
(2.2 mmol/L)

Acetate

Derived from glacial acetic acid (for pH adjustment) and sodium acetate.

51

51

70

70

70

80

80

80

Chloride

Contributed by calcium chloride, lysine hydrochloride, magnesium chloride, and sodium chloride.

39

39

39

39

39

39

39

39

Phosphate (as HPO4)

30
(15 mmol/L)

30
(15 mmol/L)

30
(15 mmol/L)

30
(15 mmol/L)

30
(15 mmol/L)

30
(15 mmol/L)

30
(15 mmol/L)

30
(15 mmol/L)

pH

pH of sulfite-free amino acid injection with electrolytes in the outlet port chamber was adjusted with glacial acetic 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)

6.0

(4.5 to 7.0)

Osmolarity (mOsmol/L) (calc)

665

920

815

1070

1825

1395

1650

1900

Caloric Content

 

From Dextrose

170

340

170

340

850

510

680

850

From Amino Acids

110

110

170

170

170

200

200

200

TOTAL (Dextrose and Amino Acids)

280

450

340

510

1020

710

880

1050


4 Contraindications



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

5.1 Pulmonary Embolism Due To Pulmonary Vascular Precipitates



Pulmonary vascular precipitates causing pulmonary vascular emboli and pulmonary distress have been reported in patients receiving parenteral nutrition. In some cases, fatal outcomes due to pulmonary embolism have occurred. Patients, especially those with hypophosphatemia, may require the addition of phosphate. To prevent hypocalcemia, calcium supplementation should always accompany phosphate administration. Excessive addition of calcium and phosphate increases the risk of the formation of calcium phosphate precipitates. Precipitates have been reported even in the absence of phosphate salt in the solution. Precipitation following passage through an in-line filter and suspected in vivo precipitate formation has also been reported. If signs of pulmonary distress occur, stop the infusion and initiate a medical evaluation. In addition to inspection of the solution [see Dosage and Administration (2.1, 2.2, 2.3, 2.4)], the infusion set and catheter should also periodically be checked for precipitates.


5.2 Precipitation With Ceftriaxone



Precipitation of ceftriaxone-calcium can occur when ceftriaxone is mixed with calcium-containing parenteral nutrition solutions, such as CLINIMIX E, in the same intravenous administration line. Do not administer ceftriaxone simultaneously with CLINIMIX E via a Y-site.

Deaths have occurred in neonates (less than 28 days of age) 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),Use in Specific Populations (8.4)].

In patients older than 28 days (including adults), ceftriaxone and CLINIMIX E may be administered sequentially if the infusion lines are thoroughly flushed between infusions with a compatible fluid.


5.3 Hypersensitivity Reactions



Hypersensitivity/infusion reactions including anaphylaxis have been reported with CLINIMIX E. Stop infusion immediately and treat patient accordingly if any signs or symptoms of a hypersensitivity reaction develop. Signs or symptoms may include: hypotension, hypertension, peripheral cyanosis, tachycardia, dyspnea, vomiting, nausea, urticaria, rash, pruritus, erythema, hyperhidrosis, pyrexia, and chills.


5.4 Risk Of Infections



Patients who require parenteral nutrition are at high risk of infections because the nutritional components of these solutions can support microbial growth. Infection and sepsis may also occur as a result of the use of intravenous catheters to administer parenteral nutrition.

The risk of infection is increased in patients with malnutrition-associated immunosuppression, hyperglycemia exacerbated by dextrose infusion, long-term use and poor maintenance of intravenous catheters, or immunosuppressive effects of other concomitant conditions, drugs, or other components of the parenteral formulation (e.g., lipid emulsion).

To decrease the risk of infection, ensure aseptic technique in catheter placement and maintenance, as well as aseptic technique in the preparation and administration of the nutritional formula.

Monitor for signs and symptoms (including fever and chills) of early infections, including laboratory test results (including leukocytosis and hyperglycemia) and frequent checks of the parenteral access device and insertion site for edema, redness and discharge.


5.5 Refeeding Syndrome



Refeeding severely undernourished patients may result in refeeding syndrome, characterized by the intracellular shift of potassium, phosphorus, and magnesium as the patient becomes anabolic. Thiamine deficiency and fluid retention may also develop. To prevent these complications, monitor severely undernourished patients and slowly increase nutrient intakes.


5.6 Hyperglycemia Or Hyperosmolar Hyperglycemic State



When using CLINIMIX E in patients with diabetes mellitus, impaired glucose tolerance may worsen hyperglycemia. Administration of dextrose at a rate exceeding the patient’s utilization rate may lead to hyperglycemia, coma, and death. Patients with underlying confusion and renal impairment who receive dextrose infusions, may be at greater risk of developing hyperosmolar hyperglycemic state. Monitor blood glucose levels and treat hyperglycemia to maintain optimum levels while administering CLINIMIX E. Insulin may be administered or adjusted to maintain optimal blood glucose levels during CLINIMIX E administration.


5.7 Vein Damage And Thrombosis



Solutions with osmolarity of 900 mOsm/L or greater must be infused through a central catheter. CLINIMIX E solutions containing more than 5% dextrose have an osmolarity greater than or equal to 900 mOsm/L. CLINIMIX E 2.75/10, 4.25/10, 4.25/25, 5/15, 5/20, and 5/25 are indicated for administration into a central vein only, such as the superior vena cava [see Dosage and Administration (2.2)]. The infusion of hypertonic nutrient injections into a peripheral vein may result in vein irritation, vein damage, and/or thrombosis.

CLINIMIX E 2.75/5 and 4.25/5 are indicated for peripheral administration, or may be infused into a central vein [see Dosage and Administration (2.2)]. The primary complication of peripheral access is venous thrombophlebitis, which manifests as pain, erythema, tenderness or a palpable cord. Remove the catheter as soon as possible, if thrombophlebitis develops.


5.8 Hepatobiliary Disorders



Hepatobiliary disorders are known to develop in some patients without preexisting liver disease who receive parenteral nutrition, including cholecystitis, cholelithiasis, cholestasis, hepatic steatosis, fibrosis and cirrhosis, possibly leading to hepatic failure. The etiology of these disorders is thought to be multifactorial and may differ between patients.

Increase in blood ammonia levels and hyperammonemia may occur in patients receiving amino acid solutions. In some patients this may indicate hepatic insufficiency or the presence of an inborn error of amino acid metabolism [see Contraindications (4)].

Monitor liver function parameters and ammonia levels. Patients developing signs of hepatobiliary disorders should be assessed early by a clinician knowledgeable in liver diseases in order to identify possible causative and contributory factors, and possible therapeutic and prophylactic interventions.


5.9 Aluminum Toxicity



CLINIMIX E contains no more than 25 mcg/L of aluminum. However, with prolonged parenteral administration in patients with renal impairment, the aluminum contained in CLINIMX E may reach toxic levels. Preterm infants are at a greater risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

Patients with renal impairment, including preterm infants, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day, accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.


5.10 Risk Of Parenteral Nutrition Associated Liver Disease



Parenteral Nutrition Associated Liver Disease (PNALD) has been reported in patients who receive parenteral nutrition for extended periods of time, especially preterm infants, and can present as cholestasis or steatohepatitis. The exact etiology is unknown and is likely multifactorial. If CLINIMIX E treated patients develop liver test abnormalities consider discontinuation or dosage reduction.


5.11 Electrolyte Imbalance And Fluid Overload



Patients with renal impairment, such as pre-renal azotemia, renal obstruction, and protein-losing nephropathy may be at increased risk of electrolyte and fluid volume imbalance. Patients with cardiac insufficiency due to left ventricular systolic dysfunction are susceptible to excess fluid accumulation. Use CLINIMIX E with caution in patients with cardiac insufficiency or renal impairment. CLINIMIX E dosage may require adjustment with specific attention to fluid, protein, and electrolyte content in these patients.

Monitor renal function parameters. Patients developing signs of renal impairment should be assessed early by a clinician knowledgeable in renal disease in order to determine the appropriate CLINIMIX E dosage and other treatment options.


5.12 Monitoring/Laboratory Tests



Monitor fluid and electrolyte status, serum osmolarity, blood glucose, liver and kidney function, blood count and coagulation parameters throughout treatment. In situations of severely elevated electrolyte levels, stop CLINIMIX E until levels have been corrected.


6 Adverse Reactions



The following serious adverse reactions are discussed in greater detail in other sections of the prescribing information.

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.


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.

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.


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.


8.4 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 (less than 28 days of age) 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.


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.


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

C2H3NaO2•3H2O

Potassium Phosphate, dibasic

K2HPO4

Magnesium Chloride

MgCl2•6H2O

Sodium Chloride

NaCl

Essential Amino Acids

Leucine

(CH3)2 CHCH2CH (NH2) COOH

Isoleucine

CH3CH2CH (CH3) CH (NH2) COOH

Valine

(CH3)2 CHCH (NH2) COOH

Lysine (added as the hydrochloride salt)

H2N (CH2)4 CH (NH2) COOH

Phenylalanine

(C6H5) CH2 CH (NH2) COOH

Histadine

(C3H3N2) CH2CH (NH2) COOH

Threonine

CH3CH (OH) CH (NH2) COO

Methionine

CH3S (CH2)2 CH (NH2) COOH

Tryptophan

(C8H6N) CH2 CH (NH2) COOH

Nonessential Amino Acids

Alanine

CH3CH (NH2) COOH

Arginine

H2NC (NH) NH (CH2)3 CH (NH2) COOH

Glycine

H2NCH2COOH

Proline

[(CH2)3 NH CH] COOH

Serine

HOCH2CH (NH2) COOH

Tyrosine

[C6H4 (OH)] CH2CH (NH2) COOH

The injection port chamber contains dextrose with calcium. The formula for Calcium Chloride is: CaCl2•2H2O. Dextrose, USP, is chemically designated D-glucose, monohydrate (C6H12O6 • H2O) 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.


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 food.


15 References



  • 1.Ayers Phil, et al. A.S.P.E.N. Parenteral Nutrition Handbook, 2nd ed. 2014, pg. 123.
  • 2.Mueller CM ed. The A.S.P.E.N. Nutrition Support Core Curriculum, 2nd ed. 2012. Chapter 29. Wolk R, Foulks C. Renal Disease, pg. 500.

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).

After mixing, the product represents1000 mL Code and NDC Number2000 mL Code and NDC NumberCLINIMIX E 2.75/5 sulfite-free (2.75% Amino Acid with Electrolytes in 5% Dextrose with Calcium) InjectionCode 2B7735
NDC 0338-1142-03Code 2B7713
NDC 0338-1107-04CLINIMIX E 2.75/10 sulfite-free (2.75% Amino Acid with Electrolytes in 10% Dextrose with Calcium) InjectionCode 2B7736
NDC 0338-1143-03Code 2B7714
NDC 0338-1109-04CLINIMIX E 4.25/5 sulfite-free (4.25% Amino Acid with Electrolytes in 5% Dextrose with Calcium) InjectionCode 2B7737
NDC 0338-1144-03Code 2B7716
NDC 0338-1113-04CLINIMIX E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) InjectionCode 2B7738
NDC 0338-1145-03Code 2B7717
NDC 0338-1115-04CLINIMIX E 4.25/25 sulfite-free (4.25% Amino Acid with Electrolytes in 25% Dextrose with Calcium) InjectionCode 2B7739
NDC 0338-1146-03Code 2B7719
NDC 0338-1119-04CLINIMIX E 5/15 sulfite-free (5% Amino Acid with Electrolytes in 15% Dextrose with Calcium) InjectionCode 2B7740
NDC 0338-1147-03Code 2B7721
NDC 0338-1123-04CLINIMIX E 5/20 sulfite-free (5% Amino Acid with Electrolytes in 20% Dextrose with Calcium) InjectionCode 2B7741
NDC 0338-1148-03Code 2B7722
NDC 0338-1125-04CLINIMIX E 5/25 sulfite-free (5% Amino Acid with Electrolytes in 25% Dextrose with Calcium) InjectionCode 2B7742
NDC 0338-1149-03Code 2B7723
NDC 0338-1127-04
Table 9: CLINIMIX E Formulations
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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 foil overwrap has been opened.

Do not use if the protective foil overwrap has been previously opened or damaged.

For storage of admixed solutions seeDosage and Administration (2.3, 2.4).


17 Patient Counseling Information



Inform patients, caregivers, or home healthcare providers of the following risks of CLINIMIX E:

Package Label - Principal Display Panel



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 with Electrolytes

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

BAXTER
BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 US
MADE IN USA

0338-1147-03
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Lot: xxxxx

Exp: xxx xx

QTY: 6 PK 500mL/500mL

Code: 2B7738

NDC 0338-1145-03

CLINIMIX E 4.25/10
(4.25% Amino Acid w/ ELECTROLYTES In 10% Dextrose w/ Calcium) INJ

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