NDC 0338-1089 Clinimix
Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonin...

Product Information

What is NDC 0338-1089?

The NDC code 0338-1089 is assigned by the FDA to the product Clinimix which is a human prescription drug product labeled by Baxter Healthcare Corporation. The generic name of Clinimix is leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, 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 0338-1089-04 2000 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 Code0338-1089
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
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, 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.
NDA020734
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.
09-29-1997
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?


Product Packages

NDC Code 0338-1089-04

Package Description: 2000 mL in 1 BAG

Product Details

What are Clinimix 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 880 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 489 mg/100mL - An essential amino acid that is physiologically active in the L-form.
  • DEXTROSE 5 g/100mL
  • GLYCINE 438 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 204 mg/100mL - An essential amino acid that is required for the production of HISTAMINE.
  • ISOLEUCINE 255 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 311 mg/100mL - An essential branched-chain amino acid important for hemoglobin formation.
  • LYSINE 247 mg/100mL - An essential amino acid. It is often added to animal feed.
  • METHIONINE 170 mg/100mL - A sulfur-containing essential L-amino acid that is important in many body functions.
  • PHENYLALANINE 238 mg/100mL - An essential aromatic amino acid that is a precursor of MELANIN; DOPAMINE; noradrenalin (NOREPINEPHRINE), and THYROXINE.
  • PROLINE 289 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 213 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.
  • THREONINE 179 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 77 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 17 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 247 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 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: 800401 - alanine 8.8 MG/ML / arginine 4.89 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 / methionine 1.7 MG/ML / phenylalanine 2.38 MG/ML / proline 2.89 MG/ML / serine 2.13 MG/ML / threonine 1.79 MG/ML / tryptophan 0.77 MG/ML / tyrosine 0.17 MG/ML / valine 2.47 MG/ML Injectable Solution
  • RxCUI: 800405 - Clinimix 4.25/10 Injectable Solution
  • RxCUI: 800405 - alanine 8.8 MG/ML / arginine 4.89 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 / methionine 1.7 MG/ML / phenylalanine 2.38 MG/ML / proline 2.89 MG/ML / serine 2.13 MG/ML / threonine 1.79 MG/ML / tryptophan 0.77 MG/ML / tyrosine 0.17 MG/ML / valine 2.47 MG/ML Injectable Solution [Clinimix 4.25/10]
  • RxCUI: 800405 - Clinimix 4.25/10 (4.25 % amino acids in dextrose 10 % ) Injectable Solution
  • RxCUI: 800416 - alanine 8.8 MG/ML / arginine 4.89 MG/ML / glucose 50 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 / methionine 1.7 MG/ML / phenylalanine 2.38 MG/ML / proline 2.89 MG/ML / serine 2.13 MG/ML / threonine 1.79 MG/ML / tryptophan 0.77 MG/ML / tyrosine 0.17 MG/ML / valine 2.47 MG/ML Injectable Solution

Clinimix 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)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the disclaimer below.

Clinimix 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 is indicated as a source of calories and protein for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX 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 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 (5.6)].
    • oFor central vein infusion only: CLINIMIX 4.25/10, 4.25/20, 4.25/25, 5/15, 5/20, 5/25
    • oFor central or peripheral vein infusion: CLINIMIX 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. 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.

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 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 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 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 formulations have varying concentrations of protein and carbohydrate; 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 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 correct severe fluid, electrolyte and acid-base disorders.
  • •Monitor levels of serum potassium during therapy. It may be necessary to add potassium to the CLINIMIX admixture.
  • •Lipid emulsion administration should be considered with prolonged use (more than 5 days) of CLINIMIX 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 are shown in Table 1.

As indicated on an individual basis, maintenance vitamins, 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 Adult Dosage

Stable Patients

Critically Ill Patients

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

Clinimix 2.75/5

Clinimix 4.25/5

Clinimix 4.25/10

Clinimix 4.25/20

Clinimix 4.25/25

Clinimix 5/15

Clinimix 5/20

Clinimix 5/25

Fluid (mL/kg/day)

30 to 40

Minimum needed to deliver adequate nutrition

29 to 40

19 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 1.7

(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 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

0.95 to 2

1.9 to 4

3.8 to 8

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 2.75/5

Clinimix 4.25/5

Clinimix 4.25/10

Clinimix 4.25/20

Clinimix 4.25/25

Clinimix 5/15

Clinimix 5/20

Clinimix 5/25

Maximum Infusion Rate (mL/kg/hour)

3.6

2.4

2.4

1.25

1

1.67

1.25

1

Corresponding infusion rate

Amino Acid (g/kg/hour)

0.1

Rate limiting factor

0.1

0.1

0.05

0.04

0.08

0.06

0.05

Dextrose (g/kg/hour)

0.18

0.12

0.24

0.25

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 administered as required [see Warnings and Precautions (5.10)].

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

Clinimix 2.75/5

Clinimix 4.25/5

Clinimix 4.25/10

Clinimix 4.25/20

Clinimix 4.25/25

Clinimix 5/15

Clinimix 5/20

Clinimix 5/25

Infusion Rate Range (mL/kg/hr)

4.5 to 6

2.9 to 3.9

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

70 to 94

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

3.5 to 4.7

7 to 9.4

14 to 18.8

17.5 to 19.8

9 to 11.9

12 to 15.8

15 to 19.8

Table 4: Pediatric Patients 1 Month to Less than 1 Year of Age

Recommended Nutritional Requirements1

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

Clinimix 2.75/5

Clinimix 4.25/5

Clinimix 4.25/10

Clinimix 4.25/20

Clinimix 4.25/25

Clinimix 5/15

Clinimix 5/20

Clinimix 5/25

Infusion Rate Range (mL/kg/hr)

3 to 4.5

2 to 2.9

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

48 to 70

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

2.4 to 3.5

4.8 to 7

9.6 to 14

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

Clinimix 2.75/5

Clinimix 4.25/5

Clinimix 4.25/10

Clinimix 4.25/20

Clinimix 4.25/25

Clinimix 5/15

Clinimix 5/20

Clinimix 5/25

Infusion Rate Range (mL/kg/hr)

1.5 to 3

1 to 2

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

24 to 48

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

1.2 to 2.4

2.4 to 4.8

4.8 to 9.6

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 Dosage in Pediatric Patients 11 Years to 17 Years of Age

Clinimix 2.75/5

Clinimix 4.25/5

Clinimix 4.25/10

Clinimix 4.25/20

Clinimix 4.25/25

Clinimix 5/15

Clinimix 5/20

Clinimix 5/25

Infusion Rate Range (mL/kg/hr)

1.2 to 2.3

0.8 to 1.5

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

19 to 36

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

1 to 1.8

1.9 to 3.6

3.8 to 7.2

4.8 to 9

2.5 to 4.7

3.4 to 6.2

4.2 to 7.8


2.9 Discontinuation Of Clinimix



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

Essential Amino Acids (mg/100 mL)Nonessential Amino Acids
(mg/100 mL)
Anion Profile
  • (mEq/L)

    Balanced by ions from amino acids.

    (kcal/L)
    Table 7 INGREDIENTS PER 100mL OF CLINIMIX

    Strength of CLINIMIX

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

    CLINIMIX 4.25/5 sulfite‑free
    (4.25% Amino Acid in 5% Dextrose) Injection

    CLINIMIX 4.25/10 sulfite‑free
    (4.25% Amino Acid in 10% Dextrose) Injection

    CLINIMIX 4.25/20 sulfite‑free
    (4.25% Amino Acid in 20% Dextrose) Injection

    CLINIMIX 4.25/25 sulfite‑free
    (4.25% Amino Acid in 25% Dextrose) Injection

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

    CLINIMIX 5/20 sulfite‑free
    (5% Amino Acid in 20% Dextrose) Injection

    CLINIMIX 5/25 sulfite‑free
    (5% Amino Acid in 25% Dextrose) Injection

    Dextrose Hydrous, USP (g/100 mL)

    5

    5

    10

    20

    25

    15

    20

    25

    Amino Acids (g/100 mL)

    2.75

    4.25

    4.25

    4.25

    4.25

    5

    5

    5

    Total Nitrogen (mg/100 mL)

    454

    702

    702

    702

    702

    826

    826

    826

     

    Leucine

    201

    311

    311

    311

    311

    365

    365

    365

    Isoleucine

    165

    255

    255

    255

    255

    300

    300

    300

    Valine

    160

    247

    247

    247

    247

    290

    290

    290

    Lysine (added as the hydrochloride salt)

    159

    247

    247

    247

    247

    290

    290

    290

    Phenylalanine

    154

    238

    238

    238

    238

    280

    280

    280

    Histidine

    132

    204

    204

    204

    204

    240

    240

    240

    Threonine

    116

    179

    179

    179

    179

    210

    210

    210

    Methionine

    110

    170

    170

    170

    170

    200

    200

    200

    Tryptophan

    50

    77

    77

    77

    77

    90

    90

    90

     

    Alanine

    570

    880

    880

    880

    880

    1035

    1035

    1035

    Arginine

    316

    489

    489

    489

    489

    575

    575

    575

    Glycine

    283

    438

    438

    438

    438

    515

    515

    515

    Proline

    187

    289

    289

    289

    289

    340

    340

    340

    Serine

    138

    213

    213

    213

    213

    250

    250

    250

    Tyrosine

    11

    17

    17

    17

    17

    20

    20

    20

      

    Acetate

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

    24

    37

    37

    37

    37

    42

    42

    42

    Chloride

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

    11

    17

    17

    17

    17

    20

    20

    20

    pH

    pH of sulfite-free amino acid injection 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)

    525

    675

    930

    1435

    1685

    1255

    1505

    1760

    Caloric

    Content

     

    From Dextrose

    170

    170

    340

    680

    850

    510

    680

    850

    From Amino Acids

    110

    170

    170

    170

    170

    200

    200

    200

    TOTAL

    (Dextrose and Amino Acids)

    280

    340

    510

    850

    1020

    710

    880

    1050


    4 Contraindications



    The use of CLINIMIX is contraindicated in:

    • •Patients with known hypersensitivity to one or more amino acids or dextrose [see Warnings and Precautions (5.2)].
    • •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. CLINIMIX contains no added phosphorus. 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 Hypersensitivity Reactions



    Hypersensitivity/infusion reactions including anaphylaxis have been reported with CLINIMIX. 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.


    5.3 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.


    5.4 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.


    5.5 Hyperglycemia Or Hyperosmolar Hyperglycemic State



    When using CLINIMIX 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. Insulin may be administered or adjusted to maintain optimal blood glucose levels during CLINIMIX administration.


    5.6 Vein Damage And Thrombosis



    Solutions with osmolarity of 900 mOsm/L or greater must be infused through a central catheter. CLINIMIX solutions containing more than 5% dextrose have an osmolarity greater than or equal to 900 mOsm/L. CLINIMIX 4.25/10, 4.25/20, 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 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.


    5.7 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.


    5.8 Aluminum Toxicity



    CLINIMIX contains no more than 25 mcg/L of aluminum. However, with prolonged parenteral administration in patients with renal impairment, the aluminum contained in CLINIMIX 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.


    5.9 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 treated patients develop liver test abnormalities consider discontinuation or dosage reduction.


    5.10 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 with caution in patients with cardiac insufficiency or renal impairment. CLINIMIX 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 dosage and other treatment options.


    5.11 Monitoring/Laboratory Tests



    Monitor fluid and electrolyte status, serum osmolarity, blood glucose, liver and kidney function, blood count and coagulation parameters throughout treatment.

    Patients receiving CLINIMIX should be monitored frequently and their electrolyte requirements individualized.


    6 Adverse Reactions



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

    8.1 Pregnancy



    Risk Summary

    There are no adequate or well-controlled studies in pregnant women with CLINIMIX. Additionally, animal reproduction studies have not been conducted with amino acids and electrolytes and dextrose. It is not known whether CLINIMIX 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 is present in human milk. There are no data on the effects of CLINIMIX 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 and any potential adverse effects on the breastfed child from CLINIMIX or from the underlying maternal condition.


    8.4 Pediatric Use



    Safety and effectiveness of CLINIMIX 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)].

    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 may be at risk of aluminum toxicity [see Warnings and Precautions (5.8)].

    Patients, including pediatric patients, may be at risk for Parenteral Nutrition Associated Liver Disease (PNALD) [see Warnings and Precautions (5.9)].

    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 (5.7)].


    8.5 Geriatric Use



    Clinical studies of CLINIMIX 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 can cause hyperglycemia, hyperosmolality, and adverse effects on water and electrolyte balance [see Warnings and Precautions (5.5, 5.10)].

    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 sulfite-free (amino acids in dextrose) 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. The formulas for the individual amino acids found in CLINIMIX sulfite-free (Amino Acid in Dextrose) Injections are provided in Table 8.

    Table 8: Formulas for Amino Acids

    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. Dextrose, USP, is chemically designated D-glucose, monohydrate (C6H12O6 • H2O) and has the following structure:


    12.1 Mechanism Of Action



    CLINIMIX is used as a supplement of nutrition in patients, providing macronutrients (amino acids and dextrose) 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 and dextrose, are essentially the same as those absorbed from ordinary 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 (amino acids in dextrose) injection (sulfite-free) is available in 1000 mL and 2000mL volumes (See Table 9).

    After mixing, the product represents1000 mL Code and NDC Number2000 mL Code and NDC NumberCLINIMIX 2.75/5 sulfite‑free
    (2.75% Amino Acid in 5% Dextrose) InjectionCode 2B7725
    NDC 0338‑1132‑03Code 2B7701
    NDC 0338‑1083‑04CLINIMIX 4.25/5 sulfite‑free
    (4.25% Amino Acid in 5% Dextrose) InjectionCode 2B7726
    NDC 0338‑1133‑03Code 2B7704
    NDC 0338‑1089‑04CLINIMIX 4.25/10 sulfite‑free
    (4.25% Amino Acid in 10% Dextrose) InjectionCode 2B7727
    NDC 0338‑1134‑03Code 2B7705
    NDC 0338‑1091‑04CLINIMIX 4.25/20 sulfite‑free
    (4.25% Amino Acid in 20% Dextrose) InjectionCode 2B7728
    NDC 0338‑1135‑03Code 2B7706
    NDC 0338‑1093‑04CLINIMIX 4.25/25 sulfite‑free
    (4.25% Amino Acid in 25% Dextrose) InjectionCode 2B7729
    NDC 0338‑1136‑03Code 2B7707
    NDC 0338‑1095‑04CLINIMIX 5/15 sulfite‑free
    (5% Amino Acid in 15% Dextrose) InjectionCode 2B7730
    NDC 0338‑1137‑03Code 2B7709
    NDC 0338‑1099‑04CLINIMIX 5/20 sulfite‑free
    (5% Amino Acid in 20% Dextrose) InjectionCode 2B7731
    NDC 0338‑1138‑03Code 2B7710
    NDC 0338‑1101‑04CLINIMIX 5/25 sulfite‑free
    (5% Amino Acid in 25% Dextrose) InjectionCode 2B7732
    NDC 0338‑1139‑03Code 2B7711
    NDC 0338‑1103‑04
    Table 9: CLINIMIX Formulations
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     

    Minimize exposure of CLINIMIX to heat and avoid excessive heat.

    Protect from freezing.

    Store CLINIMIX 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:

    Package Label - Principal Display Panel



    Container Label

    LOT EXP

    2B7725 NDC 0338-1132-03

    CLINIMIX
    2.75/5
    SULFITE-FREE

    (2.75% Amino Acid
    in 5% Dextrose)
    Injection

    500 mL INJECTION PORT CHAMBER
    10% Dextrose Injection USP

    500 mL OUTLET PORT CHAMBER
    5.5% Amino Acid Injection

    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

    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

    mEq/L
    ACETATE 24
    CHLORIDE 11

    BALANCED BY IONS FROM AMINO ACIDS

    pH ADJUSTED WITH GLACIAL ACETIC ACID

    STERILE
    SINGLE DOSE CONTAINER

    Baxter
    BAXTER HEALTHCARE CORPORATION
    DEERFIELD IL 60015 USA
    MADE IN USA

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    Carton Label

    Lot: xxxxx Exp: xxx xx

    QTY: 6 PK 500mL/500mL Code: 2B7727

    NDC 0338-1134-03

    CLINIMIX 4.25/10
    (4.25% Amino Acid in 10% Dextrose) INJ

    (17)xx00(10)xxxxx

    (01) 50303301134032

    0338-1083-04
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