Clinimix
Name: Clinimix
Indications and Usage for Clinimix
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.
Warnings and Precautions
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..
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Inform patients, caregivers, or home healthcare providers of the following risks of Clinimix:
• Pulmonary embolism due to pulmonary vascular precipitates [see Warnings and Precautions (5.1)] • Hypersensitivity reactions [see Warnings and Precautions (5.2)] • Risk of Infections [see Warnings and Precautions (5.3)] • Refeeding syndrome [see Warnings and Precautions (5.4)] • Hyperglycemia or hyperosmolar hyperglycemic state [see Warnings and Precautions (5.5)] • Vein damage and thrombosis [see Warnings and Precautions (5.6)] • Hepatobiliary disorders [see Warnings and Precautions (5.7)] • Aluminum toxicity [see Warnings and Precautions (5.8)] • Parenteral Nutrition Associated Liver Disease (PNALD) [see Warnings and Precautions (5.9)] • Electrolyte imbalance and fluid overload [see Warnings and Precautions (5.10)] Baxter Healthcare Corporation
Deerfield, IL 60015 USA
Printed in USA Baxter and Clinimix are trademarks of Baxter International Inc. 07-19-77-169
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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0338-1132-03
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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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Clinimix
leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose injection |
| Product Information | | Product Type | HUMAN PRESCRIPTION DRUG LABEL | Item Code (Source) | NDC:0338-1132 | | Route of Administration | INTRAVENOUS | DEA Schedule | | |
| Active Ingredient/Active Moiety | | Ingredient Name | Basis of Strength | Strength | | LEUCINE (LEUCINE) | LEUCINE | 201 mg in 100 mL | | PHENYLALANINE (PHENYLALANINE) | PHENYLALANINE | 154 mg in 100 mL | | LYSINE (LYSINE) | LYSINE | 159 mg in 100 mL | | METHIONINE (METHIONINE) | METHIONINE | 110 mg in 100 mL | | ISOLEUCINE (ISOLEUCINE) | ISOLEUCINE | 165 mg in 100 mL | | VALINE (VALINE) | VALINE | 160 mg in 100 mL | | HISTIDINE (HISTIDINE) | HISTIDINE | 132 mg in 100 mL | | THREONINE (THREONINE) | THREONINE | 116 mg in 100 mL | | TRYPTOPHAN (TRYPTOPHAN) | TRYPTOPHAN | 50 mg in 100 mL | | ALANINE (ALANINE) | ALANINE | 570 mg in 100 mL | | GLYCINE (GLYCINE) | GLYCINE | 283 mg in 100 mL | | ARGININE (ARGININE) | ARGININE | 316 mg in 100 mL | | PROLINE (PROLINE) | PROLINE | 187 mg in 100 mL | | SERINE (SERINE) | SERINE | 138 mg in 100 mL | | TYROSINE (TYROSINE) | TYROSINE | 11 mg in 100 mL | | DEXTROSE (DEXTROSE) | DEXTROSE | 5 g in 100 mL | |
| Inactive Ingredients | | Ingredient Name | Strength | | ACETIC ACID | | | WATER | | | NITROGEN | | |
|
| Packaging | | # | Item Code | Package Description | | 1 | NDC:0338-1132-03 | 1000 mL in 1 BAG | |
|
| Marketing Information | | Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date | | NDA | NDA020734 | 09/29/1997 | | |
Clinimix
leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose injection |
| Product Information | | Product Type | HUMAN PRESCRIPTION DRUG LABEL | Item Code (Source) | NDC:0338-1083 | | Route of Administration | INTRAVENOUS | DEA Schedule | | |
| Active Ingredient/Active Moiety | | Ingredient Name | Basis of Strength | Strength | | LEUCINE (LEUCINE) | LEUCINE | 201 mg in 100 mL | | PHENYLALANINE (PHENYLALANINE) | PHENYLALANINE | 154 mg in 100 mL | | LYSINE (LYSINE) | LYSINE | 159 mg in 100 mL | | METHIONINE (METHIONINE) | METHIONINE | 110 mg in 100 mL | | ISOLEUCINE (ISOLEUCINE) | ISOLEUCINE | 165 mg in 100 mL | | VALINE (VALINE) | VALINE | 160 mg in 100 mL | | HISTIDINE (HISTIDINE) | HISTIDINE | 132 mg in 100 mL | | THREONINE (THREONINE) | THREONINE | 116 mg in 100 mL | | TRYPTOPHAN (TRYPTOPHAN) | TRYPTOPHAN | 50 mg in 100 mL | | ALANINE (ALANINE) | ALANINE | 570 mg in 100 mL | | GLYCINE (GLYCINE) | GLYCINE | 283 mg in 100 mL | | ARGININE (ARGININE) | ARGININE | 316 mg in 100 mL | | PROLINE (PROLINE) | PROLINE | 187 mg in 100 mL | | SERINE (SERINE) | SERINE | 138 mg in 100 mL | | TYROSINE (TYROSINE) | TYROSINE | 11 mg in 100 mL | | DEXTROSE (DEXTROSE) | DEXTROSE | 5 g in 100 mL | |
| Inactive Ingredients | | Ingredient Name | Strength | | ACETIC ACID | | | WATER | | | NITROGEN | | |
|
| Packaging | | # | Item Code | Package Description | | 1 | NDC:0338-1083-04 | 2000 mL in 1 BAG | |
|
| Marketing Information | | Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date | | NDA | NDA020734 | 09/29/1997 | | |
Clinimix
leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose injection |
| Product Information | | Product Type | HUMAN PRESCRIPTION DRUG LABEL | Item Code (Source) | NDC:0338-1133 | | Route of Administration | INTRAVENOUS | DEA Schedule | | |
| Active Ingredient/Active Moiety | | Ingredient Name | Basis of Strength | Strength | | LEUCINE (LEUCINE) | LEUCINE | 311 mg in 100 mL | | PHENYLALANINE (PHENYLALANINE) | PHENYLALANINE | 238 mg in 100 mL | | LYSINE (LYSINE) | LYSINE | 247 mg in 100 mL | | METHIONINE (METHIONINE) | METHIONINE | 170 mg in 100 mL | | ISOLEUCINE (ISOLEUCINE) | ISOLEUCINE | 255 mg in 100 mL | | VALINE (VALINE) | VALINE | 247 mg in 100 mL | | HISTIDINE (HISTIDINE) | HISTIDINE | 204 mg in 100 mL | | THREONINE (THREONINE) | THREONINE | 179 mg in 100 mL | | TRYPTOPHAN (TRYPTOPHAN) | TRYPTOPHAN | 77 mg in 100 mL | | ALANINE (ALANINE) | ALANINE | 880 mg in 100 mL | | GLYCINE (GLYCINE) | GLYCINE | 438 mg in 100 mL | | ARGININE (ARGININE) | ARGININE | 489 mg in 100 mL | | PROLINE (PROLINE) | PROLINE | 289 mg in 100 mL | | SERINE (SERINE) | SERINE | 213 mg in 100 mL | | TYROSINE (TYROSINE) | TYROSINE | 17 mg in 100 mL | | DEXTROSE (DEXTROSE) | DEXTROSE | 5 g in 100 mL | |
| Inactive Ingredients | | Ingredient Name | Strength | | ACETIC ACID | | | WATER | | | NITROGEN | | |
|
| Packaging | | # | Item Code | Package Description | | 1 | NDC:0338-1133-03 | 1000 mL in 1 BAG | |
|
| Marketing Information | | Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date | | NDA | NDA020734 | 09/29/1997 | | |
Clinimix
leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose injection |
| Product Information | | Product Type | HUMAN PRESCRIPTION DRUG LABEL | Item Code (Source) | NDC:0338-1089 | | Route of Administration | INTRAVENOUS | DEA Schedule | | |
| Active Ingredient/Active Moiety | | Ingredient Name | Basis of Strength | Strength | | LEUCINE (LEUCINE) | LEUCINE | 311 mg in 100 mL | | PHENYLALANINE (PHENYLALANINE) | PHENYLALANINE | 238 mg in 100 mL | | LYSINE (LYSINE) | LYSINE | 247 mg in 100 mL | | METHIONINE (METHIONINE) | METHIONINE | 170 mg in 100 mL | | ISOLEUCINE (ISOLEUCINE) | ISOLEUCINE | 255 mg in 100 mL | | VALINE (VALINE) | VALINE | 247 mg in 100 mL | | HISTIDINE (HISTIDINE) | HISTIDINE | 204 mg in 100 mL | | THREONINE (THREONINE) | THREONINE | 179 mg in 100 mL | | TRYPTOPHAN (TRYPTOPHAN) | TRYPTOPHAN | 77 mg in 100 mL | | ALANINE (ALANINE) | ALANINE | 880 mg in 100 mL | | GLYCINE (GLYCINE) | GLYCINE | 438 mg in 100 mL | | ARGININE (ARGININE) | ARGININE | 489 mg in 100 mL | | PROLINE (PROLINE) | PROLINE | 289 mg in 100 mL | | SERINE (SERINE) | SERINE | 213 mg in 100 mL | | TYROSINE (TYROSINE) | TYROSINE | 17 mg in 100 mL | | DEXTROSE (DEXTROSE) | DEXTROSE | 5 g in 100 mL | |
| Inactive Ingredients | | Ingredient Name | Strength | | ACETIC ACID | | | WATER | | | NITROGEN | | |
|
| Packaging | | # | Item Code | Package Description | | 1 | NDC:0338-1089-04 | 2000 mL in 1 BAG | |
|
| Marketing Information | | Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date | | NDA | NDA020734 | 09/29/1997 | | |
Clinimix
leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose injection |
| Product Information | | Product Type | HUMAN PRESCRIPTION DRUG LABEL | Item Code (Source) | NDC:0338-1134 | | Route of Administration | INTRAVENOUS | DEA Schedule | | |
| Active Ingredient/Active Moiety | | Ingredient Name | Basis of Strength | Strength | | LEUCINE (LEUCINE) | LEUCINE | 311 mg in 100 mL | | PHENYLALANINE (PHENYLALANINE) | PHENYLALANINE | 238 mg in 100 mL | | LYSINE (LYSINE) | LYSINE | 247 mg in 100 mL | | METHIONINE (METHIONINE) | METHIONINE | 170 mg in 100 mL | | ISOLEUCINE (ISOLEUCINE) | ISOLEUCINE | 255 mg in 100 mL | | VALINE (VALINE) | VALINE | 247 mg in 100 mL | | HISTIDINE (HISTIDINE) | HISTIDINE | 204 mg in 100 mL | | THREONINE (THREONINE) | THREONINE | 179 mg in 100 mL | | TRYPTOPHAN (TRYPTOPHAN) | TRYPTOPHAN | 77 mg in 100 mL | | ALANINE (ALANINE) | ALANINE | 880 mg in 100 mL | | GLYCINE (GLYCINE) | GLYCINE | 438 mg in 100 mL | | ARGININE (ARGININE) | ARGININE | 489 mg in 100 mL | | PROLINE (PROLINE) | PROLINE | 289 mg in 100 mL | | SERINE (SERINE) | SERINE | 213 mg in 100 mL | | TYROSINE (TYROSINE) | TYROSINE | 17 mg in 100 mL | | DEXTROSE (DEXTROSE) | DEXTROSE | 10 g in 100 mL | |
| Inactive Ingredients | | Ingredient Name | Strength | | ACETIC ACID | | | WATER | | | NITROGEN | | |
|
| Packaging | | # | Item Code | Package Description | | 1 | NDC:0338-1134-03 | 1000 mL in 1 BAG | |
|
| Marketing Information | | Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date | | NDA | NDA020734 | 03/20/2012 | | |
Clinimix
leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose injection |
| Product Information | | Product Type | HUMAN PRESCRIPTION DRUG LABEL | Item Code (Source) | NDC:0338-1091 | | Route of Administration | INTRAVENOUS | DEA Schedule | | |
| Active Ingredient/Active Moiety | | Ingredient Name | Basis of Strength | Strength | | LEUCINE (LEUCINE) | LEUCINE | 311 mg in 100 mL | | PHENYLALANINE (PHENYLALANINE) | PHENYLALANINE | 238 mg in 100 mL | | LYSINE (LYSINE) | LYSINE | 247 mg in 100 mL | | METHIONINE (METHIONINE) | METHIONINE | 170 mg in 100 mL | | ISOLEUCINE (ISOLEUCINE) | ISOLEUCINE | 255 mg in 100 mL | | VALINE (VALINE) | VALINE | 247 mg in 100 mL | | HISTIDINE (HISTIDINE) | HISTIDINE | 204 mg in 100 mL | | THREONINE (THREONINE) | THREONINE | 179 mg in 100 mL | | TRYPTOPHAN (TRYPTOPHAN) | TRYPTOPHAN | 77 mg in 100 mL | | ALANINE (ALANINE) | ALANINE | 880 mg in 100 mL | | GLYCINE (GLYCINE) | GLYCINE | 438 mg in 100 mL | | ARGININE (ARGININE) | ARGININE | 489 mg in 100 mL | | PROLINE (PROLINE) | PROLINE | 289 mg in 100 mL | | SERINE (SERINE) | SERINE | 213 mg in 100 mL | | TYROSINE (TYROSINE) | TYROSINE | 17 mg in 100 mL | | DEXTROSE (DEXTROSE) | DEXTROSE | 10 g in 100 mL | |
| Inactive Ingredients | | Ingredient Name | Strength | | ACETIC ACID | | | WATER | | | NITROGEN | | |
|
| Packaging | | # | Item Code | Package Description | | 1 | NDC:0338-1091-04 | 2000 mL in 1 BAG | |
|
| Marketing Information | | Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date | | NDA | NDA020734 | 09/29/1997 | | |
Clinimix
leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose injection |
| Product Information | | Product Type | HUMAN PRESCRIPTION DRUG LABEL | Item Code (Source) | NDC:0338-1135 | | Route of Administration | INTRAVENOUS | DEA Schedule | | |
| Active Ingredient/Active Moiety | | Ingredient Name | Basis of Strength | Strength | | LEUCINE (LEUCINE) | LEUCINE | 311 mg in 100 mL | | PHENYLALANINE (PHENYLALANINE) | PHENYLALANINE | 238 mg in 100 mL | | LYSINE (LYSINE) | LYSINE | 247 mg in 100 mL | | METHIONINE (METHIONINE) | METHIONINE | 170 mg in 100 mL | | ISOLEUCINE (ISOLEUCINE) | ISOLEUCINE | 255 mg in 100 mL | | VALINE (VALINE) | VALINE | 247 mg in 100 mL | | HISTIDINE (HISTIDINE) | HISTIDINE | 204 mg in 100 mL | | THREONINE (THREONINE) | THREONINE | 179 mg in 100 mL | | TRYPTOPHAN (TRYPTOPHAN) | TRYPTOPHAN | 77 mg in 100 mL | | GLYCINE (GLYCINE) | GLYCINE | 438 mg in 100 mL | | ARGININE (ARGININE) | ARGININE | 489 mg in 100 mL | | PROLINE (PROLINE) | PROLINE | 289 mg in 100 mL | | SERINE (SERINE) | SERINE | 213 mg in 100 mL | | TYROSINE (TYROSINE) | TYROSINE | 17 mg in 100 mL | | DEXTROSE (DEXTROSE) | DEXTROSE | 20 g in 100 mL | |
| Inactive Ingredients | | Ingredient Name | Strength | | ACETIC ACID | | | WATER | | | NITROGEN | | |
|
| Packaging | | # | Item Code | Package Description | | 1 | NDC:0338-1135-03 | 1000 mL in 1 BAG | |
|
| Marketing Information | | Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date | | NDA | NDA020734 | 09/29/1997 | | |
Clinimix
leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose injection |
| Product Information | | Product Type | HUMAN PRESCRIPTION DRUG LABEL | Item Code (Source) | NDC:0338-1093 | | Route of Administration | INTRAVENOUS | DEA Schedule | | |
| Active Ingredient/Active Moiety | | Ingredient Name | Basis of Strength | Strength | | LEUCINE (LEUCINE) | LEUCINE | 311 mg in 100 mL | | PHENYLALANINE (PHENYLALANINE) | PHENYLALANINE | 238 mg in 100 mL | | LYSINE (LYSINE) | LYSINE | 247 mg in 100 mL | | METHIONINE (METHIONINE) | METHIONINE | 170 mg in 100 mL | | ISOLEUCINE (ISOLEUCINE) | ISOLEUCINE | 255 mg in 100 mL | | VALINE (VALINE) | VALINE | 247 mg in 100 mL | | HISTIDINE (HISTIDINE) | HISTIDINE | 204 mg in 100 mL | | THREONINE (THREONINE) | THREONINE | 179 mg in 100 mL | | TRYPTOPHAN (TRYPTOPHAN) | TRYPTOPHAN | 77 mg in 100 mL | | ALANINE (ALANINE) | ALANINE | 880 mg in 100 mL | | GLYCINE (GLYCINE) | GLYCINE | 438 mg in 100 mL | | ARGININE (ARGININE) | ARGININE | 489 mg in 100 mL | | PROLINE (PROLINE) | PROLINE | 289 mg in 100 mL | | SERINE (SERINE) | SERINE | 213 mg in 100 mL | | TYROSINE (TYROSINE) | TYROSINE | 17 mg in 100 mL | | DEXTROSE (DEXTROSE) | DEXTROSE | 20 g in 100 mL | |
| Inactive Ingredients | | Ingredient Name | Strength | | ACETIC ACID | | | WATER | | | NITROGEN | | |
|
| Packaging | | # | Item Code | Package Description | | 1 | NDC:0338-1093-04 | 2000 mL in 1 BAG | |
|
| Marketing Information | | Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date | | NDA | NDA020734 | 09/29/1997 | | |
Clinimix
leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose injection |
| Product Information | | Product Type | HUMAN PRESCRIPTION DRUG LABEL | Item Code (Source) | NDC:0338-1136 | | Route of Administration | INTRAVENOUS | DEA Schedule | | |
| Active Ingredient/Active Moiety | | Ingredient Name | Basis of Strength | Strength | | LEUCINE (LEUCINE) | LEUCINE | 311 mg in 100 mL | | PHENYLALANINE (PHENYLALANINE) | PHENYLALANINE | 238 mg in 100 mL | | LYSINE (LYSINE) | LYSINE | 247 mg in 100 mL | | METHIONINE (METHIONINE) | METHIONINE | 170 mg in 100 mL | | ISOLEUCINE (ISOLEUCINE) | ISOLEUCINE | 255 mg in 100 mL | | VALINE (VALINE) | VALINE | 247 mg in 100 mL | | HISTIDINE (HISTIDINE) | HISTIDINE | 204 mg in 100 mL | | THREONINE (THREONINE) | THREONINE | 179 mg in 100 mL | | TRYPTOPHAN (TRYPTOPHAN) | TRYPTOPHAN | 77 mg in 100 mL | | ALANINE (ALANINE) | ALANINE | 880 mg in 100 mL | | GLYCINE (GLYCINE) | GLYCINE | 438 mg in 100 mL | | ARGININE (ARGININE) | ARGININE | 489 mg in 100 mL | | PROLINE (PROLINE) | PROLINE | 289 mg in 100 mL | | SERINE (SERINE) | SERINE | 213 mg in 100 mL | | TYROSINE (TYROSINE) | TYROSINE | 17 mg in 100 mL | | DEXTROSE (DEXTROSE) | DEXTROSE | 25 g in 100 mL | |
| Inactive Ingredients | | Ingredient Name | Strength | | ACETIC ACID | | | WATER | | | NITROGEN | | |
|
| Packaging | | # | Item Code | Package Description | | 1 | NDC:0338-1136-03 | 1000 mL in 1 BAG | |
|
| Marketing Information | | Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date | | NDA | NDA020734 | 09/29/1997 | | |
Clinimix
leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose injection |
| Product Information | | Product Type | HUMAN PRESCRIPTION DRUG LABEL | Item Code (Source) | NDC:0338-1095 | | Route of Administration | INTRAVENOUS | DEA Schedule | | |
| Active Ingredient/Active Moiety | | Ingredient Name | Basis of Strength | Strength | | LEUCINE (LEUCINE) | LEUCINE | 311 mg in 100 mL | | PHENYLALANINE (PHENYLALANINE) | PHENYLALANINE | 238 mg in 100 mL | | LYSINE (LYSINE) | LYSINE | 247 mg in 100 mL | | METHIONINE (METHIONINE) | METHIONINE | 170 mg in 100 mL | | ISOLEUCINE (ISOLEUCINE) | ISOLEUCINE | 255 mg in 100 mL | | VALINE (VALINE) | VALINE | 247 mg in 100 mL | | HISTIDINE (HISTIDINE) | HISTIDINE | 204 mg in 100 mL | | THREONINE (THREONINE) | THREONINE | 179 mg in 100 mL | | TRYPTOPHAN (TRYPTOPHAN) | TRYPTOPHAN | 77 mg in 100 mL | | ALANINE (ALANINE) | ALANINE | 880 mg in 100 mL | | GLYCINE (GLYCINE) | GLYCINE | 438 mg in 100 mL | | ARGININE (ARGININE) | ARGININE | 489 mg in 100 mL | | PROLINE (PROLINE) | PROLINE | 289 mg in 100 mL | | SERINE (SERINE) | SERINE | 213 mg in 100 mL | | TYROSINE (TYROSINE) | TYROSINE | 17 mg in 100 mL | | DEXTROSE (DEXTROSE) | DEXTROSE | 25 g in 100 mL | |
| Inactive Ingredients | | Ingredient Name | Strength | | ACETIC ACID | | | WATER | | | NITROGEN | | |
|
| Packaging | | # | Item Code | Package Description | | 1 | NDC:0338-1095-04 | 2000 mL in 1 BAG | |
|
| Marketing Information | | Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date | | NDA | NDA020734 | 09/29/1997 | | |
Clinimix
leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose injection |
| Product Information | | Product Type | HUMAN PRESCRIPTION DRUG LABEL | Item Code (Source) | NDC:0338-1137 | | Route of Administration | INTRAVENOUS | DEA Schedule | | |
| Active Ingredient/Active Moiety | | Ingredient Name | Basis of Strength | Strength | | LEUCINE (LEUCINE) | LEUCINE | 365 mg in 100 mL | | PHENYLALANINE (PHENYLALANINE) | PHENYLALANINE | 280 mg in 100 mL | | LYSINE (LYSINE) | LYSINE | 290 mg in 100 mL | | METHIONINE (METHIONINE) | METHIONINE | 200 mg in 100 mL | | ISOLEUCINE (ISOLEUCINE) | ISOLEUCINE | 300 mg in 100 mL | | VALINE (VALINE) | VALINE | 290 mg in 100 mL | | HISTIDINE (HISTIDINE) | HISTIDINE | 240 mg in 100 mL | | THREONINE (THREONINE) | THREONINE | 210 mg in 100 mL | | TRYPTOPHAN (TRYPTOPHAN) | TRYPTOPHAN | 90 mg in 100 mL | | ALANINE (ALANINE) | ALANINE | 1035 mg in 100 mL | | GLYCINE (GLYCINE) | GLYCINE | 515 mg in 100 mL | | ARGININE (ARGININE) | ARGININE | 575 mg in 100 mL | | PROLINE (PROLINE) | PROLINE | 340 mg in 100 mL | | SERINE (SERINE) | SERINE | 250 mg in 100 mL | | TYROSINE (TYROSINE) | TYROSINE | 20 mg in 100 mL | | DEXTROSE (DEXTROSE) | DEXTROSE | 15 g in 100 mL | |
| Inactive Ingredients | | Ingredient Name | Strength | | ACETIC ACID | | | WATER | | | NITROGEN | | |
|
| Packaging | | # | Item Code | Package Description | | 1 | NDC:0338-1137-03 | 1000 mL in 1 BAG | |
|
| Marketing Information | | Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date | | NDA | NDA020734 | 09/29/1997 | | |
Clinimix
leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose injection |
| Product Information | | Product Type | HUMAN PRESCRIPTION DRUG LABEL | Item Code (Source) | NDC:0338-1099 | | Route of Administration | INTRAVENOUS | DEA Schedule | | |
| Active Ingredient/Active Moiety | | Ingredient Name | Basis of Strength | Strength | | LEUCINE (LEUCINE) | LEUCINE | 365 mg in 100 mL | | PHENYLALANINE (PHENYLALANINE) | PHENYLALANINE | 280 mg in 100 mL | | LYSINE (LYSINE) | LYSINE | 290 mg in 100 mL | | METHIONINE (METHIONINE) | METHIONINE | 200 mg in 100 mL | | ISOLEUCINE (ISOLEUCINE) | ISOLEUCINE | 300 mg in 100 mL | | VALINE (VALINE) | VALINE | 290 mg in 100 mL | | HISTIDINE (HISTIDINE) | HISTIDINE | 240 mg in 100 mL | | THREONINE (THREONINE) | THREONINE | 210 mg in 100 mL | | TRYPTOPHAN (TRYPTOPHAN) | TRYPTOPHAN | 90 mg in 100 mL | | ALANINE (ALANINE) | ALANINE | 1035 mg in 100 mL | | GLYCINE (GLYCINE) | GLYCINE | 515 mg in 100 mL | | ARGININE (ARGININE) | ARGININE | 575 mg in 100 mL | | PROLINE (PROLINE) | PROLINE | 340 mg in 100 mL | | SERINE (SERINE) | SERINE | 250 mg in 100 mL | | TYROSINE (TYROSINE) | TYROSINE | 20 mg in 100 mL | | DEXTROSE (DEXTROSE) | DEXTROSE | 15 g in 100 mL | |
| Inactive Ingredients | | Ingredient Name | Strength | | ACETIC ACID | | | WATER | | | NITROGEN | | |
|
| Packaging | | # | Item Code | Package Description | | 1 | NDC:0338-1099-04 | 2000 mL in 1 BAG | |
|
| Marketing Information | | Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date | | NDA | NDA020734 | 09/29/1997 | | |
Clinimix
leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose injection |
| Product Information | | Product Type | HUMAN PRESCRIPTION DRUG LABEL | Item Code (Source) | NDC:0338-1138 | | Route of Administration | INTRAVENOUS | DEA Schedule | | |
| Active Ingredient/Active Moiety | | Ingredient Name | Basis of Strength | Strength | | LEUCINE (LEUCINE) | LEUCINE | 365 mg in 100 mL | | PHENYLALANINE (PHENYLALANINE) | PHENYLALANINE | 280 mg in 100 mL | | LYSINE (LYSINE) | LYSINE | 290 mg in 100 mL | | METHIONINE (METHIONINE) | METHIONINE | 200 mg in 100 mL | | ISOLEUCINE (ISOLEUCINE) | ISOLEUCINE | 300 mg in 100 mL | | VALINE (VALINE) | VALINE | 290 mg in 100 mL | | HISTIDINE (HISTIDINE) | HISTIDINE | 240 mg in 100 mL | | THREONINE (THREONINE) | THREONINE | 210 mg in 100 mL | | TRYPTOPHAN (TRYPTOPHAN) | TRYPTOPHAN | 90 mg in 100 mL | | ALANINE (ALANINE) | ALANINE | 1035 mg in 100 mL | | GLYCINE (GLYCINE) | GLYCINE | 515 mg in 100 mL | | ARGININE (ARGININE) | ARGININE | 575 mg in 100 mL | | PROLINE (PROLINE) | PROLINE | 340 mg in 100 mL | | SERINE (SERINE) | SERINE | 250 mg in 100 mL | | TYROSINE (TYROSINE) | TYROSINE | 20 mg in 100 mL | | DEXTROSE (DEXTROSE) | DEXTROSE | 20 g in 100 mL | |
| Inactive Ingredients | | Ingredient Name | Strength | | ACETIC ACID | | | WATER | | | NITROGEN | | |
|
| Packaging | | # | Item Code | Package Description | | 1 | NDC:0338-1138-03 | 1000 mL in 1 BAG | |
|
| Marketing Information | | Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date | | NDA | NDA020734 | 09/29/1997 | | |
Clinimix
leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose injection |
| Product Information | | Product Type | HUMAN PRESCRIPTION DRUG LABEL | Item Code (Source) | NDC:0338-1101 | | Route of Administration | INTRAVENOUS | DEA Schedule | | |
| Active Ingredient/Active Moiety | | Ingredient Name | Basis of Strength | Strength | | LEUCINE (LEUCINE) | LEUCINE | 365 mg in 100 mL | | PHENYLALANINE (PHENYLALANINE) | PHENYLALANINE | 280 mg in 100 mL | | LYSINE (LYSINE) | LYSINE | 290 mg in 100 mL | | METHIONINE (METHIONINE) | METHIONINE | 200 mg in 100 mL | | ISOLEUCINE (ISOLEUCINE) | ISOLEUCINE | 300 mg in 100 mL | | VALINE (VALINE) | VALINE | 290 mg in 100 mL | | HISTIDINE (HISTIDINE) | HISTIDINE | 240 mg in 100 mL | | THREONINE (THREONINE) | THREONINE | 210 mg in 100 mL | | TRYPTOPHAN (TRYPTOPHAN) | TRYPTOPHAN | 90 mg in 100 mL | | ALANINE (ALANINE) | ALANINE | 1035 mg in 100 mL | | GLYCINE (GLYCINE) | GLYCINE | 515 mg in 100 mL | | ARGININE (ARGININE) | ARGININE | 575 mg in 100 mL | | PROLINE (PROLINE) | PROLINE | 340 mg in 100 mL | | SERINE (SERINE) | SERINE | 250 mg in 100 mL | | TYROSINE (TYROSINE) | TYROSINE | 20 mg in 100 mL | | DEXTROSE (DEXTROSE) | DEXTROSE | 20 g in 100 mL | |
| Inactive Ingredients | | Ingredient Name | Strength | | ACETIC ACID | | | WATER | | | NITROGEN | | |
|
| Packaging | | # | Item Code | Package Description | | 1 | NDC:0338-1101-04 | 2000 mL in 1 BAG | |
|
| Marketing Information | | Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date | | NDA | NDA020734 | 09/29/1997 | | |
Clinimix
leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose injection |
| Product Information | | Product Type | HUMAN PRESCRIPTION DRUG LABEL | Item Code (Source) | NDC:0338-1139 | | Route of Administration | INTRAVENOUS | DEA Schedule | | |
| Active Ingredient/Active Moiety | | Ingredient Name | Basis of Strength | Strength | | LEUCINE (LEUCINE) | LEUCINE | 365 mg in 100 mL | | PHENYLALANINE (PHENYLALANINE) | PHENYLALANINE | 280 mg in 100 mL | | LYSINE (LYSINE) | LYSINE | 290 mg in 100 mL | | METHIONINE (METHIONINE) | METHIONINE | 200 mg in 100 mL | | ISOLEUCINE (ISOLEUCINE) | ISOLEUCINE | 300 mg in 100 mL | | VALINE (VALINE) | VALINE | 290 mg in 100 mL | | HISTIDINE (HISTIDINE) | HISTIDINE | 240 mg in 100 mL | | THREONINE (THREONINE) | THREONINE | 210 mg in 100 mL | | TRYPTOPHAN (TRYPTOPHAN) | TRYPTOPHAN | 90 mg in 100 mL | | ALANINE (ALANINE) | ALANINE | 1035 mg in 100 mL | | GLYCINE (GLYCINE) | GLYCINE | 515 mg in 100 mL | | ARGININE (ARGININE) | ARGININE | 575 mg in 100 mL | | PROLINE (PROLINE) | PROLINE | 340 mg in 100 mL | | SERINE (SERINE) | SERINE | 250 mg in 100 mL | | TYROSINE (TYROSINE) | TYROSINE | 20 mg in 100 mL | | DEXTROSE (DEXTROSE) | DEXTROSE | 25 g in 100 mL | |
| Inactive Ingredients | | Ingredient Name | Strength | | ACETIC ACID | | | WATER | | | NITROGEN | | |
|
| Packaging | | # | Item Code | Package Description | | 1 | NDC:0338-1139-03 | 1000 mL in 1 BAG | |
|
| Marketing Information | | Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date | | NDA | NDA020734 | 09/29/1997 | | |
Clinimix
leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose injection |
| Product Information | | Product Type | HUMAN PRESCRIPTION DRUG LABEL | Item Code (Source) | NDC:0338-1103 | | Route of Administration | INTRAVENOUS | DEA Schedule | | |
| Active Ingredient/Active Moiety | | Ingredient Name | Basis of Strength | Strength | | LEUCINE (LEUCINE) | LEUCINE | 365 mg in 100 mL | | LYSINE (LYSINE) | LYSINE | 290 mg in 100 mL | | METHIONINE (METHIONINE) | METHIONINE | 200 mg in 100 mL | | ISOLEUCINE (ISOLEUCINE) | ISOLEUCINE | 300 mg in 100 mL | | VALINE (VALINE) | VALINE | 290 mg in 100 mL | | HISTIDINE (HISTIDINE) | HISTIDINE | 240 mg in 100 mL | | THREONINE (THREONINE) | THREONINE | 210 mg in 100 mL | | TRYPTOPHAN (TRYPTOPHAN) | TRYPTOPHAN | 90 mg in 100 mL | | ALANINE (ALANINE) | ALANINE | 1035 mg in 100 mL | | GLYCINE (GLYCINE) | GLYCINE | 515 mg in 100 mL | | ARGININE (ARGININE) | ARGININE | 575 mg in 100 mL | | PROLINE (PROLINE) | PROLINE | 340 mg in 100 mL | | SERINE (SERINE) | SERINE | 250 mg in 100 mL | | TYROSINE (TYROSINE) | TYROSINE | 20 mg in 100 mL | | DEXTROSE (DEXTROSE) | DEXTROSE | 25 g in 100 mL | |
| Inactive Ingredients | | Ingredient Name | Strength | | ACETIC ACID | | | WATER | | | NITROGEN | | |
|
| Packaging | | # | Item Code | Package Description | | 1 | NDC:0338-1103-04 | 2000 mL in 1 BAG | |
|
| Marketing Information | | Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date | | NDA | NDA020734 | 09/29/1997 | | |
| Labeler - Baxter Healthcare Corporation (005083209) |
| Establishment |
| Name | Address | ID/FEI | Operations |
| Baxter Healthcare Corporation | | 189326168 | MANUFACTURE(0338-1132, 0338-1083, 0338-1133, 0338-1089, 0338-1134, 0338-1091, 0338-1135, 0338-1093, 0338-1136, 0338-1095, 0338-1137, 0338-1099, 0338-1138, 0338-1101, 0338-1139, 0338-1103) |
| Establishment |
| Name | Address | ID/FEI | Operations |
| Baxter Healthcare Corporation | | 059140764 | MANUFACTURE(0338-1132, 0338-1083, 0338-1133, 0338-1089, 0338-1134, 0338-1091, 0338-1135, 0338-1093, 0338-1136, 0338-1095, 0338-1137, 0338-1099, 0338-1138, 0338-1101, 0338-1139, 0338-1103) |
Revised: 09/2016 Baxter Healthcare Corporation
