CLINIMIX E 1035 mg/100mL
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 · INJECTION · Baxter Healthcare Company
Clinimix E is an intravenous nutrition solution containing amino acids, electrolytes, and dextrose that is used to provide essential nutrients to patients who cannot eat or absorb food normally. This medication is typically given through an IV line to help maintain proper nutrition and support body functions in hospitalized or critically ill patients.
Key Facts
- Brand Name
- CLINIMIX E
- Generic Name
- 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
- NDC Code (Product)
0338-7030- Manufacturer
- Baxter Healthcare Company
- Strength
- 1035 mg/100mL
- Dosage Form
- INJECTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA020678
- Drug Class
- Amino Acid [EPC]
- Marketing Start
- 07/15/2024
Recall History
Baxter Healthcare Corp
Lack of Assurance of Sterility; increased complaints received for leaks
Baxter Healthcare Corp.
Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose.
Baxter Healthcare Corp.
Lack of Assurance of Sterility; leaks were observed from the bag seam and port seal
Baxter Healthcare Corp.
Presence of Particulate Matter: identified as dried skin.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE CLINIMIX E is indicated as a source of calories, protein, and electrolytes for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX E may be used to treat negative nitrogen balance in patients. CLINIMIX E is indicated as a source of calories, protein, and electrolytes for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX E may be used to treat negative nitrogen balance in patients. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION See full prescribing information for information on preparation, administration, instructions for use, dosing considerations, including the recommended dosage in adults and pediatrics, and dosage modifications in patients with kidney disease. ( 2.1 , 2.2 , 2.3 , 2.4 , 2.5 , 2.6 , 2.7 , 2.8 ) 2.1 Preparation Prior to Administration • CLINIMIX E is available in a three port container configuration and a two port container configuration. • Three Port Container: the ports consist of one medication port, one additive port and one outlet port. Additives can be introduced to the container through the medication port and lipids through the additive port on the three port container. • Two Port Container: the ports consist of one medication port and one outlet port. Additives, including lipids, can be introduced to the container through the medication port on the two port container. • Tear protective overwrap at slit and remove solution container. Small amounts of moisture may be found on the solution container from water permeating from inside the container. The amount of permeated water is insufficient to affect the solution significantly. If larger amounts of w…
Contraindications
4 CONTRAINDICATIONS The use of CLINIMIX E is contraindicated in: 1. Neonates (28 days of age or younger) receiving concomitant treatment with ceftriaxone, even if separate infusion lines are used, due to the risk of fatal ceftriaxone calcium salt precipitation in the neonate’s bloodstream [see Warnings and Precautions (5.2) , Use in Specific Populations (8.4) ] . 2. Patients with known hypersensitivity to one or more amino acids or dextrose [see Warnings and Precautions (5.3) ] . 3. Patients with inborn errors of amino acid metabolism due to risk of severe metabolic and neurologic complications. 4. Patients with pulmonary edema or acidosis due to low cardiac output. • Concomitant treatment with ceftriaxone in neonates (28 days of age or younger). ( 4 ) • Known hypersensitivity to one or more amino acids or dextrose. ( 4 ) • Inborn errors of amino acid metabolism. ( 4 ) • Patients with pulmonary edema or acidosis due to low cardiac output. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS 7.1 Drugs that Can Cause Hyperkalemia Because of its potassium content, CLINIMIX E should be administered with caution in patients treated with agents or products that can cause hyperkalemia or increase the risk of hyperkalemia, such as potassium sparing diuretics (amiloride, spironolactone, triamterene), with ACE inhibitors, angiotensin II receptor antagonists, or the immunosuppressants tacrolimus and cyclosporine.
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the prescribing information. • Pulmonary embolism due to pulmonary vascular precipitates [see Warnings and Precautions (5.1) ] • Death in neonates due to calcium-ceftriaxone precipitates [see Warnings and Precautions (5.2) ] • Hypersensitivity reactions [see Warnings and Precautions (5.3) ] • Risk of Infections [see Warnings and Precautions (5.4) ] • Refeeding syndrome [see Warnings and Precautions (5.5) ] • Hyperglycemia or hyperosmolar hyperglycemic state [see Warnings and Precautions (5.6) ] • Vein damage and thrombosis [see Warnings and Precautions (5.7) ] • Hepatobiliary disorders [see Warnings and Precautions (5.8) ] • Parenteral Nutrition Associated Liver Disease (PNALD) [see Warnings and Precautions (5.10) ] • Electrolyte imbalance and fluid overload [see Warnings and Precautions (5.11) ] The following adverse reactions from voluntary reports or clinical studies have been reported with CLINIMIX E. Because many of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establi…
Frequently Asked Questions
What is CLINIMIX E used for?
Clinimix E is an intravenous nutrition solution containing amino acids, electrolytes, and dextrose that is used to provide essential nutrients to patients who cannot eat or absorb food normally. This medication is typically given through an IV line to help maintain proper nutrition and support body functions in hospitalized or critically ill patients.
Is CLINIMIX E a controlled substance?
CLINIMIX E is not classified as a controlled substance by the DEA.
What is the generic name for CLINIMIX E?
The generic name for 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. There are no other listed brand versions of 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.
What is the NDC code for CLINIMIX E 1035 mg/100mL?
The NDC (National Drug Code) for CLINIMIX E 1035 mg/100mL is 0338-7030, listed by Baxter Healthcare Company.
Other CLINIMIX E Dosages
- CLINIMIX E1035 mg/100mL0338-7036
- CLINIMIX E880 mg/100mL0338-1144
- CLINIMIX E880 mg/100mL0338-7026
- CLINIMIX E880 mg/100mL0338-7028
- CLINIMIX E570 mg/100mL0338-1142
- CLINIMIX E880 mg/100mL0338-7024
- CLINIMIX E1035 mg/100mL0338-7032
- CLINIMIX E1035 mg/100mL0338-1148
- CLINIMIX E1035 mg/100mL0338-1123
- CLINIMIX E880 mg/100mL0338-7022
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)