CLINIMIX E Solution for injection Ref.[50762] Active ingredients: Alanine Arginine Calcium chloride Glucose Glycine Histidine Isoleucine Leucine Lysine Magnesium chloride Methionine Phenylalanine Potassium phosphate Proline Serine Sodium acetate Sodium chloride Threonine Tryptophan Tyrosine Valine

Source: FDA, National Drug Code (US)  Revision Year: 2021 

Product description

CLINIMIX E sulfite-free (amino acids with electrolytes in dextrose with calcium) injection for intravenous use consists of sterile, nonpyrogenic, hypertonic solutions in a dual chamber container.

The outlet port chamber contains essential and nonessential amino acids with electrolytes. The formulas for the individual electrolytes and amino acids are provided in Table 8.

Table 8. Formulas for Electrolytes and Amino Acids:

Electrolytes
Sodium Acetate C2H3NaO2•3H2O
Potassium Phosphate, dibasic K2HPO4
Magnesium Chloride MgCl2•6H2O
Sodium Chloride NaCl
Essential Amino Acids
Leucine (CH3)2 CHCH2CH (NH2) COOH
Isoleucine CH3CH2CH (CH3) CH (NH2) COOH
Valine (CH3)2 CHCH (NH2) COOH
Lysine (added as the hydrochloride salt) H2N (CH2)4 CH (NH2) COOH
Phenylalanine (C6H5) CH2 CH (NH2) COOH
Histidine (C3H3N2) CH2CH (NH2) COOH
Threonine CH3CH (OH) CH (NH2) COO
Methionine CH3S (CH2)2 CH (NH2) COOH
Tryptophan (C8H6N) CH2 CH (NH2) COOH
Nonessential Amino Acids
Alanine CH3CH (NH2) COOH
Arginine H2NC (NH) NH (CH2)3 CH (NH2) COOH
Glycine H2NCH2COOH
Proline [(CH2)3 NH CH] COOH
Serine HOCH2CH (NH2) COOH
Tyrosine [C6H4 (OH)] CH2CH (NH2) COOH

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

Dextrose is derived from corn.

See Table 7 for composition, pH, osmolarity, ionic concentration and caloric content of the admixed product [see Dosage Forms and Strengths (3)].

The dual chamber container is a lipid-compatible plastic container (PL 2401 Plastic).

CLINIMIX E contains no more than 25 mcg/L of aluminum.

Dosage Forms and Strengths

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

Table 7. INGREDIENTS PER 100mL OF CLINIMIX E:

Strength of CLINIMIX E CLINIMIX E
2.75/5 sulfite‑free
(2.75% Amino Acid in 5% Dextrose) Injection 		CLINIMIX E
4.25/5 sulfite‑free
(4.25% Amino Acid in 5% Dextrose) Injection 		CLINIMIX E 4.25/10 sulfite‑free
(4.25% Amino Acid in 10% Dextrose) Injection 		CLINIMIX E
5/15 sulfite‑free
(5% Amino Acid in 15% Dextrose) Injection 		CLINIMIX E
5/20 sulfite‑free
(5% Amino Acid in 20% Dextrose) Injection 		CLINIMIX E
8/10 sulfite‑free
(8% Amino Acid in 10% Dextrose) Injection 		CLINIMIX E
8/14 sulfite‑free
(8% Amino Acid in 14% Dextrose) Injection
Dextrose Hydrous, USP (g/100 mL) 5 5 10 15 20 10 14
Amino Acids (g/100 mL) 2.75 4.25 4.25 5 5 8 8
Total Nitrogen (mg/100 mL) 454 702 702 826 826 1320 1320
Essential Amino Acids (mg/100 mL) Leucine 201 311 311 365 365 584 584
Isoleucine 165 255 255 300 300 480 480
Valine 160 247 247 290 290 464 464
Lysine (added as the hydrochloride salt) 159 247 247 290 290 464 464
Phenylalanine 154 238 238 280 280 448 448
Histidine 132 204 204 240 240 384 384
Threonine 116 179 179 210 210 336 336
Methionine 110 170 170 200 200 320 320
Tryptophan 50 77 77 90 90 144 144
Nonessential Amino Acids
(mg/100 mL) 		Alanine 570 880 880 1035 1035 1656 1656
Arginine 316 489 489 575 575 920 920
Glycine 283 438 438 515 515 824 824
Proline 187 289 289 340 340 544 544
Serine 138 213 213 250 250 400 400
Tyrosine 11 17 17 20 20 32 32
Electrolytes
(mg/100 mL) 		Sodium Acetate Trihydrate, USP 217 297 297 340 340 0 0
Dibasic Potassium Phosphate, USP 261 261 261 261 261 261 261
Sodium Chloride, USP 112 77 77 59 59 205 205
Magnesium Chloride, USP 51 51 51 51 51 51 51
Calcium Chloride Dihydrate, USP 33 33 33 33 33 33 33
Electrolyte Profile
(mEq/L)* 		Sodium 35 35 35 35 35 35 35
Potassium 30 30 30 30 30 30 30
Magnesium 5 5 5 5 5 5 5
Calcium 4.5
(2.2 mmol/L) 		4.5
(2.2 mmol/L) 		4.5
(2.2 mmol/L) 		4.5
(2.2 mmol/L) 		4.5
(2.2 mmol/L) 		4.5
(2.2 mmol/L) 		4.5
(2.2 mmol/L)
Acetate† 51 70 70 80 80 83 83
Chloride‡ 39 39 39 39 39 76 76
Phosphate (as HPO4 =) 30
(15 mmol/L) 		30
(15 mmol/L) 		30
(15 mmol/L) 		30
(15 mmol/L) 		30
(15 mmol/L) 		30
(15 mmol/L) 		30
(15 mmol/L)
pH§ (Range) 6.0 (4.5 to 7.0) 6.0(4.5 to 7.0) 6.0(4.5 to 7.0) 6.0(4.5 to 7.0) 6.0(4.5 to 7.0) 6.0(4.5 to 7.0) 6.0(4.5 to 7.0)
Osmolarity (mOsmol/L) (calc) 665 815 1070 1395 1650 1450 1650
Caloric Content
(kcal/L) 		From Dextrose 170 170 340 510 680 343 477
From Amino Acids 110 170 170 200 200 320 320
TOTAL (Dextrose and Amino Acids) 280 340 510 710 880 663 797

* Balanced by ions from amino acids.
† Derived from glacial acetic acid (for pH adjustment) and sodium acetate.
‡ Contributed by calcium chloride, lysine hydrochloride, magnesium chloride, sodium chloride, and hydrochloric acid.
§ pH of sulfite-free amino acid injection with electrolytes in the outlet port chamber was adjusted with glacial acetic acid and pH of dextrose injection port chamber was adjusted with hydrochloric acid.
How Supplied

CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection (sulfite-free) is available in 1000 mL and 2000 mL volumes (See Table 9).

Table 9. CLINIMIX E Formulations:

After mixing, the product represents 1000 mL Code and NDC Number 2000 mL Code and NDC Number
CLINIMIX E 2.75/5 sulfite-free (2.75% Amino Acid with Electrolytes in 5% Dextrose with Calcium) Injection Code 2B7735
NDC 0338-1142-03
CLINIMIX E 4.25/5 sulfite-free (4.25% Amino Acid with Electrolytes in 5% Dextrose with Calcium) Injection Code 2B7737
NDC 0338-1144-03 		Code 2B7716
NDC 0338-1113-04
CLINIMIX E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injection Code 2B7738
NDC 0338-1145-03 		Code 2B7717
NDC 0338-1115-04
CLINIMIX E 5/15 sulfite-free (5% Amino Acid with Electrolytes in 15% Dextrose with Calcium) Injection Code 2B7740
NDC 0338-1147-03 		Code 2B7721
NDC 0338-1123-04
CLINIMIX E 5/20 sulfite-free (5% Amino Acid with Electrolytes in 20% Dextrose with Calcium) Injection Code 2B7741
NDC 0338-1148-03 		Code 2B7722
NDC 0338-1125-04
CLINIMIX E 8/10 sulfite-free (8% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injection Code EADB9943
NDC 0338-210-06 		Code EADB9945
NDC 0338-0214-04
CLINIMIX E 8/14 sulfite-free (8% Amino Acid with Electrolytes in 14% Dextrose with Calcium) Injection Code EADB9963
NDC 0338-0202-06 		Code EADB9965
NDC 0338-0206-04

Baxter Healthcare Corporation, Deerfield, IL 60015, USA

Drugs

Drug Countries
CLINIMIX E Canada, Finland, France, Poland, United States
 
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