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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