Travasol (Amino Acids)

TRAVASOL® Baxter Amino Acids I.V. Nutritive Supplement

Availability And Storage:

Travasol Amino Acid Injections are sterile, hypertonic, nonpyrogenic solutions of essential and nonessential amino acids presented with or without electrolytes, for i.v. administration.

Each 100 mL of Travasol Amino Acid Injections with Electrolytes or without Electrolytes in water for injection contains:

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Travasol With Electrolytes or Without Electrolytes

Blend B and Blend C

5% 5.5% 8.5% 10%

Amino Acids 5.0 g 5.5 g 8.5 g 10 g

Total Nitrogen 840 mg 924 mg 1.42 g 1.68 g

Approximate pH 6.0 6.0 6.0 6.0

Approximate mOsm/L (With Electrolytes Without Electrolytes) 695 570 850 575 1 160 890 1 300 1 050

Blend B

Esential Amino Acids 5% 5.5% 8.5% 10%

L-Leucine 310 mg 340 mg 526 mg 620 mg

L-Phenylalanine 310 mg 340 mg 526 mg 620 mg

L-Methionine 290 mg 318 mg 492 mg 580 mg

L-Lysine (HCl) 290 mg 318 mg 492 mg 580 mg

L-Isoleucine 240 mg 263 mg 406 mg 480 mg

L-Valine 230 mg 252 mg 390 mg 460 mg

L-Histidine 220 mg 241 mg 372 mg 440 mg

L-Threonine 210 mg 230 mg 356 mg 420 mg

L-Tryptophan 90 mg 99 mg 152 mg 180 mg

Non-essential Amino Acids 5% 5.5% 8.5% 10%

L-Alanine 1.04 g 1.14 g 1.76 g 2.08 g

Aminoacetic Acid 1.04 g 1.14 g 1.76 g 2.08 g

L-Arginine 520 mg 570 mg 880 mg 1.04 g

L-Proline 210 mg 231 mg 356 mg 420 mg

L-Tyrosine 20 mg 22 mg 34 mg 40 mg

Blend C

Esential Amino Acids 5% 5.5% 8.5% 10%

L-Leucine 365 mg 402 mg 620 mg 730 mg

L-Phenylalanine 280 mg 308 mg 476 mg 560 mg

L-Methionine 200 mg 220 mg 340 mg 400 mg

L-Lysine (HCl) 290 mg 319 mg 493 mg 580 mg

L-Isoleucine 300 mg 330 mg 510 mg 600 mg

L-Valine 290 mg 319 mg 493 mg 580 mg

L-Histidine 240 mg 264 mg 408 mg 480 mg

L-Threonine 210 mg 230 mg 357 mg 420 mg

L-Tryptophan 90 mg 99 mg 153 mg 180 mg

Non-essential Amino Acids 5% 5.5% 8.5% 10%

L-Alanine 1.04 g 1.14 g 1.76 g 2.07 g

Aminoacetic Acid 0.52 g 566 mg 876 mg 1.03 g

L-Arginine 0.58 g 632 mg 978 mg 1.15 g

L-Proline 340 mg 374 mg 578 mg 680 mg

L-Tyrosine 20 mg 22 mg 34 mg 40 mg

L-Serine 250 mg 275 mg 425 mg 500 mg

Acetic acid is added for pH adjustment. Quick Mix Dual Chamber Container products and Travasol solutions contain no bisulfites. In addition to the above, Travasol Amino Acid Injections with Electrolytes contain in each 100 mL the following electrolytes.

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Travasol With Electrolytes

Blend B and C

Electrolyte 5% 5.5% 8.5% 10%

Sodium Acetate, Trihydrate USP 340 mg 431 mg 594 mg 680 mg

Dibasic Potassium Phosphate USP 261 mg 522 mg 522 mg 522 mg

Sodium Chloride, USP 58.5 mg 224 mg 154 mg 117 mg

Magnesium Chloride, Hexahydrate USP 51 mg 102 mg 102 mg 102 mg

Travasol Amino Acid Injections with Electrolytes contain the following electrolytes in approximate mEq/La.

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Travasol With Electrolytes

Blend B and C

Electrolyte 5% 5.5% 8.5% 10%

Sodium 35 70 70 70

Potassium 30 60 60 60

Magnesium 5 10 10 10

Acetateb 75 102 141 150

Chloride 35 70 70 70

Phosphate (as HPO 4 =) 30 60 60 60

a Balanced by ions from amino acids.

b Acetate is added as sodium acetate and as acetic acid used for pH adjustment.

Travasol Amino Acid Injections without Electrolytes contain the following anion profiles in mmol (mEq)/L.

Travasol Without Electrolytes

Anion 5% 5.5% 8.5% 10%

Acetatea 44 48 73 87

Chlorideb 20 22 34 40

a derived from pH adjustment with acetic acid.

b contributed by the L-Lysine HCl.

The dextrose chambers of Travasol Amino Acid with and without electrolytes and dextrose in the Quick mix dual chamber container contain the following per 100 mL.

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Travasol With and Without Electrolytes and Dextrose

Ingredient 10% 20% 33.3% 40% 50%

Dextrose Hydrous USP 10.0 g 20.0 g 33.3 g 40.0 g 50.0 g

Water for Injection USP qs qs qs qs qs

Travasol Amino Acid Injection Blend B and Blend C, is available in 5.0%, 5.5%, 8.5% and 10% concentrations with Electrolytes in glass containers as well as in Viaflex plastic containers.

Travasol Amino Acid Injection Blend B and Blend C, is available in 5.0%, 5.5%, 8.5% and 10% concentrations without Electrolytes in glass containers as well as in Viaflex plastic containers.

Travasol Amino Acid Injection with Electrolytes and Dextrose Injection USP are also available in a closed transfer system Quick Mix Dual Chamber Viaflex plastic container in the following range of concentrations.

Travasol With Electrolytes and Dextrose Injection USP

Product Code Travasol Amino Acid Injection With Electrolytes Lower Chamber (Vol/%) Dextrose Injection USP Upper Chamber (Vol/%)

JB6761 500 mL 10% 500 mL 50%

JB6763 500 mL 10% 500 mL 40%

JB6767 500 mL 10% 500 mL 20%

JB6771 500 mL 10% 500 mL 33.3%

JB6751 500 mL 8.5% 500 mL 50%

JB6753 500 mL 8.5% 500 mL 40%

JB6757 500 mL 8.5% 500 mL 20%

JB6759 500 mL 8.5% 500 mL 10%

JB6741 500 mL 5.5% 500 mL 50%

JB6749 500 mL 5.5% 500 mL 10%

JB6731 500 mL 5% 500 mL 50%

JB6737 500 mL 5% 500 mL 20%

Travasol Amino Acid Injection without Electrolytes and Dextrose Injection USP are available in a closed transfer system Quick Mix Dual Chamber Viaflex plastic container in the following range of concentrations.

Travasol Without Electrolytes and Dextrose Injection USP

Product Code Travasol Amino Acid Injection Without Electrolytes Lower Chamber (Vol/%) Dextrose Injection USP Upper Chamber (Vol/%)

JB6760 500 mL 10% 500 mL 50%

JB6762 500 mL 10% 500 mL 40%

JB6766 500 mL 10% 500 mL 20%

JB6770 500 mL 10% 500 mL 33.3%

JB6756 500 mL 8.5% 500 mL 20%

JB6750 500 mL 8.5% 500 mL 50%

JB6752 500 mL 8.5% 500 mL 40%

JB6758 500 mL 8.5% 500 mL 10%

JB6768 500 mL 10% 500 mL 10%

JB6736 500 mL 5% 500 mL 20%

Storage Conditions: The dosage forms packaged in dual-chamber Viaflex plastic containers should be stored at temperatures between 15 and 25°C protected from light and kept from freezing. The prepared amino acids/dextrose admixture should be administered immediately. If not, it should be stored under refrigeration (2 to 8°C) and used within 24 hours.

TRAVASOL® Baxter Amino Acids I.V. Nutritive Supplement

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