Drugs Similar to L-THREONINE HIGH 7426

Aminosyn ™ II, Sulfite-Free, (an amino acid injection) is a sterile, nonpyrogenic solution for intravenous infusion. Aminosyn II is oxygen sensitive. The Pharmacy Bulk Package is a sterile dosage form which contains multiple single doses for use only in a pharmacy bulk admixture program. The formulations are described below: Essential Amino Acids (mg/100 mL) Aminosyn II 10% 15% Isoleucine 660 990 Leucine 1000 1500 Lysine (acetate)* 1050 1575 Methionine 172 258 Phenylalanine 298 447 Threonine 400 600 Tryptophan 200 300 Valine 500 750 *Amount cited is for lysine alone and does not include the acetate. Nonessential Amino Acids (mg/100 mL) Alanine 993 1490 Arginine 1018 1527 L-Aspartic Acid 700 1050 L-Glutamic Acid 738 1107 Histidine 300 450 Proline 722 1083 Serine 530 795 N-Acetyl-L-Tyrosine 270 405 Glycine 500 750 Other Characteristics Protein Equivalent (approx. grams/liter) 100 150 Total Nitrogen (grams/liter) 15.3 23.0 Osmolarity (mOsmol/liter, actual) 840 1270 pH a 5.8 (5.0 – 6.5) 5.8 (5.0 – 6.5) Specific Gravity 1.03 1.05 Electrolytes (mEq/L) Sodium (Na + ) b 38 50 Acetate (C 2 H 3 O 2 - ) c 71.8 107.6 a Solution contains sodium hydroxide for pH adjustment. b Figure includes Na + from the pH adjustor. c Includes acetate from lysine acetate. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. The formulas for the individual amino acids are as follows: The Pharmacy Bulk Package is designed for use with manual, gravity flow operations and automated compounding devices for preparing sterile parenteral nutrient admixtures; it contains no bacteriostat. Multiple single doses may be dispensed during continual aliquoting operations. Withdrawal of container contents should be promptly completed within 4 hours after initial closure puncture. structural formula amino acids

Aminosyn ® -PF 7%, Sulfite-Free, (an amino acid injection — pediatric formula) is a sterile, nonpyrogenic solution for intravenous infusion. Aminosyn ® -PF 7% is oxygen sensitive. The formulation is described below: Aminosyn-PF 7% An Amino Acid Injection — Pediatric Formula Essential Amino Acids (mg/100 mL) Isoleucine 534 Leucine 831 Lysine (acetate)* 475 Methionine 125 Phenylalanine 300 Threonine 360 Tryptophan 125 Valine 452 * Amount cited is for lysine alone and does not include the acetate salt. Nonessential Amino Acids (mg/100 mL) Alanine 490 Arginine 861 L-Aspartic Acid 370 L-Glutamic Acid 576 Glycine 270 Histidine 220 Proline 570 Serine 347 Taurine 50 Tyrosine 44 Electrolytes (mEq/L) Sodium (Na + ) (mEq/L) None Potassium (K + ) (mEq/L) None Chloride (Clˉ) (mEq/L) None Acetate (C 2 H 3 O 2 ˉ) a (mEq/L) 32.5 a From lysine acetate. Product Characteristics Protein Equivalent (Approx. grams/L) 70 Total Nitrogen (grams/L) 10.69 Osmolarity (mOsmol/L) 561 pH (range) 5.5 (5.0 to 6.5) The formulas for the individual amino acids present in Aminosyn-PF 7% are as follows: Essential Amino Acids Isoleucine, USP C 6 H 13 NO 2 Leucine, USP C 6 H 13 NO 2 Lysine Acetate, USP C 6 H 14 N 2 O 2 • CH 3 COOH Methionine, USP C 5 H 11 NO 2 S Phenylalanine, USP C 9 H 11 NO 2 Threonine, USP C 4 H 9 NO 3 Tryptophan, USP C 11 H 12 N 2 O 2 Valine, USP C 5 H 11 NO 2 Nonessential Amino Acids Alanine, USP C 3 H 7 NO 2 Glycine, USP C 2 H 5 NO 2 Arginine, USP C 6 H 14 N 4 O 2 L-Aspartic Acid C 4 H 7 NO 4 HO 2 CCH 2 CH(NH 2 )CO 2 H L-Glutamic Acid C 5 H 9 NO 4 HO 2 CCH 2 CHCH(NH 2 )CO 2 H Histidine, USP C 6 H 9 N 3 O 2 Proline, USP C 5 H 9 NO 2 Serine, USP C 3 H 7 NO 3 Taurine C 2 H 7 NO 3 S Tyrosine, USP C 9 H 11 NO 3 The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.

Aminosyn ® -PF 10%, Sulfite-Free, (an amino acid injection — pediatric formula) is a sterile, nonpyrogenic solution for intravenous infusion. Aminosyn-PF 10% is oxygen sensitive. The Pharmacy Bulk Package is a sterile dosage form which contains multiple single doses for use only in a pharmacy bulk admixture program. The formulation is described below: Aminosyn-PF 10% An Amino Acid Injection — Pediatric Formula Essential Amino Acids (mg/100 mL) Isoleucine 760 Leucine 1200 Lysine (acetate)* 677 Methionine 180 Phenylalanine 427 Threonine 512 Tryptophan 180 Valine 673 * Amount cited is for lysine alone and does not include the acetate salt. Nonessential Amino Acids (mg/100 mL) Alanine 698 Arginine 1227 Aspartic Acid 527 Glutamic Acid 820 Glycine 385 Histidine 312 Proline 812 Serine 495 Taurine 70 Tyrosine 44 Electrolytes (mEq/L) Sodium (Na + ) None Potassium (K + ) None Chloride (Cl − ) None Acetate (C 2 H 3 O 2 − ) a 46 Product Characteristics Protein Equivalent (Approx. grams/L) 100 Total Nitrogen (grams/L) 15.2 Osmolarity (mOsmol/L) 788 pH (range) 5.5 (5.0 to 6.5) Specific Gravity 1.03 a From lysine acetate. The formulas for the individual amino acids present in Aminosyn-PF 10% are as follows: Essential Amino Acids Isoleucine CH 3 CH 2 CH(CH 3 )CH(NH 2 )COOH Leucine (CH 3 ) 2 CHCH 2 CH(NH 2 )COOH Lysine Acetate H 2 N(CH 2 ) 4 CH(NH 2 )COOH • CH 3 COOH Methionine CH 3 S(CH 2 ) 2 CH(NH 2 )COOH Phenylalanine Threonine CH 3 CH(OH)CH(NH 2 )COOH Tryptophan Valine (CH 3 ) 2 CHCH(NH 2 )COOH Nonessential Amino Acids Alanine CH 3 CH(NH 2 )COOH Arginine H 2 NC(NH)NH(CH 2 ) 3 CH(NH 2 )COOH L-Aspartic Acid HOOCCH 2 CH(NH 2 )COOH L-Glutamic Acid HOOC(CH 2 ) 2 CH(NH 2 )COOH Glycine H 2 NCH 2 COOH Histidine Proline Serine HOCH 2 CH(NH 2 )COOH Taurine H 2 N − CH 2 CH 2 − SO 3 H Tyrosine The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. The Pharmacy Bulk Package is designed for use with manual, gravity flow operations and automated compounding devices for preparing sterile parenteral nutrient admixtures; it contains no bacteriostat. Multiple single doses may be dispensed during continual aliquoting operations. Withdrawal of container contents should be promptly completed within 4 hours after initial closure puncture. structural Phenylalanine structural formula Tryptophan structural formula Histidine structural formula Proline structural formula Tyrosine

CLINIMIX sulfite-free (amino acids in dextrose) 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. The formulas for the individual amino acids found in CLINIMIX sulfite-free (amino acids in dextrose) injections are provided in Table 8 . Table 8: Formulas for Amino Acids Essential Amino Acids Leucine (CH 3 ) 2 CHCH 2 CH (NH 2 ) COOH Isoleucine CH 3 CH 2 CH (CH 3 ) CH (NH 2 ) COOH Valine (CH 3 ) 2 CHCH (NH 2 ) COOH Lysine (added as the hydrochloride salt) H 2 N (CH 2 ) 4 CH (NH 2 ) COOH Phenylalanine (C 6 H 5 ) CH 2 CH (NH 2 ) COOH Histidine (C 3 H 3 N 2 ) CH 2 CH (NH 2 ) COOH Threonine CH 3 CH (OH) CH (NH 2 ) COO Methionine CH 3 S (CH 2 )2 CH (NH 2 ) COOH Tryptophan (C 8 H 6 N) CH 2 CH (NH 2 ) COOH Nonessential Amino Acids Alanine CH 3 CH (NH 2 ) COOH Arginine H 2 NC (NH) NH (CH 2 )3 CH (NH 2 ) COOH Glycine H 2 NCH 2 COOH Proline [(CH 2 ) 3 NH CH] COOH Serine HOCH 2 CH (NH 2 ) COOH Tyrosine [C 6 H 4 (OH)] CH 2 CH (NH 2 ) COOH The injection port chamber contains dextrose. Dextrose, USP, is chemically designated D-glucose, monohydrate (C 6 H 12 O 6 • H 2 O) 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 contains no more than 25 mcg/L of aluminum. Structural Formula Dexrose Hydrous, USP

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 C 2 H 3 NaO 2 •3H 2 O Potassium Phosphate, dibasic K 2 HPO 4 Magnesium Chloride MgCl 2 •6H 2 O Sodium Chloride NaCl Essential Amino Acids Leucine (CH 3 ) 2 CHCH 2 CH (NH 2 ) COOH Isoleucine CH 3 CH 2 CH (CH 3 ) CH (NH 2 ) COOH Valine (CH 3 ) 2 CHCH (NH 2 ) COOH Lysine (added as the hydrochloride salt) H 2 N (CH 2 ) 4 CH (NH 2 ) COOH Phenylalanine (C 6 H 5 ) CH 2 CH (NH 2 ) COOH Histidine (C 3 H 3 N 2 ) CH 2 CH (NH 2 ) COOH Threonine CH 3 CH (OH) CH (NH 2 ) COO Methionine CH 3 S (CH 2 )2 CH (NH 2 ) COOH Tryptophan (C 8 H 6 N) CH 2 CH (NH 2 ) COOH Nonessential Amino Acids Alanine CH 3 CH (NH 2 ) COOH Arginine H 2 NC (NH) NH (CH 2 )3 CH (NH 2 ) COOH Glycine H 2 NCH 2 COOH Proline [(CH 2 ) 3 NH CH] COOH Serine HOCH 2 CH (NH 2 ) COOH Tyrosine [C 6 H 4 (OH)] CH 2 CH (NH 2 ) COOH The injection port chamber contains dextrose with calcium. The formula for Calcium Chloride is: CaCl 2 •2H 2 O. Dextrose, USP, is chemically designated D-glucose, monohydrate (C 6 H 12 O 6 • H 2 O) 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. Dextrose Hydrous Structural Formula

15% CLINISOL - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package is a sterile, clear, nonpyrogenic, hypertonic solution of essential and nonessential amino acids. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous infusion. The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). Exposure to temperatures above 25ºC/77ºF during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million; however, the safety of the plastic has been confirmed in tests in animals according to USP biological test for plastic containers as well as by tissue culture toxicity studies. Each 100 mL of 15% CLINISOL - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package contains: Amino Acids Total Nitrogen pH 15.0 g 2.37 g 6.0 (5.0 to 7.0) (pH adjusted with glacial acetic acid) Essential Amino Acids Lysine - (from Lysine Acetate) C 6 H 14 N 2 O 2 Leucine - C 6 H 13 NO 2 Phenylalanine – C 9 H 11 NO 2 Valine - C 5 H 11 NO 2 Histidine - C 6 H 9 N 3 O 2 Isoleucine - C 6 H 13 NO 2 Methionine - C 5 H 11 NO 2 S Threonine - C 4 H 9 NO 3 Tryptophan - C 11 H 12 N 2 O 2 Nonessential Amino Acids Alanine - C 3 H 7 NO 2 Arginine - C 6 H 14 N 4 O 2 Glycine - C 2 H 5 NO 2 Proline - C 5 H 9 NO 2 Glutamic Acid - C 5 H 9 NO 4 Serine – C 3 H 7 NO 3 Aspartic Acid – C 4 H 7 NO 4 Tyrosine – C 9 H 11 NO 3 Anion profiles per liter* Acetate from Lysine Acetate and glacial acetic acic *Balanced by ions from amino acids Osmolarity (Calc.) 1.18 g 1.04 g 1.04 g 960 mg 894 mg 749 mg 749 mg 749 mg 250 mg 2.17 g 1.47 g 1.04 g 894 mg 749 mg 592 mg 434 mg 39 mg 127 mEq 1357 mOsmol/L

KABIVEN is a sterile, hypertonic emulsion, for central venous administration, in a Three Chamber Bag. The product contains no added sulfites. Chamber 1 contains Dextrose monohydrate solution for fluid replenishment and caloric supply. Chamber 2 contains the Amino Acid solution with Electrolytes, which comprises essential and nonessential amino acids provided with electrolytes. Chamber 3 contains Intralipid ® 20% (a 20% Lipid Injectable Emulsion), prepared for intravenous administration as a source of calories and essential fatty acids. See below for formulations of each chamber and Table 2 for strength, pH, osmolarity, ionic concentration and caloric content of KABIVEN when all the chambers are mixed together. Chamber 1: Contains sterile, hypertonic solution of Dextrose, USP in water for injection with a pH range of 3.5 to 5.5. Dextrose, USP is chemically designated D-glucose, monohydrate (C 6 H 12 O 6 • H 2 O) and has the following structure: Dextrose is derived from corn. Chamber 2 : Contains a sterile, solution of amino acids and electrolytes in water for injection. In addition, glacial acetic acid has been added to adjust the pH so that the final solution pH is 5.4 to 5.8. The formulas for the individual electrolytes and amino acids are as follows: Electrolytes Sodium Acetate Trihydrate, USP CH 3 COONax3H 2 O Potassium Chloride, USP KCl Sodium Glycerophosphate C 3 H 5 (OH) 2 PO 4 Na 2 xH 2 O Magnesium Sulfate Heptahydrate, USP MgSO 4 x7H 2 O Calcium Chloride Dihydrate, USP CaCl 2 x2H 2 O Essential Amino Acids Lysine (added as the hydrochloride salt) H 2 N(CH 2 ) 4 CH(NH 2 )COOH.HCl Phenylalanine CH 2 CH(NH 2 )COOH Leucine (CH 3 ) 2 CHCH 2 CH(NH 2 )COOH Valine (CH 3 ) 2 CHCH(NH 2 )COOH Histidine CH2CH(NH2)COOH Threonine CH 3 CH(OH)CH(NH 2 )COOH Methionine CH 3 S(CH 2 ) 2 CH(NH 2 )COOH Isoleucine CH 3 CH 2 CH(CH 3 )CH(NH 2 )COOH Tryptophan CH 2 CH(NH 2 )COOH Nonessential Amino Acids Alanine CH 3 CH(NH 2 )COOH Arginine H 2 NC(NH)NH(CH 2 ) 3 CH(NH 2 )COOH Glycine H 2 NCH 2 COOH Proline Glutamic Acid HOOC(CH 2 ) 2 CH(NH 2 )COOH Serine HOCH 2 CH(NH 2 )COOH Aspartic Acid HOOCCH 2 CH(NH 2 )COOH Tyrosine NH 2 Chamber 3: Contains a 20% Lipid Injectable Emulsion (Intralipid ® 20%) which is made up of 20% Soybean Oil, 1.2% Egg Yolk Phospholipids, 2.25% Glycerin, and water for injection. In addition, sodium hydroxide has been added to adjust the pH. The final product pH range is 6 to 9. The soybean oil is a refined natural product consisting of a mixture of neutral triglycerides of predominantly unsaturated fatty acids with the following structure: where are saturated and unsaturated fatty acid residues. The major component fatty acids are linoleic (48 to 58 %), oleic (17 to 30%), palmitic (9 to 13%), linolenic (5 to 11%) and stearic acid (2.5 to 5%). These fatty acids have the following chemical and structural formulas: Linoleic acid C 18 H 32 O 2 Oleic acid C 18 H 34 O 2 Palmitic acid C 16 H 32 O 2 Linolenic acid C 18 H 30 O 2 Stearic acid C 18 H 36 O 2 Purified egg phosphatides are a mixture of naturally occurring phospholipids which are isolated from the egg yolk. These phospholipids have the following general structure: contain saturated and unsaturated fatty acids that abound in neutral fats. R3 is primarily either the choline or ethanolamine ester of phosphoric acid. Glycerin is chemically designated C 3 H 8 O 3 and is a clear colorless, hygroscopic syrupy liquid. It has the following structural formula: The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional oxygen and moisture barrier when necessary. An oxygen absorber is placed between the inner bag and the overpouch. The container is not made with natural rubber latex or polyvinyl chloride (PVC). KABIVEN contains no more than 25 mcg/L of aluminum. Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure

INDICATIONS: Aids in providing balance in endocrine system and in amino acid, electrolyte and intermediary metabolism.† †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Take 15 minutes before meals

PERIKABIVEN is a sterile, hypertonic emulsion, for peripheral or central venous administration, in a Three Chamber Bag. The product contains no added sulfites. Chamber 1 contains Dextrose monohydrate solution for fluid replenishment and caloric supply. Chamber 2 contains the Amino Acid solution with Electrolytes, which comprises essential and nonessential amino acids provided with electrolytes. Chamber 3 contains Intralipid ® 20% (a 20% Lipid Injectable Emulsion), prepared for intravenous administration as a source of calories and essential fatty acids. See below for formulations of each chamber and Table 2 for strength, pH, osmolarity, ionic concentration and caloric content of PERIKABIVEN when all the chambers are mixed together. Chamber 1: Contains sterile, hypertonic solution of Dextrose, USP in water for injection with a pH range of 3.5 to 5.5. Dextrose, USP is chemically designated D-glucose, monohydrate (C 6 H 12 O 6 • H 2 O) and has the following structure: Dextrose is derived from corn. Chamber 2 : Contains a sterile solution of amino acids and electrolytes in water for injection. In addition, glacial acetic acid has been added to adjust the pH so that the final solution pH is 5.4 to 5.8. The formulas for the individual electrolytes and amino acids are as follows: Electrolytes Sodium Acetate Trihydrate, USP CH 3 COONax3H 2 O Potassium Chloride, USP KCl Sodium Glycerophosphate C 3 H 5 (OH) 2 PO 4 Na 2 xH 2 O Magnesium Sulfate Heptahydrate, USP MgSO 4 x7H 2 O Calcium Chloride Dihydrate, USP CaCl 2 x2H 2 O Essential Amino Acids Lysine (added as the hydrochloride salt) H 2 N(CH 2 ) 4 CH(NH 2 )COOH.HCl Phenylalanine CH 2 CH(NH 2 )COOH Leucine (CH 3 ) 2 CHCH 2 CH(NH 2 )COOH Valine (CH 3 ) 2 CHCH(NH 2 )COOH Histidine CH 2 CH(NH 2 )COOH Threonine CH 3 CH(OH)CH(NH 2 )COOH Methionine CH 3 S(CH 2 ) 2 CH(NH 2 )COOH Isoleucine CH 3 CH 2 CH(CH 3 )CH(NH 2 )COOH Tryptophan CH 2 CH(NH 2 )COOH Nonessential Amino Acids Alanine CH 3 CH(NH 2 )COOH Arginine H 2 NC(NH)NH(CH 2 ) 3 CH(NH 2 )COOH Glycine H 2 NCH 2 COOH Proline Glutamic Acid HOOC(CH 2 ) 2 CH(NH 2 )COOH Serine HOCH 2 CH(NH 2 )COOH Aspartic Acid HOOCCH 2 CH(NH 2 )COOH Tyrosine Chamber 3: Contains a 20% Lipid Injectable Emulsion (Intralipid ® 20%) which is made up of 20% Soybean Oil, 1.2% Egg Yolk Phospholipids, 2.25% Glycerin, and water for injection. In addition, sodium hydroxide has been added to adjust the pH. The final product pH range is 6 to 9. The soybean oil is a refined natural product consisting of a mixture of neutral triglycerides of predominantly unsaturated fatty acids with the following structure: where are saturated and unsaturated fatty acid residues. The major component fatty acids are linoleic (48 to 58 %), oleic (17 to 30%), palmitic (9 to 13%), linolenic (5 to 11%) and stearic acid (2.5 to 5%). These fatty acids have the following chemical and structural formulas: Linoleic acid C 18 H 32 O 2 Oleic acid C 18 H 34 O 2 Palmitic acid C 16 H 32 O 2 Linolenic acid C 18 H 30 O 2 Stearic acid C 18 H 36 O 2 Purified egg phosphatides are a mixture of naturally occurring phospholipids which are isolated from the egg yolk. These phospholipids have the following general structure: contain saturated and unsaturated fatty acids that abound in neutral fats. R3 is primarily either the choline or ethanolamine ester of phosphoric acid. Glycerin is chemically designated C 3 H 8 O 3 and is a clear colorless, hygroscopic syrupy liquid. It has the following structural formula: The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional oxygen and moisture barrier when necessary. An oxygen absorber is placed between the inner bag and the overpouch. The container is not made with natural rubber latex or polyvinyl chloride (PVC). PERIKABIVEN contains no more than 25 mcg/L of aluminum. Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure

Plenamine™ 15% Amino Acids Injection in a Pharmacy Bulk Package is a sterile, clear, nonpyrogenic solution of essential and nonessential amino acids for intravenous infusion in parenteral nutrition following appropriate dilution. Plenamine™ 15% in a Pharmacy Bulk Package is not for direct infusion. It is a sterile dosage form which contains several single doses for use in a pharmacy admixture program in the preparation of intravenous parenteral fluids. Each 100 mL contains: Essential Amino Acids Lysine (from Lysine Acetate, USP) 1.18 g Leucine, USP 1.04 g Phenylalanine, USP 1.04 g Valine, USP 960 mg Isoleucine, USP 749 mg Methionine, USP 749 mg Threonine, USP 749 mg Tryptophan, USP 250 mg Nonessential Amino Acids Alanine, USP 2.17 g Arginine, USP 1.47 g Glycine, USP 1.04 g Histidine, USP 894 mg Proline, USP 894 mg Glutamic Acid 749 mg Serine, USP 592 mg Aspartic Acid, USP 434 mg Tyrosine, USP 39 mg Water for Injection, USP qs Essential Amino Acids 6.7 g Nonessential Amino Acids 8.3 g Total Amino Acids 15.0 g Total Nitrogen 2.37 g Acetate Acetate from Lysine Acetate, USP and acetic acid used for pH adjustment. 147.4 mEq/L Osmolarity (calculated) 1378 mOsmol/L pH 5.6 (5.2–6.0) The formulas for the individual amino acids are as follows: Essential Amino Acids Lysine Acetate H 2 N(CH 2 ) 4 CH(NH 2 )COOH•CH 3 COOH Leucine (CH 3 ) 2 CHCH 2 CH(NH 2 )COOH Phenylalanine Valine (CH 3 ) 2 CHCH(NH 2 )COOH Isoleucine CH 3 CH 2 CH(CH 3 )CH(NH 2 )COOH Methionine CH 3 S(CH 2 ) 2 CH(NH 2 )COOH Threonine CH 3 CH(OH)CH(NH 2 )COOH Tryptophan Nonessential Amino Acids Alanine CH 3 CH(NH 2 )COOH Arginine H 2 NC(NH)NH(CH 2 ) 3 CH(NH 2 )COOH Glycine H 2 NCH 2 COOH Histidine Proline Glutamic Acid HOOC(CH 2 ) 2 CH(NH 2 )COOH Serine HOCH 2 CH(NH 2 )COOH Aspartic Acid HOOCCH 2 CH(NH 2 )COOH Tyrosine Chemical Structure Chemical Structure Chemical Structure Chemical Structure Chemical Structure

PREMASOL 10% injection is a sterile, nonpyrogenic, hypertonic solutions containing crystalline amino acids provided in a Pharmacy Bulk Package. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous infusion. The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride ( PL 146 Plastic). Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period (e.g., di-2-ethylhexyl phthalate, DEHP, at not more than 0.2 part per million); however, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies. Intravenous fat emulsion should not be administered in polyvinyl chloride (PVC) containers that use di-2-ethylhexyl phthalate (DEHP) as a plasticizer, because the fat emulsion facilitates the leaching of DEHP from these containers. Each 100 mL contains: Essential Amino Acids 10% Leucine - (CH 3 ) 2 CHCH 2 CH (NH 2 ) COOH 1.4 g Isoleucine - CH 3 CH 2 CH (CH 3 ) CH (NH 2 ) COOH 0.82 g Lysine (added as Lysine Acetate) - H 2 N (CH 2 ) 4 CH (NH 2 ) COOH 0.82 g Valine - (CH 3 ) 2 CHCH (NH 2 ) COOH 0.78 g Histidine Holt LE, Snyderman SE: The amino acid requirements of infants. JAMA 1961; 175(2):124-127. - (C 3 H 3 N 2 ) CH 2 CH (NH 2 ) COOH 0.48 g Phenylalanine - (C 6 H 5 ) CH 2 CH (NH 2 ) COOH 0.48 g Threonine - CH3CH (OH) CH (NH 2 ) COOH 0.42 g Methionine - CH 3 S (CH 2 ) 2 CH (NH 2 ) COOH 0.34 g Tyrosine (added as Tyrosine and N-Acetyl-L-Tyrosine) - [C 6 H 4 (OH)] CH 2 CH (NH 2 ) COOH 0.24 g Tryptophan - (C 8 H 6 N) CH 2 CH (NH 2 ) COOH 0.20 g Cysteine (added as Cysteine HCl·H 2 O) - SHCH 2 CHNH 2 COOH <0.016 g Nonessential Amino Acids Arginine - H 2 NC (NH) NH (CH 2 ) 3 CH (NH 2 ) COOH 1.2 g Proline – [(CH 2 ) 3 NHCH] COOH 0.68 g Alanine – CH 3 CH (NH 2 ) COOH 0.54 g Glutamic Acid – HOOC (CH 2 ) 2 CH (NH 2 ) COOH 0.50 g Serine - HOCH 2 CH (NH 2 ) COOH 0.38 g Glycine - H 2 NCH 2 COOH 0.36 g Aspartic Acid – HOOC CH 2 CH (NH 2 ) COOH 0.32 g Taurine Rigo J, Senterre J: Is taurine essential for the neonates? Biol Neonate 1977; 32:73-76. Gaull G, Sturman JA, Raiha NCR: Development of mammalian sulfur metabolism: Absence of cystothionase in human fetal tissues. Pediatr Res 1972: 6:538-547. - H 2 NCH 2 CH 2 SO 3 H 0.025 g pH adjusted with glacial acetic acid pH: 5.5 (5.0-6.0) Osmolarity (mOsmol/L) (Calc.) 865 Total Amino Acids (grams/100 mL) (Calc.) 10 Total Nitrogen (grams/100 mL) (Calc.) 1.55 Acetate * - (CH 3 COO-) 94 mEq/L Chloride (Calc.) <3 mEq/L *Provided as acetic acid and lysine acetate. All amino acids are added as the “L”-isomer with the exception of Glycine and Taurine, which do not have isomers.

PROSOL 20% (amino acids) injection is a sterile, nonpyrogenic, hypertonic solution of essential and nonessential amino acids supplied in a flexible container as a Pharmacy Bulk Package. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program [see Dosage and Administration (2.1) ]. PROSOL is not for direct intravenous infusion. The formulas for the individual amino acids found in PROSOL are provided in Table 4 . Table 4. Formulas for Amino Acids Essential Amino Acids Leucine (CH 3 ) 2 CHCH 2 CH (NH 2 ) COOH Isoleucine CH 3 CH 2 CH (CH 3 ) CH (NH 2 ) COOH Lysine (added as the hydrochloride salt) H 2 N (CH 2 ) 4 CH (NH 2 ) COOH Valine (CH 3 ) 2 CHCH (NH 2 ) COOH Phenylalanine (C 6 H 5 ) CH 2 CH (NH 2 ) COOH Histidine (C 3 H 3 N 2 ) CH 2 CH (NH 2 ) COOH Threonine CH 3 CH (OH) CH (NH 2 ) COO Methionine CH 3 S (CH 2 )2 CH (NH 2 ) COOH Tryptophan (C 8 H 6 N) CH 2 CH (NH 2 ) COOH Nonessential Amino Acids Alanine CH 3 CH (NH 2 ) COOH Arginine H 2 NC (NH) NH (CH 2 )3 CH (NH 2 ) COOH Aspartic Acid HOOC CH 2 CH (NH 2 ) COOH Glutamic Acid HOOC (CH 2 ) 2 CH (NH 2 ) COOH Glycine H 2 NCH 2 COOH Proline [(CH 2 ) 3 NH CH] COOH Serine HOCH 2 CH (NH 2 ) COOH Tyrosine [C 6 H 4 (OH)] CH 2 CH (NH 2 ) COOH PROSOL contains no more than 25 mcg/L of aluminum.

Uses Temporarily gives support during weight management program.†

TRAVASOL 10% (amino acids) injection is a sterile, nonpyrogenic hypertonic solution of essential and nonessential amino acids supplied in a flexible container as a Pharmacy Bulk Package. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program [see Dosage and Administration (2.1) ] . TRAVASOL is not for direct intravenous infusion. The formulas for the individual amino acids found in TRAVASOL are provided in Table 4 . Table 4. Formulas for Amino Acids Essential Amino Acids Leucine (CH 3 ) 2 CHCH 2 CH (NH 2 ) COOH Isoleucine CH 3 CH 2 CH (CH 3 ) CH (NH 2 ) COOH Lysine (added as the hydrochloride salt) H 2 N (CH 2 ) 4 CH (NH 2 ) COOH Valine (CH 3 ) 2 CHCH (NH 2 ) COOH Phenylalanine (C 6 H 5 ) CH 2 CH (NH 2 ) COOH Histidine (C 3 H 3 N 2 ) CH 2 CH (NH 2 ) COOH Threonine CH 3 CH (OH) CH (NH 2 ) COO Methionine CH 3 S (CH 2 )2 CH (NH 2 ) COOH Tryptophan (C 8 H 6 N) CH 2 CH (NH 2 ) COOH Nonessential Amino Acids Alanine CH 3 CH (NH 2 ) COOH Arginine H 2 NC (NH) NH (CH 2 )3 CH (NH 2 ) COOH Glycine H 2 NCH 2 COOH Proline [(CH 2 ) 3 NH CH] COOH Serine HOCH 2 CH (NH 2 ) COOH Tyrosine [C 6 H 4 (OH)] CH 2 CH (NH 2 ) COOH TRAVASOL contains no more than 25 mcg/L of aluminum.

TrophAmine® (10% Amino Acid Injection) is a sterile, nonpyrogenic, hypertonic solution containing crystalline amino acids. All amino acids designated USP are the “L”-isomer with the exception of Glycine USP, which does not have an isomer. Each 100 mL contains: Essential Amino Acids 10% Isoleucine USP 0.82 g Leucine USP 1.4 g Lysine 0.82 g (added as Lysine Acetate USP 1.2 g) Methionine USP 0.34 g Phenylalanine USP 0.48 g Threonine USP 0.42 g Tryptophan USP 0.2 g Valine USP 0.78 g Cysteine <0.016 g (as Cysteine HCl∙H 2 O USP <0.024 g) Histidine USP Holt LE, Snyderman SE: The amino acid requirements of infants. JAMA 1961; 175(2):124–127. 0.48 g Tyrosine 0.24 g (added as Tyrosine USP 0.044 g and N-Acetyl-L-Tyrosine 0.24 g) Nonessential Amino Acids Alanine USP 0.54 g Arginine USP 1.2 g Proline USP 0.68 g Serine USP 0.38 g Glycine USP 0.36 g L-Aspartic Acid 0.32 g L-Glutamic Acid 0.5 g Taurine Rigo J, Senterre J: Is taurine essential for the neonates? Biol Neonate 1977; 32:73–76. Gaull G, Sturman JA, Räihä NCR: Development of mammalian sulfur metabolism: Absence of cystothionase in human fetal tissues. Pediatr Res 1972; 6:538–547. 0.025 g Water for Injection USP qs pH adjusted with Glacial Acetic Acid USP pH: 5.5 (5.0–6.0) Calc. Osmolarity (mOsmol/liter) 866 Total Amino Acids (grams/liter) 100 Total Nitrogen (grams/liter) 15.5 Protein Equivalent (grams/liter) 97 Electrolytes (mEq/liter) Provided as acetic acid and lysine acetate. Acetate (CH 3 COO – ) 96.2 Chloride <3

Uses Temporarily relieves symptoms related to increased appetite, regulation of fat metabolism, headache, and fatigue.†

INDICATIONS: For temporary relief of acute and chronic vaginal inflammation, vaginal discharge, abdominal distention, edema in legs, extreme tiredness, indigestion with tiredness, insomnia from tiredness, vaginal itching, mental exhaustion, rheumatic nodules and stiffness, running or congested nose, swelling in the joints.

HOMEOPATHIC INDICATIONS: For temporary relief of symptoms related to gastroenteritis including occasional diarrhea, stomach cramps, nausea, vomiting, flatulence and bloating.** **These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.

HOMEOPATHIC INDICATIONS: For temporary relief of symptoms related to female hormonal problems such as fatigue and low energy.** **These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.

USES: For the temporary relief of symptoms of food cravings, including: constant appetite, increased or insatiable hunger.*

HOMEOPATHIC INDICATIONS: For temporary relief of sensitivity to wool, including gas, bloating, and headache.** **These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.

INDICATIONS For symptoms of thyroid metabolism, goiter, immune system TPO, inflammation of the thyroid.

INDICATIONS: Skin rash, painful skin lesions, swelling, headache, nervous, fever, warts, sores.

INDICATIONS: For the temporary relief of loss of memory, metal weakness, senile dementia, forgetfulness, confusion, anxiety, brain fog, children with slow mental and physical development.

INDICATIONS: For temporary relief of sexual debility from nervous prostration, for enhancing sexual function, nervous exhaustion causing lack of sexual desire.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

HOMEOPATHIC INDICATIONS: For temporary relief of symptoms related to Candida albicans infection such as nausea, drowsiness, lethargy, confusion, vaginal discharge, sensitivities to foods and mucous congestion.** **These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.

HOMEOPATHIC INDICATIONS: For temporary relief of symptoms related to Epstein-Barr Virus including exhaustion, swollen glands, mucous congestion, and fatigue.** **These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.

HOMEOPATHIC INDICATIONS: For the temporary relief of symptoms of allergies to calcium in foods and supplements, including cramping of muscles, fatigue, and musculoskeletal weakness.

HOMEOPATHIC INDICATIONS: For temporary relief of symptoms related to Mood swings such as loss of interest, guilt, grandiose ego, racing thoughts, hyperactivity, impulsiveness and inattention.** **These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.

INDICATIONS: For temporary relief of symptoms of cough with expectoration & dyspepsia, ill effects of melons, water & dried fruits, thick yellow ropy mucous secretions.

INDICATIONS: Kidney, Bladder support.** **These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

HOMEOPATHIC INDICATIONS: For temporary relief of exhaustion, fatigue, and feelings of low energy.** **These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.

HOMEOPATHIC INDICATIONS: For temporary relief of symptoms related to heartburn and esophageal reflux.** **These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.

INDICATIONS: May temporarily relieve symptoms associated with animal allergies such as runny nose and sneezing.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Directions: Adults: Hold the spray-top close to your open mouth and spray twice directly under your tongue, three times a day. Some people notice improvement within two or three weeks, others take longer.