SPL Set ID: 9afdcc3e-0d06-47f4-86ca-40da48b2b02b

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.