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6% and 10% PREMASOL - sulfite-free (Amino Acid) Injections

2016-08-26 08:45:47 来源: 作者: 【大中小】浏览:347次评论:0条

PREMASOL - SULFITE-FREE (AMINO ACID)- leucine, lysine, isoleucine, valine, histidine, phenylalanine, threonine, methionine, tryptophan, tyrosine, n-acetyl-tyrosine, arginine, proline, alanine, glutamic acide, serine, glycine, aspartic acid, taurine, cysteine hydrochloride injection, solution
Baxter Healthcare Corporation

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6% and 10% PREMASOL - sulfite-free (Amino Acid) Injections
in VIAFLEX Plastic Container

PHARMACY BULK PACKAGE
NOT FOR DIRECT INFUSION

Rx Only

DESCRIPTION

6% and 10% PREMASOL - sulfite-free (Amino Acid) Injections are 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:

* Holt LE, Snyderman SE: The amino acid requirements of infants. JAMA 1961; 175(2):124-127. † 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.
Essential Amino Acids	6%	10%
Leucine - (CH3)2 CHCH2CH (NH2) COOH	0.84 g	1.4 g
Isoleucine - CH3CH2CH (CH3) CH (NH2) COOH	0.49 g	0.82 g
Lysine (added as Lysine Acetate) - H2N (CH2)4 CH (NH2) COOH	0.49 g	0.82 g
Valine - (CH3)2 CHCH (NH2) COOH	0.47 g	0.78 g
Histidine* - (C3H3N2) CH2CH (NH2) COOH	0.29 g	0.48 g
Phenylalanine - (C6H5) CH2 CH (NH2) COOH	0.29 g	0.48 g
Threonine - CH3CH (OH) CH (NH2) COOH	0.25 g	0.42 g
Methionine - CH3S (CH2)2 CH (NH2) COOH	0.20 g	0.34 g
Tyrosine* (added as Tyrosine and N-Acetyl-L-Tyrosine) - [C6H4 (OH)] CH2CH (NH2) COOH	0.14 g	0.24 g
Tryptophan - (C8H6N) CH2CH (NH2) COOH	0.12 g	0.20 g
Cysteine (added as Cysteine HCl·H2O) - SHCH2 CHNH2 COOH	<0.014 g	<0.016 g
Nonessential Amino Acids
Arginine - H2NC (NH) NH (CH2)3 CH (NH2) COOH	0.73 g	1.2 g
Proline – [(CH2)3NHCH] COOH	0.41 g	0.68 g
Alanine – CH3CH (NH2) COOH	0.32 g	0.54 g
Glutamic Acid – HOOC (CH2)2 CH (NH2) COOH	0.30 g	0.50 g
Serine - HOCH2 CH (NH2) COOH	0.23 g	0.38 g
Glycine - H2NCH2COOH	0.22 g	0.36 g
Aspartic Acid – HOOC CH2 CH (NH2) COOH	0.19 g	0.32 g
Taurine†‡- H2NCH2CH2SO3H	0.015 g	0.025 g
pH adjusted with glacial acetic acid
pH: 5.5 (5.0-6.0)
Osmolarity (mOsmol/L) (Calc.)	520	865
Total Amino Acids (grams/100 mL) (Calc.)	6	10
Total Nitrogen (grams/100 mL) (Calc.)	0.93	1.55
Acetate* - (CH3COO-)	57 mEq/L	94 mEq/L
Chloride (Calc.)	<3 mEq/L	<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.

CLINICAL PHARMACOLOGY

6% and 10% PREMASOL - sulfite-free (Amino Acid) Injections provide a mixture of essential and nonessential amino acids as well as taurine and a soluble form of tyrosine, N-Acetyl-L-Tyrosine (NAT). This amino acid composition has been specifically formulated to provide a well tolerated nitrogen source for nutritional support and therapy for infants and young children. When administered in conjunction with cysteine hydrochloride, 6% and 10% Amino Acid Injections result in the normalization of the plasma amino acid concentrations to a profile consistent with that of a breast-fed infant.

The rationale for 6% and 10% Amino Acid Injections is based on the observation of inadequate levels of essential amino acids in the plasma of infants receiving total parenteral nutrition (TPN) using conventional amino acid solutions. These formulas were developed through the application of specific pharmacokinetic multiple regression analysis relating amino acid intake to the resulting plasma amino acid concentrations.

Clinical studies in infants and young children who required TPN therapy showed that infusion of 6% and 10% Amino Acid Injections with a cysteine hydrochloride admixture resulted in a normalization of the plasma amino acid concentrations. In addition, weight gains, nitrogen balance, and serum protein concentrations were consistent with an improving nutritional status.

When infused with hypertonic dextrose as a calorie source, supplemented with cysteine hydrochloride, electrolytes, vitamins, and minerals, PREMASOL - sulfite-free (Amino Acid) Injections provide total parenteral nutrition in infants and young children, with the exception of essential fatty acids.

It is thought that the acetate from lysine acetate and acetic acid, under the conditions of parenteral nutrition, does not impact net acid-base balance when renal and respiratory functions are normal. Clinical evidence seems to support this thinking; however, confirmatory experimental evidence is not available.