Hepatasol Injection

8% HEPATASOL - sulfite-free (Amino Acid) Injection is a sterile, nonpyrogenic, hypertonic solution containing crystalline amino acids.

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, 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.

Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.

Because of the potential for life-threatening events, caution should be taken to ensure that precipitates have not formed in any parenteral nutrient admixture.

Safe, effective use of parenteral nutrition requires a knowledge of nutrition as well as clinical expertise in recognition and treatment of the complications which can occur. Frequent evaluations and laboratory determinations are necessary for proper monitoring of parenteral nutrition. Studies should include blood sugar, serum proteins, kidney and liver function tests, electrolytes, hemogram, carbon dioxide content, serum osmolarities, blood cultures, and blood ammonia levels.

Administration of amino acids in the presence of impaired renal function or gastrointestinal bleeding may augment an already elevated blood urea nitrogen. Patients with azotemia from any cause should not be infused with amino acids without regard to total nitrogen intake.

Administration of intravenous solutions can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, over-hydration, congested states, or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations of the solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the solutions.

WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 μg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

See WARNINGS, and Special Precautions for Central Venous Nutrition.

Reactions reported in clinical studies as a result of infusion of the parenteral fluid were water weight gain, edema, increase in BUN, and dilutional hyponatremia. Asterixis was reported to have worsened in one patient during infusion of this amino acid formulation.

Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia.

Symptoms may result from an excess or deficit of one or more of the ions present in the solution; therefore, frequent monitoring of electrolyte levels is essential.

Phosphorus deficiency may lead to impaired tissue oxygenation and acute hemolytic anemia. Relative to calcium, excessive phosphorus intake can precipitate hypocalcemia with cramps, tetany and muscular hyperexcitability.

If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

In the event of a fluid or solute overload during parenteral therapy, re-evaluate the patient’s condition, and institute appropriate corrective treatment.

Container Label

LOT
EXP
2B6173
NDC 0338-0504-03
500 mL

8% HEPATASOL - sulfite-free
(Amino Acid) Injection

PROTECT FROM LIGHT UNTIL USE

Rx Only

EACH 100 mL CONTAINS ESSENTIAL AMINO ACIDS
LEUCINE 1.10 g ISOLEUCINE 0.90 g VALINE 0.84 g
LYSINE (ADDED AS LYSINE ACETATE) 0.61 g THREONINE 0.45 g
METHIONINE 0.10 g PHENYLALANINE 0.10 g
TRYPTOPHAN 0.066 g NONESSENTIAL AMINO ACIDS
GLYCINE 0.90 g PROLINE 0.80 g ALANINE 0.77 g
ARGININE 0.60 g SERINE 0.50 G HISTIDINE 0.24 g
CYSTEINE HYDROCHLORIDE MONOHYDRATE LESS THAN 0.020 g
PHOSPHORIC ACID NF 0.115 g pH ADJUSTED WITH GLACIAL
ACETIC ACID pH 6.5 (6.0 TO 6.8)

mEq/L* CHLORIDE LES THAN 3 PHOSPHATE (AS HPO4=) 20
(10 mmoles/L) ACETATE 68 *BALANCED BY IONS FROM AMINO
ACIDS HYPERTONIC OSMOLARITY 775 mOsmol/L (CALC)
STERILE NONPYROGENIC SINGLE DOSE CONTAINER
ADDITIVES MAY BE IMCOMPATIBLE CONSULT WITH
PHARMACIST IF AVAILABLE WHEN INTRODUCING ADDITIVES
USE ASEPTIC TECHNIQUE MIX THOROUGHLY DO NOT
STORE

DOSAGE AS DIRECTED BY A PHYSICIAN
ADMINISTER INTRAVENOUSLY USING STERILE EQUIPMENT
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 SEE ACCOMPANYING DIRECTIONS FOR USE
CHECK FOR MINUTE LEAKS BY SQUEEZING BAG FIRMLY IF LEAKS ARE FOUND
DISCARD SOLUTION AS STERILITY MAY BE IMPAIRED

STORE AT ROOM TEMPERATURE (25ºC/77ºF) SEE INSERT

CAUTION DO NOT USE UNLESS SOLUTION IS CLEAR AND SEAL IS INTACT

A SLIGHT YELLOW COLOR DOES NOT ALTER THE QUALITY AND EFFICACY OF THE PRODUCT

VIAFLEX CONTAINER
PL 146 PLASTIC

BAXTER HEPATASOL VIAFLEX
AND PL 146 ARE TRADEMARKS
OF BAXTER INTERNATIONAL INC

Baxter
BAXTER HEALTHCARE CORPORATION
CLINTEC NUTRITION DIVISION
DEERFIELD IL 60015 USA

MADE IN USA

Carton Label

Lot: x

QTY: 24-500 mL

Exp: x x

Code: 2B6173

NDC: 0338-0504-03

8% Hepatasol Sulfite-Free (Amino Acid) INJ

Viaflex Container

(17) XX00 (10) x

(01) 50303380504034