Medically reviewed by Drugs.com. Last updated on Jan 20, 2023.
Important Administration Information
NOURESS is for intravenous infusion after dilution and admixing use only. Prior to administration, NOURESS must be diluted and used as an admixture in parenteral nutrition solutions.
The resulting solution is for intravenous infusion into a central or peripheral vein. The choice of a central or peripheral venous route should depend on the osmolarity of the final infusate. Solutions with osmolarity of 900 mOsm/L or greater must be infused through a central catheter [see Warnings and Precautions (5.2)].
Preparation and Administration Information
- Prior to administration, NOURESS must be diluted and used as an admixture in parenteral nutrition solutions.
- NOURESS is to be prepared only in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area). The key factor in the preparation is careful aseptic technique to avoid inadvertent touch contamination during mixing of solutions and addition of other nutrients.
- NOURESS is for addition to amino acid solutions prior to further admixing with dextrose injection using a parenteral nutrition container.
- Calcium and phosphate ratios must be considered. Excess addition of calcium and phosphate, especially in the form of mineral salts, may result in the formation of calcium phosphate precipitates [see Warnings and Precautions (5.1)].
- Use a dedicated line for parenteral nutrition solutions.
- Intravenous lipid emulsions can be infused concurrently into the same vein as NOURESS-containing amino acid and dextrose solutions by a Y-connector located near the infusion site; flow rates of each solution should be controlled separately by infusion pumps.
- For administration, use a 0.22 micron in-line filter.
- To prevent air embolism, use a non-vented infusion set or close the vent on a vented set, avoid multiple connections, do not connect flexible containers in series, fully evacuate residual gas in the container prior to administration, do not pressurize the flexible container to increase flow rates, and if administration is controlled by a pumping device, turn off pump before the container runs dry.
- Visually inspect the diluted parenteral nutrition solution containing NOURESS for particulate matter and discoloration before admixing, after admixing, after removal from refrigeration, and prior to administration. The solution should be clear and there should be no precipitates. A slight yellow color does not alter the quality and efficacy of this product.
Preparation Instructions for Admixing Using a Parenteral Nutrition Container
- Remove NOURESS vial from the carton and inspect for particulate matter.
- Transfer the required amount of NOURESS to an amino acid solution using strict aseptic techniques to avoid microbial contamination.
- The amino acid solution containing NOURESS can then be used to prepare admixtures in the parenteral nutrition container using strict aseptic techniques.
- Amino acids solution containing NOURESS may be mixed with dextrose injection. The following proper mixing sequence must be followed to minimize pH related problems:
- Transfer dextrose injection to the parental nutrition pooling container
- Transfer phosphate salt
- Transfer NOURESS-containing amino acid solution
- Transfer electrolytes
- Transfer trace elements
- Use gentle agitation during admixing to minimize localized concentration effects; shake containers gently after each addition.
- For automated compounding, refer to Instructions for Use of the applicable compounder.
- Because additives may be incompatible, evaluate all additions to the parenteral nutrition container for compatibility and stability of the resulting preparation. Consult with a pharmacist, if available. Questions about compatibility may be directed to Avadel. If it is deemed advisable to introduce additives to the parenteral nutrition container, use aseptic technique.
- Inspect the final parenteral nutrition solution containing NOURESS to ensure that precipitates have not formed during mixing or on addition of additives. Discard if any precipitates are observed.
Stability and Storage
- For single use only. Discard unused portion of the vial of NOURESS.
- Use parenteral nutrition solution containing NOURESS promptly after mixing. Any storage of the admixture should be under refrigeration at 2°C to 8°C (36°F to 46°F) and limited to a brief period of time, no longer than 24 hours. After removal from refrigeration, inspect for precipitates, use promptly, and complete the infusion within 24 hours. Discard if any precipitates are observed.
- Discard any remaining admixture.
- Protect parenteral nutrition solution from light.
The dosage of the final parenteral nutrition solution containing NOURESS must be based on the concentrations of all components in the solution and the recommended nutritional requirements [see Dosage and Administration (2.5)]. Consult the prescribing information of all added components to determine the recommended nutritional requirements.
The dosage of NOURESS should be individualized based on the patient’s clinical condition (ability to adequately metabolize amino acids), body weight and nutritional/fluid requirements, as well as additional energy given orally/enterally to the patient. Prior to initiating parenteral nutrition, the following patient information should be reviewed: review of all medications, gastrointestinal function and laboratory data (such as electrolytes (including magnesium, calcium, and phosphorus), glucose, urea/creatinine, liver panel, and complete blood count).
Prior to administration of parenteral nutrition solution containing NOURESS, correct severe fluid, electrolyte and acid-base disorders.
Recommended Dosage for Neonates
The recommended dosage and volume of NOURESS is based upon the recommended daily protein (amino acid) requirements.
a Protein is provided as amino acids.
(g Amino Acids/kg/day)1
(mg NOURESS/g Amino Acids)
(mL NOURESS/g Amino Acids)
|Neonates||3 to 4||22||0.44|
NOURESS contains 50 mg/mL of cysteine hydrochloride (equivalent to 34.5 mg/mL of cysteine). Therefore, the recommended dosage of NOURESS provides 15 mg cysteine/gram of amino acids for neonates.
Frequently asked questions
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