` CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`APPLICATION NUMBER:
`
`212535Orig1s000
`
`
`LABELING
`
`
`
`HIGHLIGHTS OF PRESCRIBING INFORMATION
`These highlights do not include all the information needed to use
`NOURESS ™ safely and effectively. See full prescribing information for
`NOURESS.
`
`NOURESS (cysteine hydrochloride injection), for intravenous use
`Initial U.S. Approval: 1971
` __________________ INDICATIONS AND USAGE _________________
`NOURESS is a sulfur-containing amino acid indicated for use as an additive
`to amino acids solutions to meet nutritional requirements of neonates (preterm
`and term infants less than one month of age) requiring total parenteral
`nutrition. (1)
` _______________ DOSAGE AND ADMINISTRATION ______________
`NOURESS is for intravenous infusion after dilution and admixing only.
`•
`(2.1)
`See full prescribing information for information on preparation,
`administration, and instructions for use. (2.1, 2.2, 2.3, 2.4)
`The recommended dosage in neonates is based upon the recommended
`daily protein (amino acid) requirements: 22 mg NOURESS/g amino
`acids. The corresponding volume is 0.44 mL NOURESS/g amino acids.
`(2.5)
` ______________ DOSAGE FORMS AND STRENGTHS _____________
`Injection: 500 mg/10 mL (50 mg/mL) cysteine hydrochloride, USP in a
`single-dose vial. (3)
` ___________________ CONTRAINDICATIONS ___________________
`Hypersensitivity to one or more amino acids (4)
`•
`Inborn errors of amino acid metabolism (4)
`•
`•
`Pulmonary edema or acidosis due to low cardiac output (4)
`
`
`•
`
`•
`
`
`
`•
`
`•
`
` _______________ WARNINGS AND PRECAUTIONS _______________
`Pulmonary Embolism due to Pulmonary Vascular Precipitates: If signs
`•
`of pulmonary distress occur, stop the infusion and initiate a medical
`evaluation. (5.1)
`Vein Damage and Thrombosis: Solutions with osmolarity of 900
`mOsm/L or more must be infused through a central catheter (2 1, 5.2)
`Increased Blood Urea Nitrogen (BUN): Monitor laboratory parameters
`and discontinue if BUN exceeds normal postprandial limits and
`continues to increase. (5.3)
`Acid-Base Imbalance: Monitor laboratory parameters and supplement
`with electrolytes as needed. (5.4)
`Hepatobiliary Disorders: Neurocognitive delay possible in infants;
`monitor liver function parameters and ammonia levels. (5.5, 8.4)
`Aluminum Toxicity: Increased risk in patients with renal impairment,
`including preterm infants. (5.6, 8.4)
`• Monitoring and Laboratory Tests: Monitor fluid and electrolytes, serum
`osmolarity, blood glucose, kidney and liver function, blood count, and
`coagulation parameters throughout treatment. (5.7)
` ___________________ ADVERSE REACTIONS ___________________
`Most common adverse reactions are local reactions (warm sensation,
`erythema, phlebitis, and thrombosis at the infusion site), generalized flushing,
`fever, nausea, and metabolic acidosis. (6)
`
`To report SUSPECTED ADVERSE REACTIONS, contact Avadel at 1-
`877-638-4579 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
`
`See 17 for PATIENT COUNSELING INFORMATION.
`
`•
`
`•
`
`•
`
`
`Revised: 12/2019
`
`6
`8
`
`5.7 Monitoring and Laboratory Tests
`ADVERSE REACTIONS
`USE IN SPECIFIC POPULATIONS
`8.1 Pregnancy
`8.2 Lactation
`8.4 Pediatric Use
`10 OVERDOSAGE
`11 DESCRIPTION
`12 CLINICAL PHARMACOLOGY
`12.1 Mechanism of Action
`15 REFERENCES
`16 HOW SUPPLIED/STORAGE AND HANDLING
`17
`PATIENT COUNSELING INFORMATION
`
`
`*Sections or subsections omitted from the full prescribing information
`are not listed.
`
`FULL PRESCRIBING INFORMATION: CONTENTS*
`
`INDICATIONS AND USAGE
`2
`DOSAGE AND ADMINISTRATION
`2.1
`Important Administration Information
`2.2 Preparation and Administration Information
`2.3 Preparation Instructions for Admixing Using a Parenteral
`Nutrition Container
`2.4 Dosing Considerations
`2.5 Recommended Dosage for Neonates
`DOSAGE FORMS AND STRENGTHS
`3
`CONTRAINDICATIONS
`4
`5 WARNINGS AND PRECAUTIONS
`5.1 Pulmonary Embolism due to Pulmonary Vascular Precipitates
`5.2 Vein Damage and Thrombosis
`5.3
`Increased Blood Urea Nitrogen (BUN)
`5.4 Acid-Base Imbalance
`5.5 Hepatobiliary Disorders
`5.6 Aluminum Toxicity
`
` 1
`
`
`
`Reference ID: 4533723
`
`1
`
`
`
`FULL PRESCRIBING INFORMATION
`
`INDICATIONS AND USAGE
`1
`NOURESS is indicated for use as an additive to amino acids solutions to meet nutritional
`requirements of neonates (preterm and term infants less than one month of age) requiring total
`parenteral nutrition.
`
`DOSAGE AND ADMINISTRATION
`2
`Important Administration Information
`2.1
`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)].
`2.2
`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
`
`Reference ID: 4533723
`
`2
`
`
`
`2.3
`
`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:
`1. Transfer dextrose injection to the parental nutrition pooling container
`2. Transfer phosphate salt
`3. Transfer NOURESS-containing amino acid solution
`4. Transfer electrolytes
`5. 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
`pharmacist, if available. Questions about compatibility may be directed to Avadel
`Pharmaceuticals. 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 2ºC to 8ºC (36ºF to 46ºF) and
`limited to a brief period of time, no longer than 24 hours. After removal from
`
`•
`
`Reference ID: 4533723
`
`3
`
`
`
`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.
`2.4
`Dosing Considerations
`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.
`2.5
`Recommended Dosage for Neonates
`The recommended dosage and volume of NOURESS is based upon the recommended daily
`protein (amino acid) requirements.
`Table 1. Recommended Daily Dosage of NOURESS in Neonates (Preterm and Term Infants Less
`Than One Month of Age)
`Proteina Requirement
`(g Amino Acids/kg/day)1
`3 to 4
`Neonates
`a Protein is provided as amino acids.
`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.
`
`Dosage
`
`Dosage
`(mg NOURESS/g Amino Acids)
`22
`
`Volume
`(mL NOURESS/g Amino Acids)
`0.44
`
`DOSAGE FORMS AND STRENGTHS
`3
`Injection: 500 mg/10 mL (50 mg/mL) cysteine hydrochloride, USP as a clear, colorless, sterile
`solution in a single-dose vial.
`
`CONTRAINDICATIONS
`4
`NOURESS is contraindicated in:
`
`Reference ID: 4533723
`
`4
`
`
`
`• Patients with known hypersensitivity to one or more amino acids.
`• Patients with inborn errors of amino acid metabolism due to risk of severe metabolic
`or neurologic complications.
`• Patients with pulmonary edema or acidosis due to low cardiac output.
`
`WARNINGS AND PRECAUTIONS
`5
`Pulmonary Embolism due to Pulmonary Vascular Precipitates
`5.1
`Pulmonary vascular precipitates causing pulmonary vascular emboli and pulmonary distress have
`been reported in patients receiving parenteral nutrition. In some fatal cases, pulmonary embolism
`occurred as a result of calcium phosphate precipitates. Precipitation following passage through
`an in-line filter and suspected in vivo precipitate formation has also been reported. If signs of
`pulmonary distress occur, stop the parenteral nutrition infusion and initiate a medical evaluation.
`In addition to inspection of the solution [see Dosage and Administration (2.1, 2.2)], the infusion
`set and catheter should also periodically be checked for precipitates.
`5.2
`Vein Damage and Thrombosis
`NOURESS must be diluted and used as an admixture in parenteral nutrition solutions. Solutions
`with an osmolarity of 900 mOsm/L or greater must be infused through a central catheter [see
`Dosage and Administration (2.1)]. The infusion of hypertonic nutrient injections into a
`peripheral vein may result in vein irritation, vein damage, and/or thrombosis. The primary
`complication of peripheral access is venous thrombophlebitis, which manifests as pain,
`erythema, tenderness or a palpable cord. Remove the catheter as soon as possible, if
`thrombophlebitis develops.
`5.3
`Increased Blood Urea Nitrogen (BUN)
`Intravenous infusion of amino acids may induce a rise in blood urea nitrogen (BUN), especially
`in patients with impaired hepatic or renal function. Appropriate laboratory tests should be
`performed periodically and infusion discontinued if BUN levels exceed normal postprandial
`limits and continue to rise. It should be noted that a modest rise in BUN normally occurs as a
`result of increased protein intake.
`Administration of amino acid solutions in the presence of impaired renal function may augment
`an increasing BUN, as does any protein dietary component.
`5.4
`Acid-Base Imbalance
`Administration of NOURESS may result in metabolic acidosis in neonates.
`Administration of amino acid solutions to a patient with hepatic impairment may result in serum
`amino acid imbalances, metabolic alkalosis, prerenal azotemia, hyperammonemia, stupor and
`coma.
`
`Reference ID: 4533723
`
`5
`
`
`
`Frequent clinical evaluation and laboratory determinations are necessary for proper monitoring
`of acid-base balance during parenteral nutrition therapy. Significant deviations from normal
`concentrations may require the use of additional electrolyte supplements.
`5.5
`Hepatobiliary Disorders
`Hepatobiliary disorders are known to develop in some patients, including neonates, without
`preexisting liver disease who receive parenteral nutrition, including cholecystitis, cholelithiasis,
`cholestasis, hepatic steatosis, fibrosis and cirrhosis, possibly leading to hepatic failure. The
`etiology of these disorders is thought to be multifactorial and may differ between patients.
`Instances of asymptomatic hyperammonemia have been reported in patients receiving parenteral
`nutrition without overt liver dysfunction. The mechanisms of this reaction are not clearly defined
`but may involve genetic defects and immature or subclinically impaired liver function [see
`Contraindications (4), Use in Specific Populations (8.4)]
`Hyperammonemia is of special significance in infants, as it can result in neurocognitive delays.
`Monitor liver function parameters and ammonia levels during treatment with NOURESS.
`Patients developing signs of hepatobiliary disorders should be assessed early by a clinician
`knowledgeable in liver diseases in order to identify possible causative and contributory factors,
`and possible therapeutic and prophylactic interventions.
`5.6
`Aluminum Toxicity
`NOURESS contains aluminum that may be toxic.
`Aluminum may reach toxic levels with prolonged parenteral administration in patients with renal
`impairment. Neonates and preterm infants are particularly at risk for aluminum toxicity because
`their kidneys are immature, and they require large amounts of calcium and phosphate solutions,
`which also contain aluminum.
`Patients with renal impairment including neonates and preterm infants, who receive greater than
`4 to 5 mcg/kg/day of parenteral aluminum can accumulate aluminum to levels associated with
`central nervous system and bone toxicity. Tissue loading may occur at even lower rates of
`administration.
`Exposure to aluminum from NOURESS is not more than 0.25 mcg/kg/day when preterm and
`term neonates are administered the recommended maximum dosage of NOURESS (22 mg
`cysteine hydrochloride/g of amino acids and 4 g of amino acids/kg/day) [see Dosage and
`Administration (2.5)]. When prescribing NOURESS for use in parenteral nutrition containing
`other small volume parenteral products, the total daily patient exposure to aluminum from the
`admixture should be considered and maintained at no more than 5 mcg/kg/day [see Use in
`Specific Populations (8.4)].
`5.7
`Monitoring and Laboratory Tests
`Monitor fluid and electrolyte status, serum osmolarity, blood glucose, liver and kidney function,
`ammonia levels, blood count and coagulation parameters throughout treatment [see Dosage and
`Administration (2.4)].
`
`Reference ID: 4533723
`
`6
`
`
`
`ADVERSE REACTIONS
`6
`The following serious adverse reactions are discussed in greater detail in other sections of the
`prescribing information:
`• Pulmonary embolism due to pulmonary vascular precipitates [see Warnings and
`Precautions (5.1)]
`• Vein damage and thrombosis [see Warnings and Precautions (5.2)]
`Increased BUN [see Warnings and Precautions (5.3)]
`•
`• Acid-base imbalance [see Warnings and Precautions (5.4)]
`• Hepatobiliary disorders [see Warning and Precautions (5.5)]
`• Aluminum toxicity [see Warnings and Precautions (5.6)]
`Adverse reactions with the use of cysteine hydrochloride injection were identified in clinical
`studies or postmarketing reports. Because these reactions are reported voluntarily from a
`population of uncertain size, it is not always possible to estimate their frequency reliably or to
`establish a causal relationship to drug exposure.
`• Metabolic acidosis
`• Local infusion site reactions, including a warm sensation, erythema, phlebitis, and
`thrombosis at the infusion site
`• Generalized flushing, fever, and nausea
`
`USE IN SPECIFIC POPULATIONS
`8
`Pregnancy
`8.1
`Risk Summary
`NOURESS for use as an additive to amino acid solutions to meet nutritional requirements is not
`indicated for use in adults. Appropriate administration of NOURESS is not expected to cause
`major birth defects, miscarriage or adverse maternal or fetal outcomes. Animal reproduction
`studies have not been conducted with cysteine hydrochloride.
`8.2
`Lactation
`Risk Summary
`NOURESS is used as an additive to amino acid solutions to meet nutritional requirements of
`neonates requiring total parenteral nutrition and is not indicated for use in adults. There are no
`data on the presence of cysteine hydrochloride in human or animal milk or the effects on milk
`production. Data available on the effects of cysteine hydrochloride on infants, either directly or
`through breastmilk, do not suggest a significant risk of adverse reactions from exposure.
`
`Reference ID: 4533723
`
`7
`
`
`
`Pediatric Use
`8.4
`NOURESS is indicated for use as an additive to amino acid solutions to meet the nutritional
`requirements of neonates, including preterm infants, requiring total parenteral nutrition. The
`safety profile for NOURESS use in neonates includes risks of acid-base imbalance and
`hepatobiliary dysfunction.
`Acid-base imbalance, including metabolic acidosis, and liver dysfunction may occur with
`NOURESS administration in preterm infants. Frequent clinical and laboratory assessments are
`necessary to monitor and manage fluid balance, electrolyte concentrations, liver tests, and acid-
`base balance during parenteral nutrition therapy [see Warnings and Precautions (5.4)].
`Hyperammonemia is of special significance in neonates. This reaction appears to be related to a
`deficiency of the urea cycle amino acids of genetic or product origin. It is essential that blood
`ammonia be measured during treatment [see Warnings and Precautions (5.5)].
`Because of immature renal function, neonates including preterm infants, receiving prolonged
`parenteral nutrition with NOURESS may be at higher risk of aluminum toxicity [see Warnings
`and Precautions (5.7)].
`
`OVERDOSAGE
`10
`In the event of over hydration or solute overload, re-evaluate the patient and institute appropriate
`corrective measures [see Warnings and Precautions (5.3, 5.4, 5.5, 5.8)].
`
`DESCRIPTION
`11
`NOURESS (cysteine hydrochloride injection) is a sterile, nonpyrogenic solution for intravenous
`use supplied as 500 mg/10 mL cysteine hydrochloride, USP in a single-dose vial.
`Each mL of NOURESS contains 50 mg of cysteine hydrochloride, (equivalent to 34.5 mg of
`cysteine), and 0.006 mL of hydrochloric acid (6M) in water for injection. Sodium hydroxide
`and/or hydrochloric acid are used as needed to adjust the pH. The pH range of NOURESS is 1.0
`to 1.5.
`The active ingredient is cysteine hydrochloride. The chemical name of cysteine hydrochloride is
`L-cysteine hydrochloride monohydrate. Its molecular formula is C3H7NO2S • HCI • H2O and
`molecular weight is 175.63. The chemical structure of L-cysteine hydrochloride monohydrate is
`depicted below:
`
`
`
`Reference ID: 4533723
`
`
`
`8
`
`
`
`Cysteine hydrochloride is a white crystalline powder soluble in water. Cysteine is a sulfur-
`containing amino acid and is prone to oxidation when exposed to air in aqueous solution, which
`may convert cysteine to insoluble cystine resulting in precipitation over time.
`NOURESS contains no more than 145 mcg/L of aluminum.
`
`CLINICAL PHARMACOLOGY
`12
`12.1 Mechanism of Action
`Endogenous cysteine is synthesized from methionine by the enzyme, cystathionase, via the trans-
`sulfuration pathway, and serves as a precursor substrate for both glutathione and taurine.
`NOURESS provides cysteine to the systemic circulation of neonates who require parenteral
`nutrition and cannot synthesize adequate quantities of cysteine due to deficient cystathionase
`activity.
`
`15 REFERENCES
`1. Ayers P. et al. A.S.P.E.N. Parenteral Nutrition Handbook, 2nd ed. 2014 pg. 123 and 124.
`
`HOW SUPPLIED/STORAGE AND HANDLING
`16
`NOURESS (cysteine hydrochloride injection) is a clear, colorless, sterile and nonpyrogenic
`solution supplied as follows:
`500 mg/10 mL (50 mg/mL) of cysteine hydrochloride, USP in single-dose vials (NDC 76014-
`006-05), packaged as 5 vials per carton (NDC 76014-006-05)
`Store NOURESS at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to
`86°F) [see USP Controlled Room Temperature].
`Protect from light. Avoid excessive heat. Protect from freezing. If accidentally frozen, discard
`the vial.
`Vial stoppers are not made with natural rubber latex.
`For storage of admixed solution see Dosage and Administration (2.3)
`
`PATIENT COUNSELING INFORMATION
`17
`Inform caregivers or home healthcare providers of the following risks of NOURESS:
`• Pulmonary embolism due to pulmonary vascular precipitates [see Warnings and
`Precautions (5.1)]
`• Vein damage and thrombosis [see Warnings and Precautions (5.2)]
`Increased BUN [see Warnings and Precautions (5.3)]
`•
`• Acid-base imbalance [see Warnings and Precautions (5.4)]
`
`Reference ID: 4533723
`
`9
`
`
`
`• Hepatobiliary disorders [see Warning and Precautions (5.5)]
`• Aluminum toxicity [see Warnings and Precautions (5.6)]
`• Monitoring and laboratory tests [see Warnings and Precautions (5.7)]
`
`
`Manufactured for:
`Avadel Legacy Pharmaceuticals, LLC
`Chesterfield, MO 63005
`
`Rev. 12/19
`
`Reference ID: 4533723
`
`10
`
`
`
`Each mL of Nouress contains: 50mg of cysteine
`hydrochloride (equivalent to 34.5 mg of cysteine),
`and 0.006 mL of hydrochloric acid (6M) in water
`for injection. Sodium hydroxide or hydrochloric
`acid are used as needed to adjust the pH. The pH
`range is 1.0 to 1.5.
`Storage: Store at 20°C to 25°C (68°F to 77°F),
`excursions permitted to 15°C to 30°C (59°F to 86°F)
`[see USP Controlled Room Temperature]. Protect
`from light. Avoid excessive heat. Protect from
`freezing. If accidently frozen, discard the vial.
`Directions for Use: For singe 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 2ºC to
`8ºC (36ºF to 46ºF) 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.
`Recommended Dosage:
`See prescribing information.
`
`GLUE AREA
`NO INK/COAT
`
`5 x 10 mL Single-Dose Vials - Discard Unused Portion
`Must be Diluted. For Intravenous Infusion Only
`500 mg/10 mL (50 mg/mL)
`(cysteine hydrochloride injection), USP
`NouressTM
`NDC 76014-006-05
`
`Rx Only
`
`Reserved for
`2D barcode
`
`EXP YYYY-MM-DD
`LOT XXXXXX
`SN XXXXXXXXXXXXXX
`GTIN XXXXXXXXXXXXXX
`
`Rx Only
`
`NDC 76014-006-05
`NouressTM
`(cysteine hydrochloride injection), USP
`500 mg/10 mL (50 mg/mL)
`Must be Diluted. For Intravenous Infusion Only
`Contains no more than 145 mcg/L of aluminum
`Sterile
`
`5 x 10 mL Single-Dose Vials - Discard Unused Portion
`
`51/2
`
`19/16
`1423/32
`
`51/2
`
`Rev 12/2019
`
`Chesterfield, MO 63005
`Pharmaceuticals, LLC
`Manufactured for Avadel Legacy
`
`NDC 76014-006-05
`NouressTM
`(cysteine hydrochloride injection), USP
`500 mg/10 mL (50 mg/mL)
`Must be Diluted. For Intravenous Infusion Only
`Contains no more than 145 mcg/L of aluminum
`
`Rx Only
`
`5 x 10 mL Single-Dose Vials - Discard Unused Portion
`
`GLUE AREA
`NO INK/COAT
`
`117/32
`
`GLUE AREA NO INK/COAT
`
`5/8
`
`5/8
`
`117/32
`
`59/16
`
`21/8
`
`19/32
`
`Reference ID: 4533723
`
`(b) (4)
`
`
`
`EXP: YYYY-MM-DD
`LOT: XXXXXX
`
`.5468”
`
`2.625”
`
`Each mL contains: 50 mg cysteine hydrochloride
`(equivalent to 34.5 mg of cysteine), and 0006 mL
`of hydrochloric acid (6M) in water for injection.
`Sodium hydroxide and/or hydrochloric acid are
`used as needed to adjust the pH to 1.0 to 1.5.
`Contains no more han 145 mcg/L of aluminum.
`Storage: Store at 20°C to 25°C (68°F to
`77°F), excursions perm tted to 15°C to 30°C
`(59°F to 86°F) [see USP Controlled Room
`Temperature]. Do not freeze.
`Recommended Dosage:
`See prescribing information.
`Mfd. for Avadel Lgcy Phrm, LLC
`
`Rev 12/2019
`
`Rx Only
`
`NDC 76014 006 33
`NouressTM
`(cysteine hydrochloride
`injection), USP
`500 mg/10 mL (50 mg/mL)
`Must be Diluted. For Intravenous
`Infusion Only
`
`Sterile
`
`10 mL Single-Dose Vial
`Discard Unused Portion
`
`.875”
`
`2.0782”
`
`Reference ID: 4533723
`
`(b) (4)
`
`
`
`Signature Page 1 of 1
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`electronic signatures for this electronic record.
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`LISA M SOULE
`12/13/2019 04:31:19 PM
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`Reference ID: 4533723
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`(
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