Nutropin HGH Injections for Bio-Identical Growth Hormone Treatment
GENENTECH’s Nutropin [somatropin rDNA Human Growth Hormone] and Growth Hormone Injection Delivery Devices for the treatment of growth hormone deficiencies.
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NUTROPIN Somatropin HGH DESCRIPTION:
Nutropin is human growth hormone (HGH) produced by rDNA technology. Nutropin has 191 amino acid residues with a sequence identical to that of human growth hormone derived from the pituitary gland. Nutropin is synthesized using a strain of E. coli as a precusor which consists of the rhGH molecule preceded by the secretion signal from an E. coli protein.
Nutropin is a highly purified preparation. Biological potency is determined using a cell proliferation bioassay.
Nutropin is a sterile, white, lyophilized powder intended for subcutaneous administration after reconstitution with Bacteriostatic Water for Injection, USP (benzyl alcohol preserved). The reconstituted product is nearly isotonic at a concentration of 5 mg/mL growth hormone (GH) and has a pH of approximately 7.4.
Each 5 mg Nutropin vial contains 5 mg (approximately 15 IU) somatropin, lyophilized with 45 mg mannitol, 1.7 mg sodium phosphates (0.4 mg sodium phosphate monobasic and 1.3 mg sodium phosphate dibasic), and 1.7 mg glycine.
Each 10 mg Nutropin vial contains 10 mg (approximately 30 IU) somatropin, lyophilized with 90 mg mannitol, 3.4 mg sodium phosphates (0.8 mg sodium phosphate monobasic and 2.6 mg sodium phosphate dibasic), and 3.4 mg glycine.
Bacteriostatic Water for Injection, USP, is sterile water containing 0.9 percent benzyl alcohol per mL as an antimicrobial preservative packaged in a multidose vial. The diluent pH is 4.5-7.0.
In vivo and in vitro clinical and preclinical tests have shown Nutropin is equivalent to HGH derived from the pituitary gland. Children who lack sufficient endogenous growth hormone secretion, patients with chronic renal insufficiency, and Turner syndrome patients treated with Nutropin experienced an improved growth rate and an increase in insulin-like growth factor-I (IGF-I) levels similar to those seen with HGH derived from the pituitary gland.
The following actions have been shown for Nutropin, somatrem and/or HGH:
Growth hormone stimulates pediatric skeletal growth in patients with growth failure caused by insufficient endogenous GH secretion, Turner syndrome or chronic renal insufficiency. Growth hormone affects the epiphyseal plates at the end of long bones, with growth and metabolism affected by GH and IGF-I, resulting in linear growth. In GHD pediatric patients IGF-I serum levels are low, but increase with growth hormone treatment.
Human growth hormone treatment increases the size and number of skeletal muscle cells.
Growth hormone affects the size of organs. Rats with pituitary glands removed and genetic dwarf rats treated with growth hormone experienced organ growth proportional to body growth.
Growth hormone modulates the metabolism of carbohydrates. Some patients with GHD experience fasting low blood sugar, which is improved with GH treatment. Growth hormone therapy may result in decreased insulin sensitivity, with Turner syndrome patients and patients with untreated chronic renal insufficiency experiencing a higher rate of glucose intolerance. Growth hormone treatment resulted in raised serum fasting and postprandial insulin levels, especially in patients who were overweight or obese.
In GHD patients, growth hormone treatment resulted in reduced body fat stores, improved lipid mobilization, reduced plasma cholesterol levels and increased plasma fatty acids.
Body potassium retention is increased during growth hormone therapy due to cellular growth. Inorganic phosphorus serum levels can increase somewhat in patients with insufficient endogenous growth hormone secretion, Turner syndrome or chronic renal insufficiency. Sodium retention occurs, but serum calcium is not significantly changed.
Subcutaneous: The bioavailability of rhGH after subcutaneous administration in healthy adult patients was found to be 81±20%. The mean terminal t 1/2 after administration is significantly longer than that following intravenous administration, which indicates the subcutaneous absorption is slow and rate-limiting.
Distribution: Animal rhGH studies found that growth hormone localizes in the kidneys and liver in particular. The distribution volume at steady state in healthy adult males is approximately 50 mL/kg body weight.
Metabolism: The kidney and liver are found to be vital in metabolizing growth hormone. Animal studies have suggested the kidney is the dominant organ for clearance.
Elimination: The mean terminal t 1/2 after intravenous injection of recombinant human growth hormone in a healthy adult male is estimated at 19.5±3.1 minutes. Clearance of growth hormone after IV administration in healthy children and adults is estimated at 116-174 mL/hr/kg.
Pediatric: Available data suggests recombinant human growth hormone clearance is similar in children and adults.
Gender: There is no data for administered recombinant human growth hormone. Available data for pituitary-derived growth hormone, methionyl recombinant growth hormone and endogenous growth hormone does not suggest gender differences in growth hormone clearance.
Geriatrics: There is limited data that suggests plasma clearance and average steady-state plasma concentration of rhGH is no different between young and geriatric patients.
Race: Thre is no reported difference in values for half-lifes of endogenous growth hormone in healthy black males compared to healthy white males. There is no data for other races at this time.
Renal Insufficiency: Adults and children with chronic renal failure and end-stage renal disease often have lowered clearance. Endogenous growth hormone production can increase in some people with end-stage renal disease. No rhGH accumulation is reported in children with ESRD or CRF.
Growth Hormone Deficiency: Reported clearance values of rhGH in adults and children with GHD are similar to those in healthy children and adults.
Hepatic Insufficiency: Patients with severe liver dysfunction may have a reduction in growth hormone clearance, although the clinical significance of the decrease is not known.
Turner Syndrome: No data is available for administered recombinant human growth hormone in Turner Syndrome patients. Reported half-lives, elimination rates and absorption rates for these patients are similar to ranges in normal children and adults as well as GHD patients.
Summary of Nutropin Pharmacokinetic Parameters in Healthy Adult Males
0.1 mg (approximately 0.3 IU a )/kg SC C max
(µg/L) T max
(hr) t 1/2
(hr) (AUC 0-(infinity)
µg·hr/L) CL/F SC
67.2 6.2 2.1 643 158
29 37 20 12 12
Abbreviations: C max =maximum concentration; t 1/2 =half life; AUC 0-(infinity) =area under the curve; CL/F SC =systemic clearance; F SC =subcutaneous bioavailability (not determined); CV%=coefficient of variation in %; SC=subcutaneous
a Based on current International Standard of 3 IU=1 mg
Two randomized, controlled clinical studies were performed to determine whether Nutropin treatment before renal transplantation in chronic renal insufficiency patients could improve height and growth rates.
In both studies, the dose of Nutropin was 0.05 mg/kg/day administered through subcutaneous injection. After two years in the two studies, 62 patients were treated with Nutropin and 28 were in the control group receiving a placebo or no treatment. The first year mean growth rate was 10.8 cm/year for patients treated with Nutropin, compared with a mean growth rate of 6.5 cm/year for the control patients. The median second year growth rate was 7.8 cm/year for patients in the Nutropin group versus 5.5 cm/year for those in the control group.
There was a significant increase in the mean height standard deviation score in the Nutropin group but no significant change in the control group. The mean third year growth rate for Nutropin patients was 7.6 centimeters per year, suggesting that Nutropin stimulates growth after two years. There is no control data for the third year as control patients began Nutropin treatment after participation.
Gains in height were found in conjunction with appropriate advancement of skeletal age, suggesting that Nutropin both corrects acquired height deficit associated with chronic renal insufficiency as well as improves growth rate in patients.
There is insufficient data in terms of the benefit of continuing treatment beyond three years.
The North American Pediatric Renal Transplant Cooperative Study reported data for growth after transplant in children who did not receive growth hormone. The average change in height standard deviation score during the first two years following transplant was 0.18.
Controlled studies of growth hormone therapy for short stature associated with CRI were not meant to compare the growth of treated or untreated patients after a renal transplant, although data was available from some patients who were followed for a minimum of 11 months. Of 7 control patients, four increased their hieght SD score while 3 had no significant change or a decrease in height SD score. 13 patients treated with Nutropin before transplant had no significant change or an increase in height SD score following transplant, which indicates growth hormone therapy prior to transplant surgery were maintained.
A long, multicenter, randomized, concurrently controlled study, two long-term, historically controlled studies and one long-term, randomized dose-response study were done to evaluate the efficacy of growth hormone to treat girls with short stature caused by Turner syndrome.
The randomized study GDCT compared growth hormone treated patients to a concurrent control group who did not receive GH. The treated patients received a dose of 0.3mg/kg/week six times per week starting at a mean age of 11.7 years for a mean duration of 4.7 years. These patients achieved a mean near final height of 146 centimeters (n=27), compared to the near final height of 142.1 centimeters (n=19) with the control group. Growth hormone therapy produced a mean height increase of 5.4 centimeters.
In two studies, the effect of long-term growth hormone treatment given three times per week or daily on adult height was found by comparing adult heights in treated patients with those of historical controls with Turner syndrome who did not receive therapy. Study 85-023 delayed estrogen therapy until an age of at least 14. Growth hormone therapy achieved a mean adult height gain of 7.4 centimeters with a mean duration of growth hormone therapy of 7.6 years compared to mathed historical controls.
Study 85-044 gave patients early growth hormone therapy and randomized patients to receive estrogen replacement hterapy at the age of 12 or 15. Early GH therapy with a mean duration of 5.6 years with estrogen replacement at 12 years resulted in an adult height gain of 5.9 centimeters compared to matched historical controls. Patients who started estrogen at 15 years with a mean duration of 6.1 years had a mean adult height gain of 8.3 centimeters. Patients who began growth hormone therapy after age 11 with a mean duration of 3.8 years had a mean adult height gain of 5.0 centimeters.
In both studies, the greatest adult height improvement was achieved in patients who received early growth hormone therapy as well as estrogen after age 14.
A randomized, dose-response study (GDCI) had patients treated from a mean age of 11.1 years for a mean duration of 5.3 years with a weekly dose of 0.36 mg/kg or 0.27 mg/kg administered three or six times per week. The mean near final adult height of patients receiving growth hormone was 148.7 centimeters, representing a mean gain of about 5 centimeters compared with observations of untreated Turner syndrome girls.
Design a N at Adult
Height GH Age
(yr) Estrogen Age
(yr) GH Duration
(yr) Adult Height
Gain (cm) b
GDCT RCT 27 11.7 13 4.7 5.4
85-023 MHT 17 9.1 15.2 7.6 7.4
85-044: A * MHT 29 9.4 15.0 6.1 8.3
B * 26 9.6 12.3 5.6 5.9
C * 51 12.7 13.7 3.8 5.0
GDCI RDT 31 11.1 8-13.5 5.3 ~5 c
a RCT: randomized controlled trial; MHT: matched historical controlled trial; RDT: randomized dose-response trial.
b Analysis of covariance vs. controls
c Compared with historical data
*A: GH age <11 yr, estrogen age 15 yr
B: GH age <11 yr, estrogen age 12 yr
C: GH age >11 yr, estrogen at Month 12
Adult Growth Hormone Deficiency (GHD)
Two double-blind, placebo-controlled clinical trials have been conducted treating growth hormone deficient adults with Nutropin. One study was conducted on patients with adult onset GHD with a mean age of 48.3 years. A second study was conducted in previously treated patients with childhood onset GHD with a mean age of 23.8 years. These studies were meant to assess the effects of growth hormone therapy on body composition.
All Nutropin groups in both studies experienced significant body composition changes from baseline to Month 12 of treatment, while no statistically significant changes were seen in either control group. The adult onset study found that the Nutropin treated patients improved mean total body fat from 35% to 31.5%. Mean trunk fat was reduced from 33.9% to 29.5% and mean lean body mass was increased from 62.2% to 65.7%. The placebo group had mean changes of 0.2% or less. DEXA scans were repeated every three weeks after completion due to the possibility of GH-induced fluid retention.
The childhood onset study found that the high-dose Nutropin group improved mean total body fat to 32.1% from 38.4%. Mean trunk fat was lowered from 36.7% to 29.0%, and mean lean body mass was increased to 65.5% from 59.1%. The low dose Nutropin group improved total body fat from 37.1% to 31.3%; mean trunk fat to 30.6% from 37.9% and mean lean body mass from 60.0% to 66.0%. The placebo group had mean changes of 0.6% or less.
Mean Changes from Baseline to Month 12 in Proportion of Fat and Lean by DEXA for Studies M0431g and M0381g
(Adult-onset and Childhood-onset GHD, respectively) M0431g
vs. pooled Nutropin
Total body percent fat
Baseline 36.8 35.0 0.38 35.0 37.1 38.4 0.45
Month 12 36.8 31.5 35.2 31.3 32.1
Baseline to Month 12 change -0.1 -3.6 <0.0001 +0.2 -5.8 -6.3 <0.0001
Post-washout 36.4 32.2 N/A N/A N/A
Baseline to post-washout change -0.4 -2.8 <0.0001 N/A N/A N/A
Trunk percent fat
Baseline 35.3 33.9 0.50 32.5 37.9 36.7 0.23
Month 12 35.4 29.5 33.1 30.6 29.0
Baseline to Month 12 change 0.0 -4.3 <0.0001 +0.6 -7.3 -7.6 <0.0001
Post-washout 34.9 30.5 N/A N/A N/A
Baseline to post-washout change -0.3 -3.4 N/A N/A N/A
Total body percent lean
Baseline 60.4 62.2 0.37 62.0 60.0 59.1 0.48
Month 12 60.5 65.7 61.8 66.0 65.5
Baseline to Month 12 change +0.2 +3.6 <0.0001 -0.2 +6.0 +6.4 <0.0001
Post-washout 60.9 65.0 N/A N/A N/A
Baseline to post-washout change +0.4 +2.8 <0.0001 N/A N/A N/A
In the adult-onset study, significant decreases from baseline to Month 12 in LDL cholesterol and LDL:HDL ratio were seen in the Nutropin group compared to the placebo group, p<0.02; there were no statistically significant between-group differences in change from baseline to Month 12 in total cholesterol, HDL cholesterol, or triglycerides. In the childhood-onset study, significant decreases from baseline to Month 12 in total cholesterol, LDL cholesterol, and LDL:HDL ratio were seen in the high-dose Nutropin group only, compared to the placebo group, p<0.05. There were no statistically significant between-group differences in HDL cholesterol or triglycerides from baseline to Month 12.
Muscle strength, physical endurance, and quality of life measurements were not markedly abnormal at baseline, and no statistically significant effects of Nutropin therapy were observed in the two studies.
INDICATIONS AND USAGE
Nutropin is indicated for the long-term treatment of growth failure caused by insufficient endogenous growth hormone secretion. Nutropin is also indicated for the treatment of growth failure caused by chronic renal insufficiency up until transplantation. Nutropin treatment should be used along with management of chronic renal insufficiency. Nutropin is also indicated for the long-term treatment of short stature in Turner syndrome patients.
Nutropin is indicated to replace endogenous growth hormone in patients with adult growth hormone deficiency who meet both criteria:
Biochemical diagnosis of adult GHD through a subnormal response to a standard GH stimulation test.
Adult onset: Patients with adult-onset GHD alone or with hypopituitarism due to pituitary disease, surgery, radiation therapy, trauma or hypothalamic disease, OR
Childhood onset: Patients who had GHD in childhood confirmed as an adult before Nutropin is started.
Growth hormone should not be initiated to treat patients with acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma or to patients having acute respiratory failure. Two placebo-controlled clinical trials in non-growth hormone-deficient adult patients (n=522) with these conditions revealed a significant increase in mortality (41.9% vs. 19.3%) among somatropin-treated patients (doses 5.3-8 mg/day) compared to those receiving placebo (see WARNINGS ).
Nutropin should not be used for growth promotion in pediatric patients with closed epiphyses.
Nutropin should not be used in patients with active neoplasia. GH therapy should be discontinued if evidence of neoplasia develops.
Nutropin, when reconstituted with Bacteriostatic Water for Injection, USP (benzyl alcohol preserved), should not be used in patients with a known sensitivity to benzyl alcohol.
See CONTRAINDICATIONS for information on increased mortality in patients with acute critical illnesses in intensive care units due to complications following open heart or abdominal surgery, multiple accidental trauma or with acute respiratory failure. The safety of continuing growth hormone treatment in patients receiving replacement doses for approved indications who concurrently develop these illnesses has not been established. Therefore, the potential benefit of treatment continuation with growth hormone in patients having acute critical illnesses should be weighed against the potential risk.
Benzyl alcohol as a preservative in Bacteriostatic Water for Injection, USP, has been associated with toxicity in newborns. When administering Nutropin to newborns, reconstitute with Sterile Water for Injection, USP. USE ONLY ONE DOSE PER NUTROPIN VIAL AND DISCARD THE UNUSED PORTION.
General: Nutropin should be prescribed by physicians experienced in the diagnosis and management of patients with GH deficiency, Turner syndrome, or chronic renal insufficiency. No studies have been completed of Nutropin therapy in patients who have received renal transplants. Currently, treatment of patients with functioning renal allografts is not indicated.
Experience with prolonged rhGH treatment in adults is limited.
Geriatric: Clinical studies of Nutropin have not included significant numbers of patients over the age of 65 to determine if they respond differently. Reported clinical experience has not identified any differences in responses between geriatric and younger patients, although dosing for elderly patients should be cautious and begin at the low end of the range due to decreased renal, cardiac or hepatic function.
Patients with closed epiphyses who were treated with growth hormone therapy in childhood should be re-evaluated according to criteria in the INDICATIONS and USAGE sections before continuing growth hormone therapy.
Nutropin may reduce insulin sensitivity. Patients should be monitored for glucose intolerance.
Patients with diabetes mellitus may require an adjusted insulin dosage after beginning growth hormone therapy. GH may reduce insulin sensitivity, especially in patients who are obese. Patients with glucose intolerance or diabetes should be closely monitored.
Nutropin use in GHD patients with adult-onset deficiency is associated with a higher median fasting insulin.
Patients with a history of intracranial lesion should be examined for progression or recurrence of the lesion. Clinical literature in pediatric patients has found no relationship between growth hormone replacement and CNS tumor reccurence or new extracranial tumors. It is not known if there is a relationship in adult patients.
Patients who have growth failure that is secondary to chronic renal insufficiency should be examined regularly for evidence of progression of renal osteodystrophy. Physicians and parents should watch for the development or complaint of knee or hip pain in patients treated with Nutropin.
Scoliosis progression may occur in patients with rapid growth. As growth hormone accelerates growth rate, patients with a history of scoliosis should be monitored. Growth hormone has not been found to raise the incidence of scoliosis. Skeletal abnormalities are often found in untreated Turner syndrome patients, which may manifest during GH treatment.
Turner syndrome patients should be evaluated for otitis meia and ear disorders. A randomized, controlled trial found there was a significant increase, compared to control groups, in otitis media and ear disorders in patients who receive growth hormone. Turner syndrome patients should also be monitored for cardiovascular disorders.
Intracranial hypertension (IH) with visual changes, headache, nausea, or vomiting have been reported in some patients treated with growth hormone. Symptoms typically occur within eight weeks of treatment and resolve with termination or reduction in growth hormone in all reported cases.
See WARNINGS for use of Bacteriostatic Water for Injection, USP (benzyl alcohol preserved), in newborns.
Local or systemic allergic reactions are possible. Parents and patients should be informed that reactions are possible and prompt medical attention is necessary if a reaction occurs.
Laboratory Tests: Inorganic phosphorus, alkaline phosphatase and PTH serum levels may increase while taking Nutropin.
Untreated hypothyroidism will prevent optimal response to growth hormone. Changes in thyroid hormone lab measurements may develop during treatment. Patients should receive regular thyroid function tests.
Drug Interaction: Excessive glucocorticoid therapy will inhibit the growth-promoting effect of growth hormone.
Nutropin use in patients with chronic renal insufficiency who receive glucocorticoid treatment has not been evaluted.
Controlled Nutropin studies found no evidence that the growth hormone has an interaction with drugs typically used to treat CRI. Careful monitoring is recommended when growth hormone is administered with medication known to be metabolized by CP450 liver enyzmes.
Pregnancy: Category C. Animal reproduction studies have not been conducted with Nutropin, and it is not known if Nutropin can cause fetal harm or affect reproductive capacity.
Nursing Mothers: It is not known if Nutropin is excreted in breast milk, although caution should be used when administering Nutropin to a nursing woman.
Patient Information: Patients who are treated with growth hormone and/or their parents should be informed of the risks and benefits of treatment. If home use is recommended, instruction on proper use should be provided for safe, effective administration. A puncture-resistant container for the disposal of used needles and syringes is recommended.
A small number of patients may develop antibodies to the protein. Growth hormone antibody binding capacities lower than 2 mg/L are not associated with growth attenuation. In some cases in which binding capacity exceeds 2 mg/L, growth attenuation is observed.
Along with evaluating compliance with the prescribed treatment plan and thyroid status, testing for GH antibodies should be conducted on patients who do not respond to treatment.
Leukemia has been reported in a small number of growth hormone deficient patients treated with growth hormone. It is not known if this is due to a higher risk related to the pathology of GHD, growth hormone therapy or associated treatments like radiation therapy for intracranial tumors. It cannot be concluded that growth hormone treatment is responsible for these occurrences.
Other adverse reactions reported in patients treated with growth hormone include: mild, transient edema; carpal tunnel syndrome; arthralgias; rare increased growth of pre-existing nevi; gynecomastia; rare pancreatitis.
Acute overdose of growth hormone may cause hyperglycemia. Long-term overdosage can result in symptoms of gigantism and/or acromegaly consistent with the known effects of excessive growth hormone.
DOSAGE AND ADMINISTRATION
Nutropin dosage and administration should be customized to every patient. Response to GH therapy in pediatric patients typically decreases with time. Failure to increase growth rate, especially during the first year of treatment, suggests the need for an assessment of compliance and evaluation of other causes for growth failure.
Pediatric Growth Hormone Deficiency (GHD)
A weekly dosage of up to 0.30 mg/kg of body weight divided into subcutaneous injections daily is recommended.
Adult Growth Hormone Deficiency (GHD)
Recommended dosage at the beginning of treatment should not exceed 0.006 mg/kg as a daily subcutaneous injection. The dose can be increased to a maximum of 0.025 mg/kg in patients under 35 or to a maximum of 0.0125 g/kg per day in patients over 35.
Lower dosages may be required in geriatric or overweight patients to minimize adverse reactions.
Chronic Renal Insufficiency (CRI)
A weekly dosage of up to 0.35 mg/kg divided into daily injection is recommended. Nutropin may be continued up until renal transplantation.
CCPD patients should receive injections in the morning after dialysis. CAPD patients should receive injections in the evening at the time of overnight exchange.
A weekly dosage of up to 0.375 mg/kg of body weight divided into equal doses 3 to 7 times per week by subcutaneous injection is recommended.
Once a dose has been determined, reconstitute Nutropin as follows:
Each 5 mg vial should be reconstituted with 1-5mL of Bacteriostatic Water for Injection. Each 10 mg vial should be reconstituted with 1-10mL of Bacteriostatic Water for Injection.
To prepare the Nutropin solution, inject Bacteriostatic Water for Injection into the Nutropin vial, aiming the liquid stream against the glass. Swirl product gently until contents are dissolved, but do not shake, which can result in a cloudy solution. Nutropin should clear immediately upon reconstitution. If solution is cloudy upon reconstitution or refrigeration, do not inject.
STABILITY AND STORAGE
Before Reconstitution–Nutropin® [somatropin (rDNA origin) for injection] and Bacteriostatic Water for Injection, USP (benzyl alcohol preserved), must be stored at 2-8°C/36-46°F (under refrigeration). Avoid freezing the vials of Nutropin and Bacteriostatic Water for Injection, USP (benzyl alcohol preserved). Expiration dates are stated on the labels.
After Reconstitution–Vial contents are stable for 14 days when reconstituted with Bacteriostatic Water for Injection, USP (benzyl alcohol preserved), and stored at 2-8°C/36-46°F (under refrigeration). Store the unused portion of Bacteriostatic Water for Injection, USP (benzyl alcohol preserved), at 2-8°C/36-46°F (under refrigeration). Avoid freezing the reconstituted vial of Nutropin and the Bacteriostatic Water for Injection, USP (benzyl alcohol preserved).
HOW SUPPLIED Nutropin is supplied as 5 mg (approximately 15 IU) or 10 mg (approximately 30 IU) of lyophilized, sterile somatropin per vial.
Each 5 mg carton contains two vials of Nutropin® [somatropin (rDNA origin) for injection] (5 mg per vial) and one 10 mL multiple dose vial of Bacteriostatic Water for Injection, USP (benzyl alcohol preserved). NDC 50242-072-02
Each 10 mg carton contains two vials of Nutropin® [somatropin (rDNA origin) for injection] (10 mg per vial) and two 10 mL multiple dose vials of Bacteriostatic Water for Injection, USP (benzyl alcohol preserved). NDC 50242-018-20
(Above information has been provided by PDR.)
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