Somatropin (rDNA origin)Somatropin vial has an amino acid sequence identical to that of human growth hormone of pituitary origin. The quantitative composition of the lyophilized drug per vial is:. The diluent somatropin vial bacteriostatic 0. Reconstituted solutions have a pH in the range of 7. Following intravenous administration of 0.
SEDICO Pharmaceutical Co.,Somatropin Vials
It has an amino acid sequence identical to that of human growth hormone of pituitary origin. The quantitative composition of the lyophilized drug per vial is:.
The diluent contains bacteriostatic 0. Reconstituted solutions have a pH in the range of 7. Following intravenous administration of 0. In the same volunteers, after a subcutaneous injection of 0. 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.
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.
There have been reports of fatalities after initiating therapy with growth hormone in pediatric patients with Prader-Willi syndrome who had one or more of the following risk factors: Male patients with one or more of these factors may be at greater risk than females. Patients with Prader-Willi syndrome should be evaluated for signs of upper airway obstruction and sleep apnea before initiation of treatment with growth hormone.
Benzyl alcohol as a preservative in bacteriostatic normal saline, USP, has been associated with toxicity in newborns. Patients with growth hormone deficiency secondary to intracranial lesion should be examined frequently for progression or recurrence of the underlying disease process.
Patients should be observed for evidence of glucose intolerance because human growth hormone may induce a state of insulin resistance. Glucocorticoid therapy may inhibit the growth-promoting effect of human growth hormone. Patients with coexisting ACTH deficiency should have their glucocorticoid replacement dose carefully adjusted to avoid an inhibitory effect on growth.
Hypothyroidism may become manifest during treatment with human growth hormone. Inadequate treatment of hypothyroidism may negate optimal response to human growth hormone. Therefore, patients should have periodic thyroid function tests and be treated with thyroid hormone when indicated.
Slipped capital femoral epiphysis may occur more frequently in patients with endocrine disorders. Symptoms usually occurred within the first eight 8 weeks of the initiation of growth hormone therapy.
In all reported cases, IH-associated signs and symptoms resolved after termination of therapy or a reduction of the growth hormone dose.
Funduscopic examination of patients is recommended at the initiation and periodically during the course of growth hormone therapy. It is not known whether this drug is excreted in human milk. The binding capacity of the antibodies from the two antibody positive patients was not determined.
In studies of growth hormone-deficient children, headaches occurred infrequently. Injection site reactions e. Leukemia has been reported in a small number of patients treated with other growth hormone products. It is uncertain whether this risk is related to the pathology of growth hormone deficiency itself, growth hormone therapy, or other associated treatments such as radiation therapy for intracranial tumors. The recommended dosage of up to 0. Acute overdose could cause initial hypoglycemia and subsequent hyperglycemia.
A dosage of up to 0. Subcutaneous injection of greater than 1 mL of reconstituted solution is not recommended. Occasionally, after refrigeration, some cloudiness may occur.
Allow the product to warm to room temperature. Before and after injection, the septum of the vial should be wiped with rubbing alcohol or an alcoholic antiseptic solution to prevent contamination of the contents by repeated needle insertions. The syringes should be of small enough volume that the prescribed dose can be drawn from the vial with reasonable accuracy. Expiration dates are stated on the labels. Do not freeze the reconstituted solution.
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