Rx Item-Humatrope 5Mg Vial 1 By Lilly Eli & Co

HUMATROPE- somatropin
Eli Lilly and Company
1 INDICATIONS AND USAGE
1.1 Pediatric Patients

Growth Hormone Deficiency - Humatrope is indicated for the treatment of pediatric patients who have growth failure due to inadequate secretion of endogenous growth hormone (GH).

Short Stature Associated with Turner Syndrome - Humatrope is indicated for the treatment of short stature associated with Turner syndrome [see Clinical Studies (14.2)].

Idiopathic Short Stature - Humatrope is indicated for the treatment of idiopathic short stature, also called non-GH-deficient short stature, defined by height SDS ?-2.25 and associated with growth rates unlikely to permit attainment of adult height in the normal range, in pediatric patients for whom diagnostic evaluation excludes other causes of short stature that should be observed or treated by other means [see Clinical Studies (14.3)] ; SDS = standard deviation scores.

SHOX Deficiency - Humatrope is indicated for the treatment of short stature or growth failure in children with short stature homeobox-containing gene (SHOX) deficiency [see Clinical Studies (14.4)].

Small for Gestational Age - Humatrope is indicated for the treatment of growth failure in children born small for gestational age (SGA) who fail to demonstrate catch-up growth by age two to four years [see Clinical Studies (14.5)].
1.2 Adult Patients

Humatrope is indicated for the replacement of endogenous GH in adults with GH deficiency who meet either of the following two criteria [see Clinical Studies (14.1)]:

Adult-Onset (AO): Patients who have GH deficiency, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; or

Childhood-Onset (CO): Patients who were GH deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes.

Patients who were treated with somatropin for GH deficiency in childhood and whose epiphyses are closed should be reevaluated before continuation of somatropin therapy at the reduced dose level recommended for GH deficient adults. According to current standards, confirmation of the diagnosis of adult GH deficiency in both groups involves an appropriate GH provocative test with two exceptions: (1) patients with multiple other pituitary hormone deficiencies due to organic disease; and (2) patients with congenital/genetic GH deficiency.
2 DOSAGE AND ADMINISTRATION

For subcutaneous injection.

Therapy with Humatrope should be supervised by a physician who is experienced in the diagnosis and management of pediatric patients with short stature associated with GH deficiency, Turner syndrome, idiopathic short stature, SHOX deficiency, small for gestational age birth, or adult patients with either childhood-onset or adult-onset GH deficiency.

RX ITEM-Humatrope 5Mg Vial 1 By Lilly El
NDC 00002-7335-11 UPC/GTIN No.3-00027-33511-7 Mfg.Part No.733511

Humatrope 5Mg Vial 1 By Lilly Eli & Co
BRAND: HUMATROPE NDC: 00002-7335-11,2733511 UPC: 3-00027-33511-7,300027335117 Lilly Eli & Co

SOMATROPIN INJECTION VIAL
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