Rx Item-Norditropin 5Mg 1.5Ml By Novo Nordisk Pharm

NORDITROPIN- somatropin injection, solution
Novo Nordisk

1 INDICATIONS AND USAGE

1.1 Pediatric Patients
Norditropin [somatropin (rDNA origin) injection] is indicated for the treatment of pediatric patients with growth failure due to inadequate secretion of endogenous growth hormone (GH).

Norditropin [somatropin (rDNA origin) injection] is indicated for the treatment of pediatric patients with short stature associated with Noonan syndrome.

Norditropin [somatropin (rDNA origin) injection] is indicated for the treatment of pediatric patients with short stature associated with Turner syndrome.



Norditropin [somatropin (rDNA origin) injection] is indicated for the treatment of pediatric patients with short stature born small for gestational age (SGA) with no catch-up growth by age 2 to 4 years.

1.2 Adult Patients
Norditropin [somatropin (rDNA origin) injection] is indicated for the replacement of endogenous GH in adults with growth hormone deficiency (GHD) who meet either of the following two criteria:

�
Adult Onset (AO): Patients who have GHD, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; or
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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 GHD in childhood and whose epiphyses are closed should be reevaluated before continuation of somatropin therapy at the reduced dose level recommended for GHD adults. According to current standards, confirmation of the diagnosis of adult GHD in both groups involves an appropriate growth hormone provocative test with two exceptions: (1) patients with multiple other pituitary hormone deficiencies due to organic disease; and (2) patients with congenital/genetic growth hormone deficiency.

2 DOSAGE AND ADMINISTRATION

For subcutaneous injection.

Therapy with Norditropin should be supervised by a physician who is experienced in the diagnosis and management of pediatric patients with short stature associated with GHD, Noonan syndrome, Turner syndrome or SGA, and adult patients with either childhood onset or adult onset GHD.

RX ITEM-Norditropin 5Mg 1.5Ml By Novo No
Item No.:RX047233 NDC No.169770421 0169770421 0169-7704-21 00169770421 UPC No.:301697704211 NDC No. 00169-7704-21 UPC/GTIN No. 3-01697-70421-1 301697704211 301697704211 MPN 770421

Norditropin 5Mg 1.5Ml By Novo Nordisk Ph
Item No.:RX047233 NDC No.169770421 0169770421 0169-7704-21 00169770421 UPC No.:301697704211 NDC No. 00169-7704-21 UPC/GTIN No. 3-01697-70421-1 301697704211 301697704211 MPN 770421

SOMATROPIN SUB-Q PEN INJC
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