20 Jul 2015

Norditropin (Somatropin) - United Kingdom

ATC: H01AC
SYSTEMIC HORMONAL PREP EXCLUDING SEX HORMONES
PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES
ANTERIOR PITUITARY LOBE HORMONES AND ANALOGUES
SOMATROPIN AND SOMATROPIN AGONISTS
Norditropin

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Last Updated on 20 Jul 2015 by EPG Health Media Staff

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Norditropin Indication

Children:

Growth failure due to growth hormone deficiency (GHD)

Growth failure in girls due to gonadal dysgenesis (Turner syndrome)

Growth retardation in prepubertal children due to chronic renal disease

Growth disturbance (current height SDS < -2.5 and parental adjusted height SDS < -1) in short children born small for gestational age (SGA), with a birth weight and/or length below -2 SD, who failed to show catch-up growth (HV SDS < 0 during the last year) by 4 years of age or later.

 

Adults:

Childhood onset growth hormone deficiency:

Patients with childhood onset GHD should be re-evaluated for growth hormone secretory capacity after growth completion. Testing is not required for those with more than three pituitary hormone deficits, with severe GHD due to a defined genetic cause, due to structural hypothalamic pituitary abnormalities, due to central nervous system tumours or due to high-dose cranial irradiation, or with GHD secondary to a pituitary/hypothalamic disease or insult, if measurements of serum insulin-like growth factor-I (IGF-I) is < -2 SDS after at least four weeks off growth hormone treatment.

In all other patients an IGF-I measurement and one growth hormone stimulation test is required.

 

Adult onset growth hormone deficiency:

Pronounced GHD in known hypothalamic-pituitary disease, cranial irradiation, and traumatic brain injury. GHD should be associated with one other deficient axis, other than prolactin. GHD should be demonstrated by one provocative test after institution of adequate replacement therapy for any other deficient axis.

In adults, the insulin tolerance test is the provocative test of choice. When the insulin tolerance test is contraindicated, alternative provocative tests must be used. The combined arginine-growth hormone releasing hormone is recommended. An arginine or glucagon test may also be considered; however these tests have less established diagnostic value than the insulin tolerance test.

 

Norditropin Generic Name

Somatropin

Type

POM

Summary Product Characteristics (SPCs) Links
SPC - Norditropin (external site)

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Norditropin Marketing Information

Norditropin Generic Name
Somatropin
Marketing Company
Novo Nordisk Limited
Drug Type
POM
Date of Issue, Marketing Authority - Norditropin SimpleXx: 25/10/1999

- Norditropin NordiFlex: 08/12/2003

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