Norditropin NordiLet solution for s/c injection

国: アルメニア

言語: 英語

ソース: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

有効成分:

somatropin

から入手可能:

Novo Nordisk A/S

ATCコード:

H01AC01

INN（国際名）:

somatropin

投薬量:

6,7mg/ml

医薬品形態:

solution for s/c injection

パッケージ内のユニット:

pre-filled pen 1,5ml

処方タイプ:

Prescription

認証ステータス:

Registered

承認日:

2019-10-11

製品の特徴

2
SUMMARY OF PRODUCT CHARACTERISTICS
3
1.
NAME OF THE MEDICINAL PRODUCT
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Norditropin NordiLet 5 mg/1.5 ml
One ml of solution contains 3.3 mg somatropin
Norditropin NordiLet 10 mg/1.5 ml
One ml of solution contains 6.7 mg somatropin
Norditropin NordiLet 15 mg/1.5 ml
One ml of solution contains 10 mg somatropin
Somatropin (recombinant DNA origin produced in E-coli)
1 mg of somatropin corresponds to 3 IU (International Unit) of
somatropin
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection in pre-filled pen
Clear, colourless solution
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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 (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.
4
Adult onset growth hormone deficiency:
Pronounced GHD in known hypothalamic-pituitary disease, cranial
irradiation, and traumatic brain
injury. GHD sho