NORDITROPIN- somatropin injection, solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

SOMATROPIN (UNII: NQX9KB6PCL) (SOMATROPIN - UNII:NQX9KB6PCL)

Tilgjengelig fra:

Physicians Total Care, Inc.

INN (International Name):

SOMATROPIN

Sammensetning:

SOMATROPIN 5 mg in 1.5 mL

Administreringsrute:

SUBCUTANEOUS

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Norditropin [somatropin (rDNA origin) injection] is indicated for the treatment of children with growth failure due to inadequate secretion of endogenous growth hormone (GH). Norditropin [somatropin (rDNA origin) injection] is indicated for the treatment of children with short stature associated with Noonan syndrome. Norditropin [somatropin (rDNA origin) injection] is indicated for the treatment of children with short stature associated with Turner syndrome. Norditropin [somatropin (rDNA origin) injection] is indicated for the treatment of children with short stature born small for gestational age (SGA) with no catch-up growth by age 2-4 years. 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

Produkt oppsummering:

  Norditropin NordiFlex prefilled pens [somatropin (rDNA origin) injection] 5 mg/1.5 mL: Norditropin NordiFlex is individually cartoned in 5 mg/1.5 mL prefilled pens . Unused Norditropin NordiFlex pens  must be stored at 2-8°C/36-46°F (refrigerator). Do not freeze. Avoid direct light. 5 mg/1.5 mL (orange) prefilled pens: After the initial injection, a Norditropin NordiFlex (5 mg/1.5 mL) prefilled pen may be EITHER stored in the refrigerator (2-8ºC/36-46ºF) and used within 4 weeks OR stored for up to 3 weeks at not more than 25ºC (77ºF). Discard unused portion. Storage Option 1 Storage Option 2 2-8 ºC/ 36-46 ºF 2-8 ºC/36-46 ºF Up to 25ºC/77ºF

Autorisasjon status:

New Drug Application

Preparatomtale

NORDITROPIN - SOMATROPIN INJECTION, SOLUTION
PHYSICIANS TOTAL CARE, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NORDITROPIN CARTRIDGES SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NORDITROPIN
CARTRIDGES.
NO RDITRO PIN CARTRIDGES [SOMATROPIN (RDNA ORIGIN) INJECTION], FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 1987
INDICATIONS AND USAGE
Norditropin is a recombinant human growth hormone indicated for:
_PEDIATRIC_: Treatment of children with growth failure due to growth
hormone deficiency (GHD), short stature associated
with Noonan syndrome, short stature associated with Turner syndrome
and short stature born SGA with no catch-up
growth by age 2-4 years (1.1)
_ADULT_: Treatment of adults with either adult onset or childhood
onset GHD (1.2)
DOSAGE AND ADMINISTRATION
Norditropin should be administered subcutaneously (2).
_PEDIATRIC GHD: _0.024-0.034 mg/kg/day, 6-7 times a week (2.1)
_NOONAN SYNDROME:_ Up to 0.066 mg/kg/day (2.1)
_TURNER SYNDROME_: Up to 0.067 mg/kg/day (2.1)
_SGA: _Up to 0.067 mg/kg/day (2.1)
_ADULT GHD: _0.004 mg/kg/day to be increased as tolerated to not more
than 0.016 mg/kg/day after approximately 6
weeks, or a starting dose of approximately 0.2 mg/day (range,
0.15-0.30 mg/day) increased gradually every 1-2 months
by increments of approximately 0.1-0.2 mg/day (2.2)
Norditropin cartridges must be used with their corresponding
color-coded NordiPen delivery systems (2.3)
Injection sites should always be rotated to avoid lipoatrophy (2.3)
DOSAGE FORMS AND STRENGTHS
Norditropin is preloaded in the Norditropin FlexPro or Norditropin
NordiFlex pens, or cartridges for use with the
corresponding NordiPens (3):
5 mg/1.5 mL (orange): FlexPro and NordiFlex pens, and cartridges
10 mg/1.5 mL (blue): FlexPro and NordiFlex pens
15 mg/1.5 mL (green): FlexPro and NordiFlex pens, and cartridges
30 mg/3 mL (purple): Norditropin NordiFlex pen only
CONTRAINDICATIONS
Acute Critical Illness (4.1, 5.1)
Children with Prader-Willi sy