GENOTROPIN- somatropin kit

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Pfizer Laboratories Div Pfizer Inc

Designació comuna internacional (DCI):

SOMATROPIN

Composición:

SOMATROPIN 5 mg in 1 mL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

GENOTROPIN is indicated for the treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone. GENOTROPIN is indicated for the treatment of pediatric patients who have growth failure due to Prader-Willi syndrome (PWS). The diagnosis of PWS should be confirmed by appropriate genetic testing [see CONTRAINDICATIONS (4)] . GENOTROPIN is indicated for the treatment of growth failure in children born small for gestational age (SGA) who fail to manifest catch-up growth by age 2 years. GENOTROPIN is indicated for the treatment of growth failure associated with Turner syndrome. GENOTROPIN is indicated for the treatment of idiopathic short stature (ISS), also called non-growth hormone-deficient short stature, defined by height standard deviation score (SDS) ≤-2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range, in pediatric patients whose epiphyses are not closed and for whom diagnostic evaluation excludes other c

Resumen del producto:

GENOTROPIN lyophilized powder is available in the following packages: 5 mg two-chamber cartridge (with preservative) Concentration of 5 mg/mL For use with the GENOTROPIN PEN® 5 Growth Hormone Delivery Device. Package of 1 NDC 0013-2626-81 12 mg two-chamber cartridge (with preservative) Concentration of 12 mg/mL For use with the GENOTROPIN PEN 12 Growth Hormone Delivery Device. Package of 1 NDC 0013-2646-81 GENOTROPIN MINIQUICK Growth Hormone Delivery Device containing a two-chamber cartridge of GENOTROPIN (without preservative) After reconstitution, each GENOTROPIN MINIQUICK delivers 0.25 mL, regardless of strength. Available in the following strengths, each in a package of 7: 0.2 mg NDC 0013-2649-02 0.4 mg NDC 0013-2650-02 0.6 mg NDC 0013-2651-02 0.8 mg NDC 0013-2652-02 1.0 mg NDC 0013-2653-02 1.2 mg NDC 0013-2654-02 1.4 mg NDC 0013-2655-02 1.6 mg NDC 0013-2656-02 1.8 mg NDC 0013-2657-02 2.0 mg NDC 0013-2658-02 Storage and Handling Except as noted below, store GENOTROPIN lyophilized powder under refrigeration at 36°F to 46°F (2°C to 8°C).Do not freeze. Protect from light. The 5 mg and 12 mg cartridges of GENOTROPIN contain a diluent with a preservative. Thus, after reconstitution, they may be stored under refrigeration for up to 28 days. The GENOTROPIN MINIQUICK Growth Hormone Delivery Device should be refrigerated prior to dispensing, but may be stored at or below 77°F (25°C) for up to three months after dispensing. The diluent has no preservative. After reconstitution, the GENOTROPIN MINIQUICK may be stored under refrigeration for up to 24 hours before use. The GENOTROPIN MINIQUICK should be used only once and then discarded.

Estat d'Autorització:

Biologic Licensing Application

Fitxa tècnica

GENOTROPIN- SOMATROPIN
PFIZER LABORATORIES DIV PFIZER INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GENOTROPIN SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR GENOTROPIN
GENOTROPIN (SOMATROPIN) FOR INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 1987
INDICATIONS AND USAGE
GENOTROPIN is a recombinant human growth hormone indicated for:
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DOSAGE AND ADMINISTRATION
GENOTROPIN should be administered subcutaneously (2)
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DOSAGE FORMS AND STRENGTHS
GENOTROPIN lyophilized powder in a two-chamber color-coded cartridge
(3):
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GENOTROPIN MINIQUICK Growth Hormone Delivery Device containing a
two-chamber cartridge (without
preservative):
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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®
_PEDIATRIC: _Treatment of children with growth failure due to growth
hormone deficiency (GHD), Prader-
Willi syndrome, Small for Gestational Age, Turner syndrome, and
Idiopathic Short Stature (1.1)
_ADULT: _Treatment of adults with either adult onset or childhood
onset GHD (1.2)
_PEDIATRIC GHD:_ 0.16 to 0.24 mg/kg/week (2.1)
_PRADER-WILLI SYNDROME:_ 0.24 mg/kg/week (2.1)
_SMALL FOR GESTATIONAL AGE:_ Up to 0.48 mg/kg/week (2.1)
_TURNER SYNDROME:_ 0.33 mg/kg/week (2.1)
_IDIOPATHIC SHORT STATURE:_ up to 0.47 mg/kg/week (2.1)
_ADULT GHD:_ Either a non-weight based or a weight based dosing
regimen may be followed, with
doses adjusted based on treatment response and IGF-I concentrations
(2.2)
Non-weight based dosing: A starting dose of approximately 0.2mg/day
(range, 0.15–0.30 mg/day)
may be used without consideration of body weight, and increased
gradually every 1–2 months by
increments of approximately 0.1–0.2 mg/day. (2.2)
Weight based dosing: The recommended initial dose is not more than
0.04 mg/kg/week; the dose may
be increased as tolerated to not more than 0.08 mg/kg/week at 4–8
week intervals. (2.2)
GENOTROPIN cartridges are color-coded to correspond to a specific