OMNITROPE- somatropin injection, solution OMNITROPE- somatropin kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Sandoz Inc

INN (International Name):

SOMATROPIN

Composition:

SOMATROPIN 5 mg in 1.5 mL

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Omnitrope (somatropin) injection is indicated for the treatment of children with growth failure due to inadequate secretion of endogenous growth hormone (GH). Omnitrope (somatropin) injection 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) and Warnings and Precautions (5.2)] . Omnitrope (somatropin) injection 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. Omnitrope (somatropin) injection is indicated for the treatment of growth failure associated with Turner syndrome. Omnitrope (somatropin) injection 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 adul

Product summary:

Store Omnitrope refrigerated at 2° to 8°C (36° to 46°F). Do not freeze. Omnitrope is light sensitive and should be stored in the carton. Omnitrope Cartridge (somatropin) 5 mg/1.5 mL is supplied in the following package sizes: For use only with the Omnitrope Pen 5 delivery system, which is sold separately After the first use the cartridge should remain in the pen and has to be kept in a refrigerator at 2° to 8°C (36° to 46°F) for a maximum of 28 days (see Table 11 ). Omnitrope Cartridge (somatropin) injection 10 mg/1.5 mL is supplied in the following package sizes: For use only with the Omnitrope Pen 10 delivery system, which is sold separately. After the first use the cartridge should remain in the pen and has to be kept in a refrigerator at 2° to 8°C (36° to 46°F) for a maximum of 28 days (see Table 11 ). After reconstitution, the concentration is 5 mg/mL. NDC 0781-4004-36 Omnitrope 5.8 mg is supplied with a diluent containing benzyl alcohol as a preservative. After reconstitution, the contents of the vial must be used within 3 weeks. After the first injection, the vial should be stored in the carton in a refrigerator at 2° to 8°C (36° to 46°F) (see Table 11 ). Omnitrope Product Formulation Storage Requirement Before Use In-use (after 1st injection) 5 mg/1.5 mL Cartridge 2-8ºC/ 36-46ºF Until exp date 2-8 ºC/36-46 ºF 4 weeks 10 mg/1.5 mL Cartridge 2-8 ºC/36-46 ºF 4 weeks 5.8 mg/vial 2-8 ºC/36-46 ºF 3 weeks

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

OMNITROPE- SOMATROPIN INJECTION, SOLUTION
OMNITROPE- SOMATROPIN
SANDOZ INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OMNITROPE® SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR OMNITROPE®.
OMNITROPE® (SOMATROPIN) INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 1987
INDICATIONS AND USAGE
OMNITROPE is a recombinant human growth hormone indicated for:
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DOSAGE AND ADMINISTRATION
OMNITROPE should be administered subcutaneously (2).
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DOSAGE FORMS AND STRENGTHS
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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, divided into 6 to 7 daily
injections (2.1)
_Prader-Willi Syndrome:_ 0.24 mg/kg/week, divided into 6 to 7 daily
injections (2.1)
_Small for Gestational Age:_ Up to 0.48 mg/kg/week, divided into 6 to
7 daily injections (2.1)
_Turner Syndrome:_ 0.33 mg/kg/week, divided into 6 to 7 daily
injections (2.1)
_Idiopathic Short Stature:_ Up to 0.47 mg/kg/week, divided into 6 to 7
daily injections (2.1)
_Adult GHD:_ not more than 0.04 mg/kg/week (divided into daily
injections) to be increased as tolerated to not more
than 0.08 mg/kg/week); to be increased gradually every 1 to 2 months
(2.2)
OMNITROPE Cartridges 5 mg/1.5 mL and 10 mg/1.5 mL must be used with
the corresponding OMNITROPE Pen 5
and Pen 10 delivery system, respectively (2.3)
Injection sites should always be rotated to avoid lipoatrophy (2.3)
OMNITROPE Cartridge 5 mg/1.5 mL is a prefilled sterile solution in a
glass cartridge ready to be administered with
the Omnitrope Pen 5 (3)
OMNITROPE Cartridge 10 mg/1.5 mL is a prefilled sterile solution in a
glass cartridge ready to be