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Genotropin ®
Genotropin ® - (somatropin (rDNA origin) for injection)
In a Two-Chamber Cartridge
Genotropin ® is a sterile white lyophilized powder that contains somatropin (rDNA origin), which is a polypeptide hormone of recombinant DNA origin. It has 191 amino acid residues and a molecular weight of 22,124 daltons. The amino acid sequence of the product is identical to that of human growth hormone of pituitary origin (somatropin). Genotropin ® is synthesized in a strain of Escherichia coli that has been modified by the addition of the gene for human growth hormone. Genotropin ® is intended for subcutaneous injection.
Indications and Usage
Genotropin ® lyophilized powder is indicated for:
- Pediatric Patients (Children):
- Long-term treatment of children who have growth failure due to an inadequate secretion of endogenous growth hormone (GH).
- Long-term treatment of children who have growth failure due to Prader-Willi syndrome (PWS). The diagnosis of PWS should be confirmed by appropriate genetic testing.
- Long-term treatment of growth failure in children born small for gestational age (SGA) who fail to manifest catch-up growth by age 2. Other causes of short stature in children should be excluded.
- Adults Patients:
- Long-term replacement therapy in adults with growth hormone deficiency (GHD) of either childhood-or adult-onset etiology. GHD should be confirmed by an appropriate growth hormone stimulation test.
Genotropin ® - somatropin (rDNA origin) for injection - made by Pharmacia & Upjohn Company, a subsidiary of Pfizer, Incorporated. For more information call 800-242-7014 or visit www.genotropin.com
References:
Food and Drug Administration (FDA)
April 2003
www.fda.gov/MedWatch/SAFETY/2007/Mar_PI/Genotropin_PI.pdf
This summary does not include everything there is to know about the medicine mentioned above. Do not use this medicine without first talking to your doctor.
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