Description

Somatropin …………………………………. 8 mg equivalent to 24 IU
The diluent vial contains: Metacresol 0.3% , Water injection, c.b.p. 5 ml.
A cartridge with solvent for use in ONE-CLICK®, COOL-CLICKTM or EasypodTM contains: Metacresol 0.3%/Water injection, c.b.p. 1.37 ml.
Generic Name: somatropin
Dosage Form: injection
SOLUTION FOR INJECTION
Made for mixing, cartridge with solvent for use in ONE-CLICK®, COOL-CLICKTM or EasypodTM contains: Metacresol 0.3%/Water injection, c.b.p. 1.37 ml. Somatropin … … … … … ……………………. 8mg / equivalent to 24 IU’s
Saizen [somatropin (rDNA origin) for injection] is a human growth hormone produced by recombinant DNA technology. Saizen has 191 amino acid residues and a molecular weight of 22,125 daltons. Its amino acid sequence and structure are identical to the dominant form of human pituitary growth hormone.
Growth hormone is used clinically to treat children’s growth disorders and adult growth hormone deficiency. In recent years, replacement therapies with human growth hormones (HGH) have become popular in the battle against aging and weight management. Reported effects include decreased body fat, increased muscle mass, increased bone density, increased energy levels, improved skin tone and texture, increased sexual function and improved immune system function. At this time HGH is still considered a very complex hormone and many of its functions are still unknown.
DESCRIPTION SECTION
Saizen® [somatropin (rDNA origin) for injection] is a human growth hormone produced by recombinant DNA technology. Saizen® has 191 amino acid residues and a molecular weight of 22,125 daltons. Its amino acid sequence and structure are identical to the dominant form of human pituitary growth hormone. Saizen® is produced by a mammalian cell line (mouse C127) that has been modified by the addition of the human growth hormone gene. Saizen®, with the correct three-dimensional configuration, is secreted directly through the cell membrane into the cell-culture medium for collection and purification.
Saizen® is a highly purified preparation. Biological potency is determined by measuring the increase in body weight induced in hypophysectomized rats.
Saizen® is a sterile, non-pyrogenic, white, lyophilized powder intended for subcutaneous or intramuscular injection after reconstitution with Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol). The reconstituted solution has a pH of 6.5 to 8.5.
Saizen® is available in 1.33 mg vials. The quantitative composition per vial is:1.33mg (approximately 4 IU) vial:
The diluent is Bacteriostatic Water for Injection, USP containing 0.9% Benzyl Alcohol added as an antimicrobial preservative.
Saizen [somatropin (rDNA origin) for injection] is a human growth hormone produced by recombinant DNA technology.
Saizen has 191 amino acid residues and a molecular weight of 22,125 daltons. Its amino acid sequence and structure are identical to the dominant form of human pituitary growth hormone.
Growth hormone is used clinically to treat childrens growth disorders and adult growth hormone deficiency. In recent years, replacement therapies with human growth hormones (HGH) have become popular in the battle against aging and weight management. Reported effects include decreased body fat, increased muscle mass, increased bone density, increased energy levels, improved skin tone and texture, increased sexual function and improved immune system function.
At this time HGH is still considered a very complex hormone and many of its functions are still unknown.
INDICATIONS & USAGE SECTION
Pediatric Patients
Saizen® [somatropin (rDNA origin) for injection] is indicated for the long-term treatment of children with growth failure due to inadequate secretion of endogenous growth hormone.
Adult Patients
Saizen® [somatropin (rDNA origin) for injection] is indicated for replacement of endogenous growth hormone in adults with growth hormone deficiency who meet either of the following two criteria:
Adult Onset: Patients who have growth hormone deficiency, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; or
Childhood Onset: Patients who were growth hormone deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes..
In general, confirmation of the diagnosis of adult growth hormone deficiency in both groups usually requires an appropriate growth hormone stimulation test. However, confirmatory growth hormone stimulation testing may not be required in patients with congenital/genetic growth hormone deficiency or multiple pituitary hormone deficiencies due to organic disease.