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Omnitrope

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Omnitrope™
(somatropin [rDNA origin]) Cartridges and for Injection

DRUG DESCRIPTION

OMNITROPE™ (somatropin, [rDNA] origin) is a polypeptide hormone of recombinant DNA origin. It has 191 amino acid residues and a molecular weight of 22,125 daltons. The amino acid sequence of the product is identical to that of human growth hormone of pituitary origin (somatropin). OMNITROPE™ is synthesized in a strain of.Escherichia coli that has been modified by the addition of the gene for human growth hormone. OMNITROPE™ Cartridge is a clear, colorless, sterile solution for subcutaneous injection. OMNITROPE for Injection is a lyophilized powder that is reconstituted for subcutaneous injection.

Figure 1: Schematic amino acid sequence of human growth hormone including the disulfide bonds

OMNITROPE (somatropin [rDNA origin]) Schematic amino acid sequence of human growth hormone - illustration

The bioidentity of the recombinant protein is measured by comparing its growth inducing effect with the growth inducing effect of a reference preparation calibrated in International Units.

Each Omnitrope™ Cartridge or vial contains the following (see Table 3):

Table 3

Product Cartridge
5 mg/1.5 mL		 For injection
1.5 mg/vial		 For injection
5.8 mg/vial
Component
Somatropin 5 mg 1.5 mg 5.8 mg
Disodium hydrogen phosphate heptahydrate 1.3 mg 0.88 mg 2.09 mg
Sodium dihydrogen phosphate dihydrate 1.6 mg 0.21 mg 0.56 mg
Poloxamer 188 3.0 mg - -
Mannitol 52.5 mg - -
Glycine - 27.6 mg 27.6 mg
Benzyl alcohol 13.5 mg - -
Water for Injection to make 1.5 mL - -
Diluent (vials only)   Water for Injection Bacteriostatic Water for Injection
Water for injection   1.13 mL to make 1.14 mL
Benzyl alcohol   - 17 mg

Brand Name: Omnitrope
Generic Name: Somatropin [ rDNA origin] Injection

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