CSC Pharmaceuticals International




Neupogen Injection


Neupogen Injection

Filgrastim is a human granulocyte colony-stimulating factor (G-CSF)‚ produced by recombinant DNA technology. NEUPOGEN® is the Amgen Inc. trademark for Filgrastim‚ which has been selected as the name for recombinant methionyl human granulocyte colony-stimulating factor (r-metHuG-CSF).

NEUPOGEN® is a 175 amino acid protein manufactured by recombinant DNA technology.1 NEUPOGEN® is produced by Escherichia coli (E coli) bacteria into which has been inserted the human granulocyte colony-stimulating factor gene. NEUPOGEN® has a molecular weight of 18‚800 daltons. The protein has an amino acid sequence that is identical to the natural sequence predicted from human DNA sequence analysis‚ except for the addition of an N-terminal methionine necessary for expression in E coli. Because NEUPOGEN® is produced in E coli‚ the product is nonglycosylated and thus differs from G-CSF isolated from a human cell.

NEUPOGEN® is a sterile‚ clear‚ colorless‚ preservative-free liquid for parenteral administration containing Filgrastim at a specific activity of 1.0 ± 0.6 x 108 U/mg (as measured by a cell mitogenesis assay). The product is available in single use vials and prefilled syringes. The single use vials contain either 300 mcg or 480 mcg Filgrastim at a fill volume of 1.0 mL or 1.6 mL, respectively. The single use prefilled syringes contain either 300 mcg or 480 mcg Filgrastim at a fill volume of 0.5 mL or 0.8 mL, respectively. See table below for product composition of each single use vial or prefilled syringe.

   300 mcg/ 1.0 mL Vial  480 mcg/ 1.6 mL Vial  300 mcg/ 0.5 mL Syringe  480 mcg/ 0.8 mL Syringe
Filgrastim  300 mcg  480 mcg  300 mcg  480 mcg
Acetate  0.59 mg  0.94 mg  0.295 mg  0.472 mg
Sorbitol  50.0 mg  80.0 mg  25.0 mg  40.0 mg
Polysorbate 80  0.04 mg  0.064 mg  0.02 mg  0.032 mg
Sodium  0.035 mg  0.056 mg  0.0175 mg  0.028 mg
Water for Injection USP q.s. ad  1.0 mL  1.6 mL  0.5 mL  0.8 mL

REFERENCES

1. Zsebo KM‚ Cohen AM‚ Murdock DC‚ et al. Recombinant human granulocyte colonystimulating factor: Molecular and biological characterization. Immunobiol. 1986;172:175-184.




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