Activase
DRUG DESCRIPTION
Activase®, Alteplase, is a tissue plasminogen activator produced by recombinant DNA technology. It is a sterile, purified glycoprotein of 527 amino acids. It is synthesized using the complementary DNA (cDNA) for natural human tissue-type plasminogen activator obtained from a human melanoma cell line. The manufacturing process involves the secretion of the enzyme alteplase into the culture medium by an established mammalian cell line (Chinese Hamster Ovary cells) into which the cDNA for alteplase has been genetically inserted. Fermentation is carried out in a nutrient medium containing the antibiotic gentamycin, 100 mg/L. However, the presence of the antibiotic is not detectable in the final product.
Phosphoric acid and/or sodium hydroxide may be used prior to lyophilization for pH adjustment.
Activase is a sterile, white to off-white, lyophilized powder for intravenous administration after reconstitution with Sterile Water for Injection, USP.
| Quantitative Composition of the Lyophilized Product | ||
|---|---|---|
| | 100 mg Vial | 50 mg Vial |
| Alteplase
Phosphoric Acid Polysorbate 80 Vacuum | 100 mg (58 million IU) 3.5 g 1 g less than or equal to 11 mg No | 50 mg (29 million IU) 1.7 g 0.5 g less than or equal to 4 mg Yes |
Biological potency is determined by an in vitro clot lysis assay and is expressed in International Units as tested against the WHO standard. The specific activity of Activase is 580,000 IU/mg.
Generic Name: Alteplase
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Activase
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