Source: FDA, National Drug Code (US) Revision Year: 2020
Cathflo Activase (Alteplase) is a tissue plasminogen activator (t‑PA) 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 (t‑PA) obtained from an established human cell line. The manufacturing process involves 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.
Cathflo Activase (Alteplase) for injection is a sterile, white to pale yellow, lyophilized powder for intracatheter instillation for restoration of function to central venous access devices following reconstitution with Sterile Water for Injection, USP.
Each vial of Cathflo Activase contains 2.2 mg of Alteplase (which includes a 10% overfill), 77 mg of L‑arginine, 0.2 mg of polysorbate 80, and phosphoric acid for pH adjustment. Each reconstituted vial will deliver 2 mg of Cathflo Activase, at a pH of approximately 7.3.
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Cathflo Activase (Alteplase) for injection is supplied as a sterile, lyophilized powder in 2 mg vials. Cathflo Activase is available in a carton that contains one 2 mg vial of Cathflo Activase (Alteplase): NDC 50242‑041‑64 or a carton that contains ten 2 mg vials of Cathflo Activase (Alteplase): NDC 50242-041-10. Manufactured by: Genentech, Inc., A Member of the Roche Group, 1 DNA Way, South San Francisco, CA |
| Drug | Countries | |
|---|---|---|
| CATHFLO | Canada, United States |
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