What Is Activase and how is it used?
What are side effects of Activase?
- low blood pressure (hypotension),
- mild fever, or
- allergic reactions (swelling, rash, hives).
Activase 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. Activase is a sterile, white to off-white, lyophilized powder for intravenous administration after reconstitution with Sterile Water for Injection, USP.
Table 6 : Quantitative Composition of the Lyophilized Product
|100 mg Vial||50 mg Vial|
|Alteplase||100 mg (58 million IU)||50 mg (29 million IU)|
|L-Arginine||3.5 g||1.7 g|
|Phosphoric Acid||1 g||0.5 g|
|Polysorbate 80||10 mg||5 mg|
Biological potency is determined by an in vitro clot lysis assay and is expressed in International Units (IU).
The reconstituted preparation results in a colorless to pale yellow transparent solution containing Activase 1 mg/mL at approximately pH 7.3. The osmolality of this solution is approximately 215 mOsm/kg.