July 28, 2016
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Activase

"Oct. 28, 2012 -- Flu vaccines may do more than guard against infection. New research hints that the vaccine, which is recommended for all adults, may also help the heart.

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Activase

Activase
(alteplase) A Recombinant Tissue Plasminogen Activator

DRUG DESCRIPTION

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
Vacuum No Yes

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.

Last reviewed on RxList: 7/12/2016
This monograph has been modified to include the generic and brand name in many instances.

Additional Activase Information

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