Reteplase how supplied storage and handling
Reteplase |
---|
Retavase® FDA Package Insert |
Indications and Usage |
Dosage and Administration |
Contraindications |
Warnings and Precautions |
Adverse Reactions |
Drug Interactions |
Use in Specific Populations |
Description |
Clinical Pharmacology |
Nonclinical Toxicology |
How Supplied/Storage and Handling |
Labels and Packages |
Clinical Trials on Reteplase |
ClinicalTrials.gov |
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ahmed Zaghw, M.D. [2]
How Supplied
Retavase® Kit - NDC 24477-041-02
Retavase® Half-Kit - NDC 24477-040-01
Retavase®, is supplied as a sterile, preservative-free, lyophilized powder in 10.4 unit (equivalent to 18.1 mg Retavase®) vials without a vacuum, in the following packaging configurations:
Retavase® Kit: 2 single-use Retavase® vials 10.4 units (18.1 mg), 2 single-use diluent vials for reconstitution (10 mL Sterile Water for Injection, USP), 2 sterile 10 mL syringes, 2 sterile dispensing pins, 4 sterile needles, 2 alcohol swabs and a package insert;
Retavase® Half-Kit: 1 single-use Retavase® vial 10.4 units (18.1 mg), 1 single-use diluent vial for reconstitution (10 mL Sterile Water for Injection, USP), a sterile dispensing pin and a package insert.
Storage
Store Retavase® at 2-25°C (36-77°F). The box should remain sealed until use to protect the lyophilisate from exposure to light. Do not use beyond the expiration date printed on the box.[1]
References
Adapted from the FDA Package Insert.