Reteplase how supplied storage and handling: Difference between revisions
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==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.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = RETAVASE (RETEPLASE) KIT [EKR THERAPEUTICS, INC.] | url =http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=e9ae6656-977c-4105-8528-bee664aab27a | publisher = | date = | accessdate = }}</ref> | |||
==References== | ==References== | ||
{{Reflist}} | {{Reflist}} | ||
Revision as of 19:18, 6 February 2014
| 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.