This is the retyped text of a letter from Wyeth-Lederle Vaccines & Pediatrics. Contact the company for a copy of any referenced enclosures.

February 7, 2000

IMPORTANT PRODUCT STORAGE INFORMATION

Dear Health Care Provider:

This letter is to inform you of a recent change in the storage conditions for ORIMUNE, Poliovirus Vaccine Live Oral Trivalent.

As outlined in the enclosed revised package insert (Revised: 8/24/99), the storage conditions are as follows:

"STORE IN FREEZER FOR MAXIMUM SHELF LIFE."

 

"To maintain the potency of ORIMUNE, it is necessary to store this vaccine at a temperature that will maintain ice continuously in a solid state (below 0oC or 32oF). However, since the vaccine contains sorbitol it may remain fluid at temperatures above - 14oC (+7oF). Ice cubes that remain frozen continuously when stored in the same freezer compartment will confirm that the temperature is appropriate for storage of ORIMUNE."
"Immediately prior to use remove an ORIMUNE DISPETTE from the freezer, thaw completely and administer orally to patient."

Please note: Storage under refrigeration and repetitive freezing and thawing (freezer-thaw cycles) are no longer recommended.

If you need further assistance, please contact Wyeth Lederle Vaccines Biological Quality Assurance at 1-800-999-9384. Sincerely,

Raymond Shaw, Jr., Ph.D
Vice President, Quality Assurance
Global Biologicals/Vaccines

Enclosure


Wyeth-Lederle Vaccines & Pediatrics
P.O. Box 8229
Division of American Home Products
Philadelphia, Pa. 19101-8299
Phone No. 610-688-4400