• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail

Orimune (poliovirus vaccine live oral trivalent) Dear Healthcare Professional Letter Feb 2000

FDA posts safety alerts, public health advisories, press releases and other notices from companies as a service to health professionals, consumers and other interested parties. Although FDA approves medical products, FDA does not endorse either the product or the company.

 


 

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