Packaging and storage— Preserve in single-dose containers, or in light-resistant, multiple-dose containers, at a temperature between 2 and 8. Multiple-dose containers for 50 doses are adapted for use only in jet injectors, and those for 10 doses for use by jet or syringe injection.

Expiration date— The expiration date is 1 to 2 years, depending on the manufacturer's data, after date of issue from manufacturer's cold storage (20, 1 year).

Labeling— Label the Vaccine in multiple-dose containers to indicate that the contents are intended solely for use by jet injector or for use by either jet or syringe injection, whichever is applicable. Label the Vaccine in single-dose containers, if such containers are not light-resistant, to state that it should be protected from sunlight. Label it also to state that constituted Vaccine should be discarded if not used within 8 hours.

Expert Committee : (BBVV05) Biologics and Biotechnology - Vaccines and Virology

USP29–NF24 Page 1936

Phone Number : 1-301-816-8397