Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Rebel Distributors Corp
118802834
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Vivotif-B
Product Details
Drug Labeling Information
Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.
HOW SUPPLIED SECTION
HOW SUPPLIED
A single foil blister contains 4 doses of vaccine in a single package.
Storage
Vivotif (Typhoid Vaccine Live Oral Ty21a) is not stable when exposed to ambient temperatures. Vivotif should therefore be shipped and stored between 2 °C and 8 °C (35.6 °F–46.4 °F). Each package of vaccine shows an expiration date. This expiration date is valid only if the product has been maintained at 2 °C–8 °C (35.6 °F–46.4 °F).
Manufactured by
Berna Biotech Ltd, Berne, Switzerland
US-Licence No. 1632
Distributed by
Berna Products, Crucell Vaccines, Inc., Coral Gables, FL 33146
Repackaged by
Rebel Distributors Corp, Thousand Oaks, CA 91320
References
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2. Germanier R., E. Fürer. Characteristics of the attenuated oral vaccine strain S. typhi Ty21a. Develop. Biol. Standard 53: 3–7, 1983.
3. Miller S.I., E.L. Hohmann, D.A. Pegues. Salmonella (including Salmonella typhi). In: Principles and practice of infectious diseases. G.L. Mandell, J.E. Bennett, R. Dolin (ed.) fourth edition, Churchill Livingstone Inc. 2013–2033, 1995.
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10. Black R.E., M.M. Levine, C. Ferreccio, M.L. Clements, C. Lanata, J. Rooney, R. Germanier, Chilean Typhoid Committee. Efficacy of one or two doses of Ty21a Salmonella typhi vaccine in enteric-coated capsules in a controlled field trial. Vaccine 8: 81–84, 1990.
11. Levine M.M., C. Ferreccio, R.E. Black, R. Germanier, Chilean Typhoid Committee. Large-Scale Field Trial of Ty21a Typhoid Vaccine Live Oral Ty21a in Enteric-Coated Capsule Formulation. Lancet 1: 1049–1052, 1987.
12. Levine M.M., C. Ferreccio, R.E. Black, C.O. Tacket, R. Germanier, Chilean Typhoid Committee. Progress in vaccines against typhoid fever. Rev. Infect. Dis. 11 (Supplement 3): S552–S567, 1989.
13. Ferreccio C., M.M. Levine, H. Rodriguez, R. Contreras, Chilean Typhoid Committee. Comparative efficacy of two, three, or four doses of Ty21a live oral typhoid vaccine in enteric-coated capsules: a field trial in endemic area. J. Infect. Dis. 159: 766–769, 1989.
14. Simanjuntak C.H., F.P. Paleologo, N.H. Punjabi, R. Darmowigoto, Soeprawoto, H. Totosudirjo, P. Haryanto, E. Suprijanto, N.D. Witham, S.L. Hoffman. Oral immunisation against typhoid fever in Indonesia with Ty21a vaccine. Lancet 338: 1055–1059, 1991.
15. Data on File, Swiss Serum and Vaccine Institute Berne, Switzerland.
16. Gilman R.H., R.B. Hornick, W.E. Woodward, H.L. DuPont, M.J. Snyder, M.M. Levine, J.P. Libonati. Evaluation of a UDP-glucose-4-epimeraseless mutant of Salmonella typhi as a live oral vaccine. J. Infect. Dis. 136: 717–723, 1977.
17. Cryz S.J. Jr., Post-marketing experience with live oral Ty21a Vaccine. Lancet; 341: 49–50, 1993. Data on File, Swiss Serum and Vaccine Institute Berne, Switzerland.
18. Horowitz H., CA. Carbonaro, Inhibition of the Salmonella typhi oral vaccine strain Ty21a, by mefloquine and chloroquine J. Infect. Dis. 166: 1462–1464, 1992.
19. Kollaritsch H., J.U. Que, C. Kunz, G. Wiedermann, C. Herzog, S.J. Cryz Jr. Safety and immunogenicity of live oral cholera and typhoid vaccines administered alone or in combination with anti-malarial drugs, oral polio vaccine or yellow fever vaccine. J. Infect. Dis. 175: 871–875, 1997.
20. Vaccine Adverse Event Reporting System – United States. MMWR 39: 730–733, 1990.
21. Levine M.M., R.E. Black, C. Ferreccio, M.L. Clements, C. Lanata, J. Rooney, R. Gemanier. The efficacy of attenuated Salmonella typhi oral vaccine strain Ty21a evaluated in controlled field trials. In: Development of Vaccines and Drugs against Diarrhea. 11th Noble Conference, Stockholm, 1985, p. 90–101. J. Holmgren, A. Lindberg and R. Möllby (eds.). Studentlitteratur, Lund, Sweden, 1986.