VIVOTIF-B capsule

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI (UNII: 760T5R8B3O) (SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI - UNII:760T5R8B3O)

Доступна с:

Rebel Distributors Corp

ИНН (Международная Имя):

SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI

состав:

SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI 2 [CFU]

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Vivotif (Typhoid Vaccine Live Oral Ty21a) is indicated for immunization of adults and children greater than 6 years of age against disease caused by Salmonella typhi . Routine typhoid vaccination is not recommended in the United States of America. Selective immunization against typhoid fever is recommended for the following groups: 1) travelers to areas in which there is a recognized risk of exposure to S. typhi , 2) persons with intimate exposure (e.g. household contact) to a S. typhi carrier, and 3) microbiology laboratorians who work frequently with S. typhi (7). There is no evidence to support the use of typhoid vaccine to control common source outbreaks, disease following natural disasters or in persons attending rural summer camps. Not all recipients of Vivotif will be fully protected against typhoid fever. Vaccinated individuals should continue to take personal precautions against exposure to typhoid organisms. The vaccine will not afford protection against species of Salmonella other than Salmonella

Обзор продуктов:

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 1. Germanier R., E. Fürer. Isolation and characterisation of Gal E mutant Ty21a of Salmonella typhi : a candidate strain for a live, oral typhoid vaccine. J. Infect. Dis. 131: 553–558, 1975. 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. 4. Centers for Disease Control. Summary of notifiable diseases, United States 1995. MMWR 44 (Supplement), 1996. 5. Ryan C.A., N.T. Hargrett-Bean, P.A. Blake. Salmonella typhi infections in the United States, 1975–1984: Increasing role of foreign travel. Rev. Infect. Dis. 11: 1–8, 1989. 6. Taylor D.N., R.A. Pollard, P.A. Blake. Typhoid in the United States and the Risk to the International Traveler. J. Infect Dis. 148: 599–602, 1983. 7. Recommendations of the Advisory Committee on Immunization Practices (ACIP): Typhoid Immunization. MMWR 43 (RR-14), 1994. 8. Ames W.R., M. Robbins. Age and sex as factors in the development of the typhoid carrier state, and a model for estimating carrier prevalence. Am. J. Public Health 33: 221–230, 1943. 9. Wahdan M.H., C. Sérié, Y. Cerisier, S. Sallam, R. Germanier. A controlled field trial of live Salmonella typhi strain Ty21a oral vaccine against typhoid: three-year results. J. Infect. Dis. 145: 292–296, 1982. 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.

Статус Авторизация:

Biologic Licensing Application

Характеристики продукта

VIVOTIF-B- VIVOTIF-B CAPSULE
REBEL DISTRIBUTORS CORP
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VIVOTIF-B
DESCRIPTION
Vivotif (Typhoid Vaccine Live Oral Ty21a) is a live attenuated vaccine
for oral administration only.
The vaccine contains the attenuated strain _Salmonella typhi _Ty21a
(1,2).
Vivotif is manufactured by the Berna Biotech Ltd. The vaccine strain
is grown in fermentors under
controlled conditions in medium containing a digest of yeast extract,
an acid digest of casein, dextrose
and galactose. The bacteria are collected by centrifugation, mixed
with a stabilizer containing sucrose,
ascorbic acid and amino acids, and lyophilized. The lyophilized
bacteria are mixed with lactose and
magnesium stearate and filled into gelatin capsules which are coated
with an organic solution to render
them resistant to dissolution in stomach acid. The
enteric-coated, salmon/white capsules are then packaged in 4-capsule
blisters for distribution. The
contents of each enteric-coated capsule are shown in Table 1.
_Table 1: Contents of one enteric-coated capsule of Vivotif _(Typhoid
Vaccine Live Oral Ty21a)
Viable _S. typhi _Ty21a . . . . . . . . . . . . . . . . . . . . . . .
. . 2–6.8x109 colony-forming units*
Non-viable _S. typhi _Ty21a . . . . . . . . . . . . . . . . . . . . .
5–50x109 bacterial cells
Sucrose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . 26–130 mg
Ascorbic acid . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . 1–5 mg
Amino acid mixture . . . . . . . . . . . . . . . . . . . . . . . . . .
1.4–7 mg
Lactose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . 100–180 mg
Magnesium stearate . . . . . . . . . . . . . . . . . . . . . . . . .
3.6–4.4 mg
*Vaccine potency (viable cell counts per capsule) is determined by
inoculation of agar plates with
appropriate dilutions of the vaccine suspended in physiological
saline.
CLINICAL PHARMACOLOGY
_Salmonella typhi _is the etiological agent of typhoid fever, an
acute, febrile enteric disease. Typhoid
fever continues to be an important