The stopper of the vial is not made with natural rubber latex.
MassBiologics’ TDVAX is supplied in a package of 10 single dose vials.
NDC No. 13533-131-00-Individual single dose (0.5mL) vials.
NDC No. 13533-131-01-Package containing ten vials.
Store at 2°C — 8°C (36°F — 46°F). DO NOT FREEZE. Discard product if exposed to freezing.
Do not use vaccine after expiration date.
1. Latham WC, Bent DF, and Levine L. Tetanus toxin production in the absence of protein. Appl. Microbiol. 10(2): March 1962;146-152.
2. Mueller JH and Miller PA. Production of diphtheric toxin of high potency (100 Lf) on a reproducible medium. J. Immunol. 40: 1941;21-32.
3. Food and Drug Administration. Department of Health and Human Services (DHHS). Biological Products; bacterial vaccines and toxoids; implementation of efficacy review; proposed rule. Fed Reg 1985;50(240): 51002-117.
4. Wassilak SGF, et al. Tetanus toxoid. In: Plotkin SA, Orenstein WA, Offit PA, editors. Vaccines. 5th ed. Philadelphia, PA: WB Saunders Company; 2008. p. 805-839.
5. Ipsen J. Jr. Immunization of adults against diphtheria and tetanus. NEJM. 1954; 251:459-466.
6. Vitek CR and Wharton M. Diphtheria toxoid. In: Plotkin SA, Orenstein WA, Offit PA, editors. Vaccines. 5th ed. Philadelphia, PA: WB Saunders Company; 2008. p. 139-156.
7. Edsall G, Altman JS, and Gaspar AJ. Combined tetanus-diphtheria immunization of adults: Use of small doses of diphtheria toxoid. Am J Public Health Nations Health. 1954 Dec;44(12):1537-1545.
8. Levine L, Ipsen J, and McComb JA. Adult immunization: preparation and evaluation of combined fluid tetanus and diphtheria toxoids for adult use. Am. J. Hyg. 1961;73:20-35.
9. Institute of Medicine. Stratton KR, et al, eds. Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Casuality. Washington D.C.: National Academy Press. 1994:67-117.
10. Centers for Disease Control and Prevention. General recommendations on immunization: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2006;55(No. RR-15):1-48.
11. McComb JA and Levine L. Adult immunization II. Dosage reduction as a solution to increasing reactions to tetanus toxoid. NEJM. 1961;256:1152-1158.
12. Levine L and Edsall G. Tetanus toxoid: What determines reaction proneness? J. Infect. Dis. 1981;144:376.
13. Centers for Disease Control and Prevention. Preventing tetanus, diphtheria, and pertussis among adolescents: use of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2006;55(No. RR-3):1-43.
14. Centers for Disease Control and Prevention. Preventing tetanus, diphtheria, and pertussis among adults: use of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine. Recommendations of the Advisory Committee on Immunization Practices (ACIP) and recommendation of ACIP, supported by the Healthcare Infection Control Practices Advisory Committee (HICPAC), for use of Tdap among health-care personnel. MMWR 2006;55(No. RR-17):1-37.
15. Centers for Disease Control and Prevention. Recommendations of the Immunization Practices Advisory Committee (ACIP). Diphtheria, tetanus, and pertussis: recommendations for vaccine use and other preventive measures. MMWR 1991;40(No. RR-10):1-35.
University of Massachusetts Medical School
Boston, MA 02126
US Government License No. 1779
Grifols USA, LLC
Los Angeles, CA 90032
Product information as of September 2018
| TDVAX |
tetanus and diphtheria toxoids adsorbed injection
|Labeler — GRIFOLS USA, LLC (048987452)|
|Registrant — MassBiologics (038051228)|
Revised: 03/2021 GRIFOLS USA, LLC
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