Vaccine Information: TDVAX (Page 2 of 2)

HOW SUPPLIED

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.

STORAGE

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.

REFERENCES

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. 5^th 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. 5^th 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.

Manufactured by:

MassBiologics

University of Massachusetts Medical School

Boston, MA 02126

US Government License No. 1779

Distributed by:

Grifols USA, LLC

Los Angeles, CA 90032

Product information as of September 2018

Carton Label

Vial Label

TDVAX tetanus and diphtheria toxoids adsorbed injection

Product Information Product Type VACCINE Item Code (Source) NDC:13533-131 Route of Administration INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) (CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)) CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 2.0 [Lf] in 0.5 mL CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) (CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)) CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 2.0 [Lf] in 0.5 mL

Inactive Ingredients Ingredient Name Strength ALUMINUM PHOSPHATE 0.53 mg in 0.5 mL FORMALDEHYDE 100 ug in 0.5 mL THIMEROSAL 0.3 ug in 0.5 mL

Product Characteristics Color white (after shaking, the vaccine appears as a homogenous milky white suspension) Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:13533-131-01 10 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (13533-131-00) 1 NDC:13533-131-00 0.5 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (13533-131-01)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101322 07/01/2015

Labeler — GRIFOLS USA, LLC (048987452)

Registrant — MassBiologics (038051228)

Establishment
Name	Address	ID/FEI	Operations
MassBiologics		038051228	manufacture

Revised: 03/2021 GRIFOLS USA, LLC