Vaccine Information: TENIVAC (Page 3 of 3)

15 REFERENCES

1
CDC. Diphtheria, tetanus and pertussis: recommendations for vaccine use and other preventive measures. Recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 1991;40(RR-10):1-28.
2
Stratton KR, et al, editors. Adverse events associated with childhood vaccines; evidence bearing on causality. Washington, DC: National Academy Press 1994. p. 67-117.
3
Mueller JH, Miller PA. Variable factors influencing the production of tetanus toxin. J Bacteriol 1954;67(3):271-7.
4
Stainer DW. Production of diphtheria toxin. In: Manclark CR, editor. Proceedings of an informal consultation on the World Health Organization requirements for diphtheria, tetanus, pertussis and combined vaccines. United States Public Health Services, Bethesda, MD. DHHS 91-1174. 1991. p. 7-11.
5
FDA. 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.
6
Wassilak SGF, et al. Tetanus toxoid. In: Plotkin SA, Orenstein WA, Offit PA, editors. Vaccines. 5th ed. Philadelphia, PA: W.B. Saunders Company; 2008. p. 805-39.
7
Vitek CR and Wharton M. Diphtheria toxoid. In: Plotkin SA, Orenstein WA, Offit PA, editors. Vaccines. 5th ed. Philadelphia, PA: W.B. Saunders Company; 2008. p. 139-56.

16 HOW SUPPLIED/STORAGE AND HANDLING

Single-dose Vial, NDC No. 49281-215-58; in package of 10 vials, NDC No. 49281-215-10. Contains no latex.

Single-dose Syringe, NDC No. 49281-215-88; in package of 10 syringes, NDC No. 49281-215-15. The tip caps of the prefilled syringes may contain natural rubber latex. No other components contain latex.

TENIVAC should be stored at 2° to 8°C (35° to 46°F). DO NOT FREEZE. Product which has been exposed to freezing should not be used. Do not use after expiration date shown on the label.

17 PATIENT COUNSELING INFORMATION

Before administration of TENIVAC health-care providers should inform the patient, parent or guardian of the benefits and risks of the vaccine and the importance of completing the primary immunization series or receiving recommended booster doses, as appropriate, unless a contraindication to further immunization exists.

The health-care provider should inform the patient, parent or guardian about the potential for adverse reactions that have been temporally associated with TENIVAC or other vaccines containing similar components. The health-care provider should provide the Vaccine Information Statements (VISs) which are required by the National Childhood Vaccine Injury Act of 1986 to be given with each immunization. Patients, parents, or guardians should be instructed to report adverse reactions to their health-care provider.

Manufactured by:
Sanofi Pasteur Limited
Toronto Ontario Canada

Distributed by:
Sanofi Pasteur Inc.
Swiftwater PA 18370 USA

TENIVAC® is a registered trademark of the Sanofi Pasteur group and its subsidiaries.

R6-1219 USA

PRINCIPAL DISPLAY PANEL — 0.5 mL Vial Label

7 yrs of age and older
Td

NDC 49281-215-58

Tetanus and
Diphtheria
Toxoids Adsorbed

TENIVAC®

Rx only

single-dose (0.5 mL) IM only

Sanofi Pasteur Limited

PRINCIPAL DISPLAY PANEL -- 0.5 mL Vial Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 10 Vial Package

NDC 49281-215-10
Td

Tetanus and
Diphtheria Toxoids
Adsorbed

10 single-dose vials
0.5 mL each

Rx only

TENIVAC®

For persons 7 years of age and older.

SANOFI PASTEUR

PRINCIPAL DISPLAY PANEL -- 10 Vial Package
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 0.5 mL Syringe Label

NDC 49281-215-88

single-dose (0.5 mL)
Td

Tetanus and Diphtheria
Toxoids Adsorbed
TENIVAC®
7 yrs of age and older
Sanofi Pasteur Limited

IM only Rx only

PRINCIPAL DISPLAY PANEL -- 0.5 mL Syringe Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 10 Syringe Package

Td

NDC 49281-215-15

10 single-dose
prefilled syringes
0.5 mL each

Tetanus and
Diphtheria Toxoids
Adsorbed

Rx only

TENIVAC®

For persons 7 years of age and older

SANOFI PASTEUR

PRINCIPAL DISPLAY PANEL -- 10 Syringe Package
(click image for full-size original)
TENIVAC clostridium tetani toxoid antigen (formaldehyde inactivated) and corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:49281-215
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) 5 [Lf] in 0.5 mL
CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) (CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)) CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 2 [Lf] in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
ALUMINUM PHOSPHATE 1.5 mg in 0.5 mL
FORMALDEHYDE
Product Characteristics
Color WHITE (WHITE CLOUDY) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49281-215-10 10 VIAL, SINGLE-DOSE in 1 PACKAGE contains a VIAL, SINGLE-DOSE (49281-215-58)
1 NDC:49281-215-58 0.5 mL in 1 VIAL, SINGLE-DOSE This package is contained within the PACKAGE (49281-215-10)
2 NDC:49281-215-15 10 SYRINGE in 1 PACKAGE contains a SYRINGE (49281-215-88)
2 NDC:49281-215-88 0.5 mL in 1 SYRINGE This package is contained within the PACKAGE (49281-215-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103171 12/08/2010
Labeler — Sanofi Pasteur Inc. (086723285)
Establishment
Name Address ID/FEI Operations
Sanofi Pasteur Limited 208206623 MANUFACTURE

Revised: 08/2021 Sanofi Pasteur Inc.

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