KINRIX: Package Insert and Label Information (Page 3 of 3)

15 REFERENCES

1.

Vitek CR and Wharton M. Diphtheria Toxoid. In: Plotkin SA, Orenstein WA, and Offit PA, eds. Vaccines. 5th ed. Saunders; 2008:139-156.

2.

Wassilak SGF, Roper MH, Kretsinger K, and Orenstein WA. Tetanus Toxoid. In: Plotkin SA, Orenstein WA, and Offit PA, eds. Vaccines. 5th ed. Saunders; 2008:805-839.

3.

Department of Health and Human Services, Food and Drug Administration. Biological products; Bacterial vaccines and toxoids; Implementation of efficacy review; Proposed rule. Federal Register. December 13, 1985;50(240):51002-51117.

4.

Centers for Disease Control and Prevention. General Recommendations on Immunization. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 2006;55(RR-15):1-48.

5.

Sutter RW, Pallansch MA, Sawyer LA, et al. Defining surrogate serologic tests with respect to predicting protective vaccine efficacy: Poliovirus vaccination. In: Williams JC, Goldenthal KL, Burns DL, Lewis Jr BP, eds. Combined vaccines and simultaneous administration. Current issues and perspectives. New York, NY: The New York Academy of Sciences; 1995:289-299.

16 HOW SUPPLIED/STORAGE AND HANDLING

KINRIX is available in 0.5-mL single-dose, disposable, prefilled TIP‑LOK syringes (packaged without needles):

NDC 58160-812-43 Syringe in Package of 10: NDC 58160-812-52

Store refrigerated between 2° and 8°C (36° and 46°F). Do not freeze. Discard if the vaccine has been frozen.

17 PATIENT COUNSELING INFORMATION

Provide the following information to the parent or guardian:

•

Inform of the potential benefits and risks of immunization with KINRIX.

•

Inform about the potential for adverse reactions that have been temporally associated with administration of KINRIX or other vaccines containing similar components.

•

Give the Vaccine Information Statements, which are required by the National Childhood Vaccine Injury Act of 1986 to be given prior to immunization. These materials are available free of charge at the Centers for Disease Control and Prevention (CDC) website (www.cdc.gov/vaccines).

INFANRIX, KINRIX, PEDIARIX, and TIP‑LOK are trademarks owned by or licensed to the GSK group of companies. The other brand listed is a trademark owned by or licensed to its respective owner and is not owned by or licensed to the GSK group of companies. The maker of this brand is not affiliated with and does not endorse the GSK group of companies or its products.

Manufactured by GlaxoSmithKline Biologicals

Rixensart, Belgium, U.S. License 1617, and

GSK Vaccines GmbH

Marburg, Germany, U.S. License 1617

Distributed by GlaxoSmithKline

Durham, NC 27701

©2023 GSK group of companies or its licensor.

KNX:17PI

PRINCIPAL DISPLAY PANEL

NDC 58160-812-52

KINRIX

Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine

DTaP-IPV

Rx only

For Use from 4 through 6 Years of Age

10 Disposable Single-Dose Prefilled TIP-LOK Syringes each containing one 0.5-mL dose

TIP-LOK syringes are compatible with LUER-LOK needles

NEEDLES NOT INCLUDED

©2018 GSK group of companies or its licensor.

KINRIX and TIP-LOK are trademarks owned by or licensed to the GSK group of companies.

LUER-LOK is a trademark owned by or licensed to Becton, Dickinson, and Company.

Made in Belgium

Rev. 11/18

496040

KINRIX diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine injection, suspension

Product Information Product Type VACCINE Item Code (Source) NDC:58160-812 Route of Administration INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) (CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)) CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 25 [iU] in 0.5 mL CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) (CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)) CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 10 [iU] in 0.5 mL BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) (BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)) BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) 25 [iU] in 0.5 mL BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED) (BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED)) BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED) 8 ug in 0.5 mL BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED) (BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED)) BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED) 25 ug in 0.5 mL POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED) (POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED)) POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED) 40 [iU] in 0.5 mL POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED) (POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED)) POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED) 8 [iU] in 0.5 mL POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED) (POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED)) POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED) 32 [iU] in 0.5 mL

Inactive Ingredients Ingredient Name Strength ALUMINUM HYDROXIDE FORMALDEHYDE NEOMYCIN SULFATE POLYMYXIN B POLYSORBATE 80 SODIUM CHLORIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:58160-812-52 10 SYRINGE in 1 CARTON contains a SYRINGE (58160-812-43) 1 NDC:58160-812-43 0.5 mL in 1 SYRINGE This package is contained within the CARTON (58160-812-52)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA125260 07/09/2008

Labeler — GlaxoSmithKline Biologicals SA (372748392)

Revised: 01/2023 GlaxoSmithKline Biologicals SA