Vaccine Information: QUADRACEL (Page 3 of 3)

15 REFERENCES

1
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 Service, Bethesda, MD. DHHS 91-1174. 1991:7-11.
2
Mueller JH, Miller PA. Variable factors influencing the production of tetanus toxin. J Bacteriol 1954;67(3):271-7.
3
Stainer DW, Scholte MJ. A simple chemically defined medium for the production of phase I Bordetella pertussis. J Gen Microbiol 1970;63:211-20.
4
van Wezel AL, et al. Inactivated poliovirus vaccine: current production methods and new developments. Rev Infect Dis 1984;6 (Suppl 2):S335-40.
5
Montagnon BJ et al. Industrial scale production of inactivated poliovirus vaccine prepared by culture of vero cells on microcarrier. Rev Infect Dis 1984;6 (Suppl 2):S341-4.
6
Department of Health and Human Services, Food and Drug Administration. Biological products; bacterial vaccines and toxoids; implementation of efficacy review; proposed rule. Federal Register 1985;50(240):51002-117.
7
Tiwari TSP, Wharton M. Diphtheria toxoid. In: Plotkin SA, Orenstein WA, and Offit PA, editors. Vaccines. 6th ed. Philadelphia, PA: WB Saunders; 2012:153-66.
8
Roper M, Wassilak SGF, Tiwari TSP, Orenstein WA. Tetanus toxoid. In: Plotkin SA, Orenstein WA, and Offit PA, editors. Vaccines. 6th ed. Philadelphia, PA: WB Saunders; 2012:746-72.
9
Sutter RW, et al. Defining surrogate serologic tests with respect to predicting protective vaccine efficacy: Poliovirus vaccination. In: Williams JC, et al. eds. Combined vaccines and simultaneous administration. Current issues and perspectives. New York, NY: The New York Academy of Sciences. 1995:289-99.

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

The vial stopper for this product is not made with natural latex rubber.

Quadracel is supplied in a single-dose vial (NDC No. 49281-562-58) in packages of 10 vials (NDC No. 49281-562-10).

16.2 Storage and Handling

Quadracel 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

Inform the parent or guardian of the following:

  • The potential benefits and risks of immunization with Quadracel.
  • The common adverse reactions that have occurred following administration of Quadracel or other vaccines containing similar components.
  • Other adverse reactions can occur. Call healthcare provider with any adverse reactions of concern.

Provide the Vaccine Information Statements (VIS), which are required by the National Childhood Vaccine Injury Act of 1986.

Manufactured by:
Sanofi Pasteur Limited
Toronto Ontario Canada

Distributed by:
Sanofi Pasteur Inc.
Swiftwater PA 18370 USA

Quadracel® is a registered trademark of Sanofi Pasteur Limited.

R3-1219 USA

PRINCIPAL DISPLAY PANEL — 0.5 mL Vial Label

DTaP-IPV
4 yrs — 6 yrs

NDC 49281-562-58
Diphtheria and Tetanus
Toxoids and Acellular
Pertussis Adsorbed and
Inactivated Poliovirus
Vaccine

Quadracel®

Rx only
IM only

Single-dose (0.5 mL)Sanofi Pasteur Limited

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

PRINCIPAL DISPLAY PANEL — 0.5 mL Vial Carton

NDC 49281-562-10
DTaP-IPV

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

10 single-dose vials
0.5 mL

Rx only

Quadracel®

For children 4 yearsthrough 6 years of age

SANOFI PASTEUR

PRINCIPAL DISPLAY PANEL -- 0.5 mL Vial Carton
(click image for full-size original)
QUADRACEL diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:49281-562
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) 15 [Lf] in 0.5 mL
CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) (CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)) CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 5 [Lf] in 0.5 mL
BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED) (BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED)) BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED) 20 ug 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) 20 ug in 0.5 mL
BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (BORDETELLA PERTUSSIS PERTACTIN ANTIGEN) BORDETELLA PERTUSSIS PERTACTIN ANTIGEN 3 ug in 0.5 mL
BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN (BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN) BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN 5 ug in 0.5 mL
POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED) (POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED)) POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED) 40 [D'ag'U] in 0.5 mL
POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED) (POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED)) POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED) 8 [D'ag'U] in 0.5 mL
POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED) (POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED)) POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED) 32 [D'ag'U] in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
ALUMINUM PHOSPHATE 1.5 mg in 0.5 mL
PHENOXYETHANOL 3.3 mg in 0.5 mL
POLYSORBATE 80 10 [D'ag'U] in 0.5 mL
FORMALDEHYDE 5 ug in 0.5 mL
GLUTARAL 50 ng in 0.5 mL
ALBUMIN BOVINE 50 ng in 0.5 mL
NEOMYCIN 0.000004 ug in 0.5 mL
POLYMYXIN B SULFATE 0.000004 ug in 0.5 mL
WATER
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49281-562-10 10 VIAL, SINGLE-USE in 1 PACKAGE contains a VIAL, SINGLE-USE (49281-562-58)
1 NDC:49281-562-58 0.5 mL in 1 VIAL, SINGLE-USE This package is contained within the PACKAGE (49281-562-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125525 03/24/2015
Labeler — Sanofi Pasteur Inc. (086723285)
Establishment
Name Address ID/FEI Operations
Sanofi Pasteur Limited 208206623 MANUFACTURE

Revised: 04/2020 Sanofi Pasteur Inc.

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