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, its affiliates and subsidiaries.
R7-0823 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 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
QUADRACEL diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine injection, suspension | |||||||||||||||||||||||||||||||||
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Labeler — Sanofi Pasteur Inc. (086723285) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Sanofi Pasteur Limited | 208206623 | MANUFACTURE |
Revised: 08/2023 Sanofi Pasteur Inc.
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