Vaccine Information: Menactra (Page 4 of 4)
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
- Single-dose vial, 0.5 mL (NDC 49281-589-58). Supplied as a package of 5 vials (NDC 49281-589-05).
16.2 Storage and Handling
Store at 2° to 8°C (35° to 46°F). DO NOT FREEZE. Frozen/previously frozen product should not be used. Do not use after the expiration date.
Discard any unused portion.
17 PATIENT COUNSELING INFORMATION
Vaccine Information Statements are required by the National Childhood Vaccine Injury Act of 1986 to be given prior to immunization to the patient, parent, or guardian. These materials are available free of charge at the Centers for Disease Control and Prevention (CDC) website (www.cdc.gov/vaccines).
Inform the patients, parents or guardians about:
- Potential benefits and risks of immunization with Menactra.
- Potential for adverse reactions that have been temporally associated with administration of Menactra or other vaccines containing similar components.
- Reporting any adverse reactions to their healthcare provider.
- The Sanofi Pasteur Inc. Pregnancy Registry, as appropriate [see Pregnancy (8.1)].
Menactra, DAPTACEL, Menomune, IPOL, and Typhim Vi are registered trademarks of Sanofi, its affiliates and subsidiaries.
Prevnar is a registered trademark of Wyeth LLC.
ProQuad and VAQTA are registered trademarks of Merck & Co., Inc.
Manufactured by:
Sanofi Pasteur Inc.
Swiftwater, PA 18370 USA
PRINCIPAL DISPLAY PANEL — 0.5 mL Vial Label
NDC 49281-589-58
single-dose
(0.5 mL)
Meningococcal
(Groups A, C, Y and
W-135) Polysaccharide
Diphtheria Toxoid
Conjugate Vaccine
Menactra®
Rx only
Mfd by: Sanofi Pasteur Inc.
Menactra® MCV4
NDC 49281-589-58
Rx only
Mfd by: Sanofi Pasteur Inc.
(L)
7507
(L) XXXXXX
(E) DDMMMYY
PRINCIPAL DISPLAY PANEL — 5 Vial Package
NDC 49281-589-05
MCV4
Meningococcal (Groups A, C, Y and
W-135) Polysaccharide Diphtheria
Toxoid Conjugate Vaccine
5
single-
dosevials
Menactra®
Rx only
For 9 months through 55 years of age
SANOFI PASTEUR
MENACTRA neisseria meningitidis group a capsular polysaccharide diphtheria toxoid conjugate antigen, neisseria meningitidis group c capsular polysaccharide diphtheria toxoid conjugate antigen, neisseria meningitidis group y capsular polysaccharide diphtheria toxoid conjugate antigen, and neisseria meningitidis group w-135 capsular polysaccharide diphtheria toxoid conjugate antigen injection, solution | ||||||||||||||||||
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Labeler — Sanofi Pasteur Inc. (086723285) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Sanofi Pasteur Inc. | 086723285 | MANUFACTURE (49281-589) |
Revised: 01/2021 Sanofi Pasteur Inc.
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