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) XXXXXX

7507

(L) XXXXXX

(E) DDMMMYY

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

PRINCIPAL DISPLAY PANEL — 5 Vial Package

NDC 49281-589-05

MCV4

Meningococcal (Groups A, C, Y and
W-135) Polysaccharide Diphtheria
Toxoid Conjugate VaccineMenactra®

5 single-dose vials

Rx only

For 9 months through 55 years of age

SANOFI PASTEUR

PRINCIPAL DISPLAY PANEL -- 5 Vial Package
(click image for full-size original)
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
Product Information
Product Type VACCINE Item Code (Source) NDC:49281-589
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NEISSERIA MENINGITIDIS GROUP A CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN (NEISSERIA MENINGITIDIS GROUP A CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN) NEISSERIA MENINGITIDIS GROUP A CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN 4 ug in 0.5 mL
NEISSERIA MENINGITIDIS GROUP C CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN (NEISSERIA MENINGITIDIS GROUP C CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN) NEISSERIA MENINGITIDIS GROUP C CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN 4 ug in 0.5 mL
NEISSERIA MENINGITIDIS GROUP Y CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN (NEISSERIA MENINGITIDIS GROUP Y CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN) NEISSERIA MENINGITIDIS GROUP Y CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN 4 ug in 0.5 mL
NEISSERIA MENINGITIDIS GROUP W-135 CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN (NEISSERIA MENINGITIDIS GROUP W-135 CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN) NEISSERIA MENINGITIDIS GROUP W-135 CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN 4 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
formaldehyde
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49281-589-05 5 VIAL, SINGLE-DOSE in 1 PACKAGE contains a VIAL, SINGLE-DOSE (49281-589-58)
1 NDC:49281-589-58 0.5 mL in 1 VIAL, SINGLE-DOSE This package is contained within the PACKAGE (49281-589-05)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125089 01/14/2005
Labeler — Sanofi Pasteur Inc. (086723285)
Establishment
Name Address ID/FEI Operations
Sanofi Pasteur Inc. 086723285 MANUFACTURE

Revised: 01/2021 Sanofi Pasteur Inc.

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