Meningitis vaccine labels and packages

Meningitis vaccine
MENVEO® FDA Package Insert
Description
Clinical Pharmacology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Dosage and Administration
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]

Labels And Packages

Principal Display Panel - Vial Label

MenA Lyophilized

Conjugate Component

NOT TO BE USED ALONE

Reconstitute with

MenCYW-135 Liquid Conjugate

Component to form Menveo

NDC 46028-218-11

Novartis Vaccines

Rx Only

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Principal Display Panel - Vial Label

MenCYW-135 Liquid

Conjugate Component

Not to be used alone

Use to reconstitute MenA

Lyophilized Conjugate

Component to form Menveo

NDC 46028-219-11

Novartis Vaccines

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Principal Display Panel - Package Label

Meningococcal (Groups A, C, Y and W-135)

Oligosaccharide

Diphtheria CRM197 Conjugate Vaccine

MENVEO ®

For use in persons 2 months through 55 years of age

Powder and solvent

for injection

NDC 46028-208-01

Rx Only

Novartis Vaccines Contains

Five doses (10 vials) per package. One dose consists of 1 vial of MenA

Lyophilized Conjugate Component to be reconstituted with 1 vial of

MenCYW-135 Liquid Conjugate Component. No preservatives.

NEITHER MenCYW-135 NOR MenA COMPONENT TO BE USED ALONE

One dose (0.5 ml) contains

• Meningococcal group A oligosaccharide........................10 micrograms

• Meningococcal group C oligosaccharide.......................... 5 micrograms

• Meningococcal group Y oligosaccharide.......................... 5 micrograms

• Meningococcal group W-135 oligosaccharide................. 5 micrograms

conjugated to CRM197 protein

Store refrigerated, away from the freezer compartment, at 36°F to 46°F

(2°C to 8°C), protect from light

For intramuscular injection. Read the package leaflet before use.

Manufactured by

Novartis Vaccines and Diagnostics S.r.l. Bellaria-Rosia 53018 Sovicille (SI), Italy

Distributed by

Novartis Vaccines and Diagnostics Inc., 350 Massachusetts Avenue, Cambridge,

MA 02139

US License No. 1751

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References

Adapted from the FDA Package Insert.