MENVEO meningococcal (groups y and w-135) oligosaccharide diphtheria crm197 conjugate vaccine

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

NEISSERIA MENINGITIDIS GROUP A CAPSULAR OLIGOSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN (UNII: 3O44U6XYQK) (NEISSERIA MENINGITIDIS GROUP A CAPSULAR OLIGOSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN - UNII:3O44U6XYQK)

Available from:

Novartis Vaccines and Diagnostics s.r.l.

INN (International Name):

NEISSERIA MENINGITIDIS GROUP A CAPSULAR OLIGOSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN

Composition:

NEISSERIA MENINGITIDIS GROUP A CAPSULAR OLIGOSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 10 ug in 0.5 mL

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

MENVEO- MENINGOCOCCAL (GROUPS A, C, Y AND W-135) OLIGOSACCHARIDE
DIPHTHERIA CRM197
CONJUGATE VACCINE
NOVARTIS VACCINES AND DIAGNOSTICS S.R.L.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MENVEO SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR MENVEO.
MENVEO® [MENINGOCOCCAL (GROUPS A, C, Y AND W-135) OLIGOSACCHARIDE
DIPHTHERIA CRM CONJUGATE
VACCINE]
SOLUTION FOR INTRAMUSCULAR INJECTION
INITIAL U.S. APPROVAL: 2010
RECENT MAJOR CHANGES
INDICATIONS AND USAGE (1) 8/2013
DOSAGE AND ADMINISTRATION (2)
Dosing Schedule (2.3) 8/2013
INDICATIONS AND USAGE
MENVEO is a vaccine indicated for active immunization to prevent
invasive meningococcal disease caused by _Neisseria_
_meningitidis_ serogroups A, C, Y and W-135. MENVEO is approved for
use in persons 2 months through 55 years of age.
MENVEO does not prevent _N. meningitidis_ serogroup B infections. (1)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Solution for intramuscular injection supplied as a lyophilized Men A
conjugate vaccine component to be reconstituted with
the accompanying Men CYW-135 liquid conjugate vaccine component. A
single dose, after reconstitution is 0.5 mL (3)
CONTRAINDICATIONS
Severe allergic reaction (e.g., anaphylaxis) after a previous dose of
MENVEO, any component of this vaccine, or any other
CRM
, diphtheria toxoid or meningococcal-containing vaccine is a
contraindication to administration of MENVEO. (4)
WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
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TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT NOVARTIS VACCINES AT
1-877-683-4732 OR VAERS AT 1-
800-822-7967 OR HTTP://VAERS.HHS.GOV.
DRUG INTERACTIONS
Do not mix MENVEO or any of its components with any other vaccine or
diluent in the same syringe or vial. (7.1)
USE IN SPECIFIC POPULATIONS
Pregnancy: Safety and effectiveness have not been established in
pregnant women. Pregnancy registry available at +1
877-413-4759. (8.1)
19 7
For intramuscular injection only (0.5