MENOMUNE A/C/Y/W-135 COMBINED- neisseria meningitidis group capsular polysaccharide antigen and

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

NEISSERIA MENINGITIDIS GROUP A CAPSULAR POLYSACCHARIDE ANTIGEN (UNII: 1I86B47NY4) (NEISSERIA MENINGITIDIS GROUP A CAPSULAR POLYSACCHARIDE ANTIGEN - UNII:1I86B47NY4)

Предлага се от:

Sanofi Pasteur Inc.

INN (Международно Name):

NEISSERIA MENINGITIDIS GROUP A CAPSULAR POLYSACCHARIDE ANTIGEN

Композиция:

NEISSERIA MENINGITIDIS GROUP A CAPSULAR POLYSACCHARIDE ANTIGEN 50 ug in 0.5 mL

Статус Оторизация:

Biologic Licensing Application

Данни за продукта

MENOMUNE - A/C/Y/W-135 COMBINED- NEISSERIA MENINGITIDIS GROUP A
CAPSULAR
POLYSACCHARIDE ANTIGEN, NEISSERIA MENINGITIDIS GROUP C CAPSULAR
POLYSACCHARIDE ANTIGEN, NEISSERIA
MENINGITIDIS GROUP Y CAPSULAR POLYSACCHARIDE ANTIGEN, AND NEISSERIA
MENINGITIDIS GROUP W-135
CAPSULAR POLYSACCHARIDE ANTIGEN
SANOFI PASTEUR INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MENOMUNE – A/C/Y/W-135 VACCINE SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MENOMUNE – A/C/Y/W-135 VACCINE.
MENOMUNE – A/C/Y/W-135, MENINGOCOCCAL POLYSACCHARIDE VACCINE, GROUPS A, C, Y
AND W-135 COMBINED
SOLUTION FOR SUBCUTANEOUS INJECTION
INITIAL U.S. APPROVAL: 1981
RECENT MAJOR CHANGES
Warnings and Precautions, Latex (5.1)
The latex warning has been removed for the diluent vial.
[4/2016]
INDICATIONS AND USAGE
Menomune – A/C/Y/W-135 vaccine is a vaccine indicated for active
immunization against invasive meningococcal
disease caused by _Neisseria meningitidis_ serogroups A, C, Y, and
W-135. Menomune – A/C/Y/W-135 vaccine is
approved for use in persons 2 years of age and older. Menomune –
A/C/Y/W-135 vaccine does not prevent _N_
_meningitidis_ serogroup B disease. (1)
DOSAGE AND ADMINISTRATION
Single 0.5 mL subcutaneous injection. (2)
DOSAGE FORMS AND STRENGTHS
Menomune – A/C/Y/W-135 vaccine is supplied as a single dose or
multidose (10 dose) vial of lyophilized vaccine, with
corresponding single dose or multidose vial of diluent. After
reconstitution of the lyophilized vaccine with the diluent,
each dose consists of a 0.5 mL solution for injection. (3)
CONTRAINDICATIONS
Do not administer to anyone with a history of a severe allergic
reaction (e.g., anaphylaxis) to Menomune – A/C/Y/W-
135 vaccine or any component of the vaccine. (4)
WARNINGS AND PRECAUTIONS
The stopper to the vial of lyophilized vaccine contains natural rubber
latex which may cause allergic reactions. (5.1)
ADVERSE REACTIONS
Common (>10%) adverse events in children 2 to 10 years of age were
in