MENACTRA- neisseria meningitidis group a capsular polysaccharide diphtheria toxoid conjugate antigen, neisseria meningitidis gro

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

NEISSERIA MENINGITIDIS GROUP A CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN (UNII: RE9A0H8OAB) (NEISSERIA MENINGITIDIS GROUP A CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN - UNII:RE9A0H8OAB), NEISSERIA MENINGITIDIS GROUP C CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN (UNII: 2J57K2523T) (NEISSERIA MENINGITIDIS GROUP C CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN - UNII:2J57K2523T), NEISSERIA MENINGITIDIS GROUP Y CAPSULAR POLYSACCHARIDE DIPHTHERIA

Предлага се от:

Sanofi Pasteur Inc.

INN (Международно Name):

NEISSERIA MENINGITIDIS GROUP A CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN

Композиция:

NEISSERIA MENINGITIDIS GROUP A CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN 4 ug in 0.5 mL

Начин на приложение:

INTRAMUSCULAR

Терапевтични показания:

Menactra® , Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine, is indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135. Menactra is approved for use in individuals 9 months through 55 years of age. Menactra does not prevent N meningitidis serogroup B disease. Severe allergic reaction (eg, anaphylaxis) after a previous dose of a meningococcal capsular polysaccharide-, diphtheria toxoid- or CRM197 -containing vaccine, or to any component of Menactra [see Description (11) ]. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Menactra during pregnancy. To enroll in or obtain information about the registry, call Sanofi Pasteur at 1-800-822-2463. Risk Summary All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects an

Каталог на резюме:

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.

Статус Оторизация:

Biologic Licensing Application

Данни за продукта

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
SANOFI PASTEUR INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MENACTRA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MENACTRA VACCINE.
MENACTRA , MENINGOCOCCAL (GROUPS A, C, Y AND W-135) POLYSACCHARIDE
DIPHTHERIA TOXOID
CONJUGATE VACCINE
SOLUTION FOR INTRAMUSCULAR INJECTION
INITIAL U.S. APPROVAL: 2005
INDICATIONS AND USAGE
Menactra is indicated for active immunization to prevent invasive
meningococcal disease caused by
_Neisseria meningitidis_ serogroups A, C, Y and W-135. Menactra is
approved for use in individuals 9 months
through 55 years of age. Menactra does not prevent _N meningitidis_
serogroup B disease. (1)
DOSAGE AND ADMINISTRATION
A 0.5 mL dose for intramuscular injection. (2)
Primary Vaccination:
Children 9 through 23 months of age: Two doses, three months apart.
Individuals 2 through 55 years of age: A single dose.
Booster Vaccination:
A single booster dose may be given to individuals 15 through 55 years
of age at continued risk for
meningococcal disease, if at least 4 years have elapsed since the
prior dose.
DOSAGE FORMS AND STRENGTHS
Solution supplied in 0.5 mL single-dose vials (3)
CONTRAINDICATIONS
Severe allergic reaction (eg, anaphylaxis) after a previous dose of a
meningococcal capsular
polysaccharide-, diphtheria toxoid- or CRM
-containing vaccine, or to any component of Menactra. (4)
WARNINGS AND PRECAUTIONS
Persons previously diagnosed with Guillain-Barré syndrome (GBS) may
be at increased risk of GBS
following receipt of Menactra. The decision to give Menactra should
take into account the potential
benefi