Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
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
Sanofi Pasteur Inc.
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
INTRAMUSCULAR
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
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.
Biologic Licensing Application
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 Lugege kogu dokumenti