País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
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)
Novartis Vaccines and Diagnostics s.r.l.
NEISSERIA MENINGITIDIS GROUP A CAPSULAR OLIGOSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN
NEISSERIA MENINGITIDIS GROUP A CAPSULAR OLIGOSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 10 ug in 0.5 mL
Biologic Licensing Application
MENVEO- MENINGOCOCCAL (GROUPS A, C, Y AND W-135) OLIGOSACCHARIDE DIPHTHERIA CRM197 CONJUGATE VACCINE NOVARTIS VACCINES AND DIAGNOSTICS S.R.L. ---------- 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 • • • • • 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 • • • ADVERSE REACTIONS • • • • 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 Leia o documento completo