Страна: Канада
мова: англійська
Джерело: Health Canada
RECOMBINANT NEISSERIA MENINGITIDIS GROUP B NHBA FUSION PROTEIN; RECOMBINANT NEISSERIA MENINGITIDIS GROUP B NADA PROTEIN; RECOMBINANT NEISSERIA MENINGITIDIS GROUP B FHBP FUSION PROTEIN; OUTER MEMBRANE VESICLES (NEISSERIA MENINGITIDIS GROUP B NZ98/254 STRAIN)
GLAXOSMITHKLINE INC
J07AH09
MENINGOCOCCUS B, MULTICOMPONENT VACCINE
50MCG; 50MCG; 50MCG; 25MCG
SUSPENSION
RECOMBINANT NEISSERIA MENINGITIDIS GROUP B NHBA FUSION PROTEIN 50MCG; RECOMBINANT NEISSERIA MENINGITIDIS GROUP B NADA PROTEIN 50MCG; RECOMBINANT NEISSERIA MENINGITIDIS GROUP B FHBP FUSION PROTEIN 50MCG; OUTER MEMBRANE VESICLES (NEISSERIA MENINGITIDIS GROUP B NZ98/254 STRAIN) 25MCG
INTRAMUSCULAR
1/10 PFS
Schedule D
VACCINES
Active ingredient group (AIG) number: 0455051001; AHFS:
APPROVED
2013-12-06
_BEXSERO, Multicomponent Meningococcal B Vaccine _ _Page 1 of 57_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION BEXSERO Multicomponent Meningococcal B Vaccine (recombinant, adsorbed) 0.5 mL suspension of Recombinant _Neisseria meningitidis_ serogroup B NHBA fusion protein, 50 mcg; Recombinant _Neisseria meningitidis_ serogroup B NadA protein, 50 mcg; Recombinant Neisseria meningitidis serogroup B fHbp fusion protein, 50 mcg; and, Outer membrane vesicles (OMV) from Neisseria meningitidis serogroup B strain NZ98/254, 25 mcg measured as amount of total protein containing the PorA P1.4 Suspension for Injection, Intramuscular Active Immunizing Agent for the Prevention of Meningococcal Disease ATC Code: J07AH09 GlaxoSmithKline Inc. 100 Milverton Drive Suite 800 Mississauga, Ontario L5R 4H1 Date of Initial Authorization: December 6, 2013 Date of Revision: November 9, 2023 Submission Control Number: 276312 _ _ _©_ _2023 GSK group of companies or its licensor _ _Trademarks are owned by or licensed to the GSK group of companies _ _BEXSERO, Multicomponent Meningococcal B Vaccine _ _Page 2 of 57_ RECENT MAJOR LABEL CHANGES SECTION DATE 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage Adjustment APR 2023 TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED. RECENT MAJOR LABEL CHANGES ............................................................................................ 2 TABLE OF CONTENTS .............................................................................................................. 2 1 INDICATIONS ............................................................................................................... 4 1.1 Pediatrics ................................................................................................................ 4 1.2 Geriatrics ................................................................................................................ 4 2 CONTRAINDICATIONS ....................................... Прочитайте повний документ