BEXSERO SUSPENSION

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

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)

Pieejams no:

GLAXOSMITHKLINE INC

ATĶ kods:

J07AH09

SNN (starptautisko nepatentēto nosaukumu):

MENINGOCOCCUS B, MULTICOMPONENT VACCINE

Deva:

50MCG; 50MCG; 50MCG; 25MCG

Zāļu forma:

SUSPENSION

Kompozīcija:

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

Ievadīšanas:

INTRAMUSCULAR

Vienības iepakojumā:

1/10 PFS

Receptes veids:

Schedule D

Ārstniecības joma:

VACCINES

Produktu pārskats:

Active ingredient group (AIG) number: 0455051001; AHFS:

Autorizācija statuss:

APPROVED

Autorizācija datums:

2013-12-06

Produkta apraksts

_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
.......................................