HIBERIX POWDER FOR SOLUTION

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

HAEMOPHILUS INFLUENZAE TYPE B-PRP AND TETANUS TOXOID CONJUGATE (PRP-T)

Beschikbaar vanaf:

GLAXOSMITHKLINE INC

ATC-code:

J07AG51

INN (Algemene Internationale Benaming):

HEMOPHILUS INFLUENZAE B, COMBINATIONS WITH TOXOIDS

Dosering:

10MCG

farmaceutische vorm:

POWDER FOR SOLUTION

Samenstelling:

HAEMOPHILUS INFLUENZAE TYPE B-PRP AND TETANUS TOXOID CONJUGATE (PRP-T) 10MCG

Toedieningsweg:

INTRAMUSCULAR

Eenheden in pakket:

100

Prescription-type:

Schedule D

Therapeutisch gebied:

VACCINES

Product samenvatting:

Active ingredient group (AIG) number: 0153511001; AHFS:

Autorisatie-status:

CANCELLED POST MARKET

Autorisatie datum:

2023-04-12

Productkenmerken

_Page 1 of 16_
PRODUCT MONOGRAPH
HIBERIX
_Haemophilus influenzae_ type b (Hib) conjugate vaccine
(Tetanus Protein – Conjugate)
Lyophilized vaccine for reconstitution
Active immunizing agent against infection by _Haemophilus influenzae_
type b
Submission Control No: 227564
Date of Revision:
August 14, 2019
_© 2019 GSK group of companies or its licensor. _
_Trademarks are owned by or licensed to the GSK group of companies. _
_ _
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
_Page 2 of 16_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................ 3
SUMMARY PRODUCT INFORMATION
........................................................... 3
DESCRIPTION.......................................................................................................
3
INDICATIONS AND CLINICAL USE
................................................................. 3
CONTRAINDICATIONS
......................................................................................
4
WARNINGS AND PRECAUTIONS
.....................................................................
4
ADVERSE REACTIONS
.......................................................................................
5
ACTION AND CLINICAL PHARMACOLOGY
............................................... 10
STORAGE AND STABILITY
.............................................................................
10
PART II: SCIENTIFIC INFORMATION
.................................................................. 12
DETAILED PHARMACOLOGY
........................................................................
12
MICROBIOLOGY
...............................................................................................
12
TOXICOLOGY
....................................................................................................
12
REFERENCES
.....................................................................................................
13
PART III: CONSUMER
INFORMATION..............................................