HAVRIX 720 JUNIOR SUSPENSION

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

HEPATITIS A VIRUS, INACTIVATED

Предлага се от:

GLAXOSMITHKLINE INC

АТС код:

J07BC02

INN (Международно Name):

HEPATITIS A, INACTIVATED, WHOLE VIRUS

дозиране:

720UNIT

Лекарствена форма:

SUSPENSION

Композиция:

HEPATITIS A VIRUS, INACTIVATED 720UNIT

Начин на приложение:

INTRAMUSCULAR

Броя в опаковка:

15G/50G

Вид предписание :

Schedule D

Терапевтична област:

VACCINES

Каталог на резюме:

Active ingredient group (AIG) number: 0165325001; AHFS:

Статус Оторизация:

APPROVED

Дата Оторизация:

2001-06-12

Данни за продукта

_HAVRIX (hepatitis A vaccine, inactivated) _
_Page 1 of 20_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
HAVRIX
Hepatitis A vaccine, inactivated
720 ELISA units per 0.5 mL of formaldehyde-inactivated hepatitis A
virus (HM175 hepatitis A virus
strain) or 1440 ELISA units per 1 mL of formaldehyde-inactivated
hepatitis A virus (HM175 hepatitis A
virus strain)
Suspension for injection, Intramuscular
Active immunizing agent against infection by hepatitis A virus
ATC Code: J07BC02
GlaxoSmithKline Inc.
100 Milverton Drive, Suite 800
Mississauga, Ontario
L5R 4H1
Date of Initial Authorization:
December 31, 1996
Date of Revision:
November 9, 2023
Submission Control Number: 276326
_©_
_2023 GSK group of companies or its licensor _
_Trademarks are owned by or licensed to the GSK group of companies _
_HAVRIX (hepatitis A vaccine, inactivated) _
_Page 2 of 20_
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
.................................................................................................
4
4
DOSAGE AND ADMINISTRATION
.................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
.........................