TYPHERIX LIQUID

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

SALMONELLA TYPHI VI CAPSULAR POLYSACCHARIDE VACCINE

Доступна з:

GLAXOSMITHKLINE INC

Код атс:

J07AP03

ІПН (Міжнародна Ім'я):

TYPHOID, PURIFIED POLYSACCHARIDE ANTIGEN

Дозування:

25MCG

Фармацевтична форма:

LIQUID

Склад:

SALMONELLA TYPHI VI CAPSULAR POLYSACCHARIDE VACCINE 25MCG

Адміністрація маршрут:

INTRAMUSCULAR

Одиниць в упаковці:

0.5 ML

Тип рецепту:

Schedule D

Терапевтична области:

VACCINES

Огляд продуктів:

Active ingredient group (AIG) number: 0144342001; AHFS:

Статус Авторизація:

CANCELLED POST MARKET

Дата Авторизація:

2017-12-21

Характеристики продукта

_Webtop/1134/535/131-pm-non-TYPHERIX.doc _
_January 24, 2014 _
_ _
_Page 1 of 14_
PRODUCT MONOGRAPH
TYPHERIX
®
_Salmonella typhi_ Vi Capsular Polysaccharide Vaccine
Liquid for injection
Active Immunizing Agent
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
Date of Revision:
Submission Control No: 171120
Date of Approval: Feb 10 2014
_©_
_ 2014 GlaxoSmithKline Inc. All Rights Reserved _
_TYPHERIX_
_©_
_ is a registered trademark, used under license by GlaxoSmithKline
Inc. _
_ _
_Webtop/1134/535/131-pm-non-TYPHERIX.doc _
_January 24, 2014 _
_ _
_Page 2 of 14_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................ 3
SUMMARY PRODUCT INFORMATION
........................................................... 3
INDICATIONS AND CLINICAL USE
................................................................. 3
CONTRAINDICATIONS
......................................................................................
4
WARNINGS AND PRECAUTIONS
.....................................................................
4
DRUG INTERACTIONS
.......................................................................................
7
DOSAGE AND ADMINISTRATION
................................................................... 7
OVERDOSAGE
.....................................................................................................
8
ACTION AND CLINICAL PHARMACOLOGY
................................................. 9
STORAGE AND STABILITY
...............................................................................
9
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................. 9
PART II: SCIENTIFIC INFORMATION
.................................................................. 10
PHARMACEUTICAL INFORMATION
............................................................. 10
REFERENCES
.....................................................................................................
11
PART III: CONSUMER
INFORMATION...................................