ZOSTAVAX POWDER FOR SUSPENSION

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

VARICELLA-ZOSTER VIRUS VACCINE LIVE ATTENUATED (OKA/MERCK STRAIN)

Доступна з:

MERCK CANADA INC

Код атс:

J07BK02

ІПН (Міжнародна Ім'я):

ZOSTER, LIVE ATTENUATED

Дозування:

19400PFU

Фармацевтична форма:

POWDER FOR SUSPENSION

Склад:

VARICELLA-ZOSTER VIRUS VACCINE LIVE ATTENUATED (OKA/MERCK STRAIN) 19400PFU

Адміністрація маршрут:

SUBCUTANEOUS

Одиниць в упаковці:

0.65ML

Тип рецепту:

Schedule D

Терапевтична области:

VACCINES

Огляд продуктів:

Active ingredient group (AIG) number: 0152480003; AHFS:

Статус Авторизація:

CANCELLED POST MARKET

Дата Авторизація:

2015-05-06

Характеристики продукта

_ _
_ZOSTAVAX_

_ _
_(zoster vaccine live, attenuated [Oka/Merck]) _
_Page 1 of 27_
PRODUCT MONOGRAPH
ZOSTAVAX

(zoster vaccine live, attenuated [Oka/Merck]) _ _
Powder for suspension for injection
Live, attenuated virus varicella-zoster vaccine
MERCK CANADA INC.
16750 route Transcanadienne
Kirkland QC Canada H9H 4M7
http://www.merck.ca
Date of Revision:
July 4, 2014
GLOBAL TRADE IDENTIFICATION NO.:
0 67055 04736 7 (1 vial)
CONTROL NO: 176177
DATE OF APPROVAL: 25 JULY 2014
_ _
_ZOSTAVAX_

_ _
_(zoster vaccine live, attenuated [Oka/Merck]) _
_Page 2 of 27_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT
INFORMATION.........................................................................
3
DESCRIPTION
....................................................................................................................
3
INDICATIONS AND CLINICAL USE
..............................................................................
3
CONTRAINDICATIONS
....................................................................................................
3
WARNINGS AND PRECAUTIONS
..................................................................................
4
ADVERSE REACTIONS
....................................................................................................
5
DRUG INTERACTIONS
..................................................................................................
10
DOSAGE AND ADMINISTRATION
..............................................................................
10
OVERDOSAGE
.................................................................................................................
11
ACTION AND CLINICAL PHARMACOLOGY
............................................................. 11
STORAGE AND STABILITY
..........................................................................................
13
DOSAGE FORMS, COMPOSITION AND
PACKAGING.............................................. 13
PART