VARILRIX POWDER FOR SOLUTION

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

VARICELLA-ZOSTER VIRUS VACCINE LIVE ATTENUATED (OKA-STRAIN); WATER

可用日期:

GLAXOSMITHKLINE INC

ATC代码:

J07BK01

INN（国际名称）:

VARICELLA, LIVE ATTENUATED

剂量:

1995PFU; 0.5ML

药物剂型:

POWDER FOR SOLUTION

组成:

VARICELLA-ZOSTER VIRUS VACCINE LIVE ATTENUATED (OKA-STRAIN) 1995PFU; WATER 0.5ML

给药途径:

SUBCUTANEOUS

每包单位数:

0.5 ML DOSE X 1, 10

处方类型:

Schedule D

治疗领域:

VACCINES

產品總結:

Active ingredient group (AIG) number: 0262214002; AHFS:

授权状态:

APPROVED

授权日期:

1999-10-13

产品特点

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_Page 1 of 21_
PRODUCT MONOGRAPH
VARILRIX
Varicella virus vaccine, live, attenuated (Oka-strain)
Lyophilized powder for injection
Active immunizing agent against infection by varicella-zoster virus
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
Date of Revision:
August 14, 2019
Submission Control No: 228245
_©_
_2019 GSK group of companies or its licensor _
Trademarks are owned by or licensed to the GSK group of companies._ _
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_Page 2 of 21_
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
.....................................................................
5
ADVERSE REACTIONS
.......................................................................................
7
DOSAGE AND ADMINISTRATION
................................................................. 10
OVERDOSAGE
...................................................................................................
12
ACTION AND CLINICAL PHARMACOLOGY
............................................... 13
STORAGE AND STABILITY
.............................................................................
13
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................ 13
PART II: SCIENTIFIC INFORMATION
.................................................................. 15
PHARMACEUTICAL INFORMATION
............................................................. 15
CLINICAL TRIALS
.............................................................................................
15
DETAILED PHARMACOLOGY
...................