ZOSTAVAX POWDER FOR SUSPENSION
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
02-09-2014
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Active ingredient:
VARICELLA-ZOSTER VIRUS VACCINE LIVE ATTENUATED (OKA/MERCK STRAIN)
Available from:
MERCK CANADA INC
ATC code:
J07BK02
INN (International Name):
ZOSTER, LIVE ATTENUATED
Dosage:
19400PFU
Pharmaceutical form:
POWDER FOR SUSPENSION
Composition:
VARICELLA-ZOSTER VIRUS VACCINE LIVE ATTENUATED (OKA/MERCK STRAIN) 19400PFU
Administration route:
SUBCUTANEOUS
Units in package:
0.65ML
Prescription type:
Schedule D
Therapeutic area:
VACCINES
Product summary:
Active ingredient group (AIG) number: 0152480003; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2015-05-06
Summary of Product characteristics
_ _
_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
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