ZOSTAVAX II POWDER FOR SUSPENSION
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
13-11-2018
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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 (AFTER RECONST.)
Prescription type:
Schedule D
Therapeutic area:
VACCINES
Product summary:
Active ingredient group (AIG) number: 0152480003; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2022-10-14
Summary of Product characteristics
_ _
_ZOSTAVAX_
_® _
_II (zoster vaccine live, attenuated [Oka/Merck], refrigerator-stable)
_
_Page 1 of 29_
PRODUCT MONOGRAPH
ZOSTAVAX
®
II
(zoster vaccine live, attenuated [Oka/Merck], refrigerator-stable) _ _
Powder for suspension for injection
Live, attenuated virus varicella-zoster vaccine
MERCK CANADA INC.
16750 route Transcanadienne
Kirkland, QC Canada H9H 4M7
www.merck.ca
Date of Revision:
August 14, 2018
CONTROL NO: 219232
DATE OF APPROVAL: NOVEMBER 13, 2018
_ _
_ZOSTAVAX_
_® _
_II (zoster vaccine live, attenuated [Oka/Merck], refrigerator-stable)
_
_Page 2 of 29_
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...................................................................................................
11
DOSAGE AND ADMINISTRATION
..............................................................................
11
OVERDOSAGE
.................................................................................................................
12
ACTION AND CLINICAL PHARMACOLOGY
............................................................. 13
STORAGE AND STABILITY
..........................................................................................
14
DOSAGE FORMS, COMPOSITION AND
PACKAGING...........................................
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