VARIVAX III POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

VARICELLA VIRUS LIVE ATTENUATED (OKA/MERCK STRAIN)

Available from:

MERCK CANADA INC

ATC code:

J07BK01

INN (International Name):

VARICELLA, LIVE ATTENUATED

Dosage:

1350UNIT

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

VARICELLA VIRUS LIVE ATTENUATED (OKA/MERCK STRAIN) 1350UNIT

Administration route:

SUBCUTANEOUS

Units in package:

1/10X0.5ML

Prescription type:

Schedule D

Therapeutic area:

VACCINES

Product summary:

Active ingredient group (AIG) number: 0165422001; AHFS:

Authorization status:

APPROVED

Authorization date:

2005-07-08

Summary of Product characteristics

_VARIVAX_
_®_
_ III (varicella virus vaccine, live, attenuated [Oka/Merck])_
_ _
_Page 1 of 28_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
VARIVAX® III
(varicella virus vaccine, live, attenuated [Oka/Merck])
Lyophilized powder for subcutaneous injection
1350 plaque forming units (PFU) per 0.5 mL single dose vials of
Oka/Merck varicella virus, live,
attenuated
Active immunizing agent against varicella
ATC code: J07BK01
Merck Canada Inc.
16750 route Transcanadienne
Kirkland QC Canada H9H 4M7
www.merck.ca
Date of Initial Authorization:
JUN 19, 2002
Date of Revision:
November 28, 2023
SUBMISSION CONTROL NUMBER: 276760
_ _
_VARIVAX_
_®_
_ III (varicella virus vaccine, live, attenuated [Oka/Merck])_
_ _
_Page 2 of 28_
RECENT MAJOR LABEL CHANGES
8 Adverse Reactions, 8.5 Post-Market Adverse Reactions
06/2023
9 Drug Interactions, 9.4 Drug-Drug Interaction
09/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
RECENT MAJOR LABEL CHANGES
............................................................................................
2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................................
4
1
INDICATIONS
...............................................................................................................
4
1.1
Pediatrics (Less than 1 year old)
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
4
DOSAGE AND ADMINISTRATION
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5
4.2
Recommended Dose and Dosage Adjustment
.................................