VARIVAX III POWDER FOR SOLUTION

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

VARICELLA VIRUS LIVE ATTENUATED (OKA/MERCK STRAIN)

Disponible des:

MERCK CANADA INC

Codi ATC:

J07BK01

Designació comuna internacional (DCI):

VARICELLA, LIVE ATTENUATED

Dosis:

1350UNIT

formulario farmacéutico:

POWDER FOR SOLUTION

Composición:

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

Vía de administración:

SUBCUTANEOUS

Unidades en paquete:

1/10X0.5ML

tipo de receta:

Schedule D

Área terapéutica:

VACCINES

Resumen del producto:

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

Estat d'Autorització:

APPROVED

Data d'autorització:

2005-07-08

Fitxa tècnica

_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
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................................
4
1
INDICATIONS
...............................................................................................................
4
1.1
Pediatrics (Less than 1 year old)
.............................................................................
4
1.2
Geriatrics
................................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
4
DOSAGE AND ADMINISTRATION
.................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
.................................