ZOSTAVAX POWDER FOR SUSPENSION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

VARICELLA-ZOSTER VIRUS VACCINE LIVE ATTENUATED (OKA/MERCK STRAIN)

Disponible depuis:

MERCK CANADA INC

Code ATC:

J07BK02

DCI (Dénomination commune internationale):

ZOSTER, LIVE ATTENUATED

Dosage:

19400PFU

forme pharmaceutique:

POWDER FOR SUSPENSION

Composition:

VARICELLA-ZOSTER VIRUS VACCINE LIVE ATTENUATED (OKA/MERCK STRAIN) 19400PFU

Mode d'administration:

SUBCUTANEOUS

Unités en paquet:

0.65ML

Type d'ordonnance:

Schedule D

Domaine thérapeutique:

VACCINES

Descriptif du produit:

Active ingredient group (AIG) number: 0152480003; AHFS:

Statut de autorisation:

CANCELLED POST MARKET

Date de l'autorisation:

2015-05-06

Résumé des caractéristiques du produit

_ _
_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