PROQUAD POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

MEASLES VIRUS VACCINE LIVE ATTENUATED (EDMONSTON B STRAIN); MUMPS VIRUS VACCINE LIVE ATTENUATED (JERYL LYNN STRAIN); RUBELLA VIRUS VACCINE LIVE ATTENUATED (WISTAR RA27/3 STRAIN); VARICELLA-ZOSTER VIRUS VACCINE LIVE ATTENUATED (OKA/MERCK STRAIN)

Available from:

MERCK CANADA INC

ATC code:

J07BD54

INN (International Name):

MEASLES, COMBINATIONS WITH MUMPS, RUBELLA AND VARICELLA, LIVE ATTENUATED

Dosage:

3.00Log10 TCID50; 4.30Log10 TCID50; 3.00Log10 TCID50; 3.99Log10 PFU

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

MEASLES VIRUS VACCINE LIVE ATTENUATED (EDMONSTON B STRAIN) 3.00Log10 TCID50; MUMPS VIRUS VACCINE LIVE ATTENUATED (JERYL LYNN STRAIN) 4.30Log10 TCID50; RUBELLA VIRUS VACCINE LIVE ATTENUATED (WISTAR RA27/3 STRAIN) 3.00Log10 TCID50; VARICELLA-ZOSTER VIRUS VACCINE LIVE ATTENUATED (OKA/MERCK STRAIN) 3.99Log10 PFU

Administration route:

SUBCUTANEOUS

Units in package:

0.5ML

Prescription type:

Schedule D

Therapeutic area:

VACCINES

Product summary:

Active ingredient group (AIG) number: 0453533002; AHFS:

Authorization status:

APPROVED

Authorization date:

2012-12-21

Summary of Product characteristics

_ProQuad®_ _(Measles, Mumps, Rubella and Varicella Virus Vaccine
Live)_
_ _
_Page 1 of 45 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PROQUAD®
(Measles, Mumps, Rubella and Varicella Virus Vaccine Live)
Lyophilized powder for injection
(0.5 mL/dose after reconstitution)
Active Immunizing Agent Against
Measles, Mumps, Rubella and Varicella
Merck Canada Inc.
16750 route Transcanadienne
Kirkland QC Canada H9H 4M7
www.merck.ca
Date of Initial Authorization:
December 21, 2012
Date of Revision:
October 13, 2022
Submission Control Number: 259191
_ProQuad_
_®_
_ (Measles, Mumps, Rubella and Varicella Virus Vaccine Live) _
_Page 2 of 45_
RECENT MAJOR LABEL CHANGES
Not applicable.
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
RECENT MAJOR LABEL
CHANGES............................................................................................
2
NOT
APPLICABLE........................................................................................................................
2
TABLE OF CONTENTS
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
..............................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
4
DOSAGE AND
ADMINISTRATION.................................................................................
5
4.1
Dosing Considerations
.......................................................................................
5
4.2
Recommended Dose and Dosage
Adjustment..................................................... 5
4.3
Reconstitution
...................................................................................................
5
4.4
Administration.........................