PRIORIX-TETRA POWDER FOR SOLUTION

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

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

Beschikbaar vanaf:

GLAXOSMITHKLINE INC

ATC-code:

J07BD54

INN (Algemene Internationale Benaming):

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

Dosering:

25118.9CCID50; 1000CCID50; 1000CCID50; 1995.2623CCID50

farmaceutische vorm:

POWDER FOR SOLUTION

Samenstelling:

MUMPS VIRUS VACCINE LIVE ATTENUATED (JERYL LYNN STRAIN) 25118.9CCID50; MEASLES VIRUS VACCINE LIVE ATTENUATED 1000CCID50; RUBELLA VIRUS VACCINE LIVE ATTENUATED (WISTAR RA27/3 STRAIN) 1000CCID50; VARICELLA-ZOSTER VIRUS VACCINE LIVE ATTENUATED (OKA-STRAIN) 1995.2623CCID50

Toedieningsweg:

INTRAMUSCULAR

Eenheden in pakket:

10X0.5ML

Prescription-type:

Schedule D

Therapeutisch gebied:

VACCINES

Product samenvatting:

Active ingredient group (AIG) number: 0464901001; AHFS:

Autorisatie-status:

APPROVED

Autorisatie datum:

2007-07-30

Productkenmerken

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_Page 1 of 37_
PRODUCT MONOGRAPH
PRIORIX-TETRA
Combined measles, mumps, rubella and varicella vaccine, live,
attenuated
Lyophilized powder for injection
Active immunizing agent
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
Date of Revision:
August 14, 2019
Submission Control No: 228247
_© 2019 GSK group of companies or its licensor _
_Trademarks are owned by or licensed to the GSK group of companies _
_ _
_Page 2 of 37_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................ 3
SUMMARY PRODUCT INFORMATION
........................................................... 3
DESCRIPTION.......................................................................................................
3
INDICATIONS AND CLINICAL USE
................................................................. 3
CONTRAINDICATIONS
......................................................................................
4
WARNINGS AND PRECAUTIONS
.....................................................................
4
ADVERSE REACTIONS
.......................................................................................
6
DRUG INTERACTIONS
.......................................................................................
9
DOSAGE AND ADMINISTRATION
................................................................. 10
OVERDOSAGE
...................................................................................................
13
ACTION AND CLINICAL PHARMACOLOGY
............................................... 13
STORAGE AND STABILITY
.............................................................................
14
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................ 15
PART II: SCIENTIFIC INFORMATION
.................................................................. 16
PHARMACEUTICAL INFORMATION
............................................................. 16
CLINICAL TRIALS
..................................................................................