IMOVAX POLIO SOLUTION

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

POLIOVIRUS TYPE 1 MAHONEY (INACTIVATED); POLIOVIRUS TYPE 2 MEF1 (INACTIVATED); POLIOVIRUS TYPE 3 SAUKETT (INACTIVATED)

Saatavilla:

SANOFI PASTEUR LIMITED

ATC-koodi:

J07BF03

INN (Kansainvälinen yleisnimi):

POLIOMYELITIS, TRIVALENT, INACTIVATED, WHOLE VIRUS

Annos:

29UNIT; 7UNIT; 26UNIT

Lääkemuoto:

SOLUTION

Koostumus:

POLIOVIRUS TYPE 1 MAHONEY (INACTIVATED) 29UNIT; POLIOVIRUS TYPE 2 MEF1 (INACTIVATED) 7UNIT; POLIOVIRUS TYPE 3 SAUKETT (INACTIVATED) 26UNIT

Antoreitti:

SUBCUTANEOUS

Kpl paketissa:

15G/50G

Prescription tyyppi:

Schedule D

Terapeuttinen alue:

VACCINES

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0365241002; AHFS:

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2000-05-01

Valmisteyhteenveto

Sanofi Pasteur
059 – IMOVAX® Polio
Product Monograph
_ _
_IMOVAX® Polio - Inactivated Poliomyelitis Vaccine (Vero Cell Origin)
_
_Page 1 of 16_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
IMOVAX® POLIO
INACTIVATED POLIOMYELITIS VACCINE (VERO CELL ORIGIN)
Each 0.5 mL dose contains Poliovirus (Formaldehyde Inactivated)
[Type 1 Mahoney, Type 2 MEF1, Type 3 Saukett]
Suspension for Injection
Active Immunizing Agent
(for the Prevention of Poliomyelitis)
ATC Code: J07BF03 Poliomyelitis, trivalent, inactivated, whole virus
SANOFI PASTEUR LIMITED
Toronto, Ontario, Canada
Date of Initial Authorization:
Feb 16, 1995
Date of Revision:
Oct 30, 2023
Submission Control Number: 276217
Sanofi Pasteur
059 – IMOVAX® Polio
Product Monograph
_ _
_IMOVAX® Polio - Inactivated Poliomyelitis Vaccine (Vero Cell Origin)
_
_Page 2 of 16_
RECENT MAJOR LABEL CHANGES
4 DOSAGE AND ADMINISTRATION
10/2023
7 WARNINGS AND PRECAUTIONS
04/2023
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
................................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
4
DOSAGE AND ADMINISTRATION
.................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
....................................................... 4
4.4
Administration
................