IMOVAX POLIO SOLUTION

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

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Letöltés Termékjellemzők (SPC)
30-10-2023

Aktív összetevők:

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

Beszerezhető a:

SANOFI PASTEUR LIMITED

ATC-kód:

J07BF03

INN (nemzetközi neve):

POLIOMYELITIS, TRIVALENT, INACTIVATED, WHOLE VIRUS

Adagolás:

29UNIT; 7UNIT; 26UNIT

Gyógyszerészeti forma:

SOLUTION

Összetétel:

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

Az alkalmazás módja:

SUBCUTANEOUS

db csomag:

15G/50G

Recept típusa:

Schedule D

Terápiás terület:

VACCINES

Termék összefoglaló:

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

Engedélyezési státusz:

APPROVED

Engedély dátuma:

2000-05-01

Termékjellemzők

                                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
................
                                
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