INFLUVAC TETRA SUSPENSION

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

HAEMAGGLUTININ-STRAIN A (H1N1); HAEMAGGLUTININ-STRAIN A (H3N2); HAEMAGGLUTININ-STRAIN B (VICTORIA); HAEMAGGLUTININ-STRAIN B (YAMAGATA)

Disponibbli minn:

BGP PHARMA ULC

Kodiċi ATC:

J07BB02

INN (Isem Internazzjonali):

INFLUENZA, INACTIVATED, SPLIT VIRUS OR SURFACE ANTIGEN

Dożaġġ:

15MCG; 15MCG; 15MCG; 15MCG

Għamla farmaċewtika:

SUSPENSION

Kompożizzjoni:

HAEMAGGLUTININ-STRAIN A (H1N1) 15MCG; HAEMAGGLUTININ-STRAIN A (H3N2) 15MCG; HAEMAGGLUTININ-STRAIN B (VICTORIA) 15MCG; HAEMAGGLUTININ-STRAIN B (YAMAGATA) 15MCG

Rotta amministrattiva:

INTRAMUSCULAR

Unitajiet fil-pakkett:

15G/50G

Tip ta 'preskrizzjoni:

Schedule D

Żona terapewtika:

VACCINES

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0455410003; AHFS:

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2019-03-01

Karatteristiċi tal-prodott

_INFLUVAC_
_®_
_ TETRA Product Monograph _
_Date of Revision: MAY 25, 2023 _
_ _
_ _
_Page 1 of 31_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
INFLUVAC® TETRA
Quadrivalent influenza vaccine, surface antigen, inactivated
Suspension for Injection, each 0.5 mL pre-filled syringe contains
neuraminidase and 15 mcg
haemagglutinin of each virus strain as recommended by the WHO and
NACI, intramuscular injection or
deep subcutaneous injection
Active Immunizing Agent for the Prevention of Influenza
ATC Code: J07BB02
BGP Pharma ULC
85 Advance Road
Etobicoke, Ontario
M8Z 2S6
Date of Initial Authorization:
MAR 01, 2019
Date of Revision:
MAY 25, 2023
Submission Control Number: 275362
®Registered Trademark of BGP Products B.V., licensed use by BGP
Pharma ULC, Etobicoke, Ontario, M8Z 2S6
_ _
_INFLUVAC_
_®_
_ TETRA Product Monograph _
_Date of Revision: May 25, 2023 _
_ _
_ _
_Page 2 of 31_
RECENT MAJOR LABEL CHANGES
1 Indications, 1.1 Pediatrics
11/2021
4 Dosage and Administration, 4.1 Dosing Considerations, 4.4
Administration
11/2021
7 Warnings and Precautions, 7.1.3 Pediatric
11/2021
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
1.2
Geriatrics
...................................................................................................................
4
2
CONTRAINDICATIONS
.....................................................