INFLUVAC SUSPENSION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

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

Available from:

BGP PHARMA ULC

ATC code:

J07BB01

INN (International Name):

INFLUENZA, INACTIVATED, WHOLE VIRUS

Dosage:

15MCG; 15MCG; 15MCG

Pharmaceutical form:

SUSPENSION

Composition:

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

Administration route:

INTRAMUSCULAR

Units in package:

0.5ML/10X0.5ML

Prescription type:

Schedule D

Therapeutic area:

VACCINES

Product summary:

Active ingredient group (AIG) number: 0324197002; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2022-10-25

Summary of Product characteristics

______________________________________________________________________________________________
_
INFLUVAC
®
influenza vaccine, surface antigen, inactivated_ Page 1 of 28 _
Date of Revision: April 25, 2018
PRODUCT MONOGRAPH
D
INFLUVAC
®
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.
Active Immunizing Agent for the Prevention of Influenza
ATC Code: J07BB02
BGP Pharma.ULC
85 Advance Road
Etobicoke, Ontario
M8Z 2S6
Submission Control No.: 212659
Date of Approval: May 1, 2018
®
Registered Trademark BGP Products B.V., licensed use by BGP
Pharma.ULC, Etobicoke, Ontario, M8Z 2S6
______________________________________________________________________________________________
_
INFLUVAC
®
influenza vaccine, surface antigen, inactivated_ Page 2 of 28 _
Date of Revision: April 25, 2018
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
.................................................................................................
11
DOSAGE AND ADMINISTRATION
.............................................................................
11
OVERDOSAGE
........................................................