SUPEMTEK SOLUTION

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

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

Disponibbli minn:

SANOFI PASTEUR LIMITED

Kodiċi ATC:

J07BB02

INN (Isem Internazzjonali):

INFLUENZA, INACTIVATED, SPLIT VIRUS OR SURFACE ANTIGEN

Dożaġġ:

45MCG; 45MCG; 45MCG; 45MCG

Għamla farmaċewtika:

SOLUTION

Kompożizzjoni:

RECOMBINANT HAEMAGGLUTININ PROTEIN-STRAIN A (H1N1) 45MCG; RECOMBINANT HAEMAGGLUTININ PROTEIN-STRAIN A (H3N2) 45MCG; RECOMBINANT HAEMAGGLUTININ PROTEIN-STRAIN B (VICTORIA) 45MCG; RECOMBINANT HAEMAGGLUTININ PROTEIN-STRAIN B (YAMAGATA) 45MCG

Rotta amministrattiva:

INTRAMUSCULAR

Unitajiet fil-pakkett:

100/200

Tip ta 'preskrizzjoni:

Schedule D

Żona terapewtika:

VACCINES

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0462721001; AHFS:

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2021-01-14

Karatteristiċi tal-prodott

SUPEMTEK™ (QUADRIVALENT RECOMBINANT INFLUENZA VACCINE)
PAGE 1 OF 23
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
SUPEMTEK
TM
Quadrivalent Recombinant Influenza Vaccine
Each 0.5 mL dose contains 45 mcg haemagglutinin of each
Influenza Virus Type A (H1N1), Type A (H3N2), Type B (Victoria) and
Type B
(Yamagata) strains
Solution for Intramuscular Injection
Active Immunizing Agent for the Prevention of Influenza
ATC Code: J07B B02
Submission Control No: 263892 Date of Approval: May 10, 2022
Sanofi Pasteur Limited
1755 Steeles Ave. W
Toronto, Ontario, M2R 3T4
Date of Initial Authorization:
JAN 14, 2021
Date of Revision:
April 28, 2022
SANOFI PASTEUR
SECTION 1.3.1
529 – SUPEMTEK
TM
PRODUCT MONOGRAPH
SUPEMTEK™ (QUADRIVALENT RECOMBINANT INFLUENZA VACCINE)
PAGE 2 OF 23
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
PART I: HEALTH PROFESSIONAL INFORMATION
...............................................................................4
1
INDICATIONS..................................................................................................................4
1.1
Pediatrics.....................................................................................................................4
1.2
Geriatrics
.....................................................................................................................4
2
CONTRAINDICATIONS
.....................................................................................................4
4
DOSAGE AND
ADMINISTRATION.......................................................................................4
4.2
Recommended Dose and Dosage Adjustment
...................................................................4
4.4
Administration..............................................................................................................5
5
OVERDOSAGE.................................................................................................................5
6
DOSAGE FORMS, STRENG