FLUZONE SUSPENSION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

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

Διαθέσιμο από:

SANOFI PASTEUR INC

Φαρμακολογική κατηγορία (ATC):

J07BB02

INN (Διεθνής Όνομα):

INFLUENZA, INACTIVATED, SPLIT VIRUS OR SURFACE ANTIGEN

Δοσολογία:

7.5MCG; 7.5MCG; 7.5MCG

Φαρμακοτεχνική μορφή:

SUSPENSION

Σύνθεση:

HAEMAGGLUTININ-STRAIN A (H1N1) 7.5MCG; HAEMAGGLUTININ-STRAIN A (H3N2) 7.5MCG; HAEMAGGLUTININ-STRAIN B 7.5MCG

Οδός χορήγησης:

INTRAMUSCULAR

Μονάδες σε πακέτο:

0.25ML

Τρόπος διάθεσης:

Schedule D

Θεραπευτική περιοχή:

VACCINES

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0324197003; AHFS:

Καθεστώς αδειοδότησης:

CANCELLED PRE MARKET

Ημερομηνία της άδειας:

2016-12-21

Αρχείο Π.Χ.Π.

SANOFI PASTEUR
SECTION 1.3.1 CLEAN PRODUCT MONOGRAPH
271/371 FLUZONE
®
Page 1 of 26
PRODUCT MONOGRAPH
FLUZONE
®
INFLUENZA VIRUS VACCINE TRIVALENT TYPES A AND B (SPLIT VIRION)
Suspension for Injection
Active Immunizing Agent for the Prevention of Influenza
ATC Code: J07B B
Manufactured by:
SANOFI PASTEUR INC.
Swiftwater, PA 18370 USA
Distributed by:
SANOFI PASTEUR LIMITED
Toronto, Ontario, Canada
DATE OF REVISION:
August 2014
CONTROL NO.: 177170 DATE OF APPROVAL: SEPTEMBER 4, 2014
SANOFI PASTEUR
SECTION 1.3.1 CLEAN PRODUCT MONOGRAPH
271/371 FLUZONE
®
Page 2 of 26
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................... 4
SUMMARY PRODUCT INFORMATION
..................................................................................
4
DESCRIPTION
...............................................................................................................................
4
INDICATIONS AND CLINICAL USE
........................................................................................
4
CONTRAINDICATIONS
...............................................................................................................
5
WARNINGS AND PRECAUTIONS
.............................................................................................
5
General
..........................................................................................................................................
5
Hematologic
......................................................................................................................................
6
Immune
..........................................................................................................................................
6
Neurologic
.........................................................................................................................................
6
Respiratory
.......................................................................................................................