INTANZA 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 LIMITED

Φαρμακολογική κατηγορία (ATC):

J07BB02

INN (Διεθνής Όνομα):

INFLUENZA, INACTIVATED, SPLIT VIRUS OR SURFACE ANTIGEN

Δοσολογία:

15MCG; 15MCG; 15MCG

Φαρμακοτεχνική μορφή:

SUSPENSION

Σύνθεση:

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

Οδός χορήγησης:

INTRADERMAL

Μονάδες σε πακέτο:

10X0.1ML

Τρόπος διάθεσης:

Schedule D

Θεραπευτική περιοχή:

VACCINES

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0324197005; AHFS:

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2015-07-03

Αρχείο Π.Χ.Π.

SANOFI PASTEUR
SECTION 1.3.1 CLEAN PRODUCT MONOGRAPH
415/416 – INTANZA
®
NOTIFIABLE CHANGE – REVISED LABELLING
PAGE 1 OF 31
PRODUCT MONOGRAPH
INTANZA
®
INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)
Suspension for Injection
For active immunization against Influenza
ATC Code: J07B B02
Manufactured by:
SANOFI PASTEUR SA
_ _
Lyon, France
Distributed by:
DATE OF APPROVAL:
SANOFI PASTEUR LIMITED
30
April 2013
Toronto, Ontario, Canada
CONTROL NO.: 163591
SANOFI PASTEUR
SECTION 1.3.1 CLEAN PRODUCT MONOGRAPH
415/416 – INTANZA
®
NOTIFIABLE CHANGE – REVISED LABELLING
PAGE 2 OF 31
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.................................. 4
SUMMARY PRODUCT INFORMATION
.............................................................................
4
DESCRIPTION...........................................................................................................................
4
INDICATIONS AND CLINICAL USE
....................................................................................
5
Pediatrics
............................................................................................................................
5
Geriatrics
............................................................................................................................
5
CONTRAINDICATIONS
..........................................................................................................
5
Hypersensitivity
....................................................................................................................
5
WARNINGS AND PRECAUTIONS
........................................................................................
5
General
............................................................................................................................
5
Immune
............................................................................................................................
6
Neurologic
......................................................................