SMALLPOX VACCINE (DRIED) POWDER FOR SOLUTION

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

SMALLPOX VACCINE DRIED

Disponible desde:

SANOFI PASTEUR LIMITED

Código ATC:

J07BX01

Designación común internacional (DCI):

SMALLPOX AND MONKEYPOX VACCINES

Dosis:

100M

formulario farmacéutico:

POWDER FOR SOLUTION

Composición:

SMALLPOX VACCINE DRIED 100M

Vía de administración:

INTRADERMAL

Unidades en paquete:

10DOSE

tipo de receta:

Schedule D

Área terapéutica:

VACCINES

Resumen del producto:

Active ingredient group (AIG) number: 0106228002; AHFS:

Estado de Autorización:

CANCELLED POST MARKET

Fecha de autorización:

2021-10-05

Ficha técnica

SANOFI PASTEUR
SECTION 1.3.2
375 – SMALLPOX VACCINE (DRIED)
PACKAGE INSERT
PAGE 1 OF 15
PACKAGE INSERT
SMALLPOX VACCINE (DRIED)
LIVE VACCINIA VIRUS (BOVINE ORIGIN)
Powder for resuspension
(For active immunization against Smallpox disease)
ATC Code: J07BX Other Viral Vaccines
SANOFI PASTEUR LIMITED
Toronto, Ontario, Canada
Date of Revision:
September 30, 2020
CONTROL#: 243449
SANOFI PASTEUR
SECTION 1.3.2
375 – SMALLPOX VACCINE (DRIED)
PACKAGE INSERT
PAGE 2 OF 15
Table of Contents
SUMMARY PRODUCT INFORMATION
........................................................................
3
DESCRIPTION
.....................................................................................................................
3
INDICATIONS AND CLINICAL
USE...............................................................................
3
CONTRAINDICATIONS
.....................................................................................................
4
WARNINGS AND PRECAUTIONS
...................................................................................
5
ADVERSE REACTIONS
.....................................................................................................
6
DRUG INTERACTIONS
.....................................................................................................
9
DOSAGE AND ADMINISTRATION
.................................................................................
9
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 13
STORAGE AND STABILITY
...........................................................................................
14
SPECIAL HANDLING INSTRUCTIONS
.......................................................................
14
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 14
REFERENCES
....................................................................................................................
15
SANOFI PASTEUR
SECTION 1.3.2
375 – SMALLPOX VACCINE (DRIED)
PACKAGE INSERT
PAGE 3 OF 15