SMALLPOX VACCINE (DRIED) POWDER FOR SOLUTION

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

SMALLPOX VACCINE DRIED

Предлага се от:

SANOFI PASTEUR LIMITED

АТС код:

J07BX01

INN (Международно Name):

SMALLPOX AND MONKEYPOX VACCINES

дозиране:

100M

Лекарствена форма:

POWDER FOR SOLUTION

Композиция:

SMALLPOX VACCINE DRIED 100M

Начин на приложение:

INTRADERMAL

Броя в опаковка:

10DOSE

Вид предписание :

Schedule D

Терапевтична област:

VACCINES

Каталог на резюме:

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

Статус Оторизация:

CANCELLED POST MARKET

Дата Оторизация:

2021-10-05

Данни за продукта

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