SMALLPOX VACCINE (DRIED) POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

SMALLPOX VACCINE DRIED

Available from:

SANOFI PASTEUR LIMITED

ATC code:

J07BX01

INN (International Name):

SMALLPOX AND MONKEYPOX VACCINES

Dosage:

100M

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

SMALLPOX VACCINE DRIED 100M

Administration route:

INTRADERMAL

Units in package:

10DOSE

Prescription type:

Schedule D

Therapeutic area:

VACCINES

Product summary:

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

Authorization status:

CANCELLED POST MARKET

Authorization date:

2021-10-05

Summary of Product characteristics

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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
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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
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