SMALLPOX VACCINE (DRIED) POWDER FOR SOLUTION

Land: Canada

Språk: engelsk

Kilde: Health Canada

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Preparatomtale Preparatomtale (SPC)
30-09-2020

Aktiv ingrediens:

SMALLPOX VACCINE DRIED

Tilgjengelig fra:

SANOFI PASTEUR LIMITED

ATC-kode:

J07BX01

INN (International Name):

SMALLPOX AND MONKEYPOX VACCINES

Dosering :

100M

Legemiddelform:

POWDER FOR SOLUTION

Sammensetning:

SMALLPOX VACCINE DRIED 100M

Administreringsrute:

INTRADERMAL

Enheter i pakken:

10DOSE

Resept typen:

Schedule D

Terapeutisk område:

VACCINES

Produkt oppsummering:

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

Autorisasjon status:

CANCELLED POST MARKET

Autorisasjon dato:

2021-10-05

Preparatomtale

                                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

                                
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