SMALLPOX VACCINE (DRIED) POWDER FOR SOLUTION

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

קנה את זה

מאפייני מוצר מאפייני מוצר (SPC)
30-09-2020

מרכיב פעיל:

SMALLPOX VACCINE DRIED

זמין מ:

SANOFI PASTEUR LIMITED

קוד ATC:

J07BX01

INN (שם בינלאומי):

SMALLPOX AND MONKEYPOX VACCINES

כמות:

100M

טופס פרצבטיות:

POWDER FOR SOLUTION

הרכב:

SMALLPOX VACCINE DRIED 100M

מסלול נתינה (של תרופות):

INTRADERMAL

יחידות באריזה:

10DOSE

סוג מרשם:

Schedule D

איזור תרפויטי:

VACCINES

leaflet_short:

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

מצב אישור:

CANCELLED POST MARKET

תאריך אישור:

2021-10-05

מאפייני מוצר

                                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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