RABAVERT POWDER FOR SOLUTION

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

INACTIVATED RABIES VIRUS (FLURY LEP)

זמין מ:

BAVARIAN NORDIC AS

קוד ATC:

J07BG01

INN (שם בינלאומי):

RABIES, INACTIVATED, WHOLE VIRUS

כמות:

2.5UNIT

טופס פרצבטיות:

POWDER FOR SOLUTION

הרכב:

INACTIVATED RABIES VIRUS (FLURY LEP) 2.5UNIT

מסלול נתינה (של תרופות):

INTRAMUSCULAR

יחידות באריזה:

15G/50G

סוג מרשם:

Schedule D

איזור תרפויטי:

VACCINES

leaflet_short:

Active ingredient group (AIG) number: 0165642001; AHFS:

מצב אישור:

APPROVED

תאריך אישור:

2010-02-05

מאפייני מוצר

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_Page 1 of 37_
PRODUCT MONOGRAPH
RABAVERT
Rabies Vaccine
Lyophilized
powder for reconstitution with a diluent
2.5 IU of rabies antigen
Therapeutic Classification:
Active Immunising
Agent
Bavarian Nordic A/S
Philip Heymans Alle 3
DK-2900 Hellerup
Denmark
Control #: 249134
DATE OF INITIAL APPROVAL:
April 29, 2005
DATE OF REVISION:
July 23, 2021
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_Trademarks are owned by Bavarian Nordic A/S _
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_Page 2 of 37_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................... 3
SUMMARY PRODUCT INFORMATION
................................................................... 3
DESCRIPTION
...........................................................................................................
3
INDICATIONS AND CLINICAL USE
........................................................................
4
CONTRAINDICATIONS
............................................................................................
7
WARNINGS AND PRECAUTIONS
............................................................................
8
ADVERSE
REACTIONS............................................................................................11
DRUG INTERACTIONS
............................................................................................14
DOSAGE AND ADMINISTRATION
.........................................................................15
OVERDOSAGE
.........................................................................................................18
ACTION AND CLINICAL
PHARMACOLOGY.........................................................18
STORAGE AND STABILITY
....................................................................................19
SPECIAL HANDLING INSTRUCTIONS
...................................................................19
DOSAGE FORMS, COMPOSITION AND PACKAGING
..........................................20
PART II: SCIENTIFIC INFORMATION
.........................................................................
21
PHARMACEUTICAL INF