IMOVAX RABIES POWDER FOR SUSPENSION

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

RABIES VACCINE INACTIVATED (HUMAN DIPLOID-CELL CULTURE)

Dostępny od:

SANOFI PASTEUR LIMITED

Kod ATC:

J07BG01

INN (International Nazwa):

RABIES, INACTIVATED, WHOLE VIRUS

Dawkowanie:

2.5UNIT

Forma farmaceutyczna:

POWDER FOR SUSPENSION

Skład:

RABIES VACCINE INACTIVATED (HUMAN DIPLOID-CELL CULTURE) 2.5UNIT

Droga podania:

INTRAMUSCULAR

Sztuk w opakowaniu:

1ML

Typ recepty:

Schedule D

Dziedzina terapeutyczna:

VACCINES

Podsumowanie produktu:

Active ingredient group (AIG) number: 0151401001; AHFS:

Status autoryzacji:

APPROVED

Data autoryzacji:

2000-03-08

Charakterystyka produktu

SANOFI PASTEUR PRODUCT MONOGRAPH
046 – IMOVAX
® RABIES
_ _
_ _
_IMOVAX_
_®_
_ Rabies (Rabies Vaccine Inactivated (DCO)) _
_Page 1 of 32_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
IMOVAX
® RABIES
RABIES VACCINE INACTIVATED (DCO)
Powder and Diluent for Suspension for Injection
1 Dose = ≥2.5 IU Rabies Antigen
Active Immunizing Agent for the Prevention of Rabies
ATC Code: J07BG01 Rabies, inactivated, whole virus
SANOFI PASTEUR LIMITED
Toronto, ON Canada
www.sanofi.ca
Date of Initial Authorization:
APR 01, 1980
Date of Revision:
March 22, 2021
Submission Control Number: 245883
SANOFI PASTEUR PRODUCT MONOGRAPH
046 – IMOVAX
® RABIES
_ _
_ _
_IMOVAX_
_®_
_ Rabies (Rabies Vaccine Inactivated (DCO)) _
_Page 2 of 32_
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
TABLE OF CONTENTS
..................................................................................................................
2
1
INDICATIONS
...................................................................................................................
4
1.1
Pediatrics
...............................................................................................................
4
1.2
Geriatrics
...............................................................................................................
4
2
CONTRAINDICATIONS
.....................................................................................................
4
4
DOSAGE AND ADMINISTRATION
....................................................................................
4
4.1
Dosing
Considerations............................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
........................................................ 7
4.3
Reconstitution
.......................................................................................................
9
4.4
Administration
..............................................................