IMOVAX RABIES POWDER FOR SUSPENSION

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

RABIES VACCINE INACTIVATED (HUMAN DIPLOID-CELL CULTURE)

Boleh didapati daripada:

SANOFI PASTEUR LIMITED

Kod ATC:

J07BG01

INN (Nama Antarabangsa):

RABIES, INACTIVATED, WHOLE VIRUS

Dos:

2.5UNIT

Borang farmaseutikal:

POWDER FOR SUSPENSION

Komposisi:

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

Laluan pentadbiran:

INTRAMUSCULAR

Unit dalam pakej:

1ML

Jenis preskripsi:

Schedule D

Kawasan terapeutik:

VACCINES

Ringkasan produk:

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

Status kebenaran:

APPROVED

Tarikh kebenaran:

2000-03-08

Ciri produk

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
..............................................................