IMOGAM RABIES PASTEURIZED SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

RABIES IMMUNOGLOBULIN (HUMAN)

Tersedia dari:

SANOFI PASTEUR LIMITED

Kode ATC:

J06BB05

INN (Nama Internasional):

RABIES IMMUNOGLOBULIN

Dosis:

150UNIT

Bentuk farmasi:

SOLUTION

Komposisi:

RABIES IMMUNOGLOBULIN (HUMAN) 150UNIT

Rute administrasi :

INTRAMUSCULAR

Unit dalam paket:

2ML

Jenis Resep:

Schedule D

Area terapi:

SERUMS

Ringkasan produk:

Active ingredient group (AIG) number: 0110666002; AHFS:

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2022-03-31

Karakteristik produk

SANOFI PASTEUR
SECTION 1.3.1
194 – IMOGAM
® RABIES PASTEURIZED
PRODUCT MONOGRAPH
Product Monograph Template – Schedule D
Page
1 of 21
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
IMOGAM
® RABIES PASTEURIZED
RABIES IMMUNE GLOBULIN, PASTEURIZED (HUMAN)
Solution for Injection (150 IU/mL)
2.0 mL vials and 10.0 mL vials
Passive Immunizing Agent for the Prevention of Rabies
ATC: Code J06BB05
Manufactured by:
DATE OF REVISION:
SANOFI PASTEUR SA
November 2015
Lyon, France
Distributed by:
DATE OF APPROVAL:
SANOFI PASTEUR LIMITED
December 9, 2015
Toronto, Ontario, Canada
SUBMISSION CONTROL NO: 177025
SANOFI PASTEUR
SECTION 1.3.1
194 – IMOGAM
® RABIES PASTEURIZED
PRODUCT MONOGRAPH
Product Monograph Template – Schedule D
Page
2 of 21
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................... 3
SUMMARY PRODUCT INFORMATION
......................................................................................
3
DESCRIPTION
.................................................................................................................................
3
INDICATIONS AND CLINICAL USE
...........................................................................................
3
CONTRAINDICATIONS
.................................................................................................................
8
WARNINGS AND PRECAUTIONS
...............................................................................................
8
ADVERSE REACTIONS
.................................................................................................................
9
DRUG INTERACTIONS
................................................................................................................
10
DOSAGE AND
ADMINISTRATION............................................................................................
10
OVERDOSAGE
..............................................................................................................................
12