IMOGAM RABIES PASTEURIZED SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

RABIES IMMUNOGLOBULIN (HUMAN)

Διαθέσιμο από:

SANOFI PASTEUR LIMITED

Φαρμακολογική κατηγορία (ATC):

J06BB05

INN (Διεθνής Όνομα):

RABIES IMMUNOGLOBULIN

Δοσολογία:

150UNIT

Φαρμακοτεχνική μορφή:

SOLUTION

Σύνθεση:

RABIES IMMUNOGLOBULIN (HUMAN) 150UNIT

Οδός χορήγησης:

INTRAMUSCULAR

Μονάδες σε πακέτο:

2ML

Τρόπος διάθεσης:

Schedule D

Θεραπευτική περιοχή:

SERUMS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2022-03-31

Αρχείο Π.Χ.Π.

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