SINCALIDE FOR INJECTION POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

SINCALIDE

Available from:

AVIR PHARMA INC.

ATC code:

V04CC03

INN (International Name):

SINCALIDE

Dosage:

5MCG

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

SINCALIDE 5MCG

Administration route:

INTRAVENOUS

Units in package:

15G/50G

Prescription type:

Ethical

Therapeutic area:

GALLBLADDER FUNCTION

Product summary:

Active ingredient group (AIG) number: 0113162001; AHFS:

Authorization status:

APPROVED

Authorization date:

2019-11-22

Summary of Product characteristics

_SINCALIDE FOR INJECTION (sincalide) _
_Page 1 of 16_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
SINCALIDE FOR INJECTION
Sincalide for Injection
Powder for Solution, 5 mcg / vial, Intravenous
House Std.
Diagnostic Cholecystokinetic
AVIR PHARMA INC.
660 Boul. Industriel
Blainville, Quebec
J7C 3V4
www.avirpharma.com
Date of Initial Authorization:
November 22, 2019
Date of Revision:
October 20, 2022
Submission Control Number: 264855
_SINCALIDE FOR INJECTION (sincalide) _
_Page 2 of 16_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, General
10/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL
CHANGES............................................................................................
2
TABLE OF CONTENTS
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics
..........................................................................................................
4
1.2
Geriatrics...........................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
4
DOSAGE AND
ADMINISTRATION.................................................................................
5
4.2
Recommended Dose and Dosage
Adjustment..................................................... 5
4.3
Reconstitution
...................................................................................................
5
5
OVERDOSAGE
.............................................................................................................
6
6
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKA