KINEVAC POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

SINCALIDE

Available from:

BRACCO IMAGING CANADA

ATC code:

V04CC03

INN (International Name):

SINCALIDE

Dosage:

5MCG

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

SINCALIDE 5MCG

Administration route:

INTRAVENOUS

Units in package:

5 ML

Prescription type:

Ethical

Therapeutic area:

GALLBLADDER FUNCTION

Product summary:

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

Authorization status:

MARKETED

Authorization date:

1998-07-08

Summary of Product characteristics

_Product Monograph _
_KINEVAC® (Sincalide) _
_Page 1 of 16_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION KINEVAC®
Sincalide
Powder for Solution, 5 mcg/vial, Intravenous
ATC Code: V04CC03
Diagnostic Cholecystokinetic
Bracco Imaging Canada
11065 boul. Louis-H.-Lafontaine
Montreal, Quebec
Canada H1J 2Z4
Date of Initial Authorization:
JUL 8, 1998
Date of Revision:
MAR 1, 2022
Submission Control Number: 256771
_ _
_Product Monograph _
_KINEVAC® (Sincalide) _
_Page 2 of 16_
RECENT MAJOR LABEL CHANGES
Not applicable.
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
................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
........................................................ 4
4.3
Reconstitution
..........................................................................................................
5
5
OVERDOSAGE
............................................................................................................
5
6
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
................