Država: Kanada
Jezik: engleski
Izvor: Health Canada
SINCALIDE
AVIR PHARMA INC.
V04CC03
SINCALIDE
5MCG
POWDER FOR SOLUTION
SINCALIDE 5MCG
INTRAVENOUS
15G/50G
Ethical
GALLBLADDER FUNCTION
Active ingredient group (AIG) number: 0113162001; AHFS:
APPROVED
2019-11-22
_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 Pročitajte cijeli dokument