Country: Canada
Language: English
Source: Health Canada
INDOCYANINE GREEN
NOVADAQ TECHNOLOGIES ULC
V04CX01
INDOCYANINE GREEN
25MG
KIT
INDOCYANINE GREEN 25MG
INTRAVENOUS
15G/50G
Ethical
ROENTGENOGRAPHY
Active ingredient group (AIG) number: 0150962001; AHFS:
APPROVED
2018-12-05
SPY AGENT™ GREEN Indocyanine Green for Injection, USP 25 mg/vial Lyophilized powder for intravenous or interstitial injection Fluorescent Imaging Agent Novadaq Technologies ULC. (now a part of Stryker) 8329 Eastlake Drive, Unit 101 Burnaby, British Columbia V5A 4W2 Date of Draft: November 28, 2018 Date of Initial Approval: Date of Revision: Submission Control No: 213662 Page 2 of 20 TABLE OF CONTENTS TABLE OF CONTENTS ..............................................................................................................2 PART I: HEALTH PROFESSIONAL INFORMATION ..........................................................4 1 INDICATIONS ..................................................................................................................4 1.1 Pediatrics ...............................................................................................................4 1.2 Geriatrics ...............................................................................................................4 2 CONTRAINDICATIONS .................................................................................................4 3 DOSAGE AND ADMINISTRATION .............................................................................5 3.1 Dosing Considerations ..........................................................................................5 3.2 Recommended Dose and Dosage Adjustment ......................................................5 3.3 Administration ......................................................................................................5 3.4 Reconstitution .......................................................................................................6 3.5 Missed Dose ..........................................................................................................7 4 OVERDOSAGE .................................................................................................................7 5 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................8 6 WARNINGS AN Read the complete document