SPY AGENT GREEN LYMPHATICS KIT FOR ADVANCED IMAGING MODALITY (AIM) AND PINPOINT
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
28-11-2018
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Active ingredient:
INDOCYANINE GREEN
Available from:
NOVADAQ TECHNOLOGIES ULC
ATC code:
V04CX01
INN (International Name):
INDOCYANINE GREEN
Dosage:
25MG
Pharmaceutical form:
KIT
Composition:
INDOCYANINE GREEN 25MG
Administration route:
INTERSTITIAL
Units in package:
15G/50G
Prescription type:
Ethical
Therapeutic area:
ROENTGENOGRAPHY
Product summary:
Active ingredient group (AIG) number: 0150962001; AHFS:
Authorization status:
APPROVED
Authorization date:
2020-05-01
Summary of Product characteristics
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
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