SPY AGENT GREEN KIT FOR SPY ELITE

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

INDOCYANINE GREEN

Beschikbaar vanaf:

NOVADAQ TECHNOLOGIES ULC

ATC-code:

V04CX01

INN (Algemene Internationale Benaming):

INDOCYANINE GREEN

Dosering:

25MG

farmaceutische vorm:

KIT

Samenstelling:

INDOCYANINE GREEN 25MG

Toedieningsweg:

INTRAVENOUS

Eenheden in pakket:

15G/50G

Prescription-type:

Ethical

Therapeutisch gebied:

ROENTGENOGRAPHY

Product samenvatting:

Active ingredient group (AIG) number: 0150962001; AHFS:

Autorisatie-status:

APPROVED

Autorisatie datum:

2018-12-05

Productkenmerken

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