SPY AGENT GREEN KIT FOR SPY ELITE

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

INDOCYANINE GREEN

זמין מ:

NOVADAQ TECHNOLOGIES ULC

קוד ATC:

V04CX01

INN (שם בינלאומי):

INDOCYANINE GREEN

כמות:

25MG

טופס פרצבטיות:

KIT

הרכב:

INDOCYANINE GREEN 25MG

מסלול נתינה (של תרופות):

INTRAVENOUS

יחידות באריזה:

15G/50G

סוג מרשם:

Ethical

איזור תרפויטי:

ROENTGENOGRAPHY

leaflet_short:

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

מצב אישור:

APPROVED

תאריך אישור:

2018-12-05

מאפייני מוצר

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