SPY AGENT GREEN KIT FOR ADVANCED IMAGING MODALITY (AIM) AND PINPOINT

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:

2020-05-01

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 (a part of Stryker)
8329 Eastlake Drive, Unit 101
Burnaby, British Columbia
V5A 4W2
Date of Initial Approval:
December 5, 2018
Date of Revision:
June 2, 2022
Submission Control No: 259784
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
................................................................................................
6
3.4
Reconstitution
................................................................................................
7
3.5
Missed Dose
..................................................................................................
7
4
OVERDOSAGE
...........................................................................................................
7
5
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
........................ 8
6
WARNINGS AND PRECAUTIONS
..................................