SPY AGENT GREEN POWDER FOR SOLUTION

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

INDOCYANINE GREEN

Dostępny od:

NOVADAQ TECHNOLOGIES ULC

Kod ATC:

V04CX01

INN (International Nazwa):

INDOCYANINE GREEN

Dawkowanie:

25MG

Forma farmaceutyczna:

POWDER FOR SOLUTION

Skład:

INDOCYANINE GREEN 25MG

Droga podania:

INTERSTITIAL

Sztuk w opakowaniu:

15G/50G

Typ recepty:

Ethical

Dziedzina terapeutyczna:

ROENTGENOGRAPHY

Podsumowanie produktu:

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

Status autoryzacji:

APPROVED

Data autoryzacji:

2018-12-05

Charakterystyka produktu

_ _
_SPY AGENT_
_®_
_ GREEN (indocyanine green for injection, USP) _
_Page 1 of 23 _
Product Monograph
Including Patient Medication Information
SPY AGENT
® GREEN
Indocyanine Green for Injection, USP
25 mg/vial
Lyophilized powder for intravenous, interstitial or intradermal
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:
November 8, 2023
Submission Control No: 270566
_ _
_SPY AGENT_
_®_
_ GREEN (indocyanine green for injection, USP) _
_Page 2 of 23 _
RECENT MAJOR LABEL CHANGES
1 INDICATIONS
11/2023
1 INDICATIONS, 1.1 Pediatrics
11/2023
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and
Dosage Adjustment
11/2023
4 DOSAGE AND ADMINISTRATION, 4.3 Reconstitution
11/2023
4 DOSAGE AND ADMINISTRATION, 4.4 Administration
11/2023
7 WARNINGS AND PRECAUTIONS
11/2023
7 WARNINGS AND PRECAUTIONS, 7.1.3 Pediatrics
11/2023
7 WARNINGS AND PRECAUTIONS, 7.1.4 Geriatrics
11/2023
TABLE OF CONTENTS
Sections or subsections that are not applicable at the time of
authorization are not listed.
RECENT MAJOR LABEL CHANGES
................................................................................................
2
TABLE OF CONTENTS
..........................................................................................................
2
PART I: HEALTH PROFESSIONAL
INFORMATION...............................................................
4
1
INDICATIONS..............................................................................................................
4
1.1
Pediatrics
.......................................................................................................
4
1.2
Geriatrics
.......................................................................................................
4
2
CONTRAINDICATIONS
...............................................................................................
5
4
DOSAGE AND ADMINISTRATION
..............................