SPY AGENT GREEN POWDER FOR SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

INDOCYANINE GREEN

Tersedia dari:

NOVADAQ TECHNOLOGIES ULC

Kode ATC:

V04CX01

INN (Nama Internasional):

INDOCYANINE GREEN

Dosis:

25MG

Bentuk farmasi:

POWDER FOR SOLUTION

Komposisi:

INDOCYANINE GREEN 25MG

Rute administrasi :

INTERSTITIAL

Unit dalam paket:

15G/50G

Jenis Resep:

Ethical

Area terapi:

ROENTGENOGRAPHY

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2018-12-05

Karakteristik produk

_ _
_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
..............................