INDOCYANINE GREEN FOR INJECTION, USP POWDER FOR SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

INDOCYANINE GREEN

Tersedia dari:

DIAGNOSTIC GREEN LIMITED

Kode ATC:

V04CX01

INN (Nama Internasional):

INDOCYANINE GREEN

Dosis:

25MG

Bentuk farmasi:

POWDER FOR SOLUTION

Komposisi:

INDOCYANINE GREEN 25MG

Rute administrasi :

INTRAVENOUS

Unit dalam paket:

15G/50G

Jenis Resep:

Ethical

Area terapi:

CARDIAC FUNCTION

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2019-02-15

Karakteristik produk

_Indocyanine Green for Injection, USP Product Monograph _
_Page 1 of 14 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Indocyanine Green for Injection, USP
Lyophilized green powder containing 25 mg of indocyanine green,
Intravenous Injection
Diagnostic Agent
Imported and Distributed By:
Seaford Pharmaceuticals Inc.
28-1530 Drew Road
Mississauga Ontario
Canada L5S 1W8
Date of Initial Approval:
FEB 15, 2019
Date of Revision:
June 30, 2021
Marketing Authorization Holder:
Diagnostic Green GmbH
Otto-Hahn-Straße 20
85609 Aschheim-Dornach
Bavaria, Germany
Submission Control No: 248253
_Indocyanine Green for Injection, USP Product Monograph _
_Page 2 of 14 _
TABLE OF CONTENTS
TABLE OF CONTENTS
......................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION ...................................................... 3
1
INDICATIONS ..........................................................................................................
3
1.1
Pediatrics...........................................................................................................
3
1.2
Geriatrics...........................................................................................................
3
2
CONTRAINDICATIONS ..........................................................................................
3
3
DOSAGE AND ADMINISTRATION ........................................................................
3
3.1
Recommended Dose and Dosage Adjustment
..................................................... 3
3.1.1
Indicator-Dilution Studies
...............................................................................
3
3.1.2
Hepatic Function Studies
................................................................................
4
3.1.3
Ophthalmic Angiography
Studies....................................................................
7
4
OVERDOSAGE .....................................................................................................