INDOCYANINE GREEN FOR INJECTION, USP POWDER FOR SOLUTION

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

INDOCYANINE GREEN

Mevcut itibaren:

DIAGNOSTIC GREEN LIMITED

ATC kodu:

V04CX01

INN (International Adı):

INDOCYANINE GREEN

Doz:

25MG

Farmasötik formu:

POWDER FOR SOLUTION

Kompozisyon:

INDOCYANINE GREEN 25MG

Uygulama yolu:

INTRAVENOUS

Paketteki üniteler:

15G/50G

Reçete türü:

Ethical

Terapötik alanı:

CARDIAC FUNCTION

Ürün özeti:

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

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2019-02-15

Ürün özellikleri

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