SPY AGENT GREEN KIT FOR SPY ELITE

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

INDOCYANINE GREEN

Предлага се от:

NOVADAQ TECHNOLOGIES ULC

АТС код:

V04CX01

INN (Международно Name):

INDOCYANINE GREEN

дозиране:

25MG

Лекарствена форма:

KIT

Композиция:

INDOCYANINE GREEN 25MG

Начин на приложение:

INTRAVENOUS

Броя в опаковка:

15G/50G

Вид предписание :

Ethical

Терапевтична област:

ROENTGENOGRAPHY

Каталог на резюме:

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

Статус Оторизация:

APPROVED

Дата Оторизация:

2018-12-05

Данни за продукта

SPY AGENT™ GREEN
Indocyanine Green for Injection, USP
25 mg/vial
Lyophilized powder for intravenous or interstitial injection
Fluorescent Imaging Agent
Novadaq Technologies ULC. (now a part of Stryker)
8329 Eastlake Drive, Unit 101
Burnaby, British Columbia
V5A 4W2
Date of Draft:
November 28, 2018
Date of Initial Approval:
Date of Revision:
Submission Control No: 213662
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
......................................................................................................5
3.4
Reconstitution
.......................................................................................................6
3.5
Missed Dose
..........................................................................................................7
4
OVERDOSAGE
.................................................................................................................7
5
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................8
6
WARNINGS AN