SPY AGENT GREEN KIT FOR SPY ELITE

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

INDOCYANINE GREEN

から入手可能:

NOVADAQ TECHNOLOGIES ULC

ATCコード:

V04CX01

INN（国際名）:

INDOCYANINE GREEN

投薬量:

25MG

医薬品形態:

KIT

構図:

INDOCYANINE GREEN 25MG

投与経路:

INTRAVENOUS

パッケージ内のユニット:

15G/50G

処方タイプ:

Ethical

治療領域:

ROENTGENOGRAPHY

製品概要:

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

認証ステータス:

APPROVED

承認日:

2018-12-05

製品の特徴

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