SPY AGENT GREEN LYMPHATICS KIT FOR ADVANCED IMAGING MODALITY (AIM) AND PINPOINT

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

INDOCYANINE GREEN

Mevcut itibaren:

NOVADAQ TECHNOLOGIES ULC

ATC kodu:

V04CX01

INN (International Adı):

INDOCYANINE GREEN

Doz:

25MG

Farmasötik formu:

KIT

Kompozisyon:

INDOCYANINE GREEN 25MG

Uygulama yolu:

INTERSTITIAL

Paketteki üniteler:

15G/50G

Reçete türü:

Ethical

Terapötik alanı:

ROENTGENOGRAPHY

Ürün özeti:

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

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2020-05-01

Ürün özellikleri

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
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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