SPY AGENT GREEN POWDER FOR SOLUTION

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

INDOCYANINE GREEN

Dostopno od:

NOVADAQ TECHNOLOGIES ULC

Koda artikla:

V04CX01

INN (mednarodno ime):

INDOCYANINE GREEN

Odmerek:

25MG

Farmacevtska oblika:

POWDER FOR SOLUTION

Sestava:

INDOCYANINE GREEN 25MG

Pot uporabe:

INTERSTITIAL

Enote v paketu:

15G/50G

Tip zastaranja:

Ethical

Terapevtsko območje:

ROENTGENOGRAPHY

Povzetek izdelek:

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

Status dovoljenje:

APPROVED

Datum dovoljenje:

2018-12-05

Lastnosti izdelka

_ _
_SPY AGENT_
_®_
_ GREEN (indocyanine green for injection, USP) _
_Page 1 of 23 _
Product Monograph
Including Patient Medication Information
SPY AGENT
® GREEN
Indocyanine Green for Injection, USP
25 mg/vial
Lyophilized powder for intravenous, interstitial or intradermal
injection
Fluorescent Imaging Agent
Novadaq Technologies ULC (a part of Stryker)
8329 Eastlake Drive, Unit 101
Burnaby, British Columbia
V5A 4W2
Date of Initial Approval:
December 5, 2018
Date of Revision:
November 8, 2023
Submission Control No: 270566
_ _
_SPY AGENT_
_®_
_ GREEN (indocyanine green for injection, USP) _
_Page 2 of 23 _
RECENT MAJOR LABEL CHANGES
1 INDICATIONS
11/2023
1 INDICATIONS, 1.1 Pediatrics
11/2023
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and
Dosage Adjustment
11/2023
4 DOSAGE AND ADMINISTRATION, 4.3 Reconstitution
11/2023
4 DOSAGE AND ADMINISTRATION, 4.4 Administration
11/2023
7 WARNINGS AND PRECAUTIONS
11/2023
7 WARNINGS AND PRECAUTIONS, 7.1.3 Pediatrics
11/2023
7 WARNINGS AND PRECAUTIONS, 7.1.4 Geriatrics
11/2023
TABLE OF CONTENTS
Sections or subsections that are not applicable at the time of
authorization are not listed.
RECENT MAJOR LABEL CHANGES
................................................................................................
2
TABLE OF CONTENTS
..........................................................................................................
2
PART I: HEALTH PROFESSIONAL
INFORMATION...............................................................
4
1
INDICATIONS..............................................................................................................
4
1.1
Pediatrics
.......................................................................................................
4
1.2
Geriatrics
.......................................................................................................
4
2
CONTRAINDICATIONS
...............................................................................................
5
4
DOSAGE AND ADMINISTRATION
..............................