LEVULAN KERASTICK POWDER FOR SOLUTION

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

AMINOLEVULINIC ACID HYDROCHLORIDE

Boleh didapati daripada:

DUSA PHARMACEUTICALS INC

Kod ATC:

L01XD04

INN (Nama Antarabangsa):

AMINOLEVULINIC ACID

Dos:

20%

Borang farmaseutikal:

POWDER FOR SOLUTION

Komposisi:

AMINOLEVULINIC ACID HYDROCHLORIDE 20%

Laluan pentadbiran:

TOPICAL

Unit dalam pakej:

1.5ML

Jenis preskripsi:

Prescription

Kawasan terapeutik:

MISC. SKIN AND MUCOUS MEMBRANE AGENTS

Ringkasan produk:

Active ingredient group (AIG) number: 0143983001; AHFS:

Status kebenaran:

APPROVED

Tarikh kebenaran:

2004-04-05

Ciri produk

_Levulan_
_® _
_Kerastick_
_® _
_(aminolevulinic acid hydrochloride) _
_Page 1 of 24_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
LEVULAN
® KERASTICK
®
(aminolevulinic acid hydrochloride)
Powder for Topical Solution
20% aminolevulinic acid hydrochloride after admixed
Sensitizers used in photodynamic / radiation therapy
MANUFACTURED BY:
DUSA Pharmaceuticals, Inc., a Sun Pharma company
29 Dunham Road
Billerica, MA 01821
IMPORTED AND DISTRIBUTED BY:
Clarion Medical Technologies Inc.
125 Fleming Drive
Cambridge, ON N1T 2B8
Canada
Date of Initial Authorization:
May 06, 2004
Date of Revision:
January 31, 2023
Submission Control Number: 263865
_Levulan_
_® _
_Kerastick_
_® _
_(aminolevulinic acid hydrochloride) _
_Page 2 of 24_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Neurologic
03/2022
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
.................................................................................................
4
4
DOSAGE AND
ADMINISTRATION.................................................................................
4
4.1
Dosing Considerations
.......................................................................................
4
4.2
Recommended Dose