Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
AMINOLEVULINIC ACID HYDROCHLORIDE
DUSA PHARMACEUTICALS INC
L01XD04
AMINOLEVULINIC ACID
20%
POWDER FOR SOLUTION
AMINOLEVULINIC ACID HYDROCHLORIDE 20%
TOPICAL
1.5ML
Prescription
MISC. SKIN AND MUCOUS MEMBRANE AGENTS
Active ingredient group (AIG) number: 0143983001; AHFS:
APPROVED
2004-04-05
_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 Přečtěte si celý dokument