GLEOLAN POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

AMINOLEVULINIC ACID HYDROCHLORIDE

Available from:

MEDEXUS PHARMACEUTICALS INC.

ATC code:

L01XD04

INN (International Name):

AMINOLEVULINIC ACID

Dosage:

1.5G

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

AMINOLEVULINIC ACID HYDROCHLORIDE 1.5G

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

ROENTGENOGRAPHY

Product summary:

Active ingredient group (AIG) number: 0143983002; AHFS:

Authorization status:

APPROVED

Authorization date:

2020-09-09

Summary of Product characteristics

_GLEOLAN _
_Page 1 of 22_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
GLEOLAN
Aminolevulinic Acid Hydrochloride Powder for Oral Solution
1.5 g / vial
Imaging Agent
Medexus Inc.
35 Nixon Road, Unit 1
Bolton, Ontario
L7E 1K1
Date of Revision:
September 8, 2020
Submission Control No: 234673
_GLEOLAN _
_Page 2 of 22_
RECENT MAJOR LABEL CHANGES
None.
TABLE OF CONTENTS
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
3
DOSAGE AND ADMINISTRATION
................................................................................
5
3.1
Recommended Dose and Dosage Adjustment
....................................................... 5
3.2
Administration
........................................................................................................
5
3.3
Reconstitution
........................................................................................................
5
4
OVERDOSAGE
...............................................................................................................
6
5
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
......................... 6
6
WARNINGS AND PRECAUTIONS
.................................................................................
6
6.1
Special Popu