GLEOLAN POWDER FOR SOLUTION

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

AMINOLEVULINIC ACID HYDROCHLORIDE

Tilgængelig fra:

MEDEXUS PHARMACEUTICALS INC.

ATC-kode:

L01XD04

INN (International Name):

AMINOLEVULINIC ACID

Dosering:

1.5G

Lægemiddelform:

POWDER FOR SOLUTION

Sammensætning:

AMINOLEVULINIC ACID HYDROCHLORIDE 1.5G

Indgivelsesvej:

ORAL

Enheder i pakken:

15G/50G

Recept type:

Prescription

Terapeutisk område:

ROENTGENOGRAPHY

Produkt oversigt:

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

Autorisation status:

APPROVED

Autorisation dato:

2020-09-09

Produktets egenskaber

_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