GLEOLAN POWDER FOR SOLUTION

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

AMINOLEVULINIC ACID HYDROCHLORIDE

제공처:

MEDEXUS PHARMACEUTICALS INC.

ATC 코드:

L01XD04

INN (국제 이름):

AMINOLEVULINIC ACID

복용량:

1.5G

약제 형태:

POWDER FOR SOLUTION

구성:

AMINOLEVULINIC ACID HYDROCHLORIDE 1.5G

관리 경로:

ORAL

패키지 단위:

15G/50G

처방전 유형:

Prescription

치료 영역:

ROENTGENOGRAPHY

제품 요약:

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

승인 상태:

APPROVED

승인 날짜:

2020-09-09

제품 특성 요약

_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