ODAN-INDOMETHACIN SUPPOSITORY

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

INDOMETHACIN

Available from:

ODAN LABORATORIES LTD

ATC code:

M01AB01

INN (International Name):

INDOMETACIN

Dosage:

50MG

Pharmaceutical form:

SUPPOSITORY

Composition:

INDOMETHACIN 50MG

Administration route:

RECTAL

Units in package:

30

Prescription type:

Prescription

Therapeutic area:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Product summary:

Active ingredient group (AIG) number: 0101832002; AHFS:

Authorization status:

APPROVED

Authorization date:

1997-08-13

Summary of Product characteristics

_ODAN-INDOMETHACIN _ _1_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ODAN-INDOMETHACIN
Indomethacin Suppositories
Suppositories, 50 mg and 100 mg, For Rectal Use
USP
Anti-Inflammatory – Analgesic
ATC Code: M01AB01
Odan Laboratories Ltd.
325 Stillview Avenue
Pointe Claire, Quebec,
Canada H9R 2Y6
Date of Initial Authorization:
AUG 23, 2023
Submission
Control
Number:
277174
_ODAN-INDOMETHACIN _ _2_
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
02/2022
3 SERIOUSWARNINGSAND PRECAUTIONSBOX
02/2022
7 WARNINGSAND PRECAUTIONS, Cardiovascular
02/2022
7 WARNINGSAND PRECAUTIONS, Monitoring and Laboratory Tests
02/2022
7 WARNINGSAND PRECAUTIONS, Skin
02/2022
7 WARNINGSAND PRECAUTIONS, 7.1 Special Populations
02/2022
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
......................................................................................................
5
1.2
Geriatrics
......................................................................................................
5
2
CONTRAINDICATIONS
................................................................................................5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
................................................................ 6
4
DOSAGE AND ADMINISTRATION
................................................................................7
4.1
Dosing considerations
..................................................................................
7
4.2
Recommended Dose and Dosage Adjustment
..............