MINT-INDOMETHACIN CAPSULE

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

INDOMETHACIN

Boleh didapati daripada:

MINT PHARMACEUTICALS INC

Kod ATC:

M01AB01

INN (Nama Antarabangsa):

INDOMETACIN

Dos:

25MG

Borang farmaseutikal:

CAPSULE

Komposisi:

INDOMETHACIN 25MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

100

Jenis preskripsi:

Prescription

Kawasan terapeutik:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Ringkasan produk:

Active ingredient group (AIG) number: 0101832001; AHFS:

Status kebenaran:

APPROVED

Tarikh kebenaran:

2017-02-17

Ciri produk

_MINT-INDOMETHACIN, Indomethacin _
_Page 1 of 40_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR MINT-INDOMETHACIN
Indomethacin Capsules
Capsules, 25 mg and 50 mg, Oral
USP
Non-Steroidal Anti-Inflammatory Drug
ATC Code: C01EB03
Mint Pharmaceuticals Inc.
6575 Davand Drive
Mississauga, Ontario
L5T 2M3
Date of Initial Authorization:
February 17, 2017
Date of Revision:
February 6, 2023
Submission Control Number: 267320
_MINT-INDOMETHACIN, Indomethacin _
_Page 2 of 40_
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
02/2023
7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests
02/2023
7 WARNINGS AND PRECAUTIONS, Skin
02/2023
7 WARNINGS AND PRECAUTIONS, 7.1 Special Populations
02/2023
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 a