MINT-INDOMETHACIN CAPSULE

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

INDOMETHACIN

Fáanlegur frá:

MINT PHARMACEUTICALS INC

ATC númer:

M01AB01

INN (Alþjóðlegt nafn):

INDOMETACIN

Skammtar:

50MG

Lyfjaform:

CAPSULE

Samsetning:

INDOMETHACIN 50MG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

100

Gerð lyfseðils:

Prescription

Lækningarsvæði:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Vörulýsing:

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

Leyfisstaða:

APPROVED

Leyfisdagur:

2017-02-17

Vara einkenni

_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