MINT-CELECOXIB CAPSULE

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

CELECOXIB

Tersedia dari:

MINT PHARMACEUTICALS INC

Kode ATC:

M01AH01

INN (Nama Internasional):

CELECOXIB

Dosis:

100MG

Bentuk farmasi:

CAPSULE

Komposisi:

CELECOXIB 100MG

Rute administrasi :

ORAL

Unit dalam paket:

30/1000

Jenis Resep:

Prescription

Area terapi:

CYCLOOXYGENASE-2 (COX-2) INHIBITORS

Ringkasan produk:

Active ingredient group (AIG) number: 0137043001; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2014-11-17

Karakteristik produk

_MINT-CELECOXIB (celecoxib) _
_Page 1 of 57 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MINT-CELECOXIB
Celecoxib Capsules
Capsules, 100 mg and 200 mg, for oral use
Non-steroidal Anti-Inflammatory Drug (NSAID)
Mint Pharmaceuticals Inc.
6575 Davand Drive
Mississauga, Ontario
L5T 2M3
Date of Initial Authorization:
November 17, 2014
Date of Revision:
September 23, 2022
Submission Control No: 263511
_MINT-CELECOXIB (celecoxib) _
_Page 2 of 57 _
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
09/2022
7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests, Pregnancy
09/2022
7 WARNINGS AND PRECAUTIONS, Skin, _Serious skin reactions_
09/2022
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant women
09/2022
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
.....................................................................................................................4
1.2
Geriatrics
.....................................................................................................................4
2
CONTRAINDICATIONS
...........................................................................................................5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
......................................................................6
4
DOSAGE AND ADMINISTRATION
...........................................................................................7
4.1
Dosing Considerations
...........