Страна: Канада
Язык: английский
Источник: Health Canada
CELECOXIB
MINT PHARMACEUTICALS INC
M01AH01
CELECOXIB
100MG
CAPSULE
CELECOXIB 100MG
ORAL
30/1000
Prescription
CYCLOOXYGENASE-2 (COX-2) INHIBITORS
Active ingredient group (AIG) number: 0137043001; AHFS:
APPROVED
2014-11-17
_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 ........... Прочитать полный документ