MYLAN-CELECOXIB CAPSULE

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

CELECOXIB

Pieejams no:

MYLAN PHARMACEUTICALS ULC

ATĶ kods:

M01AH01

SNN (starptautisko nepatentēto nosaukumu):

CELECOXIB

Deva:

100MG

Zāļu forma:

CAPSULE

Kompozīcija:

CELECOXIB 100MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

100/500

Receptes veids:

Prescription

Ārstniecības joma:

CYCLOOXYGENASE-2 (COX-2) INHIBITORS

Produktu pārskats:

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

Autorizācija statuss:

CANCELLED POST MARKET

Autorizācija datums:

2018-07-12

Produkta apraksts

_ _
_Mylan-Celecoxib Product Monograph _
_Page 1 of 62_
PRODUCT MONOGRAPH
Pr
MYLAN-CELECOXIB
(celecoxib)
100 mg and 200 mg Capsules
Non-steroidal anti-inflammatory drug (NSAID)
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
DATE OF REVISION:
July 11, 2017
Submission Control No: 206993
_ _
_Mylan-Celecoxib Product Monograph _
_Page 2 of 62_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
5
ADVERSE REACTIONS
.................................................................................................
17
DRUG INTERACTIONS
.................................................................................................
26
DOSAGE AND ADMINISTRATION
.............................................................................
30
OVERDOSAGE
...............................................................................................................
32
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 32
STORAGE AND STABILITY
.........................................................................................
35
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 35
PART II: SCIENTIFIC INFORMATION
...............................................................................
36
PHARMACEUTICAL INFORMATION
.........................................................................
36
CLINICAL TRIALS
.........................................................................................................
38
DETAILED PHARMACOL