TEVA-INDOMETHACIN CAPSULE

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

INDOMETHACIN

Verfügbar ab:

TEVA CANADA LIMITED

ATC-Code:

M01AB01

INN (Internationale Bezeichnung):

INDOMETACIN

Dosierung:

25MG

Darreichungsform:

CAPSULE

Zusammensetzung:

INDOMETHACIN 25MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

100/500/1000

Verschreibungstyp:

Prescription

Therapiebereich:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Produktbesonderheiten:

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

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2014-06-12

Fachinformation

_TEVA-INDOMETHACIN_
_ Page 1 of 44 _
PRODUCT
MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA-INDOMETHACIN
Indomethacin
Capsules
Capsules, 25 mg and 50 mg, For Oral Use
USP
Non-Steroidal Anti-Inflammatory Drug
ATC Code: C01EB03
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Canada
www.tevacanada.com
Submission Control No: 255834
Date of initial authorization:
October 08, 1980
Date of Revision:
February 07, 2022
_TEVA-INDOMETHACIN Page 2 of 44 _
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
02/2022
7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests
02/2022
7 WARNINGS AND PRECAUTIONS, Skin
02/2022
7 WARNINGS AND PRECAUTIONS, 7.1 Special Populations
02/2022
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
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 and dosage adjustment
.......................................................... 8
4.4
Administration.....................