TEVA-TICAGRELOR TABLET

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

TICAGRELOR

Fáanlegur frá:

TEVA CANADA LIMITED

ATC númer:

B01AC24

INN (Alþjóðlegt nafn):

TICAGRELOR

Skammtar:

90MG

Lyfjaform:

TABLET

Samsetning:

TICAGRELOR 90MG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

6X10/60

Gerð lyfseðils:

Prescription

Lækningarsvæði:

PLATELET AGGREGATION INHIBITORS

Vörulýsing:

Active ingredient group (AIG) number: 0152934001; AHFS:

Leyfisstaða:

APPROVED

Leyfisdagur:

2021-04-21

Vara einkenni

_ _
_Teva-Ticagrelor _
_Page 1 of 61_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA-TICAGRELOR
Ticagrelor Tablets
Tablets, 60 mg and 90 mg, Oral
Ph. Eur.
Platelet Aggregation Inhibitor
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Date of Initial Authorization:
April 19, 2021
Date of Revision:
January 31, 2023
Submission Control No: 266401
_ _
_Teva-Ticagrelor _
_Page 2 of 61_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Cardiovascular
01/2023
7 WARNINGS AND PRECAUTIONS, Central Sleep Apnea
01/2023
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
..............................................................................................................
4
1.2
Geriatrics
..............................................................................................................
4
2
CONTRAINDICATIONS
...................................................................................................4
4
DOSAGE AND
ADMINISTRATION...................................................................................5
4.1
Dosing Considerations
...........................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
........................................................ 5
4.4
Administration
......................................................................................................
7
4.5
Missed
Dose.......................................