TEVA-TICAGRELOR TABLET

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

TICAGRELOR

可用日期:

TEVA CANADA LIMITED

ATC代码:

B01AC24

INN（国际名称）:

TICAGRELOR

剂量:

90MG

药物剂型:

TABLET

组成:

TICAGRELOR 90MG

给药途径:

ORAL

每包单位数:

6X10/60

处方类型:

Prescription

治疗领域:

PLATELET AGGREGATION INHIBITORS

產品總結:

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

授权状态:

APPROVED

授权日期:

2021-04-21

产品特点

_ _
_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.......................................