LONSURF TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

TRIFLURIDINE; TIPIRACIL (TIPIRACIL HYDROCHLORIDE)

제공처:

TAIHO PHARMA CANADA, INC.

ATC 코드:

L01BC59

INN (국제 이름):

TRIFLURIDINE, COMBINATIONS

복용량:

15MG; 6.14MG

약제 형태:

TABLET

구성:

TRIFLURIDINE 15MG; TIPIRACIL (TIPIRACIL HYDROCHLORIDE) 6.14MG

관리 경로:

ORAL

패키지 단위:

20

처방전 유형:

Prescription

치료 영역:

ANTINEOPLASTIC AGENTS

제품 요약:

Active ingredient group (AIG) number: 0259910001; AHFS:

승인 상태:

APPROVED

승인 날짜:

2018-01-25

제품 특성 요약

_ _
_Page 1 of 42_
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
LONSURF
®
trifluridine and tipiracil tablet
15 mg trifluridine/ 6.14 mg tipiracil (as tipiracil hydrochloride)
20 mg trifluridine / 8.19 mg tipiracil (as tipiracil hydrochloride)
Antineoplastic Agent
Thymidine phosphorylase inhibitor/nucleoside metabolic inhibitor
Taiho Pharma Canada, Inc.
2010 Winston Park Drive, Suite 503
Oakville, Ontario L6H 5R7
Canada
Date of Initial Approval:
JAN 23, 2018
Date of Revision:
OCT 29, 2020
Submission Control No: 235999
_ _
_ _
_Page 2 of 42_
RECENT MAJOR LABEL CHANGES
INDICATIONS (1)
11-2019
WARNINGS AND PRECAUTIONS (6), Geriatrics (6.1.4)
11-2019
DOSAGE AND ADMINISTRATION (3.3)
10-2020
WARNINGS AND PRECAUTIONS (6), Renal
10-2020
TABLE OF CONTENTS
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
3
DOSAGE AND ADMINISTRATION
.................................................................... 4
3.1
Dosing
Considerations................................................................................
4
3.2
Recommended Dose and Dosage Adjustment
........................................... 5
3.3
Administration
.............................................................................................
9
3.4
Missed Dose
...............................................................