LONSURF TABLET

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

TRIFLURIDINE; TIPIRACIL (TIPIRACIL HYDROCHLORIDE)

Verfügbar ab:

TAIHO PHARMA CANADA, INC.

ATC-Code:

L01BC59

INN (Internationale Bezeichnung):

TRIFLURIDINE, COMBINATIONS

Dosierung:

15MG; 6.14MG

Darreichungsform:

TABLET

Zusammensetzung:

TRIFLURIDINE 15MG; TIPIRACIL (TIPIRACIL HYDROCHLORIDE) 6.14MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

20

Verschreibungstyp:

Prescription

Therapiebereich:

ANTINEOPLASTIC AGENTS

Produktbesonderheiten:

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

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2018-01-25

Fachinformation

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