MINT-CAPECITABINE TABLET

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

CAPECITABINE

Dostupné z:

MINT PHARMACEUTICALS INC

ATC kód:

L01BC06

INN (Medzinárodný Name):

CAPECITABINE

Dávkovanie:

500MG

Forma lieku:

TABLET

Zloženie:

CAPECITABINE 500MG

Spôsob podávania:

ORAL

Počet v balení:

15G/50G

Typ predpisu:

Prescription

Terapeutické oblasti:

ANTINEOPLASTIC AGENTS

Prehľad produktov:

Active ingredient group (AIG) number: 0134120002; AHFS:

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2020-11-17

Súhrn charakteristických

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MINT-CAPECITABINE
Capecitabine Tablets
Tablets, 150 mg and 500 mg
USP
Antineoplastic Agent
Mint Pharmaceuticals Inc.
6575 Davand Drive
Mississauga, ON, L5T 2M3
Canada
Date of Initial Authorization:
November 17, 2020
Date of Revision:
June 28, 2022
Submission Control No: 260947
_Product Monograph MINT-CAPECITABINE _
_ _
_Page 2 of 66 _
RECENT MAJOR LABEL CHANGES
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations
06/2022
7 WARNINGS AND PRECAUTIONS
06/2022
7 WARNINGS AND PRECAUTIONS, 7.1 Special Populations
06/2022
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 ................................................................................................................2
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...................................................................................6
4.1
Dosing Considerations
.........................................................................................6
4.2
Recommended Dose and Dosage
Adjustment.......................................................7
4.5
Missed Dose
........................................