MINT-CAPECITABINE TABLET

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

CAPECITABINE

Disponibbli minn:

MINT PHARMACEUTICALS INC

Kodiċi ATC:

L01BC06

INN (Isem Internazzjonali):

CAPECITABINE

Dożaġġ:

500MG

Għamla farmaċewtika:

TABLET

Kompożizzjoni:

CAPECITABINE 500MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

15G/50G

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

ANTINEOPLASTIC AGENTS

Sommarju tal-prodott:

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

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2020-11-17

Karatteristiċi tal-prodott

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
........................................