APO-CAPECITABINE TABLET

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

CAPECITABINE

Beszerezhető a:

APOTEX INC

ATC-kód:

L01BC06

INN (nemzetközi neve):

CAPECITABINE

Adagolás:

500MG

Gyógyszerészeti forma:

TABLET

Összetétel:

CAPECITABINE 500MG

Az alkalmazás módja:

ORAL

db csomag:

100

Recept típusa:

Prescription

Terápiás terület:

ANTINEOPLASTIC AGENTS

Termék összefoglaló:

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

Engedélyezési státusz:

APPROVED

Engedély dátuma:

2016-02-12

Termékjellemzők

Pr
APO-CAPECITABINE
Page 1 of 76
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
APO-CAPECITABINE
Capecitabine Tablets, USP
Tablets, 150 mg and 500 mg
Antineoplastic Agent
APOTEX INC.
150 Signet Drive
Toronto Ontario
Canada, M9L 1T9
Date of Initial Authorization
February 12, 2016
Date of Revision:
February 14, 2022
Submission Control No: 256530
Pr
APO-CAPECITABINE
Page 2 of 76
RECENT MAJOR LABEL CHANGES
4. DOSAGE AND ADMINISTRATION, 4.1 DOSING CONSIDERATIONS
02/2022
7. WARNINGS AND PRECAUTIONS
02/2022
7. WARNINGS AND PRECAUTIONS, 7.1 SPECIAL POPULATIONS
02/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
..................................................................................................2
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................................5
1
INDICATIONS
.....................................................................................................................5
1.1 Pediatrics ..............................................................................................................................
6
1.2 Geriatrics ..............................................................................................................................
6
2
CONTRAINDICATIONS
........................................................................................................6
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
...................................................................7
4
DOSAGE AND ADMINISTRATION
........................................................................................7
4.1 Dosing Considerations
.........................................................................................................
7
4.2 Recommended Dose and Dosage Adjustment
.....................................................................
8
4.5 Missed
Dose.........................................................................