TARO-CAPECITABINE TABLET

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

CAPECITABINE

Pieejams no:

TARO PHARMACEUTICALS INC

ATĶ kods:

L01BC06

SNN (starptautisko nepatentēto nosaukumu):

CAPECITABINE

Deva:

500MG

Zāļu forma:

TABLET

Kompozīcija:

CAPECITABINE 500MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

120

Receptes veids:

Prescription

Ārstniecības joma:

ANTINEOPLASTIC AGENTS

Produktu pārskats:

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

Autorizācija statuss:

APPROVED

Autorizācija datums:

2016-09-09

Produkta apraksts

_Taro-Capecitabine (Capecitabine Tablets) _
_Page 1 of 61_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TARO-CAPECITABINE
Capecitabine Tablets
Tablets, 150 mg and 500 mg, Oral
Taro Standard
Antineoplastic Agent
Taro Pharmaceuticals Inc.
130 East Drive
Brampton, Ontario
L6T 1C1
Submission Control Number: 253729
Date of Initial Authorization:
September 08, 2016
Date of Revision:
January 11, 2022
_Taro-Capecitabine (Capecitabine Tablets) Page 2 of 61_
RECENT MAJOR LABEL CHANGES
3. SERIOUS WARNINGS AND PRECAUTIONS BOX
01/2022
4. DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations
01/2022
7. WARNINGS AND PRECAUTIONS
01/2022
7. WARNINGS AND PRECAUTIONS, 7.1 Special Populations
01/2022
TABLE OF CONTENTS
SECTIONS AND 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
..................................................................................................................
4
1.2 Geriatrics
..................................................................................................................
5
2 CONTRAINDICATIONS
.....................................................................................................
5
3 SERIOUS WARNINGS AND PRECAUTIONS
BOX................................................................. 5
4 DOSAGE AND ADMINISTRATION
.....................................................................................
6
4.1 Dosing Considerations
...............................................................................................
6
4.2 Recommend