LETROZOLE TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

LETROZOLE

Boleh didapati daripada:

SANIS HEALTH INC

Kod ATC:

L02BG04

INN (Nama Antarabangsa):

LETROZOLE

Dos:

2.5MG

Borang farmaseutikal:

TABLET

Komposisi:

LETROZOLE 2.5MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

15G/50G

Jenis preskripsi:

Prescription

Kawasan terapeutik:

ANTINEOPLASTIC AGENTS

Ringkasan produk:

Active ingredient group (AIG) number: 0132937001; AHFS:

Status kebenaran:

APPROVED

Tarikh kebenaran:

2020-09-02

Ciri produk

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
LETROZOLE
letrozole tablets
Tablets, 2.5 mg, for oral use
USP
Aromatase inhibitor
Sanis Health Inc.
1 President's Choice Circle
Brampton, Ontario
L6Y 5S5
Submission Control Number:
278227
Date of Initial Authorization:
SEP
02, 2020
Date of Revision:
SEP 01, 2023
LETROZOLE
_(letrozole)_ Tablets
Page 2 of 58
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, MUSCULOSKELETAL
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES
...........................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1.
INDICATIONS
..............................................................................................................
4
1.1.
Paediatrics
.........................................................................................................................
4
1.2.
Geriatrics
...........................................................................................................................
4
2.
CONTRAINDICATIONS
.................................................................................................
4
3.
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4.
DOSAGE AND ADMINISTRATION
.................................................................................
5
4.1.
Dosing Considerations
......................................................................................................
5
4.2.
Recommended Dose and Dosage Adjustment
................................................................. 5
4.4.
Administration
..................................................................................................................
6
4.5.
Missed Dose
......................................................................................................................
6
5.
OVERDOSAGE
...........................................................................