LETROZOLE TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

LETROZOLE

Boleh didapati daripada:

PRO DOC LIMITEE

Kod ATC:

L02BG04

INN (Nama Antarabangsa):

LETROZOLE

Dos:

2.5MG

Borang farmaseutikal:

TABLET

Komposisi:

LETROZOLE 2.5MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

30

Jenis preskripsi:

Prescription

Kawasan terapeutik:

ANTINEOPLASTIC AGENTS

Ringkasan produk:

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

Status kebenaran:

APPROVED

Tarikh kebenaran:

2013-02-14

Ciri produk

PR
_ Letrozole_
_®_
_ (letrozole) Tablets _
_Page 1 of 68_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR LETROZOLE
®
Letrozole tablets
Tablets, 2.5 mg, for oral use
Aromatase inhibitor
Pro Doc Ltée.
2925 Boulevard Industriel
Laval, Québec, H7L 3W9
Date of Initial Authorization:
FEB 14, 2013
Date of Revision:
JUN 16, 2023
Submission Control Number: 275917
_ _
_ _
_ _
PR
_ Letrozole_
_®_
_ (letrozole) Tablets _
_Page 2 of 68 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Musculoskeletal
06 / 2023
RECENT MAJOR LABEL CHANGES
............................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................................
4
1
INDICATIONS
...............................................................................................................
4
1.1 Pediatrics
....................................................................................................................
4
1.2 Geriatrics
....................................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
5
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
.................................................