LETROZOLE TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

LETROZOLE

Tersedia dari:

SANIS HEALTH INC

Kode ATC:

L02BG04

INN (Nama Internasional):

LETROZOLE

Dosis:

2.5MG

Bentuk farmasi:

TABLET

Komposisi:

LETROZOLE 2.5MG

Rute administrasi :

ORAL

Unit dalam paket:

15G/50G

Jenis Resep:

Prescription

Area terapi:

ANTINEOPLASTIC AGENTS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2020-09-02

Karakteristik 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
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1.
INDICATIONS
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4
1.1.
Paediatrics
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4
1.2.
Geriatrics
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4
2.
CONTRAINDICATIONS
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4
3.
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4.
DOSAGE AND ADMINISTRATION
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5
4.1.
Dosing Considerations
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5
4.2.
Recommended Dose and Dosage Adjustment
................................................................. 5
4.4.
Administration
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6
4.5.
Missed Dose
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6
5.
OVERDOSAGE
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