LETROZOLE TABLET

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

LETROZOLE

Dostupno od:

SANIS HEALTH INC

ATC koda:

L02BG04

INN (International ime):

LETROZOLE

Doziranje:

2.5MG

Farmaceutski oblik:

TABLET

Sastav:

LETROZOLE 2.5MG

Administracija rute:

ORAL

Jedinice u paketu:

15G/50G

Tip recepta:

Prescription

Područje terapije:

ANTINEOPLASTIC AGENTS

Proizvod sažetak:

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

Status autorizacije:

APPROVED

Datum autorizacije:

2020-09-02

Svojstava lijeka

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
...........................................................................