MINT-LETROZOLE TABLET

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

LETROZOLE

Disponible des:

MINT PHARMACEUTICALS INC

Codi ATC:

L02BG04

Designació comuna internacional (DCI):

LETROZOLE

Dosis:

2.5MG

formulario farmacéutico:

TABLET

Composición:

LETROZOLE 2.5MG

Vía de administración:

ORAL

Unidades en paquete:

15G/50G

tipo de receta:

Prescription

Área terapéutica:

ANTINEOPLASTIC AGENTS

Resumen del producto:

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

Estat d'Autorització:

APPROVED

Data d'autorització:

2020-11-20

Fitxa tècnica

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MINT-LETROZOLE
letrozole tablets
Tablets, 2.5 mg, for oral use
USP
Aromatase inhibitor
Mint Pharmaceuticals Inc.
6575 Davand Drive
Mississauga, ON, L5T 2M3
Canada
Date of Initial Authorization:
NOV 20, 2020
Date of Revision:
MAR 07, 2024
Submission Control Number: 279174
Mint-Letrozole _(letrozole)_ Tablets
Page 2 of 58
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, MUSCULOSKELETAL
03/2024
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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