AFINITOR TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

EVEROLIMUS

Tersedia dari:

NOVARTIS PHARMACEUTICALS CANADA INC

Kode ATC:

L04AH02

INN (Nama Internasional):

EVEROLIMUS

Dosis:

5MG

Bentuk farmasi:

TABLET

Komposisi:

EVEROLIMUS 5MG

Rute administrasi :

ORAL

Unit dalam paket:

30

Jenis Resep:

Prescription

Area terapi:

ANTINEOPLASTIC AGENTS

Ringkasan produk:

Active ingredient group (AIG) number: 0152682001; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2009-12-14

Karakteristik produk

_AFINITOR (everolimus) and AFINITOR DISPERZ Product Monograph _
_Page 1 of 123_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AFINITOR
®
Everolimus
Tablets, 2.5 mg, 5 mg and 10 mg, Oral
PR
AFINITOR
®
DISPERZ
®
Everolimus
Tablets for oral suspension, 2 mg, 3 mg and 5 mg, Oral
Protein kinase inhibitors
ATC Code: L01XE10
_ _
Novartis Pharmaceuticals Canada Inc.
385 Bouchard Blvd., Dorval, Quebec
H9S 1A9
_ _
_ _
Date of Initial Authorization:
December 11, 2009
Date of Revision:
November 30, 2021_ _
_ _
Submission Control Number: 255457
_AFINITOR_
_ _
_(everolimus) and AFINITOR DISPERZ Product Monograph _
_Page 2 of 123 _
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, Radiation Sensitization and
Radiation Recall
11/2021
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES .................................................................................2
TABLE OF CONTENTS
........................................................................................................2
PART I: HEALTH PROFESSIONAL INFORMATION ........................................................5
1
INDICATIONS ............................................................................................................5
1.1
Pediatrics
............................................................................................................6
1.2
Geriatrics.............................................................................................................7
2
CONTRAINDICATIONS ............................................................................................7
3
SERIOUS WARNINGS AND PRECAUTIONS BOX ...............................................8
4
DOSAGE AND ADMINISTRATION ..........................................................................9
4.1
Dosing Considerations
.........................................................................................9
4.2
Recommended Dose and Dosage
Adjustment..............