AFINITOR DISPERZ TABLET FOR SUSPENSION

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Viambatanisho vya kazi:

EVEROLIMUS

Inapatikana kutoka:

NOVARTIS PHARMACEUTICALS CANADA INC

ATC kanuni:

L04AH02

INN (Jina la Kimataifa):

EVEROLIMUS

Kipimo:

2MG

Dawa fomu:

TABLET FOR SUSPENSION

Tungo:

EVEROLIMUS 2MG

Njia ya uendeshaji:

ORAL

Vitengo katika mfuko:

90

Dawa ya aina:

Prescription

Eneo la matibabu:

ANTINEOPLASTIC AGENTS

Bidhaa muhtasari:

Active ingredient group (AIG) number: 0152682007; AHFS:

Idhini hali ya:

APPROVED

Idhini ya tarehe:

2014-06-11

Tabia za bidhaa

_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..............