NAT-EVEROLIMUS TABLET

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

EVEROLIMUS

Dostupno od:

NATCO PHARMA (CANADA) INC

ATC koda:

L04AH02

INN (International ime):

EVEROLIMUS

Doziranje:

5MG

Farmaceutski oblik:

TABLET

Sastav:

EVEROLIMUS 5MG

Administracija rute:

ORAL

Jedinice u paketu:

15G/50G

Tip recepta:

Prescription

Proizvod sažetak:

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

Status autorizacije:

APPROVED

Datum autorizacije:

2022-08-29

Svojstava lijeka

_ _
_NAT-EVEROLIMUS_
_Product Monograph _
_Page 1 of 93_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
NAT-EVEROLIMUS
Everolimus
Tablets, 2.5 mg, 5 mg, 7.5 mg, and 10 mg, Oral
Protein kinase inhibitors
ATC Code: L01XE10
Natco Pharma (Canada) Inc.
2000 Argentia Road
Plaza 1, Suite 200
Mississauga, Ontario
L5N 1P7
Date of Initial Authorization:
August 22, 2022
Date of Revision:
January 25, 2023
Submission Control Number: 267697
_ _
_NAT-EVEROLIMUS_
_Product Monograph _
_Page 2 of 93_
RECENT MAJOR LABEL CHANGES
Not applicable.
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
................................................................................
4
1
INDICATIONS
.....................................................................................................................
4
1.1
Pediatrics.................................................................................................................
5
1.2
Geriatrics
.................................................................................................................
6
2
CONTRAINDICATIONS.........................................................................................................
6
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
.......................................................................
7
4
DOSAGE AND ADMINISTRATION
..........................................................................................
8
4.1
Dosing
Considerations...............................................................................................
8
4.2
Recommended Dose and Dosage Adjustment
............................................................... 8
4.3
Reconst