PMS-EVEROLIMUS TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

EVEROLIMUS

Sẵn có từ:

PHARMASCIENCE INC

Mã ATC:

L04AH02

INN (Tên quốc tế):

EVEROLIMUS

Liều dùng:

5MG

Dạng dược phẩm:

TABLET

Thành phần:

EVEROLIMUS 5MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

15G/50G

Loại thuốc theo toa:

Prescription

Khu trị liệu:

ANTINEOPLASTIC AGENTS

Tóm tắt sản phẩm:

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

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2020-09-04

Đặc tính sản phẩm

_pms-EVEROLIMUS (everolimus)_
_Page 1 of 91_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
PMS-EVEROLIMUS
Everolimus Tablets
Tablets, 2.5 mg, 5 mg and 10 mg, Oral
Protein Kinase inhibitors
ATC Code: L01XE10
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
www.pharmascience.com
Submission Control Number: 256066
Date of Initial Authorization
4 SEP 2020
Date of Revision:
27 JAN 2022
_pms-EVEROLIMUS (everolimus)_
_Page 2 of 91_ RECENT MAJOR LABEL CHANGES
1.1 Pediatrics
01/2022
4.1 Dosing Considerations
01/2022
4.4 Administration, Switching Dosage Forms
01/2022
7 WARNINGS AND PRECAUTIONS, Radiation Sensitization and Radiation
Recall
01/2022
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
.................................................................................................................
5
2
CONTRAINDICATIONS.....................................................................................................
6
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................. 6
4
DOSAGE AND ADMINISTRATION
....................................................................................
7
4.1
Dosing Considerations
.............................................................................................
7
4.2
Recommended Dose and Dosage
Adjustment..