SANDOZ EVEROLIMUS TABLET

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

EVEROLIMUS

可用日期:

SANDOZ CANADA INCORPORATED

ATC代码:

L04AH02

INN（国际名称）:

EVEROLIMUS

剂量:

5MG

药物剂型:

TABLET

组成:

EVEROLIMUS 5MG

给药途径:

ORAL

每包单位数:

15G/50G

处方类型:

Prescription

治疗领域:

ANTINEOPLASTIC AGENTS

產品總結:

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

授权状态:

APPROVED

授权日期:

2019-10-04

产品特点

_Sandoz Everolimus Product Monograph _
_Page _1_ of 95_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
SANDOZ EVEROLIMUS
Everolimus
Tablets, 2.5 mg, 5 mg, and 10 mg, Oral
Protein kinase inhibitors
ATC Code: L01XE10
Sandoz Canada Inc.
110 Rue de Lauzon
Boucherville, Quebec
J4B 1E6
Date of Initial Authorization:
January 27, 2020
Date of revision:
July 04, 2022
Submission Control Number: 261603
_Sandoz Everolimus Product Monograph _
_Page _2_ of 95_
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, Radiation Sensitization and
Radiation Recall
07/2022
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
.................................................... 8
4.3
Reconstitution.....................................................................................