METHOTREXATE TABLETS, USP

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

METHOTREXATE

可用日期:

PFIZER CANADA ULC

ATC代码:

L01BA01

INN（国际名称）:

METHOTREXATE

剂量:

10MG

药物剂型:

TABLET

组成:

METHOTREXATE 10MG

给药途径:

ORAL

每包单位数:

100

处方类型:

Prescription

治疗领域:

ANTINEOPLASTIC AGENTS

產品總結:

Active ingredient group (AIG) number: 0107545004; AHFS:

授权状态:

APPROVED

授权日期:

2003-12-05

产品特点

PRODUCT MONOGRAPH
PR
METHOTREXATE TABLETS, USP
10 mg (as methotrexate)
Antimetabolite and Antirheumatic
Pfizer Canada ULC
17300 Trans-Canada Highway
Kirkland, Québec
H9J 2M5
SUBMISSION CONTROL NO.: 224778
Date of Revision:
September 12, 2019
_Product Monograph - _
_Pr_
_Methotrexate Tablets, USP _
_ _
_Page 2 of 44 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
..................................................................................................12
DRUG INTERACTIONS
..................................................................................................16
DOSAGE AND ADMINISTRATION
..............................................................................20
OVERDOSAGE
................................................................................................................23
ACTION AND CLINICAL PHARMACOLOGY
............................................................24
STORAGE AND STABILITY
..........................................................................................26
SPECIAL HANDLING INSTRUCTIONS
.......................................................................27
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................28
PART II: SCIENTIFIC INFORMATION
...............................................................................29
PHARMACEUTICAL INFORMATION
..........................................................................29
CLINICAL TRIALS
................................................................