METHOTREXATE TABLETS, USP

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

METHOTREXATE

제공처:

PFIZER CANADA ULC

ATC 코드:

L01BA01

INN (국제 이름):

METHOTREXATE

복용량:

10MG

약제 형태:

TABLET

구성:

METHOTREXATE 10MG

관리 경로:

ORAL

패키지 단위:

100

처방전 유형:

Prescription

치료 영역:

ANTINEOPLASTIC AGENTS

제품 요약:

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

승인 상태:

APPROVED

승인 날짜:

2003-12-05

제품 특성 요약

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
................................................................