METHOTREXATE INJECTION BP SOLUTION

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

METHOTREXATE (METHOTREXATE SODIUM)

제공처:

UMAN PHARMA INC

ATC 코드:

L01BA01

INN (국제 이름):

METHOTREXATE

복용량:

25MG

약제 형태:

SOLUTION

구성:

METHOTREXATE (METHOTREXATE SODIUM) 25MG

관리 경로:

INTRA-ARTERIAL

패키지 단위:

2ML

처방전 유형:

Prescription

치료 영역:

ANTINEOPLASTIC AGENTS

제품 요약:

Active ingredient group (AIG) number: 0107545002; AHFS:

승인 상태:

APPROVED

승인 날짜:

2009-09-16

제품 특성 요약

_PRODUCT MONOGRAPH; Methotrexate Injection BP – Uman Pharma Inc. _
_Page 1 of 43_
_ _
PRODUCT MONOGRAPH
PR
METHOTREXATE INJECTION, BP 25 MG/ML
Sterile
Antimetabolite and Antirheumatic
Uman Pharma Inc.
Date of Preparation: September 2, 2009
100, boul. de l’Industrie
Candiac, QC, J5R 1J1
Canada
Control No. 132325
_PRODUCT MONOGRAPH; Methotrexate Injection BP – Uman Pharma Inc. _
_Page 2 of 43_
_ _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION......................................................... 3
SUMMARY
PRODUCT
INFORMATION
............................................................................
3
INDICATIONS
AND
CLINICAL
USE
...................................................................................
3
CONTRAINDICATIONS
........................................................................................................
4
WARNINGS
AND
PRECAUTIONS
.......................................................................................
5
ADVERSE
REACTIONS
.......................................................................................................
12
DRUG
INTERACTIONS
........................................................................................................
14
DOSAGE
AND
ADMINISTRATION
....................................................................................
17
OVERDOSAGE
......................................................................................................................
26
ACTION
AND
CLINICAL
PHARMACOLOGY
................................................................ 27
STORAGE
AND
STABILITY
...............................................................................................
29
SPECIAL
HANDLING
INSTRUCTIONS
...........................................................................
29
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING
................................................ 30
PART II: SCIENTIFIC INFORMATION
...............................................................................
31
PHARMACEUTICAL
INFORMATION
.