METHOTREXATE INJECTION BP SOLUTION

国家: 加拿大

语言: 英文

来源: Health Canada

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下载 产品特点 (SPC)
14-09-2009

有效成分:

METHOTREXATE (METHOTREXATE SODIUM)

可用日期:

UMAN PHARMA INC

ATC代码:

L01BA01

INN(国际名称):

METHOTREXATE

剂量:

25MG

药物剂型:

SOLUTION

组成:

METHOTREXATE (METHOTREXATE SODIUM) 25MG

给药途径:

INTRA-ARTERIAL

每包单位数:

2ML

处方类型:

Prescription

治疗领域:

ANTINEOPLASTIC AGENTS

產品總結:

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

授权状态:

APPROVED

授权日期:

2009-09-16

产品特点

                                _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
.
                                
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