METHOTREXATE INJECTION USP SOLUTION

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

METHOTREXATE (METHOTREXATE SODIUM)

Доступно од:

SANDOZ CANADA INCORPORATED

АТЦ код:

L01BA01

INN (Међународно име):

METHOTREXATE

Дозирање:

25MG

Фармацеутски облик:

SOLUTION

Састав:

METHOTREXATE (METHOTREXATE SODIUM) 25MG

Пут администрације:

INTRA-ARTERIAL

Јединице у пакету:

2ML/20ML

Тип рецептора:

Prescription

Терапеутска област:

ANTINEOPLASTIC AGENTS

Резиме производа:

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

Статус ауторизације:

CANCELLED POST MARKET

Датум одобрења:

2023-07-28

Карактеристике производа

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_Methotrexate Injection USP _
_Page 1 of 48_
PRODUCT MONOGRAPH
PR
METHOTREXATE INJECTION USP
25 mg / mL methotrexate (as methotrexate sodium)
Sterile Solution
Antimetabolite and Antirheumatic
Sandoz Canada Inc.
110 Rue de Lauzon
Boucherville, Quebec
J4B 1E6
Date of Revision:
September 16, 2019
Submission Control No: 231325
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_Methotrexate Injection USP _
_Page 2 of 48_
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
.................................................................................................
14
DRUG INTERACTIONS
.................................................................................................
17
DOSAGE AND ADMINISTRATION
.............................................................................
21
OVERDOSAGE
...............................................................................................................
28
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 28
STORAGE AND STABILITY
.........................................................................................
31
SPECIAL HANDLING INSTRUCTIONS
......................................................................
31
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 33
PART II: SCIENTIFIC INFORMATION
..............................................................................
34
PHARMACEUTICAL INFORMATION
.........................................................................
34
DETAILED PHARMACOLOGY