METHOTREXATE INJECTION BP SOLUTION

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

METHOTREXATE (METHOTREXATE SODIUM)

Dostopno od:

ACCORD HEALTHCARE INC

Koda artikla:

L01BA01

INN (mednarodno ime):

METHOTREXATE

Odmerek:

25MG

Farmacevtska oblika:

SOLUTION

Sestava:

METHOTREXATE (METHOTREXATE SODIUM) 25MG

Pot uporabe:

INTRAVENOUS

Enote v paketu:

40ML

Tip zastaranja:

Prescription

Terapevtsko območje:

ANTINEOPLASTIC AGENTS

Povzetek izdelek:

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

Status dovoljenje:

APPROVED

Datum dovoljenje:

2018-04-12

Lastnosti izdelka

Page 1 of 55
_ _
PRODUCT MONOGRAPH
PR
METHOTREXATE INJECTION BP
25 MG / ML METHOTREXATE (AS METHOTREXATE SODIUM)
FORMULATION WITHOUT PRESERVATIVE
PR
METHOTREXATE INJECTION BP
25 MG / ML METHOTREXATE (AS METHOTREXATE SODIUM)
FORMULATION WITH PRESERVATIVE
Sterile Solution
Antimetabolite and Antirheumatic
Accord Healthcare Inc.
3535 boul. St. Charles suite 704
Kirkland, QC, H9H 5B9
Canada
Date of Revision:
October 30, 2019
Control No. 231320
Page 2 of 55
_ _
_Pr_
_Methotrexate Injection BP, Product Monograph, Accord Healthcare Inc.
_
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
.......................................................................................................
19
DOSAGE AND ADMINISTRATION
...................................................................................
23
OVERDOSAGE
.....................................................................................................................
34
ACTION AND CLINICAL PHARMACOLOGY
................................................................. 35
STORAGE AND STABILITY
...............................................................................................
37
SPECIAL HANDLING INSTRUCTIONS
............................................................................
38
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 39
PART