METHOTREXATE INJECTION BP SOLUTION

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

METHOTREXATE (METHOTREXATE SODIUM)

Dostupné z:

ACCORD HEALTHCARE INC

ATC kód:

L01BA01

INN (Medzinárodný Name):

METHOTREXATE

Dávkovanie:

25MG

Forma lieku:

SOLUTION

Zloženie:

METHOTREXATE (METHOTREXATE SODIUM) 25MG

Spôsob podávania:

INTRAVENOUS

Počet v balení:

40ML

Typ predpisu:

Prescription

Terapeutické oblasti:

ANTINEOPLASTIC AGENTS

Prehľad produktov:

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

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2018-04-12

Súhrn charakteristických

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