METHOTREXATE TABLET
Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Charakteristika produktu
(SPC)
17-10-2019
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Aktivní složka:
METHOTREXATE (METHOTREXATE SODIUM)
Dostupné s:
APOTEX INC
ATC kód:
L01BA01
INN (Mezinárodní Name):
METHOTREXATE
Dávkování:
2.5MG
Léková forma:
TABLET
Složení:
METHOTREXATE (METHOTREXATE SODIUM) 2.5MG
Podání:
ORAL
Jednotky v balení:
100
Druh předpisu:
Prescription
Terapeutické oblasti:
ANTINEOPLASTIC AGENTS
Přehled produktů:
Active ingredient group (AIG) number: 0107545001; AHFS:
Stav Autorizace:
APPROVED
Datum autorizace:
2019-03-21
Charakteristika produktu
Page 1 of 42
PRODUCT MONOGRAPH
PR
METHOTREXATE
Methotrexate Tablets USP
2.5 mg Methotrexate (as Methotrexate Sodium)
Antimetabolite
APOTEX INC.
150 Signet Drive Toronto,
Ontario M9L 1T9
DATE OF REVISION:
October 17, 2019
Submission Control No.: 231321
Page 2 of 42
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..............................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
.................................................................................4
ADVERSE REACTIONS
................................................................................................11
DRUG INTERACTIONS
..................................................................................................15
DOSAGE AND ADMINISTRATION
.............................................................................19
OVERDOSAGE.................................................................................................................22
ACTION AND CLINICAL PHARMACOLOGY
...........................................................22
STORAGE AND STABILITY
..........................................................................................25
SPECIAL HANDLING INSTRUCTIONS
....................................................................25
DOSAGE FORMS, COMPOSITION AND PACKAGING
...........................................26
PART II: SCIENTIFIC INFORMATION
....................................................................27
PHARMACEUTICAL INFORMATION
..........................................................................27
CLINICAL TRIALS
..........................................................................................................27
DETAILED PHARMACOLOGY
....................
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