METHOTREXATE TABLET
Country: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
17-10-2019
Sum skjöl fyrir þessa vöru eru ekki tiltæk eins og er, þú getur sent beiðni til þjónustu við viðskiptavini okkar og við munum láta þig vita um leið og við getum fengið þau.
Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
METHOTREXATE (METHOTREXATE SODIUM)
Fáanlegur frá:
APOTEX INC
ATC númer:
L01BA01
INN (Alþjóðlegt nafn):
METHOTREXATE
Skammtar:
2.5MG
Lyfjaform:
TABLET
Samsetning:
METHOTREXATE (METHOTREXATE SODIUM) 2.5MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
100
Gerð lyfseðils:
Prescription
Lækningarsvæði:
ANTINEOPLASTIC AGENTS
Vörulýsing:
Active ingredient group (AIG) number: 0107545001; AHFS:
Leyfisstaða:
APPROVED
Leyfisdagur:
2019-03-21
Vara einkenni
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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