Страна: Канада
Язык: английский
Источник: Health Canada
METHOTREXATE (METHOTREXATE DISODIUM)
MANTRA PHARMA INC
L01BA01
METHOTREXATE
2.5MG
TABLET
METHOTREXATE (METHOTREXATE DISODIUM) 2.5MG
ORAL
100
Prescription
Active ingredient group (AIG) number: 0107545001; AHFS:
APPROVED
2023-02-03
PRODUCT MONOGRAPH PR M-METHOTREXATE Methotrexate Tablets USP Tablets, 2.5 mg methotrexate (supplied as methotrexate disodium), Oral USP ATC CODE: L01BA01 ANTIMETABOLITE Mantra Pharma Inc. 9150 Leduc Blvd., Suite 201 Brossard, Quebec J4Y 0E3 SUBMISSION CONTROL NUMBER: 268193 _ _ _ _ Date of Initial Authorization: FEB 1, 2023 _M-METHOTREXATE Product Monograph_ Page 2 of 43 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 ................................................................................................... 12 DRUG INTERACTIONS ................................................................................................... 16 DOSAGE AND ADMINISTRATION ............................................................................... 20 OVERDOSAGE .................................................................................................................. 23 ACTION AND CLINICAL PHARMACOLOGY .............................................................. 24 STORAGE AND STABILITY ........................................................................................... 26 SPECIAL HANDLING INSTRUCTIONS ......................................................................... 27 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................. 27 PART II: SCIENTIFIC INFORMATION ............................................................................... 29 PHARMACEUTICAL INFORMATION .......................................................................... Прочитать полный документ