AURO-METHOTREXATE TABLET

দেশ: কানাডা

ভাষা: ইংরেজি

সূত্র: Health Canada

সক্রিয় উপাদান:

METHOTREXATE (METHOTREXATE DISODIUM)

থেকে পাওয়া:

AURO PHARMA INC

এটিসি কোড:

L04AX03

INN (আন্তর্জাতিক নাম):

METHOTREXATE

ডোজ:

2.5MG

ফার্মাসিউটিকাল ফর্ম:

TABLET

রচনা:

METHOTREXATE (METHOTREXATE DISODIUM) 2.5MG

প্রশাসন রুট:

ORAL

প্যাকেজ ইউনিট:

15G/50G

প্রেসক্রিপশন টাইপ:

Prescription

পণ্য সারাংশ:

Active ingredient group (AIG) number: 0107545001; AHFS:

অনুমোদন অবস্থা:

APPROVED

অনুমোদন তারিখ:

2022-01-05

পণ্য বৈশিষ্ট্য

Page 1 of 40
PRODUCT MONOGRAPH
PR
AURO-METHOTREXATE
Methotrexate Tablets USP
2.5 mg methotrexate (as methotrexate disodium)
ATC Code: L01BA01
ANTIMETABOLITE
AURO PHARMA INC. DATE OF REVISION:
3700 Steeles Avenue West, Suite # 402 May 15, 2023
Woodbridge, Ontario, L4L 8K8,
Canada
SUBMISSION CONTROL NO: 267435
Page 2 of 40
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
.................................................................................................15
DOSAGE AND ADMINISTRATION
.............................................................................19
OVERDOSAGE
................................................................................................................22
ACTION AND CLINICAL PHARMACOLOGY
............................................................23
STORAGE AND STABILITY
.........................................................................................25
SPECIAL HANDLING INSTRUCTIONS
.......................................................................25
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................26
PART II: SCIENTIFIC INFORMATION
.............................................................................27
PHARMACEUTICAL INFORMATION
.........................................................................27
CLINICAL TRIALS
...................................................................