AURO-EFAVIRENZ TABLET

দেশ: কানাডা

ভাষা: ইংরেজি

সূত্র: Health Canada

সক্রিয় উপাদান:

EFAVIRENZ

থেকে পাওয়া:

AURO PHARMA INC

এটিসি কোড:

J05AG03

INN (আন্তর্জাতিক নাম):

EFAVIRENZ

ডোজ:

600MG

ফার্মাসিউটিকাল ফর্ম:

TABLET

রচনা:

EFAVIRENZ 600MG

প্রশাসন রুট:

ORAL

প্যাকেজ ইউনিট:

10/30/90/500

প্রেসক্রিপশন টাইপ:

Prescription

থেরাপিউটিক এলাকা:

NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS

পণ্য সারাংশ:

Active ingredient group (AIG) number: 0137031005; AHFS:

অনুমোদন অবস্থা:

APPROVED

অনুমোদন তারিখ:

2013-12-17

পণ্য বৈশিষ্ট্য

Page 1 of 53
PRODUCT MONOGRAPH
Pr
AURO-EFAVIRENZ
Efavirenz Tablets, 600 mg
House Standard
Antiretroviral Agent
AURO PHARMA INC.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8
CANADA
Date of Revision:
February 11, 2020
Control Number:
235726
Page 2 of 53
TABLE OF CONTENTS
_ _
PRODUCT MONOGRAPH
............................................................................................1
TABLE OF CONTENTS
................................................................................................
2
PART I:
HEALTH PROFESSIONAL INFORMATION.......………..............
3
SUMMARY PRODUCT INFORMATION .....................….............
3
INDICATIONS AND CLINICAL USE .....................……...........
3
CONTRAINDICATIONS
.........................................………........... 3
WARNINGS AND PRECAUTIONS
..........................…….............. 4
ADVERSE
REACTIONS.....................................………….............
10
DRUG INTERACTIONS
..............................……………................ 16
DOSAGE AND ADMINISTRATION .............…............................
22
OVERDOSAGE
......................................………….........................
23
ACTION AND CLINICAL PHARMACOLOGY….........................
23
STORAGE AND STABILITY
........................................…….......... 30
DOSAGE FORMS, COMPOSITION AND PACKAGING….......
30
PART II:
SCIENTIFIC
INFORMATION..........................…………….….......
31
PHARMACEUTICAL INFORMATION.........................….............
31
CLINICAL TRIALS
...............................................……………......
32
DETAILED PHARMACOLOGY ..............................……………..
39
VIROLOGY
.............................…………………………............
40
TOXICOLOGY
............................…………………………............
42
REFERENCES
....................................………………………….....
48
PART III:
CONSUMER
INFORMATION....................…�