AURO-DARUNAVIR TABLET

Country: কানাডা

ভাষা: ইংরেজি

সূত্র: Health Canada

সক্রিয় উপাদান:

DARUNAVIR (DARUNAVIR PROPYLENE GLYCOLATE)

থেকে পাওয়া:

AURO PHARMA INC

এটিসি কোড:

J05AE10

INN (International Name):

DARUNAVIR

ডোজ:

600MG

ফার্মাসিউটিকাল ফর্ম:

TABLET

রচনা:

DARUNAVIR (DARUNAVIR PROPYLENE GLYCOLATE) 600MG

প্রশাসন রুট:

ORAL

প্যাকেজ ইউনিট:

15G/50G

প্রেসক্রিপশন টাইপ:

Prescription

Therapeutic area:

HIV PROTEASE INHIBITORS

পণ্য সারাংশ:

Active ingredient group (AIG) number: 0151656003; AHFS:

অনুমোদন অবস্থা:

APPROVED

অনুমোদন তারিখ:

2020-01-02

পণ্য বৈশিষ্ট্য

Auro-Darunavir Product Monograph
Page 1 of 96
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AURO-DARUNAVIR
Darunavir Tablets
Tablets, 400 mg, 600 mg, 800 mg darunavir (as darunavir propylene
glycolate), Oral
Human Immunodeficiency Virus (HIV) Protease Inhibitor
Auro Pharma Inc.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada
Date of Initial Authorization:
January 2, 2020
Date of Revision:
December 7, 2023
Submission Control Number: 276175
Auro-Darunavir Product Monograph
Page 2 of 96
RECENT MAJOR LABEL CHANGES
None at the time of the most recent authorization
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES .................................................................................................
2
TABLE OF CONTENTS ....................................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION ..........................................................................
4
1 INDICATIONS .............................................................................................................................
4
1.1 Pediatrics
..................................................................................................................
4
1.2 Geriatrics
...................................................................................................................
4
2 CONTRAINDICATIONS
...........................................................................................................
4
4 DOSAGE AND ADMINISTRATION
...........................................................................................
5
4.1 Dosing Considerations
...............................................................................................
5
4.2 Recommended Dose and Dosage Adjustment
.......................................................... 5
4.5 Missed Dose
............................................