AURO-DARUNAVIR TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

DARUNAVIR (DARUNAVIR PROPYLENE GLYCOLATE)

Mevcut itibaren:

AURO PHARMA INC

ATC kodu:

J05AE10

INN (International Adı):

DARUNAVIR

Doz:

400MG

Farmasötik formu:

TABLET

Kompozisyon:

DARUNAVIR (DARUNAVIR PROPYLENE GLYCOLATE) 400MG

Uygulama yolu:

ORAL

Paketteki üniteler:

100

Reçete türü:

Prescription

Terapötik alanı:

HIV PROTEASE INHIBITORS

Ürün özeti:

Active ingredient group (AIG) number: 0151656002; AHFS:

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2020-01-02

Ürün özellikleri

_Auro-Darunavir Product Monograph _Page 1 of 88
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AURO-DARUNAVIR
Darunavir Tablets
Tablets, 400 mg, 600 mg and 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:
January 4, 2023
Submission Control Number: 270155
_Auro-Darunavir Product Monograph _Page 2 of 88
RECENT MAJOR LABEL CHANGES
N/A
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
................................................................................................................
8
5 OVE