PMS-EFAVIRENZ-EMTRICITABINE-TENOFOVIR TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Sẵn có từ:

PHARMASCIENCE INC

Mã ATC:

J05AR06

INN (Tên quốc tế):

EMTRICITABINE, TENOFOVIR DISOPROXIL AND EFAVIRENZ

Liều dùng:

600MG; 200MG; 300MG

Dạng dược phẩm:

TABLET

Thành phần:

EFAVIRENZ 600MG; EMTRICITABINE 200MG; TENOFOVIR DISOPROXIL FUMARATE 300MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

15G/50G

Loại thuốc theo toa:

Prescription

Khu trị liệu:

NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0352327001; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2019-04-10

Đặc tính sản phẩm

PRODUCT MONOGRAPH
Pr
PMS-EFAVIRENZ-EMTRICITABINE-TENOFOVIR
Efavirenz, Emtricitabine and Tenofovir Tablets
Manufacturer Standard
600 mg / 200 mg / 300 mg
(efavirenz / emtricitabine / tenofovir disoproxil fumarate)
ANTIRETROVIRAL AGENT
PHARMASCIENCE INC.
DATE OF REVISION:
6111 Ave. Royalmount
June 11, 2020
Montréal, Canada
H4P 2T4
www.pharmascience.com
Submission Control No: 239754
_pms-EFAVIRENZ-EMTRICITABINE-TENOFOVIR Product Monograph _
_Page 2 of 73_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
3
WARNINGS AND PRECAUTIONS
.................................................................................
5
ADVERSE REACTIONS
.................................................................................................
16
DRUG INTERACTIONS
.................................................................................................
24
DOSAGE AND ADMINISTRATION
.............................................................................
40
OVERDOSAGE
...............................................................................................................
41
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 42
STORAGE AND STABILITY
.........................................................................................
46
SPECIAL HANDLING INSTRUCTIONS
......................................................................
46
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 46
PART II: SCIENTIFIC INFORMATION
..............................................................................
47
PHARMACEUTICAL INFORMATION
...................