AURO-EFAVIRENZ-EMTRICITABINE-TENOFOVIR TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Boleh didapati daripada:

AURO PHARMA INC

Kod ATC:

J05AR06

INN (Nama Antarabangsa):

EMTRICITABINE, TENOFOVIR DISOPROXIL AND EFAVIRENZ

Dos:

600MG; 200MG; 300MG

Borang farmaseutikal:

TABLET

Komposisi:

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

Laluan pentadbiran:

ORAL

Unit dalam pakej:

30

Jenis preskripsi:

Prescription

Kawasan terapeutik:

NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS

Ringkasan produk:

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

Status kebenaran:

APPROVED

Tarikh kebenaran:

2018-07-04

Ciri produk

Page 1 of 67
PRODUCT MONOGRAPH
PR
AURO-EFAVIRENZ-EMTRICITABINE-TENOFOVIR
EFAVIRENZ, EMTRICITABINE AND TENOFOVIR TABLETS
HOUSE STANDARD
600 MG / 200 MG / 300 MG
(as efavirenz/emtricitabine/tenofovir disoproxil fumarate)
ANTIRETROVIRAL AGENT
AURO PHARMA INC.
3700 Steeles Avenue West Suite 402
Woodbridge, Ontario,
L4L 8K8, CANADA
Submission Control No.: 238768
Date of Revision:
May 29, 2020
Page 2 of 67
TABLE OF CONTENTS
PART I.
HEALTH PROFESSIONAL
INFORMATION……………………………………..3
SUMMARY PRODUCT
INFORMATION………………………………………………3
INDICATIONS AND CLINICAL
USE…………………………………………………..3
CONTRAINDICATIONS………………………………………………………………...3
WARNINGS AND PRECAUTIONS
.................................................................................4
ADVERSE REACTIONS
...............................................................................................15
DRUG INTERACTIONS
................................................................................................23
DOSAGE AND ADMINISTRATION
............................................................................38
OVERDOSAGE
..............................................................................................................38
ACTION AND CLINICAL PHARMACOLOGY
..........................................................39
STORAGE AND STABILITY
........................................................................................43
SPECIAL HANDLING INSTRUCTIONS
.....................................................................43
DOSAGE FORMS, COMPOSITION AND PACKAGING
...........................................43
PART II.
SCIENTIFIC
INFORMATION……………………………………………………44
PHARMACEUTICAL INFORMATION
........................................................................44
CLINICAL TRIALS
..................................................................................................