MYLAN-EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Boleh didapati daripada:

MYLAN PHARMACEUTICALS ULC

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:

2017-07-26

Ciri produk

PAGE 1 OF 75
PRODUCT MONOGRAPH
PR MYLAN-EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE
EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE TABLETS
600 MG EFAVIRENZ
200 MG EMTRICITABINE
300 MG TENOFOVIR DISOPROXIL FUMARATE
MYLAN STD.
ANTIRETROVIRAL AGENT
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, Ontario
M8Z 2S6
Date of Revision: July 27, 2020
Submission Control No: 241548
PAGE 2 OF 75
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
.......................................................................................................................................
15
DRUG
INTERACTIONS
.......................................................................................................................................
24
DOSAGE
AND
ADMINISTRATION....................................................................................................................
40
OVERDOSAGE
.....................................................................................................................................................
41
ACTION
AND
CLINICAL
PHARMACOLOGY
..................................................................................................
42
STORAGE
AND
STABILITY
.......................................................................................................................