AURO-EFAVIRENZ-EMTRICITABINE-TENOFOVIR TABLET

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Dostupno od:

AURO PHARMA INC

ATC koda:

J05AR06

INN (International ime):

EMTRICITABINE, TENOFOVIR DISOPROXIL AND EFAVIRENZ

Doziranje:

600MG; 200MG; 300MG

Farmaceutski oblik:

TABLET

Sastav:

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

Administracija rute:

ORAL

Jedinice u paketu:

30

Tip recepta:

Prescription

Područje terapije:

NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS

Proizvod sažetak:

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

Status autorizacije:

APPROVED

Datum autorizacije:

2018-07-04

Svojstava lijeka

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
..................................................................................................