APO-EFAVIRENZ-EMTRICITABINE-TENOFOVIR TABLET

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Pieejams no:

APOTEX INC

ATĶ kods:

J05AR06

SNN (starptautisko nepatentēto nosaukumu):

EMTRICITABINE, TENOFOVIR DISOPROXIL AND EFAVIRENZ

Deva:

600MG; 200MG; 300MG

Zāļu forma:

TABLET

Kompozīcija:

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

Ievadīšanas:

ORAL

Vienības iepakojumā:

30/90

Receptes veids:

Prescription

Ārstniecības joma:

NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS

Produktu pārskats:

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

Autorizācija statuss:

APPROVED

Autorizācija datums:

2017-09-14

Produkta apraksts

Page 1 of 77
PRODUCT MONOGRAPH
PR
APO-EFAVIRENZ-EMTRICITABINE-TENOFOVIR
EFAVIRENZ, EMTRICITABINE
AND
TENOFOVIR TABLETS
APOTEX STANDARD
600 MG EFAVIRENZ
200 MG EMTRICITABINE
300 MG TENOFOVIR DISOPROXIL FUMARATE
ANTIRETROVIRAL AGENT
APOTEX INC.
Date of Revision:
150 Signet Drive
June 24, 2020.
Toronto, Ontario
M9L 1T9
Submission Control No.: 239967
Page 2 of 77
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
.........................................................................................................
25
DOSAGE AND ADMINISTRATION
.....................................................................................
42
OVERDOSAGE
.......................................................................................................................
43
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
44
STORAGE AND STABILITY
.................................................................................................
48
SPECIAL HANDLING INSTRUCTIONS
..............................................................................
48
DOSAGE FORMS, COMPOSITION AND
PACKAGING..................................................... 48
PART II.
SCIENTIFIC INFORMATION
...................................................................................
49
PHARMACEUTICAL INFORMATION
..........