MYLAN-EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE TABLET

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Pieejams no:

MYLAN PHARMACEUTICALS ULC

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

Receptes veids:

Prescription

Ārstniecības joma:

NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS

Produktu pārskats:

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

Autorizācija statuss:

APPROVED

Autorizācija datums:

2017-07-26

Produkta apraksts

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