AG-EMTRICITABINE / TENOFOVIR DISOPROXIL FUMARATE TABLET

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

TENOFOVIR DISOPROXIL FUMARATE; EMTRICITABINE

Pieejams no:

ANGITA PHARMA INC.

ATĶ kods:

J05AR03

SNN (starptautisko nepatentēto nosaukumu):

TENOFOVIR DISOPROXIL AND EMTRICITABINE

Deva:

300MG; 200MG

Zāļu forma:

TABLET

Kompozīcija:

TENOFOVIR DISOPROXIL FUMARATE 300MG; EMTRICITABINE 200MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

15G/50G

Receptes veids:

Prescription

Ārstniecības joma:

NUCLEOSIDE AND NUCLEOTIDE REVERSE TRANSCRIPTASE INHIBITORS

Produktu pārskats:

Active ingredient group (AIG) number: 0251568001; AHFS:

Autorizācija statuss:

APPROVED

Autorizācija datums:

2020-02-19

Produkta apraksts

PRODUCT MONOGRAPH
Pr
AG-Emtricitabine / Tenofovir Disoproxil Fumarate
Emtricitabine and Tenofovir Tablets
200 mg / 300 mg
(Emtricitabine / Tenofovir disoproxil fumarate)
House Standard
Antiretroviral Agent
Angita Pharma Inc.
1310 rue Nobel
Boucherville,
Quebec
J4B 5H3, Canada
Submission Control No.: 265244
Date of Preparation: November 28, 2022
AG-Emtricitabine / Tenofovir Disoproxil Fumarate
(emtricitabine/tenofovir
disoproxil fumarate) tablets Product Monograph
Page 2
TABLE OF CONTENTS
PART I.
HEALTH PROFESSIONAL INFORMATION
.............................................................................................
3
SUMMARY PRODUCT INFORMATION
...........................................................................................................
3
INDICATIONS AND CLINICAL USE
.................................................................................................................
3
CONTRAINDICATIONS
.......................................................................................................................................
5
WARNINGS AND PRECAUTIONS
.....................................................................................................................
5
ADVERSE
REACTIONS......................................................................................................................................
14
DRUG INTERACTIONS
......................................................................................................................................
22
DOSAGE AND ADMINISTRATION
.................................................................................................................
34
OVERDOSAGE
.....................................................................................................................................................
36
ACTION AND CLINICAL
PHARMACOLOGY................................................................................................
37
STORAGE AND
STABILITY................................................................