AG-EMTRICITABINE / TENOFOVIR DISOPROXIL FUMARATE TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

TENOFOVIR DISOPROXIL FUMARATE; EMTRICITABINE

Disponible depuis:

ANGITA PHARMA INC.

Code ATC:

J05AR03

DCI (Dénomination commune internationale):

TENOFOVIR DISOPROXIL AND EMTRICITABINE

Dosage:

300MG; 200MG

forme pharmaceutique:

TABLET

Composition:

TENOFOVIR DISOPROXIL FUMARATE 300MG; EMTRICITABINE 200MG

Mode d'administration:

ORAL

Unités en paquet:

15G/50G

Type d'ordonnance:

Prescription

Domaine thérapeutique:

NUCLEOSIDE AND NUCLEOTIDE REVERSE TRANSCRIPTASE INHIBITORS

Descriptif du produit:

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

Statut de autorisation:

APPROVED

Date de l'autorisation:

2020-02-19

Résumé des caractéristiques du produit

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