AG-EMTRICITABINE / TENOFOVIR DISOPROXIL FUMARATE TABLET

País: Canadà

Idioma: anglès

Font: Health Canada

Compra'l ara

Fitxa tècnica Fitxa tècnica (SPC)
28-11-2022

ingredients actius:

TENOFOVIR DISOPROXIL FUMARATE; EMTRICITABINE

Disponible des:

ANGITA PHARMA INC.

Codi ATC:

J05AR03

Designació comuna internacional (DCI):

TENOFOVIR DISOPROXIL AND EMTRICITABINE

Dosis:

300MG; 200MG

formulario farmacéutico:

TABLET

Composición:

TENOFOVIR DISOPROXIL FUMARATE 300MG; EMTRICITABINE 200MG

Vía de administración:

ORAL

Unidades en paquete:

15G/50G

tipo de receta:

Prescription

Área terapéutica:

NUCLEOSIDE AND NUCLEOTIDE REVERSE TRANSCRIPTASE INHIBITORS

Resumen del producto:

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

Estat d'Autorització:

APPROVED

Data d'autorització:

2020-02-19

Fitxa tècnica

                                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................................................................
                                
                                Llegiu el document complet
                                
                            

Documents en altres idiomes

Fitxa tècnica Fitxa tècnica francès 17-02-2020