JAMP EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

TENOFOVIR DISOPROXIL FUMARATE; EMTRICITABINE

Disponible depuis:

JAMP PHARMA CORPORATION

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:

2019-05-21

Résumé des caractéristiques du produit

JAMP Emtricitabine / Tenofovir Disoproxil Fumarate (Emtricitabine and
Tenofovir Tablets) Page 1 of 67
PRODUCT MONOGRAPH
Pr
JAMP Emtricitabine / Tenofovir Disoproxil Fumarate
Emtricitabine and Tenofovir Tablets
200 mg / 300 mg
(Emtricitabine / Tenofovir disoproxil fumarate)
House Standard
Antiretroviral Agent
JAMP Pharma Corporation
1310 rue Nobel,
Boucherville,
Québec
J4B 5H3, Canada
Submission Control No.: 248455
Date of Revision: May 19, 2021
JAMP Emtricitabine / Tenofovir Disoproxil Fumarate (Emtricitabine and
Tenofovir Tablets) Page 2 of 67
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