AG-EMTRICITABINE / TENOFOVIR DISOPROXIL FUMARATE TABLET

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

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Termékjellemzők Termékjellemzők (SPC)
28-11-2022

Aktív összetevők:

TENOFOVIR DISOPROXIL FUMARATE; EMTRICITABINE

Beszerezhető a:

ANGITA PHARMA INC.

ATC-kód:

J05AR03

INN (nemzetközi neve):

TENOFOVIR DISOPROXIL AND EMTRICITABINE

Adagolás:

300MG; 200MG

Gyógyszerészeti forma:

TABLET

Összetétel:

TENOFOVIR DISOPROXIL FUMARATE 300MG; EMTRICITABINE 200MG

Az alkalmazás módja:

ORAL

db csomag:

15G/50G

Recept típusa:

Prescription

Terápiás terület:

NUCLEOSIDE AND NUCLEOTIDE REVERSE TRANSCRIPTASE INHIBITORS

Termék összefoglaló:

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

Engedélyezési státusz:

APPROVED

Engedély dátuma:

2020-02-19

Termékjellemzők

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