SANDOZ EFAVIRENZ/EMTRICITABINE/TENOFOVIR TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Saatavilla:

SANDOZ CANADA INCORPORATED

ATC-koodi:

J05AR06

INN (Kansainvälinen yleisnimi):

EMTRICITABINE, TENOFOVIR DISOPROXIL AND EFAVIRENZ

Annos:

600MG; 200MG; 300MG

Lääkemuoto:

TABLET

Koostumus:

EFAVIRENZ 600MG; EMTRICITABINE 200MG; TENOFOVIR DISOPROXIL FUMARATE 300MG

Antoreitti:

ORAL

Kpl paketissa:

100

Prescription tyyppi:

Prescription

Terapeuttinen alue:

NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0352327001; AHFS:

Valtuutuksen tilan:

CANCELLED POST MARKET

Valtuutus päivämäärä:

2022-05-12

Valmisteyhteenveto

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_Sandoz Efavirenz/Emtricitabine/Tenofovir _
_Page 1 of 70_
PRODUCT MONOGRAPH
PR
SANDOZ
® EFAVIRENZ/EMTRICITABINE/TENOFOVIR
Efavirenz, Emtricitabine and Tenofovir Tablets
Manufacturer Standard
600 mg/200 mg/300 mg
(efavirenz/emtricitabine/tenofovir disoproxil fumarate)
Antiretroviral Agent
Sandoz Canada Inc.
110 de Lauzon street
Boucherville, Quebec
J4B 1E6
Date of Revision:
June 18, 2020
Submission Control No: 238792
_ _
_Sandoz Efavirenz/Emtricitabine/Tenofovir _
_Page 2 of 70_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT
INFORMATION........................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
...................................................................................................
3
WARNINGS AND PRECAUTIONS
.................................................................................
5
ADVERSE REACTIONS
.................................................................................................
15
DRUG INTERACTIONS
.................................................................................................
23
DOSAGE AND ADMINISTRATION
.............................................................................
38
OVERDOSAGE
................................................................................................................
38
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 39
STORAGE AND STABILITY
.........................................................................................
43
SPECIAL HANDLING INSTRUCTIONS
.......................................................................
43
DOSAGE FORMS, COMPOSITION AND
PACKAGING............................................. 44
PART II: SCIENTIFIC INFORMATION
..............................................................................
45
PHARMACEUTI