PMS-EFAVIRENZ-EMTRICITABINE-TENOFOVIR TABLET
País: Canadà
Idioma: anglès
Font: Health Canada
Fitxa tècnica
(SPC)
11-06-2020
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ingredients actius:
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Disponible des:
PHARMASCIENCE INC
Codi ATC:
J05AR06
Designació comuna internacional (DCI):
EMTRICITABINE, TENOFOVIR DISOPROXIL AND EFAVIRENZ
Dosis:
600MG; 200MG; 300MG
formulario farmacéutico:
TABLET
Composición:
EFAVIRENZ 600MG; EMTRICITABINE 200MG; TENOFOVIR DISOPROXIL FUMARATE 300MG
Vía de administración:
ORAL
Unidades en paquete:
15G/50G
tipo de receta:
Prescription
Área terapéutica:
NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS
Resumen del producto:
Active ingredient group (AIG) number: 0352327001; AHFS:
Estat d'Autorització:
APPROVED
Data d'autorització:
2019-04-10
Fitxa tècnica
PRODUCT MONOGRAPH
Pr
PMS-EFAVIRENZ-EMTRICITABINE-TENOFOVIR
Efavirenz, Emtricitabine and Tenofovir Tablets
Manufacturer Standard
600 mg / 200 mg / 300 mg
(efavirenz / emtricitabine / tenofovir disoproxil fumarate)
ANTIRETROVIRAL AGENT
PHARMASCIENCE INC.
DATE OF REVISION:
6111 Ave. Royalmount
June 11, 2020
Montréal, Canada
H4P 2T4
www.pharmascience.com
Submission Control No: 239754
_pms-EFAVIRENZ-EMTRICITABINE-TENOFOVIR Product Monograph _
_Page 2 of 73_
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
.................................................................................................
16
DRUG INTERACTIONS
.................................................................................................
24
DOSAGE AND ADMINISTRATION
.............................................................................
40
OVERDOSAGE
...............................................................................................................
41
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 42
STORAGE AND STABILITY
.........................................................................................
46
SPECIAL HANDLING INSTRUCTIONS
......................................................................
46
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 46
PART II: SCIENTIFIC INFORMATION
..............................................................................
47
PHARMACEUTICAL INFORMATION
...................
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