SUSTIVA 50MG CAPSULE

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

EFAVIRENZ

Доступно од:

BRISTOL-MYERS SQUIBB CANADA

АТЦ код:

J05AG03

INN (Међународно име):

EFAVIRENZ

Дозирање:

50MG

Фармацеутски облик:

CAPSULE

Састав:

EFAVIRENZ 50MG

Пут администрације:

ORAL

Јединице у пакету:

30

Тип рецептора:

Prescription

Терапеутска област:

NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS

Резиме производа:

Active ingredient group (AIG) number: 0137031001; AHFS:

Статус ауторизације:

CANCELLED POST MARKET

Датум одобрења:

2023-03-31

Карактеристике производа

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_Page 1 of 55 _
PRODUCT MONOGRAPH
Pr
SUSTIVA
®
(efavirenz, USP)
efavirenz Capsules USP, 50 and 200 mg
Antiretroviral Agent
Bristol-Myers Squibb Canada
Date of Preparation:
Montreal, Canada
March 18, 1999
®
Registered trademark of Bristol-Myers
Date of Revision:
Squibb Pharma Company used under licence by
August 16, 2023
Bristol-Myers Squibb Canada
Control Number: 273530
_ _
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_Page 2 of 55 _
TABLE OF CONTENTS
PRODUCT MONOGRAPH
........................................................................................................
1
TABLE OF CONTENTS
............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................... 3
SUMMARY PRODUCT INFORMATION
............................................................................
3
INDICATIONS AND CLINICAL USE
..................................................................................
3
CONTRAINDICATIONS
........................................................................................................
3
WARNINGS AND PRECAUTIONS
......................................................................................
4
ADVERSE REACTIONS
......................................................................................................
11
DRUG INTERACTIONS
......................................................................................................
17
DOSAGE AND ADMINISTRATION
..................................................................................
23
OVERDOSAGE
.....................................................................................................................
24
ACTION AND CLINICAL PHARMACOLOGY
................................................................. 25
STORAGE AND STABILITY
..............................................................................................
32
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................. 33