TARO-ACITRETIN CAPSULE

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

ACITRETIN

Доступно од:

TARO PHARMACEUTICALS INC

АТЦ код:

D05BB02

INN (Међународно име):

ACITRETIN

Дозирање:

25MG

Фармацеутски облик:

CAPSULE

Састав:

ACITRETIN 25MG

Пут администрације:

ORAL

Јединице у пакету:

30

Тип рецептора:

Prescription

Терапеутска област:

MISC. SKIN AND MUCOUS MEMBRANE AGENTS

Резиме производа:

Active ingredient group (AIG) number: 0122473001; AHFS:

Статус ауторизације:

APPROVED

Датум одобрења:

2017-07-10

Карактеристике производа

Page 1 of 52
PRODUCT MONOGRAPH
PR
TARO-ACITRETIN
(Acitretin Capsules)
10 mg and 25 mg
Taro Standard
Keratinization Disorder Treatment
TARO PHARMACEUTICALS INC.
130 East Drive,
Brampton, Ontario
Canada L6T 1C1
CONTROL NUMBER: 200188
DATE OF PREPARATION:
July 07, 2017
Page 2 of 52
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
.......................................................................3
INDICATIONS AND CLINICAL USE
.............................................................................3
CONTRAINDICATIONS
..................................................................................................4
WARNINGS AND PRECAUTIONS
.................................................................................6
ADVERSE REACTIONS
.................................................................................................16
DRUG INTERACTIONS
.................................................................................................24
DOSAGE AND ADMINISTRATION
.............................................................................26
OVERDOSAGE
...............................................................................................................27
ACTION AND CLINICAL PHARMACOLOGY
...........................................................28
STORAGE AND STABILITY
.........................................................................................30
SPECIAL HANDLING INSTRUCTIONS
......................................................................30
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................30
PART II: SCIENTIFIC INFORMATION
...............................................................................31
PHARMACEUTICAL INFORMATION
.........................................................................31
CLINICAL TRIALS
.........................................................................................................31
DETAILED