TARO-ACITRETIN CAPSULE

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

ACITRETIN

متاح من:

TARO PHARMACEUTICALS INC

ATC رمز:

D05BB02

INN (الاسم الدولي):

ACITRETIN

جرعة:

25MG

الشكل الصيدلاني:

CAPSULE

تركيب:

ACITRETIN 25MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

30

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

MISC. SKIN AND MUCOUS MEMBRANE AGENTS

ملخص المنتج:

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

الوضع إذن:

APPROVED

تاريخ الترخيص:

2017-07-10

خصائص المنتج

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