TARO-ACITRETIN CAPSULE

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

ACITRETIN

Dostupno od:

TARO PHARMACEUTICALS INC

ATC koda:

D05BB02

INN (International ime):

ACITRETIN

Doziranje:

25MG

Farmaceutski oblik:

CAPSULE

Sastav:

ACITRETIN 25MG

Administracija rute:

ORAL

Jedinice u paketu:

30

Tip recepta:

Prescription

Područje terapije:

MISC. SKIN AND MUCOUS MEMBRANE AGENTS

Proizvod sažetak:

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

Status autorizacije:

APPROVED

Datum autorizacije:

2017-07-10

Svojstava lijeka

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