MINT-ACITRETIN CAPSULE

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

ACITRETIN

Dostupno od:

MINT 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:

2017-10-18

Svojstava lijeka

Page 1 of 51
PRODUCT MONOGRAPH
PR
MINT-ACITRETIN
Acitretin Capsules, BP
10 mg and 25 mg
Keratinization Disorder Treatment
Mint Pharmaceuticals Inc.
Date of Preparation: October 4, 2017
1093 Meyerside Drive, Unit 1
Mississauga, Ontario
L5T 1J6
Submission Control No: 194389
Page 2 of 51
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
....................................................................................................
15
DRUG INTERACTIONS
.....................................................................................................
23
DOSAGE AND ADMINISTRATION
.................................................................................
25
OVERDOSAGE
...................................................................................................................
26
ACTION AND CLINICAL PHARMACOLOGY
............................................................... 27
STORAGE AND STABILITY
............................................................................................
29
SPECIAL HANDLING INSTRUCTIONS
..........................................................................
29
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................ 29
PART II: SCIENTIFIC INFORMATION
...................................................................................
30
PHARMACEUTICAL INFORMATION
............................................................................
30
CLINICAL
TRIALS..........................................