MINT-ACITRETIN CAPSULE

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

ACITRETIN

Beszerezhető a:

MINT PHARMACEUTICALS INC

ATC-kód:

D05BB02

INN (nemzetközi neve):

ACITRETIN

Adagolás:

10MG

Gyógyszerészeti forma:

CAPSULE

Összetétel:

ACITRETIN 10MG

Az alkalmazás módja:

ORAL

db csomag:

30

Recept típusa:

Prescription

Terápiás terület:

MISC. SKIN AND MUCOUS MEMBRANE AGENTS

Termék összefoglaló:

Active ingredient group (AIG) number: 0122473002; AHFS:

Engedélyezési státusz:

APPROVED

Engedély dátuma:

2017-10-18

Termékjellemzők

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..........................................