SILKIS OINTMENT

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

CALCITRIOL

זמין מ:

GALDERMA CANADA INC

קוד ATC:

D05AX03

INN (שם בינלאומי):

CALCITRIOL

כמות:

3MCG

טופס פרצבטיות:

OINTMENT

הרכב:

CALCITRIOL 3MCG

מסלול נתינה (של תרופות):

TOPICAL

יחידות באריזה:

5G/30G/60G/100G

סוג מרשם:

Prescription

איזור תרפויטי:

MISC. SKIN AND MUCOUS MEMBRANE AGENTS

leaflet_short:

Active ingredient group (AIG) number: 0113628006; AHFS:

מצב אישור:

APPROVED

תאריך אישור:

2009-12-01

מאפייני מוצר

PRODUCT MONOGRAPH
Pr
SILKIS
®
(Calcitriol)
Ointment
3 µg/g
Topical Non-Steroidal
Antipsoriatic Agent
GALDERMA CANADA INC.
55 Commerce Valley Drive W., Suite 400
Thornhill, ON
L3T 7V9
www.galderma.ca
DATE OF PREPARATION:
November 30, 2009
DATE OF REVISION:
October 17, 2017
SUBMISSION CONTROL NO: 206311
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
...................................................................................................
3
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
5
DRUG INTERACTIONS
...................................................................................................
7
DOSAGE AND ADMINISTRATION
...............................................................................
7
OVERDOSAGE
..................................................................................................................
8
ACTION AND CLINICAL PHARMACOLOGY
.............................................................. 8
STORAGE AND STABILITY
...........................................................................................
9
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................... 9
PART II: SCIENTIFIC INFORMATION
................................................................................10
PHARMACEUTICAL INFORMATION
..........................................................................10
CLINICAL TRIALS
..........................................................................................................
10
DETAILED PHARMACOLOGY
......................................