TEVA-MOMETASONE OINTMENT

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

MOMETASONE FUROATE

זמין מ:

TEVA CANADA LIMITED

קוד ATC:

D07AC13

INN (שם בינלאומי):

MOMETASONE

כמות:

0.1%

טופס פרצבטיות:

OINTMENT

הרכב:

MOMETASONE FUROATE 0.1%

מסלול נתינה (של תרופות):

TOPICAL

יחידות באריזה:

15G/50G

סוג מרשם:

Prescription

איזור תרפויטי:

ANTI-INFLAMMATORY AGENTS

leaflet_short:

Active ingredient group (AIG) number: 0121732001; AHFS:

מצב אישור:

APPROVED

תאריך אישור:

2013-03-12

מאפייני מוצר

TEVA-MOMETASONE
1 of 28
PRODUCT MONOGRAPH
Pr
TEVA-MOMETASONE
Mometasone Furoate 0.1% Ointment, USP
Topical Corticosteroid
Teva Canada Limited
30 Novopharm Court
Toronto, Canada
M1B 2K9
www.tevacanada.com
CONTROL # 215362
Date of Revision:
May 7, 2018
TEVA-MOMETASONE
2 of 28
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
.............................................................................................
8
DRUG
INTERACTIONS
.............................................................................................
9
DOSAGE
AND
ADMINISTRATION
........................................................................
9
OVERDOSAGE
..........................................................................................................
11
ACTION
AND
CLINICAL
PHARMACOLOGY
.................................................... 11
STORAGE
AND
STABILITY
...................................................................................
12
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING
.................................... 12
PART II: SCIENTIFIC INFORMATION ................................................................ 13
PHARMACEUTICAL
INFORMATION
.....................................................................
13
CLINICAL
TRIALS
...................................................................................................
14
DETAILED
PHARMACOLOGY
.............................................................................
17
TOXICOLOGY
...................................................................................................