MOMETASONE SPRAY, METERED DOSE

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

MOMETASONE FUROATE (MOMETASONE FUROATE MONOHYDRATE)

זמין מ:

SANIS HEALTH INC

קוד ATC:

R01AD09

INN (שם בינלאומי):

MOMETASONE

כמות:

50MCG

טופס פרצבטיות:

SPRAY, METERED DOSE

הרכב:

MOMETASONE FUROATE (MOMETASONE FUROATE MONOHYDRATE) 50MCG

מסלול נתינה (של תרופות):

NASAL

יחידות באריזה:

15G/50G

סוג מרשם:

Prescription

איזור תרפויטי:

CORTICOSTEROIDS

leaflet_short:

Active ingredient group (AIG) number: 0121732002; AHFS:

מצב אישור:

APPROVED

תאריך אישור:

2021-08-18

מאפייני מוצר

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_MOMETASONE _
_Page 1 of 31_
PRODUCT MONOGRAPH
PR
MOMETASONE
Mometasone Furoate Monohydrate Aqueous Nasal Spray
50 mcg/metered spray (as mometasone furoate)
Manufacturer’s Standard
Corticosteroid
Sanis Health Inc.
1 President's Choice Circle
Brampton, Ontario
L6Y 5S5
Submission Control No: 269507
Date of Initial Authorization:
AUG
18, 2021
Date of
Revision:
DEC 01, 2022
_ _
_MOMETASONE _
_Page 2 of 31_
RECENT MAJOR LABEL CHANGES
INDICATIONS
12/2022
DOSAGE AND ADMINISTRATION
12/2022
TABLE OF CONTENTS
RECENT MAJOR LABEL
CHANGES......................................................................................2
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS
...................................................................................................................
3
CONTRAINDICATIONS
..................................................................................................
3
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
6
DRUG INTERACTIONS
...................................................................................................
8
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
...........................................................