SANDOZ MOMETASONE SPRAY, METERED DOSE

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

MOMETASONE FUROATE (MOMETASONE FUROATE MONOHYDRATE)

Beschikbaar vanaf:

SANDOZ CANADA INCORPORATED

ATC-code:

R01AD09

INN (Algemene Internationale Benaming):

MOMETASONE

Dosering:

50MCG

farmaceutische vorm:

SPRAY, METERED DOSE

Samenstelling:

MOMETASONE FUROATE (MOMETASONE FUROATE MONOHYDRATE) 50MCG

Toedieningsweg:

NASAL

Eenheden in pakket:

140 DOSES

Prescription-type:

Prescription

Therapeutisch gebied:

CORTICOSTEROIDS

Product samenvatting:

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

Autorisatie-status:

APPROVED

Autorisatie datum:

2015-12-07

Productkenmerken

_ _
_Sandoz Mometasone _
_Page 1 of 31_
PRODUCT MONOGRAPH
PR
SANDOZ MOMETASONE
Mometasone Furoate Monohydrate Aqueous Nasal Spray
50 mcg/metered spray (as mometasone furoate)
Manufacturer’s Standard
Corticosteroid
Sandoz Canada Inc.
110 rue de Lauzon
Boucherville, Quebec, Canada
J4B 1E6
Date of Initial Authorization:
July 27, 2016
Date of Revision:
July 29, 2022
Submission Control No: 264167
_ _
_Sandoz Mometasone _
_Page 2 of 31_
RECENT MAJOR LABEL CHANGES
INDICATIONS
07/2022
DOSAGE AND ADMINISTRATION
07/2022
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
..................................