TEVA-MOMETASONE SPRAY, METERED DOSE

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

MOMETASONE FUROATE

Beszerezhető a:

TEVA CANADA LIMITED

ATC-kód:

R01AD09

INN (nemzetközi neve):

MOMETASONE

Adagolás:

50MCG

Gyógyszerészeti forma:

SPRAY, METERED DOSE

Összetétel:

MOMETASONE FUROATE 50MCG

Az alkalmazás módja:

NASAL

db csomag:

140 DOSES (20ML)

Recept típusa:

Prescription

Terápiás terület:

CORTICOSTEROIDS

Termék összefoglaló:

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

Engedélyezési státusz:

APPROVED

Engedély dátuma:

2018-05-18

Termékjellemzők

_ _
TEVA-MOMETASONE
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_Page 1 of 36_
PRODUCT MONOGRAPH
PR
TEVA-MOMETASONE
Mometasone furoate aqueous nasal spray
50 mcg per metered spray
Teva Standard
Corticosteroid
Teva Canada Limited
30 Novopharm Court
Toronto, ON M1B 2K9
Date of Initial Authorization:
May 18, 2018
Date of Revision:
November 2, 2022
Submission Control No: 267830
_ _
TEVA-MOMETASONE
_ _
_Page 2 of 36_
RECENT MAJOR LABEL CHANGES
INDICATIONS
11/2022
DOSAGE AND ADMINISTRATION
11/2022
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............