TEVA-MOMETASONE SPRAY, METERED DOSE

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

MOMETASONE FUROATE

Disponibil de la:

TEVA CANADA LIMITED

Codul ATC:

R01AD09

INN (nume internaţional):

MOMETASONE

Dozare:

50MCG

Forma farmaceutică:

SPRAY, METERED DOSE

Compoziție:

MOMETASONE FUROATE 50MCG

Calea de administrare:

NASAL

Unități în pachet:

140 DOSES (20ML)

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

CORTICOSTEROIDS

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2018-05-18

Caracteristicilor produsului

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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
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TEVA-MOMETASONE
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_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............