APO-CICLESONIDE SPRAY, METERED DOSE

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

CICLESONIDE

Disponible depuis:

APOTEX INC

Code ATC:

R01AD13

DCI (Dénomination commune internationale):

CICLESONIDE

Dosage:

50MCG

forme pharmaceutique:

SPRAY, METERED DOSE

Composition:

CICLESONIDE 50MCG

Mode d'administration:

NASAL

Unités en paquet:

120 METERED SPRAYS

Type d'ordonnance:

Prescription

Domaine thérapeutique:

CORTICOSTEROIDS

Descriptif du produit:

Active ingredient group (AIG) number: 0151669004; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2015-05-01

Résumé des caractéristiques du produit

PRODUCT MONOGRAPH
APO-CICLESONIDE
CICLESONIDE NASAL SPRAY
50 MCG/METERED SPRAY
CORTICOSTEROID FOR NASAL USE
ANTIALLERGIC
APOTEX INC.
DATE OF REVISION:
150 SIGNET DRIVE
JULY 27, 2017
TORONTO ONTARIO
M9L 1T9
CONTROL NO.: 206051
Page 2 of 26
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
.........................................................................................................
6
DRUG INTERACTIONS
..........................................................................................................
8
DOSAGE AND ADMINISTRATION
.........................................................................................
9
OVERDOSAGE
.......................................................................................................................
9
ACTION AND CLINICAL PHARMACOLOGY
.......................................................................
10
STORAGE AND STABILITY
.................................................................................................
11
SPECIAL HANDLING INSTRUCTIONS
................................................................................
11
DOSAGE FORMS, COMPOSITION AND PACKAGING
...................................................... 11
PART II: SCIENTIFIC INFORMATION
......................................................................................
12
PHARMACEUTICAL INFORMATION
...................................................................................
12
CLINICAL
TRIALS...........