APO-FLUTICASONE SPRAY, METERED DOSE

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

FLUTICASONE PROPIONATE

Commercializzato da:

APOTEX INC

Codice ATC:

R01AD08

INN (Nome Internazionale):

FLUTICASONE

Dosaggio:

50MCG

Forma farmaceutica:

SPRAY, METERED DOSE

Composizione:

FLUTICASONE PROPIONATE 50MCG

Via di somministrazione:

NASAL

Confezione:

120

Tipo di ricetta:

Prescription

Area terapeutica:

CORTICOSTEROIDS

Dettagli prodotto:

Active ingredient group (AIG) number: 0124685001; AHFS:

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2007-05-04

Scheda tecnica

PRODUCT MONOGRAPH
Pr
APO-FLUTICASONE
FLUTICASONE PROPIONATE AQUEOUS NASAL SPRAY
50 MCG/METERED DOSE
APOTEX STANDARD
CORTICOSTEROID FOR NASAL USE
APOTEX INC.
DATE OF REVISION:
150 SIGNET DRIVE
May 19, 2020
TORONTO, ONTARIO
M9L 1T9
SUBMISSION CONTROL NO. 237382
Page 1 of 37
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION............................................................
2
SUMMARY PRODUCT INFORMATION
.......................................................................................
2
INDICATIONS AND CLINICAL USE
.............................................................................................
2
CONTRAINDICATIONS
..................................................................................................................
2
WARNINGS AND PRECAUTIONS
.................................................................................................
2
ADVERSE REACTIONS
..................................................................................................................
7
DRUG INTERACTIONS
...................................................................................................................
9
DOSAGE AND ADMINISTRATION
.............................................................................................
11
OVERDOSAGE
...............................................................................................................................
12
ACTION AND CLINICAL PHARMACOLOGY
............................................................................
13
STORAGE AND STABILITY
.........................................................................................................
15
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................................ 15
PART II: SCIENTIFIC INFORMATION
...................................................................................
16
PHARMACEUTICAL INFORMATION
.........................................................................................
16
CLINICAL TRIALS
.............