APO-CICLESONIDE SPRAY, METERED DOSE

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

CICLESONIDE

Dostopno od:

APOTEX INC

Koda artikla:

R01AD13

INN (mednarodno ime):

CICLESONIDE

Odmerek:

50MCG

Farmacevtska oblika:

SPRAY, METERED DOSE

Sestava:

CICLESONIDE 50MCG

Pot uporabe:

NASAL

Enote v paketu:

120 METERED SPRAYS

Tip zastaranja:

Prescription

Terapevtsko območje:

CORTICOSTEROIDS

Povzetek izdelek:

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

Status dovoljenje:

APPROVED

Datum dovoljenje:

2015-05-01

Lastnosti izdelka

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...........