APO-CICLESONIDE SPRAY, METERED DOSE

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

CICLESONIDE

متاح من:

APOTEX INC

ATC رمز:

R01AD13

INN (الاسم الدولي):

CICLESONIDE

جرعة:

50MCG

الشكل الصيدلاني:

SPRAY, METERED DOSE

تركيب:

CICLESONIDE 50MCG

طريقة التعاطي:

NASAL

الوحدات في الحزمة:

120 METERED SPRAYS

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

CORTICOSTEROIDS

ملخص المنتج:

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

الوضع إذن:

APPROVED

تاريخ الترخيص:

2015-05-01

خصائص المنتج

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...........