APO-FLUTICASONE SPRAY, METERED DOSE

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

FLUTICASONE PROPIONATE

제공처:

APOTEX INC

ATC 코드:

R01AD08

INN (국제 이름):

FLUTICASONE

복용량:

50MCG

약제 형태:

SPRAY, METERED DOSE

구성:

FLUTICASONE PROPIONATE 50MCG

관리 경로:

NASAL

패키지 단위:

120

처방전 유형:

Prescription

치료 영역:

CORTICOSTEROIDS

제품 요약:

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

승인 상태:

APPROVED

승인 날짜:

2007-05-04

제품 특성 요약

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
.............