PMS-FLUTICASONE PROPIONATE/SALMETEROL DPI POWDER

국가: 캐나다

언어: 영어

출처: Health Canada

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제품 특성 요약 제품 특성 요약 (SPC)
09-11-2020

유효 성분:

FLUTICASONE PROPIONATE; SALMETEROL (SALMETEROL XINAFOATE)

제공처:

PHARMASCIENCE INC

ATC 코드:

R03AK06

INN (International Name):

SALMETEROL AND FLUTICASONE

복용량:

100MCG; 50MCG

약제 형태:

POWDER

구성:

FLUTICASONE PROPIONATE 100MCG; SALMETEROL (SALMETEROL XINAFOATE) 50MCG

관리 경로:

INHALATION

패키지 단위:

15G/50G

처방전 유형:

Prescription

치료 영역:

ADRENALS

제품 요약:

Active ingredient group (AIG) number: 0238341001; AHFS:

승인 상태:

APPROVED

승인 날짜:

2019-12-10

제품 특성 요약

                                PR
PMS-FLUTICASONE PROPIONATE / SALMETEROL DPI
Fluticasone Propionate and Salmeterol Inhalation Powder USP
Pr
pms-FLUTICASONE PROPIONATE / SALMETEROL DPI _ _
100 mcg Fluticasone Propionate and 50 mcg Salmeterol (as the Xinafoate
salt)
Dry Powder Inhaler
Pr
pms-FLUTICASONE PROPIONATE / SALMETEROL DPI
250 mcg Fluticasone Propionate and 50 mcg Salmeterol (as the Xinafoate
salt)
Dry Powder Inhaler
Pr
pms-FLUTICASONE PROPIONATE / SALMETEROL DPI
500 mcg Fluticasone Propionate and 50 mcg Salmeterol (as the Xinafoate
salt)
Dry Powder Inhaler
CORTICOSTEROID AND BRONCHODILATOR FOR ORAL INHALATION
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Canada
H4P 2T4
www.pharmascience.com
DATE OF PREPARATION:
November 9, 2020
Submission Control No: 242762
_pms-FLUTICASONE PROPIONATE-SALMETEROL DPI Product Monograph _
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_ Page 2 of 53_
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
...................................................... 3
SUMMARY PRODUCT INFORMATION
.............................................................................
3
INDICATIONS AND CLINICAL
USE...................................................................................
3
CONTRAINDICATIONS
........................................................................................................
4
WARNINGS AND PRECAUTIONS
......................................................................................
4
ADVERSE REACTIONS
......................................................................................................
14
DRUG INTERACTIONS
.......................................................................................................
21
DOSAGE AND ADMINISTRATION
...................................................................................
23
OVERDOSAGE
.....................................................................................................................
25
ACTION AND CLINICAL PHARMACOLOGY
................................................................. 25
STORAGE AND STABILITY
..
                                
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