PMS-SALBUTAMOL SOLUTION
국가: 캐나다
언어: 영어
출처: Health Canada
제품 특성 요약
(SPC)
25-07-2018
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유효 성분:
SALBUTAMOL (SALBUTAMOL SULFATE)
제공처:
PHARMASCIENCE INC
ATC 코드:
R03AC02
INN (International Name):
SALBUTAMOL
복용량:
1MG
약제 형태:
SOLUTION
구성:
SALBUTAMOL (SALBUTAMOL SULFATE) 1MG
관리 경로:
INHALATION
패키지 단위:
2.5ML
처방전 유형:
Prescription
치료 영역:
SELECTIVE BETA 2-ADRENERGIC AGONISTS
제품 요약:
Active ingredient group (AIG) number: 0108887007; AHFS:
승인 상태:
APPROVED
승인 날짜:
2010-05-04
제품 특성 요약
PRODUCT MONOGRAPH
PR
PMS-SALBUTAMOL
Salbutamol Sulphate Inhalation Solution, BP
0.05%; 0.1%; 0.2%
0.5 mg/mL; 1 mg/mL; 2 mg/mL
BRONCHODILATOR
Beta
2
-adrenergic stimulant
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Canada
H4P 2T4
Date of Revision:
August 10, 2018
www.pharmascience.com
Submission Control No: 217525
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_pms-SALBUTAMOL Product Monograph Page 2 of 24_
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
...................................................................................................
7
DRUG INTERACTIONS
....................................................................................................
8
DOSAGE AND ADMINISTRATION
................................................................................
9
OVERDOSAGE
................................................................................................................
11
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 11
STORAGE AND STABILITY
.........................................................................................
13
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 13
PART II: SCIENTIFIC INFORMATION
...............................................................................
14
PHARMACEUTICAL INFORMATION
.........................................................................
14
CLINICAL TRIALS
...........................................................................................
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