PHL-SALBUTAMOL RESPIRATOR SOLUTION

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

SALBUTAMOL (SALBUTAMOL SULFATE)

제공처:

PHARMEL INC

ATC 코드:

R03AC02

INN (국제 이름):

SALBUTAMOL

복용량:

2MG

약제 형태:

SOLUTION

구성:

SALBUTAMOL (SALBUTAMOL SULFATE) 2MG

관리 경로:

INHALATION

패키지 단위:

2.5ML(POLYNEBS)

처방전 유형:

Prescription

치료 영역:

SELECTIVE BETA 2-ADRENERGIC AGONISTS

제품 요약:

Active ingredient group (AIG) number: 0108887001; AHFS:

승인 상태:

CANCELLED POST MARKET

승인 날짜:

2016-10-08

제품 특성 요약

PRODUCT MONOGRAPH
PR
PHL-SALBUTAMOL RESPIRATOR SOLUTION
Salbutamol Sulphate Inhalation Solution
0.05%; 0.1%; 0.2%; 0.5%
0.5 mg/mL; 1 mg/mL; 2 mg/mL; 5 mg/mL
BRONCHODILATOR
Beta
2
-adrenergic stimulant
PHARMEL INC.
6111 Royalmount Ave., Suite 100
Montréal, Canada
H4P 2T4
Date of Revision:
October 07, 2016
Submission Control No: 198569
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_phl-SALBUTAMOL RESPIRATOR SOLUTION Product Monograph Page 2 of 36_
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
................................................................................................................
12
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 12
STORAGE AND STABILITY
.........................................................................................
14
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 14
PART II: SCIENTIFIC INFORMATION
...............................................................................
15
PHARMACEUTICAL INFORMATION
.........................................................................
15
CLINICAL TRIALS
...................................................................