APO-SALBUTAMOL HFA METERED-DOSE AEROSOL

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

SALBUTAMOL (SALBUTAMOL SULFATE)

제공처:

APOTEX INC

ATC 코드:

R03AC02

INN (국제 이름):

SALBUTAMOL

복용량:

100MCG

약제 형태:

METERED-DOSE AEROSOL

구성:

SALBUTAMOL (SALBUTAMOL SULFATE) 100MCG

관리 경로:

INHALATION

패키지 단위:

15G/50G

처방전 유형:

Prescription

치료 영역:

SELECTIVE BETA 2-ADRENERGIC AGONISTS

제품 요약:

Active ingredient group (AIG) number: 0108887003; AHFS:

승인 상태:

APPROVED

승인 날짜:

2019-08-09

제품 특성 요약

_Page 1 of 25_
PRODUCT MONOGRAPH
PR
APO-SALBUTAMOL HFA
salbutamol pressurised inhalation, suspension
Mfr. Std.
100 mcg salbutamol (as salbutamol sulfate) / metered dose
Bronchodilator
(beta
2
-adrenergic agonist)
Apotex Inc.
150 Signet Drive
Toronto, Ontario
Canada M9L 1T9
Date of Revision:
June 25, 2021
Submission Control No.: 252563
_ _
_Page 2 of 25_
_ _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION..........................................................
3
SUMMARY PRODUCT INFORMATION
........................................................................
3
INDICATIONS AND CLINICAL USE
..............................................................................
3
CONTRAINDICATIONS
...................................................................................................
3
WARNINGS AND
PRECAUTIONS..................................................................................
3
ADVERSE REACTIONS
...................................................................................................
6
DRUG INTERACTIONS
....................................................................................................
9
DOSAGE AND ADMINISTRATION
..............................................................................
10
OVERDOSAGE
................................................................................................................
12
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 12
STORAGE AND
STABILITY..........................................................................................
13
SPECIAL HANDLING INSTRUCTIONS
.......................................................................
14
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 14
PART II: SCIENTIFIC INFORMATION
................................................................................
15
PHARMACEUTICAL INFORMATION
.........................................................................
15
CLINICAL TRIALS
..........