TEVA-COMBO STERINEBS SOLUTION

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

SALBUTAMOL (SALBUTAMOL SULFATE); IPRATROPIUM BROMIDE (IPRATROPIUM BROMIDE MONOHYDRATE)

제공처:

TEVA CANADA LIMITED

ATC 코드:

R03AL02

INN (국제 이름):

SALBUTAMOL AND IPRATROPIUM BROMIDE

복용량:

2.5MG; 0.5MG

약제 형태:

SOLUTION

구성:

SALBUTAMOL (SALBUTAMOL SULFATE) 2.5MG; IPRATROPIUM BROMIDE (IPRATROPIUM BROMIDE MONOHYDRATE) 0.5MG

관리 경로:

INHALATION

패키지 단위:

2.5ML

처방전 유형:

Prescription

치료 영역:

ANTIMUSCARINICS ANTISPASMODICS

제품 요약:

Active ingredient group (AIG) number: 0232902001; AHFS:

승인 상태:

APPROVED

승인 날짜:

2009-09-03

제품 특성 요약

PAGE 1 OF 48
PRODUCT MONOGRAPH
Pr
TEVA-COMBO STERINEBS
®
(salbutamol sulphate and ipratropium bromide Nebulizer Solution)
Each Unit Dose Vial (UDV) contains 0.50 mg of ipratropium bromide (as
ipratropium bromide monohydrate) and 2.5 mg salbutamol (as salbutamol
sulphate)
in 2.5 mL of saline
BRONCHODILATOR
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Submission Control No:
191820
Date of Revision:
March 1, 2016
PAGE 2 OF 48
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
................................................................................................................
9
DRUG
INTERACTIONS
...............................................................................................................
15
DOSAGE
AND
ADMINISTRATION
...........................................................................................
16
OVERDOSAGE
.............................................................................................................................
18
ACTION
AND
CLINICAL
PHARMACOLOGY
..........................................................................
18
STORAGE
AND
STABILITY
.......................................................................................................
26
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ...........................................................
26
PART II: SCIENTIFIC INFORMATION
..................................................................................