RATIO-SALBUTAMOL SOLUTION
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
03-07-2013
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Active ingredient:
SALBUTAMOL (SALBUTAMOL SULFATE)
Available from:
TEVA CANADA LIMITED
ATC code:
R03AC02
INN (International Name):
SALBUTAMOL
Dosage:
0.5MG
Pharmaceutical form:
SOLUTION
Composition:
SALBUTAMOL (SALBUTAMOL SULFATE) 0.5MG
Administration route:
INHALATION
Units in package:
2.5ML
Prescription type:
Prescription
Therapeutic area:
SELECTIVE BETA 2-ADRENERGIC AGONISTS
Product summary:
Active ingredient group (AIG) number: 0108887009; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2019-07-09
Summary of Product characteristics
PRODUCT MONOGRAPH
RATIO-SALBUTAMOL
salbutamol sulphate nebules P.F. 1.25MG/2.5 ML, 5.0 MG/2.5 ML AMPOULES
Bronchodilator
(beta
2
-adrenergic stimulant)
TEVA CANADA LIMITED..
30 NOVOPHARM COURT
TORONTO, ONTARIO
CANADA, M1B 2K9
Control: 165512
DATE OF PREPARATION:
JULY 3, 2013
Teva Canada Limited.
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................................................
3
SUMMARY PRODUCT INFORMATION
.............................................................................................................
3
INDICATIONS AND CLINICAL USE
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3
CONTRAINDICATIONS
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3
WARNINGS AND PRECAUTIONS
......................................................................................................................
3
ADVERSE REACTIONS
........................................................................................................................................
7
DRUG INTERACTIONS
.........................................................................................................................................
7
DOSAGE AND ADMINISTRATION
....................................................................................................................
10
OVERDOSAGE
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11
ACTION AND CLINICAL PHARMACOLOGY
...................................................................................................
12
STORAGE AND STABILITY
...............................................................................................................................
13
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................
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