RATIO-SALBUTAMOL SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

SALBUTAMOL (SALBUTAMOL SULFATE)

Available from:

TEVA CANADA LIMITED

ATC code:

R03AC02

INN (International Name):

SALBUTAMOL

Dosage:

5MG

Pharmaceutical form:

SOLUTION

Composition:

SALBUTAMOL (SALBUTAMOL SULFATE) 5MG

Administration route:

INHALATION

Units in package:

10ML

Prescription type:

Prescription

Therapeutic area:

SELECTIVE BETA 2-ADRENERGIC AGONISTS

Product summary:

Active ingredient group (AIG) number: 0108887006; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2018-05-18

Summary of Product characteristics

Teva Canada Limited.
1/33
PRODUCT MONOGRAPH
RATIO-SALBUTAMOL
salbutamol sulphate respirator solution
5 mg/mL
Bronchodilator
(beta
2
-adrenergic agonist)
Teva Canada Limited.
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9
Control: 182939
DATE OF REVISION:
March 19, 2015
Teva Canada Limited.
2/33
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
......................................................................................
10
OVERDOSAGE
.........................................................................................................................
11
ACTION AND CLINICAL
PHARMACOLOGY.....................................................................
12
STORAGE AND STABILITY
..................................................................................................
13
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................... 14
PART II: SCIENTIFIC INFORMATION
....................................................................................
15
PHARMACEUTICAL INFORMATION
..................................................................................
15
CLINICAL TRIALS
................................................................