PHL-SALBUTAMOL RESPIRATOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

SALBUTAMOL (SALBUTAMOL SULFATE)

Available from:

PHARMEL INC

ATC code:

R03AC02

INN (International Name):

SALBUTAMOL

Dosage:

1MG

Pharmaceutical form:

SOLUTION

Composition:

SALBUTAMOL (SALBUTAMOL SULFATE) 1MG

Administration route:

INHALATION

Units in package:

2.5ML POLYNEBS

Prescription type:

Prescription

Therapeutic area:

SELECTIVE BETA 2-ADRENERGIC AGONISTS

Product summary:

Active ingredient group (AIG) number: 0108887007; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2016-10-08

Summary of Product characteristics

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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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
...................................................................