TEVA-SALBUTAMOL STERINEBS P.F. 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:

1MG

Pharmaceutical form:

SOLUTION

Composition:

SALBUTAMOL (SALBUTAMOL SULFATE) 1MG

Administration route:

INHALATION

Units in package:

20(2.5ML UNIT DOSES)

Prescription type:

Prescription

Therapeutic area:

SELECTIVE BETA 2-ADRENERGIC AGONISTS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2012-07-05

Summary of Product characteristics

PRODUCT MONOGRAPH
PR
TEVA-SALBUTAMOL STERINEBS
TM P.F.
Salbutamol Sulphate Solution
1 mg / mL (2.5 mg / 2.5 mL) salbutamol per ampoule
2 mg / mL (5 mg / 2.5 mL) salbutamol per ampoule
Bronchodilator
(beta
2
-adrenergic agonist)
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Canada
www.tevacanada.com
Submission Control No: 254982
Date of Revision::
Dec. 21, 2021
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
............................................................................................................
9
DOSAGE
AND
ADMINISTRATION
......................................................................................
10
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
TRIAL