APO-SALVENT 5MG/ML SOLUTION
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
16-03-2020
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Active ingredient:
SALBUTAMOL (SALBUTAMOL SULFATE)
Available from:
APOTEX INC
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:
APPROVED
Authorization date:
1993-08-11
Summary of Product characteristics
_Page 1 of 32_
PRODUCT MONOGRAPH
PR
APO-SALVENT RESPIRATOR SOLUTIONS
(SALBUTAMOL SULFATE SOLUTIONS BP)
PR
APO-SALVENT RESPIRATOR SOLUTION 50 MG IN 10 ML (5 MG/ML SALBUTAMOL)
PR
APO-SALVENT STERULES 1.25 MG IN 2.5 ML (0.5 MG/ML SALBUTAMOL)
PR
APO-SALVENT STERULES 2.5 MG IN 2.5 ML (1 MG/ML SALBUTAMOL)
PR
APO-SALVENT STERULES 5.0 MG IN 2.5 ML (2 MG/ML SALBUTAMOL)
BRONCHODILATOR,
Β
2
-ADRENERGIC STIMULANT
APOTEX INC.
150 SIGNET DRIVE
TORONTO, ONTARIO
DATE OF REVISION:
M9L 1T9
March 16, 2020
CONTROL # 236795
_Page 2 of 32_
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
..........................................................................................................................................................
12
ACTION AND CLINICAL PHARMACOLOGY
......................................................................................
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