DOM-SALBUTAMOL RESPIRATOR SOLUTION-1MG/ML

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

SALBUTAMOL (SALBUTAMOL SULFATE)

Dostupné z:

DOMINION PHARMACAL

ATC kód:

R03AC02

INN (Medzinárodný Name):

SALBUTAMOL

Dávkovanie:

1MG

Forma lieku:

SOLUTION

Zloženie:

SALBUTAMOL (SALBUTAMOL SULFATE) 1MG

Spôsob podávania:

INHALATION

Počet v balení:

2.5ML

Typ predpisu:

Prescription

Terapeutické oblasti:

SELECTIVE BETA 2-ADRENERGIC AGONISTS

Prehľad produktov:

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

Stav Autorizácia:

MARKETED

Dátum Autorizácia:

1997-05-16

Súhrn charakteristických

PRODUCT MONOGRAPH
PR
DOM-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
DOMINION PHARMACAL
6111 Royalmount Ave., Suite 100
Montréal, Canada
H4P 2T4
Date of Revision:
02 November, 2016
Submission Control No: 198847
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_Dom-SALBUTAMOL RESPIRATOR SOLUTION Product Monograph Page 2 of 36_
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
.....................................................................................................
16
DET