PHL-SALBUTAMOL RESPIRATOR SOLUTION

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

SALBUTAMOL (SALBUTAMOL SULFATE)

Dostępny od:

PHARMEL INC

Kod ATC:

R03AC02

INN (International Nazwa):

SALBUTAMOL

Dawkowanie:

2MG

Forma farmaceutyczna:

SOLUTION

Skład:

SALBUTAMOL (SALBUTAMOL SULFATE) 2MG

Droga podania:

INHALATION

Sztuk w opakowaniu:

2.5ML(POLYNEBS)

Typ recepty:

Prescription

Dziedzina terapeutyczna:

SELECTIVE BETA 2-ADRENERGIC AGONISTS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0108887001; AHFS:

Status autoryzacji:

CANCELLED POST MARKET

Data autoryzacji:

2016-10-08

Charakterystyka produktu

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
_ _
_phl-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
...................................................................