PHL-SALBUTAMOL RESPIRATOR SOLUTION

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

SALBUTAMOL (SALBUTAMOL SULFATE)

Prieinama:

PHARMEL INC

ATC kodas:

R03AC02

INN (Tarptautinis Pavadinimas):

SALBUTAMOL

Dozė:

0.5MG

Vaisto forma:

SOLUTION

Sudėtis:

SALBUTAMOL (SALBUTAMOL SULFATE) 0.5MG

Vartojimo būdas:

INHALATION

Vienetai pakuotėje:

2.5ML POLYNEBS

Recepto tipas:

Prescription

Gydymo sritis:

SELECTIVE BETA 2-ADRENERGIC AGONISTS

Produkto santrauka:

Active ingredient group (AIG) number: 0108887009; AHFS:

Autorizacija statusas:

CANCELLED POST MARKET

Leidimo data:

2016-10-08

Prekės savybės

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