PMS-SALBUTAMOL SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

SALBUTAMOL (SALBUTAMOL SULFATE)

Disponibil de la:

PHARMASCIENCE INC

Codul ATC:

R03AC02

INN (nume internaţional):

SALBUTAMOL

Dozare:

5MG

Forma farmaceutică:

SOLUTION

Compoziție:

SALBUTAMOL (SALBUTAMOL SULFATE) 5MG

Calea de administrare:

INHALATION

Unități în pachet:

10ML

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

SELECTIVE BETA 2-ADRENERGIC AGONISTS

Rezumat produs:

Active ingredient group (AIG) number: 0108887006; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2010-05-04

Caracteristicilor produsului

PRODUCT MONOGRAPH
PR
PMS-SALBUTAMOL
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
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Canada
H4P 2T4
Date of Revision:
August 23, 2016
www.pharmascience.com
Submission Control No: 197457
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_pms-SALBUTAMOL Product Monograph Page 2 of 35_
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
.........................................................................................
13
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 14
PART II: SCIENTIFIC INFORMATION
...............................................................................
15
PHARMACEUTICAL INFORMATION
.........................................................................
15
CLINICAL TRIALS
................................................................................