PMS-SALBUTAMOL SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

SALBUTAMOL (SALBUTAMOL SULFATE)

Διαθέσιμο από:

PHARMASCIENCE INC

Φαρμακολογική κατηγορία (ATC):

R03AC02

INN (Διεθνής Όνομα):

SALBUTAMOL

Δοσολογία:

5MG

Φαρμακοτεχνική μορφή:

SOLUTION

Σύνθεση:

SALBUTAMOL (SALBUTAMOL SULFATE) 5MG

Οδός χορήγησης:

INHALATION

Μονάδες σε πακέτο:

10ML

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

SELECTIVE BETA 2-ADRENERGIC AGONISTS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2010-05-04

Αρχείο Π.Χ.Π.

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
_ _
_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
................................................................................